Point Roberts, WA, LINCOLNSHIRE, Ill – July 15, 2011 –(Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals, as industry buzz builds on talk of partners or acquisition with value up to $1 Billion.
As BioSante's lead product LibiGel ® (transdermal testosterone gel), for the treatment of female sexual dysfunction gets closer to market, the company is now on the radar as a biotech company to watch.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, there is an old saying in the market, that the trading tells the story. The activity and interest in your stock is building from both analysts and retail investors. Can you give us some insight to the key points of the recent analyst coverage and what the industry is saying about your company?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We have been in development of LibiGel for quite a number of years. Finally the finish line is in site. We have completed enrollment of women into our three LibiGel Phase III clinical studies and efficacy data should be available in the fourth quarter of this year. Safety data should be available in the third quarter of 2012 and our objective is to submit the LibiGel new drug application (NDA) to the FDA in the fourth quarter of 2012. All of these dates are near-term opportunities in the biotech/pharma world. Analysts and investors are taking note of the progress we have made with LibiGel.
Q: Investorideas.com
Can you discuss the potential dollar value for a female sexual dysfunction drug hitting the market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market for a drug for female sexual dysfunction is potentially bigger than the market for erectile dysfunction drugs, a $2 billion market if the U.S., and male testosterone, a $1.3 billion market in the U.S. Our belief is based on current off-label use of products to treat female sexual dysfunction as well as publications that indicate the potential size of the market for treatment of female sexual dysfunction. It has been over 13 years since Viagra was approved and we believe strongly that women deserve an FDA-approved therapeutic choice for their sexual health issues.
Q: Investorideas.com
With LibiGel ® getting closer to market, how will the process of potential partners or acquisition play out in the pharma industry?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our focus is on completing the LibiGel Phase III clinical work and submitting an NDA in 2012. Our LibiGel partnering strategy from the beginning has been and remains to develop LibiGel as far as we can since we believe the best way to maximize our stockholder value is to bring LibiGel to the latest stage of product development and regulatory status possible. Although we would entertain a license/partnership at this time, we believe the value of LibiGel will increase as new efficacy and safety data become available and these data will be available beginning in the coming months.
Q: Investorideas.com
With other players abandoning the female sexual dysfunction market, your company stayed through the long process and is now postured to be first to market. How significant is it that you have no current competition?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Assuming positive safety and efficacy data, we believe LibiGel will be the first product approved by the FDA for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder. In our primary market research with prescribing physicians, they tell us that there is a great need for an FDA-approved product and that they are dissatisfied with their choices for off-label use. If and when LibiGel is approved we believe it will be a very successful product and result in a very attractive choice for prescribers and women in need, and continued increasing value for our stockholders.
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued 4,000 women-years of exposure. The study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the second half of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Friday, July 15, 2011
Tuesday, July 12, 2011
Biotech/Pharma Trading News Alert for BioSante (NASDAQ: BPAX); Leerink Swann Initiates Analyst Coverage with $6.00 per share Fair Value
Point Roberts, WA, LINCOLNSHIRE, Ill - July 12, 2011 - Investorideas.com, a leader in sector stock research for independent investors , issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for July 11 th. The stock traded as high as $3.90 on over 9 Million shares.
The stock has reached a new 52 week high following coverage from Leerink Swann, initiating an outperform rating and a $6 fair value estimate in 12 months.
Research Coverage:Leerlink Swann (http://www.leerink.com/equity-research.aspx)
Excerpt:
"We estimate there are 1.5MM women with HSDD due to surgically induced menopause and 5MM naturally postmenopausal women with HSDD. According to the Centers for Disease Control (CDC), ~500,000 women in the U.S. undergo oophorectomy per year, adding to a pool of ~10MM women without ovaries, 15% of which have HSDD, according to specialists we spoke to. Similarly, we estimate that 10% of the ~50MM naturally postmenopausal women above the age of 50 have HSDD.
Competitive landscape favorable, with no other product candidates in Phase III. There is no pharmaceutical product currently approved in the U.S. for FSD, specifically HSDD, and we are not aware of any other product for the treatment of HSDD in active Phase III clinical development in the U.S."
The report also made the following valuation on BPAX
"We estimate a ~$6 per share fair value for BPAX in 12 months representing a $740MM market capitalization, using a discounted cash flow (DCF) valuation methodology. We use a 12% WACC as our discount rate since the risks involved with drug development and regulatory approval have been handicapped by probability-weighting our free-cash-flow assumptions. We assume an 80% probability of BPAX obtaining approval for LibiGel with the HSDD in surgically menopausal women label and a 70% probability to obtain approval with the HSDD in naturally menopausal women label with patent expiration in 2026. Our per share valuation is based on the fully diluted share count, and accounts for currently outstanding options to purchase 5.4MM shares of common stock, and warrants to purchase 23.7MM shares of common stock."
More info on Leerlink Swann: http://www.leerink.com/equity-research.aspx
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
The research report and note are property of the sponsoring investment firm, not BioSante, and contain opinions, conclusions and/or forecasts that are not necessarily those of BioSante. BioSante does not in any way endorse or ratify the contents contained in the report and note.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
The stock has reached a new 52 week high following coverage from Leerink Swann, initiating an outperform rating and a $6 fair value estimate in 12 months.
Research Coverage:Leerlink Swann (http://www.leerink.com/equity-research.aspx) Excerpt:
"We estimate there are 1.5MM women with HSDD due to surgically induced menopause and 5MM naturally postmenopausal women with HSDD. According to the Centers for Disease Control (CDC), ~500,000 women in the U.S. undergo oophorectomy per year, adding to a pool of ~10MM women without ovaries, 15% of which have HSDD, according to specialists we spoke to. Similarly, we estimate that 10% of the ~50MM naturally postmenopausal women above the age of 50 have HSDD.
Competitive landscape favorable, with no other product candidates in Phase III. There is no pharmaceutical product currently approved in the U.S. for FSD, specifically HSDD, and we are not aware of any other product for the treatment of HSDD in active Phase III clinical development in the U.S."
The report also made the following valuation on BPAX
"We estimate a ~$6 per share fair value for BPAX in 12 months representing a $740MM market capitalization, using a discounted cash flow (DCF) valuation methodology. We use a 12% WACC as our discount rate since the risks involved with drug development and regulatory approval have been handicapped by probability-weighting our free-cash-flow assumptions. We assume an 80% probability of BPAX obtaining approval for LibiGel with the HSDD in surgically menopausal women label and a 70% probability to obtain approval with the HSDD in naturally menopausal women label with patent expiration in 2026. Our per share valuation is based on the fully diluted share count, and accounts for currently outstanding options to purchase 5.4MM shares of common stock, and warrants to purchase 23.7MM shares of common stock."
More info on Leerlink Swann: http://www.leerink.com/equity-research.aspx
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
The research report and note are property of the sponsoring investment firm, not BioSante, and contain opinions, conclusions and/or forecasts that are not necessarily those of BioSante. BioSante does not in any way endorse or ratify the contents contained in the report and note.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
Friday, July 8, 2011
Biotech/Pharma Investor Trading News Alert and Stock Chart for BioSante (NASDAQ: BPAX)
Point Roberts, WA, LINCOLNSHIRE, Ill – July 8, 2011 – Investorideas.com, a leader in sector stock research for independent investors, issues a trading alert and 5-day stock chart for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). The stock has reached as high as $3.20 following its latest news of completing Phase III Safety Study for Biosante’s flagship product LibiGel®.
Recent 5-Day Chart for BPAX
Recent News/Commentary:
Biotech/ Pharma Stocks Battle for the Sexual Health Market: BioSante Pharmaceuticals, (NASDAQ: BPAX), Pfizer (NYSE: PFE), Tea Pharmaceutical (Nasdaq: TEVA), Watson (NYSE: WPI) "POINT ROBERTS, WA- - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features a sector snapshot of biotech/pharma stocks in the sexual dysfunction and sexual health markets.
The competition is heating up in the men's sexual dysfunction market for Pfizer's Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX - News), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc is battling it out in court with Teva Pharmaceutical and Watson Pharmaceuticals for generic versions of Viagra. Teva has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires. More info http://www.fiercepharma.com/story/ pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13 "
Full News at: http://www.investorideas.com/CO/ BPAX/news/2011/06271.asp
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
The full BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
Recent 5-Day Chart for BPAX
Recent News/Commentary: Biotech/ Pharma Stocks Battle for the Sexual Health Market: BioSante Pharmaceuticals, (NASDAQ: BPAX), Pfizer (NYSE: PFE), Tea Pharmaceutical (Nasdaq: TEVA), Watson (NYSE: WPI) "POINT ROBERTS, WA- - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features a sector snapshot of biotech/pharma stocks in the sexual dysfunction and sexual health markets.
The competition is heating up in the men's sexual dysfunction market for Pfizer's Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX - News), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc is battling it out in court with Teva Pharmaceutical and Watson Pharmaceuticals for generic versions of Viagra. Teva has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires. More info http://www.fiercepharma.com/story/ pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13 "
Full News at: http://www.investorideas.com/CO/ BPAX/news/2011/06271.asp
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Wednesday, July 6, 2011
Biotech/Pharma Stocks Investor Alert: AEMD, ZLCS, INO, VVUS, CYTR
Point Roberts, WA - July 6, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for July 5, 2011. The NASDAQ Biotech Stock Index closed at 1,123.61, up 3.05. The AMEX Biotech Index (^BTK) closed up at 1,478.30, up 1.16 (0.08%).
Biotech/Pharma Sector Snapshot Trading July 5 th
Aethlon Medical (OTCBB: AEMD) traded higher by 0.0022 (2.51%) to $0.090. More than 414K shares traded hands, compared to its average volume of 245K shares.
Zalicus, Inc. (NASDAQ:ZLCS) was one of the biggest gainer among the biotech companies and soared 12.88% after analyst at Oppenheimer & Co. analyst initiated a coverage on the stock with an "Outperform" rating.
Inovio Pharmaceuticals, Inc. (AMEX:INO) shares also climbed 8.20% after the company said that its SynCon DNA vaccine against HIV, which was published in two different scientific journals, showed that the vaccine protected against the disease in non-human primates.
VIVUS, Inc. (NASDAQ:VVUS) climbed 4.33% to $8.43 on high volume. On July 03, the company said a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED).
CytRx Corporation (NASDAQ:CYTR) added 4.41% to $0.71 following the company said that the U.S. Food and Drug Administration (FDA) has granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas.
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
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At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC (OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock) Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Biotech/Pharma Sector Snapshot Trading July 5 th
Aethlon Medical (OTCBB: AEMD) traded higher by 0.0022 (2.51%) to $0.090. More than 414K shares traded hands, compared to its average volume of 245K shares.
Zalicus, Inc. (NASDAQ:ZLCS) was one of the biggest gainer among the biotech companies and soared 12.88% after analyst at Oppenheimer & Co. analyst initiated a coverage on the stock with an "Outperform" rating.
Inovio Pharmaceuticals, Inc. (AMEX:INO) shares also climbed 8.20% after the company said that its SynCon DNA vaccine against HIV, which was published in two different scientific journals, showed that the vaccine protected against the disease in non-human primates.
VIVUS, Inc. (NASDAQ:VVUS) climbed 4.33% to $8.43 on high volume. On July 03, the company said a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED).
CytRx Corporation (NASDAQ:CYTR) added 4.41% to $0.71 following the company said that the U.S. Food and Drug Administration (FDA) has granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas.
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the AEMD showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
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At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC (OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock) Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
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Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Tuesday, June 28, 2011
Q&A with Aethlon Medical (OTCBB: AEMD) CEO, Jim Joyce; The Potential for the Hemopurifier® Medical Device in Cancer Immunotherapy
Point Roberts, WA. June 28, 2011 – Investorideas.com, a leader in sector stock research presents a new interview in its series of biotech Q&A’s, featuring Jim Joyce, CEO of Aethlon Medical (OTCBB: AEMD), discussing how the Hemopurifier® medical device can be used in Cancer Immunotherapy treatment.
Q&A Interview
Q: InvestorIdeas.com
Jim, can you begin by explaining to investors the theory behind Cancer Immunotherapy and the various approaches and methods within it?
The basis of cancer immunotherapy is the reality that patient survival is primarily determined by the immune system’s ability to recognize and respond to cancer. So instead of attacking cancer directly with traditional drugs, immunotherapeutic strategies aim to increase immune cell activation or improve the capability of immune cells to identify and attack cancer.
Q: InvestorIdeas.com
Can you explain to investors how the Hemopurifier® medical device approach differentiates from using drugs as a treatment and how it could potentially impact results? And potentially would there be less side effects to deal with?
In cancer care, the purpose of our Hemopurifier® is to shield immune cells from particles released by tumors to accelerate cancer proliferation. These particles, known as exosomes, trigger the death of immune cells that are needed to combat cancer. In later-stage cancers, exosomes can snowball to massive levels in the circulatory system. By selectively removing these exosomes from circulation, we envision our Hemopurifier® will preserve immune function and unlock the capabilities of both traditional and evolving immunotherapeutic drug strategies. And, as a medical device, oncologists should appreciate a technology that can be combined with other treatments without adding additional drug toxicity or interaction risks. We believe our Hemopurifier® represents the sole therapeutic strategy to address cancer-enhancing exosomes.
Q: InvestorIdeas.com
Can you give investors some examples of publicly traded stocks in the Cancer Immunotherapy treatment market?
I would start by looking at organizations that have already advanced cancer immunotherapy drugs into the marketplace. This would include Dendreon (NASDAQ:DNDN) and Bristol-Meyers Squibb (NYSE:BMY). Companies with candidate drugs in the clinical pipeline include Roche (OTCPK:RHHBY) and GlaxoSmithKline (NYSE:GSK).
Q: InvestorIdeas.com
Can you also give us an overview of other key markets and applications for the Hemopurifier® and where do you see your biggest markets down the road?
In addition to capturing exosomes, our Hemopurifier® has demonstrated broad-spectrum activity against infectious viral pathogens. We are currently conducting a clinical program to demonstrate the ability of our Hemopurifier® to improve outcomes of Hepatitis C infected patients who initiate current standard of care drug therapy. This market opportunity consists of approximately 170 million infected individuals worldwide.
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
From the Company:
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit www.aethlonmedical.com.
Contact:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC (OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock) Effective March 15, 2011
800-665-0411 – dvanzant@investorideas.com
Source - Investorideas.com
Monday, June 27, 2011
Biotech/ Pharma Stocks Battle for the Sexual Health Market: BioSante Pharmaceuticals, (NASDAQ: BPAX), Pfizer (NYSE: PFE), Teva Pharmaceutical (Nasdaq: TEVA), Watson (NYSE: WPI)
Point Roberts, WA - June 27th, 2011 - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features a sector snapshot of biotech/ pharma stocks in the sexual dysfunction and sexual health markets.
The competition is heating up in the men's sexual dysfunction market for Pfizer (NYSE: PFE)'s Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc (NYSE: PFE) is battling it out in court with Teva Pharmaceutical (Nasdaq: TEVA) and Watson Pharmaceuticals (NYSE: WPI) for generic versions of Viagra. Teva (NASDAQ: TEVA) has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires.
More info http://www.fiercepharma.com/story/pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13
Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals (NASDAQ: BPAX), recently commented in an Investorideas.com interview, “We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.”
http://www.investorideas.com/news/2011/main/06073.asp
Investor Spotlight forBioSante Pharmaceuticals (NASDAQ: BPAX) :
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. www.biosantepharma.com.
Recent News for LibiGel Product: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
LINCOLNSHIRE , Ill. - May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
Updates from the LibiGel Brochure:
Progress and Plans in Phase III: Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials, which are underway and have completed enrollment of subjects, are randomized, double-blind, placebocontrolled trials of over 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway and in which enrollment of subjects is complete. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of approximately 3,600 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, BioSante intends to submit a LibiGel NDA for review and potential approval by FDA by the end of 2012.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in 3,550 women enrolled comprising approximately 3,800 women-years of exposure, there have been only 22 adjudicated cardiovascular events, even though the safety study has enrolled women with a higher risk of cardiovascular events. Enrollment in the LibiGel safety study is complete at approximately 3,600 subjects
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.com
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Sign up for the free investor news letter and get stock alerts in leading sectors! http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com 800 665 0411 cvanzant@investorideas.com
The competition is heating up in the men's sexual dysfunction market for Pfizer (NYSE: PFE)'s Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc (NYSE: PFE) is battling it out in court with Teva Pharmaceutical (Nasdaq: TEVA) and Watson Pharmaceuticals (NYSE: WPI) for generic versions of Viagra. Teva (NASDAQ: TEVA) has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires.
More info http://www.fiercepharma.com/story/pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13
Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals (NASDAQ: BPAX), recently commented in an Investorideas.com interview, “We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.”
http://www.investorideas.com/news/2011/main/06073.asp
Investor Spotlight forBioSante Pharmaceuticals (NASDAQ: BPAX) :
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. www.biosantepharma.com.
Recent News for LibiGel Product: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
LINCOLNSHIRE , Ill. - May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
Updates from the LibiGel Brochure:
Progress and Plans in Phase III: Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials, which are underway and have completed enrollment of subjects, are randomized, double-blind, placebocontrolled trials of over 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway and in which enrollment of subjects is complete. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of approximately 3,600 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, BioSante intends to submit a LibiGel NDA for review and potential approval by FDA by the end of 2012.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in 3,550 women enrolled comprising approximately 3,800 women-years of exposure, there have been only 22 adjudicated cardiovascular events, even though the safety study has enrolled women with a higher risk of cardiovascular events. Enrollment in the LibiGel safety study is complete at approximately 3,600 subjects
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.com
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Sign up for the free investor news letter and get stock alerts in leading sectors! http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com 800 665 0411 cvanzant@investorideas.com
Friday, June 17, 2011
Biotech/Pharma Stocks; (OTCBB: AEMD), (NYSE: BMY ), (NasdaqGS: DNDN , (NYSE: GSK ) Take A New Approach to Cancer
Biotech/Pharma Stocks; (OTCBB: AEMD), (NYSE: BMY ), (NasdaqGS: DNDN , (NYSE: GSK ) Take A New Approach to Cancer
Cancer Immunotherapy Advances Hold New Hope
Point Roberts, WA- June 17, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, reports on advances in Cancer Immunotherapy featuring Aethlon Medical (OTCBB: AEMD), Bristol-Myers Squibb Company (NYSE: BMY ) ,Dendreon Corporation (NasdaqGS: DNDN ) and GlaxoSmithKline (NYSE: GSK ).
Immunotherapy is a treatment that uses the patient’s body immune system to help fight cancer. According to the American Cancer Society, “This can be done in a couple of ways:
stimulating your own immune system to work harder or smarter, or giving you immune system components, such as man-made immune system proteins. “
Biotech/Pharma Sector Snapshot Trading as of Close June 16th
Aethlon Medical (OTCBB: AEMD) closed at $0.10
Bristol-Myers Squibb Company (NYSE: BMY ) closed at $27.47,up 0.05 (0.18%
Dendreon Corporation (NasdaqGS: DNDN ) ended trading at $38.99, up 0.21 (0.54%), followed by additional gains in after hours trading.
GlaxoSmithKline (NYSE: GSK ) closed at $41.18
Aethlon Medical (OTCBB: AEMD) uses technology instead of drugs to help the patient’s immune system. The Hemopurifier®, the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. The company has discovered that the Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer.
Dendreon Corporation (NasdaqGS: DNDN ) was the first to receive FDA approval for its
PROVENGE® (sipuleucel-T) immune cell treatment of cancer. According to the company, it is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to induce an immune response against prostate cancer.
Bristol-Myers Squibb Company (NYSE: BMY ) has (FDA) approval for YERVOY™ (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma. YERVOY is the first and only therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase 3 study. Median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY, 6 months (95% CI: 5.5-8.7) for gp100 and 10 months (95% CI: 8.5-11.5) for YERVOY + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for YERVOY and 0.0004 for YERVOY + gp100 vs. gp100, respectively. As published in the New England Journal of Medicine, the Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%2 (95% CI: 8.0, 20.0) in the gp100 arm. YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4).
Full News: http://www.investorideas.com/news/2011/main/03281.asp
GlaxoSmithKline (NYSE: GSK ) MAGE-A3 ASCI (Antigen-Specific Cancer Immunotherapeutic)
Is targeting melanoma and lung cancer.
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, 200,000 144 shares )
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
More Investorideas Biotech Stocks info wwww.BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks, Biotech, Pharma and Industry News and Biotech Investor Research Tools including a Biotech Stocks Directory Biotech Companies - become a biotech showcase stock on www.investorideas.com and www.biotechindustrystocks.com for as little as $1000 month !
Cancer Immunotherapy Advances Hold New Hope
Point Roberts, WA- June 17, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, reports on advances in Cancer Immunotherapy featuring Aethlon Medical (OTCBB: AEMD), Bristol-Myers Squibb Company (NYSE: BMY ) ,Dendreon Corporation (NasdaqGS: DNDN ) and GlaxoSmithKline (NYSE: GSK ).
Immunotherapy is a treatment that uses the patient’s body immune system to help fight cancer. According to the American Cancer Society, “This can be done in a couple of ways:
stimulating your own immune system to work harder or smarter, or giving you immune system components, such as man-made immune system proteins. “
Biotech/Pharma Sector Snapshot Trading as of Close June 16th
Aethlon Medical (OTCBB: AEMD) closed at $0.10
Bristol-Myers Squibb Company (NYSE: BMY ) closed at $27.47,up 0.05 (0.18%
Dendreon Corporation (NasdaqGS: DNDN ) ended trading at $38.99, up 0.21 (0.54%), followed by additional gains in after hours trading.
GlaxoSmithKline (NYSE: GSK ) closed at $41.18
Aethlon Medical (OTCBB: AEMD) uses technology instead of drugs to help the patient’s immune system. The Hemopurifier®, the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. The company has discovered that the Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer.
Dendreon Corporation (NasdaqGS: DNDN ) was the first to receive FDA approval for its
PROVENGE® (sipuleucel-T) immune cell treatment of cancer. According to the company, it is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to induce an immune response against prostate cancer.
Bristol-Myers Squibb Company (NYSE: BMY ) has (FDA) approval for YERVOY™ (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma. YERVOY is the first and only therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase 3 study. Median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY, 6 months (95% CI: 5.5-8.7) for gp100 and 10 months (95% CI: 8.5-11.5) for YERVOY + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for YERVOY and 0.0004 for YERVOY + gp100 vs. gp100, respectively. As published in the New England Journal of Medicine, the Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%2 (95% CI: 8.0, 20.0) in the gp100 arm. YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4).
Full News: http://www.investorideas.com/news/2011/main/03281.asp
GlaxoSmithKline (NYSE: GSK ) MAGE-A3 ASCI (Antigen-Specific Cancer Immunotherapeutic)
Is targeting melanoma and lung cancer.
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, 200,000 144 shares )
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
More Investorideas Biotech Stocks info wwww.BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks, Biotech, Pharma and Industry News and Biotech Investor Research Tools including a Biotech Stocks Directory Biotech Companies - become a biotech showcase stock on www.investorideas.com and www.biotechindustrystocks.com for as little as $1000 month !
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