POINT ROBERTS, Wash., May 5, 2011 - www.InvestorIdeas.com, a leader in investor research including biotech and stem cell stocks, issues the company profile for stem cell company, Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) for investors following the sector.
About Vitro Diagnostics, Inc. (OTCQB: VODG)
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) (http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development™", including human mesenchymal stem cells and derivatives, optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix®, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute Lumenesc™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.
Recent News;
Stem Cell Stock Vitro (OTCQB: VODG) Announces Progress in the Achievement of Profitability
Revenue Increase Due to Licensing Fertility Drug Patents, Products and Technology
GOLDEN, Colo. - May 3, 2011 (Investorideas.com Newswire) - Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced progress and achievement of key financial goals in the transformation of the Company from a research operation to a profitable commercial operation with sustained earnings growth. Income was recently increased by $200,000 through license fees obtained by licensing our fertility drug patents, products and technology. This infertility treatment technology was developed previously and is no longer a primary operational goal as the Company is now focused on commercialization of stem cell products and technology. Thus, the recent license of this intellectual property allows the Company to monetize previously written-off assets through income from license fees and potential sales royalties while also pursuing additional product revenues through sales of its stem cell products.
Full News: http://www.investorideas.com/CO/VODG/news/2011/05031.asp
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Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising .
Disclosure: VODG is a paid showcase stem cell stock on Investorideas.com (one month $1000)
www.InvestorIdeas.com/About/Disclaimer.asp
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company and its subsidiary companies. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors.
www.Investorideas.com
Dawn Van Zant: 800-665-0411 - dvanzant@investorideas.com
Source - Investorideas.com
Thursday, May 5, 2011
Wednesday, May 4, 2011
Biotech and Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at JMP Securities Research Conference
LINCOLNSHIRE, Ill. - May 4, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will be presenting at The JMP Securities Tenth Annual Research Conference. The event will take place from May 9, through May 11, 2011, at The Ritz-Carlton, San Francisco.
Stephen M. Simes, BioSante's president & CEO, will speak on May 9, 2011 at 3:00 PM PT. He will provide an overview of the company, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program. A live audio webcast of Mr. Simes' remarks may be accessed at: http://www.wsw.com/webcast/jmp13/bpa/. The webcast will be archived approximately three hours after the live event and will be available for 90 days.
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. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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," "potential," "could," "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 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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Stephen M. Simes, BioSante's president & CEO, will speak on May 9, 2011 at 3:00 PM PT. He will provide an overview of the company, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program. A live audio webcast of Mr. Simes' remarks may be accessed at: http://www.wsw.com/webcast/jmp13/bpa/. The webcast will be archived approximately three hours after the live event and will be available for 90 days.
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. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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," "potential," "could," "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 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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Tuesday, May 3, 2011
Stem Cell Stock Vitro (OTCQB: VODG) Announces Progress in the Achievement of Profitability
GOLDEN, Colo. � May 3, 2011 (Investorideas.com Newswire) - Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced progress and achievement of key financial goals in the transformation of the Company from a research operation to a profitable commercial operation with sustained earnings growth. Income was recently increased by $200,000 through license fees obtained by licensing our fertility drug patents, products and technology. This infertility treatment technology was developed previously and is no longer a primary operational goal as the Company is now focused on commercialization of stem cell products and technology. Thus, the recent license of this intellectual property allows the Company to monetize previously written-off assets through income from license fees and potential sales royalties while also pursuing additional product revenues through sales of its stem cell products.
Vitro's stem cell products provide key tools needed to expand emerging stem cell technology into viable clinical products to treat a vast array of conditions resulting from cellular degeneration or injury, such as heart disease, stroke and Alzheimer's disease. The Company's products include cell culture media used to expand and differentiate stem cells prior to transplantation and in research applications. This market alone is estimated to be $1.2 billion in 2015 1. A leading global stem cell company and prospective customer has recently reported superior performance of one of the Company's media products in an extensive comparison with competing products. Sales of stem cell media is a primary focus for accelerated revenue generation. Our distribution and marketing plan currently targets select distributors together with direct sales to key accounts representing substantial sales volume. We are now in discussions and product evaluations with distributors and key initial accounts. Numerous studies by the Company and other independent groups have shown strong competitive advantages of the Company's stem cell media. We intend to leverage our highly competitive media products into aggressive penetration of this emerging market. Management projects achievement of profitable operations by the end of its current fiscal year (10-31-11) or sooner.
To sustain future revenues and earnings growth, the Company intends to expand and improve its current product offering of tools for stem cell research and is now developing clinical grade products to support clinical trials and eventual therapeutic applications of stem cells. Furthermore, the Company intends to identify synergistic M&A candidates with existing product sales and profits to provide rapid growth of revenue and earnings. Early stage discussions are now underway with a privately held stem cell firm regarding a business combination with the Company.
Current liabilities have also been reduced by $250,000, through fees obtained from recent patent out-licenses and debt refinancing activities. Operating expenses have also been reduced by approximately $100,000 (37%) per year through debt service expense reduction, reduction of interest expenses, and executive salary reduction. These activities enable a more rapid turn-around and improve shareholder's equity.
About Vitro Diagnostics, Inc.
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) (http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development™", including human mesenchymal stem cells and derivatives, optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix�, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute Lumenesc™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.
1. Market research data provided by BCC Research.
Contact:
Vitro Diagnostics, Inc.
Dr. James Musick, 303-999-2130
Chief Executive Officer
jim@vitrodiag.com
Vitro's stem cell products provide key tools needed to expand emerging stem cell technology into viable clinical products to treat a vast array of conditions resulting from cellular degeneration or injury, such as heart disease, stroke and Alzheimer's disease. The Company's products include cell culture media used to expand and differentiate stem cells prior to transplantation and in research applications. This market alone is estimated to be $1.2 billion in 2015 1. A leading global stem cell company and prospective customer has recently reported superior performance of one of the Company's media products in an extensive comparison with competing products. Sales of stem cell media is a primary focus for accelerated revenue generation. Our distribution and marketing plan currently targets select distributors together with direct sales to key accounts representing substantial sales volume. We are now in discussions and product evaluations with distributors and key initial accounts. Numerous studies by the Company and other independent groups have shown strong competitive advantages of the Company's stem cell media. We intend to leverage our highly competitive media products into aggressive penetration of this emerging market. Management projects achievement of profitable operations by the end of its current fiscal year (10-31-11) or sooner.
To sustain future revenues and earnings growth, the Company intends to expand and improve its current product offering of tools for stem cell research and is now developing clinical grade products to support clinical trials and eventual therapeutic applications of stem cells. Furthermore, the Company intends to identify synergistic M&A candidates with existing product sales and profits to provide rapid growth of revenue and earnings. Early stage discussions are now underway with a privately held stem cell firm regarding a business combination with the Company.
Current liabilities have also been reduced by $250,000, through fees obtained from recent patent out-licenses and debt refinancing activities. Operating expenses have also been reduced by approximately $100,000 (37%) per year through debt service expense reduction, reduction of interest expenses, and executive salary reduction. These activities enable a more rapid turn-around and improve shareholder's equity.
About Vitro Diagnostics, Inc.
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) (http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development™", including human mesenchymal stem cells and derivatives, optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix�, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute Lumenesc™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.
1. Market research data provided by BCC Research.
Contact:
Vitro Diagnostics, Inc.
Dr. James Musick, 303-999-2130
Chief Executive Officer
jim@vitrodiag.com
Biotech and Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Paving the Way for Sexual Equality for Women!
Point Roberts WA, LINCOLNSHIRE, Ill. May 3, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive discussion with Mr. Stephen M. Simes, president and chief executive officer of specialty pharmaceutical company, BioSante Pharmaceuticals ( NASDAQ: BPAX ) . Mr. Simes discusses how their product LibiGel ®, (testosterone gel) for the treatment of female sexual dysfunction, paves the way for women's equality in the sexual dysfunction market, currently dominated by male products.
Women always have had to wait for their rights; from the right to vote, to equal pay and now in the treatment of sexual health matters. Stephen M. Simes discusses his personal and corporate commitment to women's health, and BioSante's objective to be first to market with a pharmaceutical product to treat women's sexual health.
In an interesting perspective from a male CEO bringing his product to market for women, Mr. Simes passionately explains the problem and the solution (LibiGel ®) that is coming to market in the not so distant future. Interestingly, BioSante's vice president of clinical development in charge of LibiGel's clinical studies is a woman!
Sexual Equality for Women!
Why is there no biotech or pharmaceutical product for the treatment of female sexual dysfunction?
By Stephen M. Simes
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Men have enjoyed access to Viagra and other erectile drugs for over 13 years.
For women, specifically women suffering from hypoactive sexual desire disorder (HSDD), product development has been notably lacking. Today in the United States there is no FDA approved pharmaceutical product for the treatment of HSDD.
Yet HSDD - lack of sexual desire - affects an untold number of women. It is more common than erectile dysfunction in men - which is a $2 billion a year prescription business in the US.
In a study by investigators the University of Chicago, of 1,400 men and 1,700 women between the ages of 18 and 59, 43% of women said they have experienced some degree of sexual dysfunction, compared with just 31% of men. Among the women surveyed, 32% lacked interest in sex. Another study by the same group at the University also found that 43% of American women between the ages of 57 and 85 (about 40 million) experience some degree of low sexual desire.
The majority of women with female sexual dysfunction (FSD) are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
Today, there is only one company in the world in active clinical development of a product for this true unmet medical need in women. The company in development of a product is BioSante Pharmaceuticals Inc., in Lincolnshire, Illinois. The product is a transdermal testosterone gel (LibiGel ®). LibiGel currently is in Phase III clinical studies for the treatment of HSDD in post-menopausal women. The LibiGel Phase III clinical development program includes two traditional pivotal Phase III randomized, placebo-controlled, multi-center, safety and efficacy trials, both of which are covered by an FDA SPA (special protocol assessment).
In addition, BioSante is conducting a LibiGel Phase III randomized, placebo controlled, multi-center, cardiovascular event and breast cancer safety study. Over 3,000 of a potential 4,000 women have been enrolled in the study and randomized to LibiGel or placebo. This LibiGel safety study represents the largest database of the safety of testosterone in women ever. To date, the cardiovascular event and breast cancer event rates in the study are lower than predicted. BioSante plans on submitting a new drug application (NDA) to FDA seeking approval for LibiGel by the end of 2012.
LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
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.
BioSante is committed to the success of LibiGel and to women's health. The time for equal treatment of men's and women's sexuality is here. Practitioners and women are waiting for solutions.
- Stephen M. Simes is president and CEO of BioSante Pharmaceuticals Inc. (http://www.biosantepharma.com), Lincolnshire, IL.
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) 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. 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 with a PDUFA date of November 14, 2011, 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.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
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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.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (two thousand per month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 and other statements identified by words such as “will,” “potential,” “could,” “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 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.
Contact Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Women always have had to wait for their rights; from the right to vote, to equal pay and now in the treatment of sexual health matters. Stephen M. Simes discusses his personal and corporate commitment to women's health, and BioSante's objective to be first to market with a pharmaceutical product to treat women's sexual health.
In an interesting perspective from a male CEO bringing his product to market for women, Mr. Simes passionately explains the problem and the solution (LibiGel ®) that is coming to market in the not so distant future. Interestingly, BioSante's vice president of clinical development in charge of LibiGel's clinical studies is a woman!
Sexual Equality for Women!
Why is there no biotech or pharmaceutical product for the treatment of female sexual dysfunction?
By Stephen M. Simes
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Men have enjoyed access to Viagra and other erectile drugs for over 13 years.
For women, specifically women suffering from hypoactive sexual desire disorder (HSDD), product development has been notably lacking. Today in the United States there is no FDA approved pharmaceutical product for the treatment of HSDD.
Yet HSDD - lack of sexual desire - affects an untold number of women. It is more common than erectile dysfunction in men - which is a $2 billion a year prescription business in the US.
In a study by investigators the University of Chicago, of 1,400 men and 1,700 women between the ages of 18 and 59, 43% of women said they have experienced some degree of sexual dysfunction, compared with just 31% of men. Among the women surveyed, 32% lacked interest in sex. Another study by the same group at the University also found that 43% of American women between the ages of 57 and 85 (about 40 million) experience some degree of low sexual desire.
The majority of women with female sexual dysfunction (FSD) are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
Today, there is only one company in the world in active clinical development of a product for this true unmet medical need in women. The company in development of a product is BioSante Pharmaceuticals Inc., in Lincolnshire, Illinois. The product is a transdermal testosterone gel (LibiGel ®). LibiGel currently is in Phase III clinical studies for the treatment of HSDD in post-menopausal women. The LibiGel Phase III clinical development program includes two traditional pivotal Phase III randomized, placebo-controlled, multi-center, safety and efficacy trials, both of which are covered by an FDA SPA (special protocol assessment).
In addition, BioSante is conducting a LibiGel Phase III randomized, placebo controlled, multi-center, cardiovascular event and breast cancer safety study. Over 3,000 of a potential 4,000 women have been enrolled in the study and randomized to LibiGel or placebo. This LibiGel safety study represents the largest database of the safety of testosterone in women ever. To date, the cardiovascular event and breast cancer event rates in the study are lower than predicted. BioSante plans on submitting a new drug application (NDA) to FDA seeking approval for LibiGel by the end of 2012.
LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
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.
BioSante is committed to the success of LibiGel and to women's health. The time for equal treatment of men's and women's sexuality is here. Practitioners and women are waiting for solutions.
- Stephen M. Simes is president and CEO of BioSante Pharmaceuticals Inc. (http://www.biosantepharma.com), Lincolnshire, IL.
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) 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. 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 with a PDUFA date of November 14, 2011, 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.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.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.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (two thousand per month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 and other statements identified by words such as “will,” “potential,” “could,” “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 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.
Contact Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Thursday, April 28, 2011
Q&A With Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Discussing BioSante's Pipeline into 2012
Point Roberts WA, LINCOLNSHIRE, Ill. April 28, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of specialty pharmaceutical company, BioSante Pharmaceuticals. Mr Simes discusses the current product line of LibiGel�, Bio-T-Gel� and Elestrin� into 2012.
Postured to be the first-to-market with an FDA approved product for the treatment of female sexual dysfunction with LibiGel ®, Mr. Simes lays out the roadmap as the company heads into 2012.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, can you give investors an overview of your first FDA-approved product Elestrin™?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Elestrin is FDA-approved for the treatment of hot flashes in menopausal women, an over $1.5 billion market in the U.S. alone. Significantly, the product development team at BioSante developed Elestrin from just a product formulation through clinical trials, a new drug application submitted to the FDA, and a full non-conditional FDA-approval. It is this same BioSante team that is working on our much bigger potential product, LibiGel.
Q: Investorideas.com
Your leading product, LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) currently in Phase III clinical development, will bring BioSante to market first in this category - can you give us insight as to the significance of what this represents?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is the only product in the world in clinical development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, for which there is no FDA-Approved product, a full 13 years after Viagra was approved for men. It is time that women had a choice for treatment of their sexual health. We believe LibiGel will be the first product to be FDA-approved for this exciting indication, estimated to be a multi-billion market. Importantly, there were 4 million testosterone prescriptions written off-label for women in the U.S. in 2009. Physicians surveyed commented that they will switch 96% of their patients over to the FDA-approved, precise metered dose alternative when it becomes available.
Q: Investorideas.com
Bio-T-Gel™, a testosterone gel for male hypogonadism, has a pending NDA; can you give us a brief overview of the status and predicted timelines for this product?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Bio-T-Gel is our male testosterone product already licensed to TEVA (NASDAQ: TEVA) for marketing in the U.S. The current market for male testosterone products in the U.S. is over $1.2 billion and growing. TEVA is a dynamic sales and marketing company and we are confident they can capture a significant share of market. BioSante will be paid a royalty on TEVA sales of Bio-T-Gel. The FDA's assigned target (PDUFA date) to complete their review of the Bio-T-Gel NDA is November 14, 2011. Therefore, Bio-T-Gel could be launched late this year or early next.
Q: Investorideas.com
Can you give investors a brief overview of the company's financial status?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
At March 31, 2011, we had approximately $51.3 million in cash. This cash balance is sufficient to take us well into 2012 without any need to raise additional capital. We believe we have removed the financing risk from BioSante for the foreseeable future.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) 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. 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 has been filed with a PDUFA date of November 14, 2011, 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.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research; JMP Securities
Full report: http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
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.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 and other statements identified by words such as "will," "potential," "could," "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 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.
Contact Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Postured to be the first-to-market with an FDA approved product for the treatment of female sexual dysfunction with LibiGel ®, Mr. Simes lays out the roadmap as the company heads into 2012.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, can you give investors an overview of your first FDA-approved product Elestrin™?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Elestrin is FDA-approved for the treatment of hot flashes in menopausal women, an over $1.5 billion market in the U.S. alone. Significantly, the product development team at BioSante developed Elestrin from just a product formulation through clinical trials, a new drug application submitted to the FDA, and a full non-conditional FDA-approval. It is this same BioSante team that is working on our much bigger potential product, LibiGel.
Q: Investorideas.com
Your leading product, LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) currently in Phase III clinical development, will bring BioSante to market first in this category - can you give us insight as to the significance of what this represents?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is the only product in the world in clinical development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, for which there is no FDA-Approved product, a full 13 years after Viagra was approved for men. It is time that women had a choice for treatment of their sexual health. We believe LibiGel will be the first product to be FDA-approved for this exciting indication, estimated to be a multi-billion market. Importantly, there were 4 million testosterone prescriptions written off-label for women in the U.S. in 2009. Physicians surveyed commented that they will switch 96% of their patients over to the FDA-approved, precise metered dose alternative when it becomes available.
Q: Investorideas.com
Bio-T-Gel™, a testosterone gel for male hypogonadism, has a pending NDA; can you give us a brief overview of the status and predicted timelines for this product?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Bio-T-Gel is our male testosterone product already licensed to TEVA (NASDAQ: TEVA) for marketing in the U.S. The current market for male testosterone products in the U.S. is over $1.2 billion and growing. TEVA is a dynamic sales and marketing company and we are confident they can capture a significant share of market. BioSante will be paid a royalty on TEVA sales of Bio-T-Gel. The FDA's assigned target (PDUFA date) to complete their review of the Bio-T-Gel NDA is November 14, 2011. Therefore, Bio-T-Gel could be launched late this year or early next.
Q: Investorideas.com
Can you give investors a brief overview of the company's financial status?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
At March 31, 2011, we had approximately $51.3 million in cash. This cash balance is sufficient to take us well into 2012 without any need to raise additional capital. We believe we have removed the financing risk from BioSante for the foreseeable future.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) 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. 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 has been filed with a PDUFA date of November 14, 2011, 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.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research; JMP Securities
Full report: http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
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.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 and other statements identified by words such as "will," "potential," "could," "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 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.
Contact Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Wednesday, April 27, 2011
Biotech /Pharma Stocks Snapshot; Technology and Medical Devices on the Rise Within Healthcare; Aethlon Medical (OTCBB: AEMD), ELI Lilly (LLY) Medtronic (MDT), Pfizer (PFE), (Apple (AAPL)
Point Roberts, WA- April 27, 2011-Investorideas.com, a leader in sector stock research including
biotech/pharma stocks, reports on new trends in the healthcare sector where the industry is
reporting that medical technology is on the rise, and the development of new drugs may be
slowing down. The cost to bring a new drug to market, and the success rates may be a factor
in why some of the leading companies are looking at advancement in medical technology and
devices.
“In our case, we are leveraging our Hemopurifier® device to provide therapeutic capabilities
that target to improve infectious disease and cancer drug therapies,” stated Jim Joyce, CEO of
Aethlon Medical (OTCBB: AEMD).
Partnering technology to advance delivery of drugs is also a key to the future of healthcare. Eli
Lilly and Company (NYSE:LLY) and Medtronic, Inc. (NYSE:MDT) recently announced they have
entered into a collaboration to research and develop a new approach to treating Parkinson's
disease that involves delivering a potential new medicine to the brain using an implantable
drug delivery system. The goal of the collaboration is to develop a therapeutic approach for
Parkinson's disease that combines the strengths of Lilly's biologic, a modified form of glial
cell derived neurotrophic factor (GDNF), with Medtronic's implantable drug infusion system
technology.
As technology plays a key role in healthcare , new players enter the market from within the tech
sector including Apple’s (NasdaqGS: AAPL ) iPad, predicted to potentially revolutionize the
health-care universe.
Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at $ 0.0911 - 0.10
Apple Inc.(NasdaqGS: AAPL ) trading at $348.69, down 1.73 (0.49%) 11:40AM EDT
Eli Lilly and Company (NYSE: LLY ) trading up at$ 37.10, up 0.28 (0.76%) 11:41AM EDT
Medtronic Inc.(NYSE: MDT ) trading at $41.38, up 0.14 (0.34%) 11:42AM EDT
Pfizer, Inc. Common Stock(NYSE: PFE ) trading at $20.44, up 0.25 (1.24%) 11:43AM EDT
Market Snapshot
Dow 12,609.68 +14.31 +0.11%
Nasdaq 2,847.00 -0.54 -0.02%
S&P 500 1,346.08 -1.16 -0.09%
10 Yr Bond(%) 3.3680% +0.0480
Oil 112.04 -0.17 -0.15%
Gold 1,508.50 +1.50 +0.10%
Recent article; Are Medical Devices the New Drugs? QMed.com
Published: April 20, 2011
w.qmed.com/mpmn/blog/44335/are-medical-devices-new-drugs
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase profile at Investorideas.com
http://www.investorideas.com/CO/AEMD/
Recent News:
About the Company:
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. All showcase company
info is obtained from public filings, news, or directly from management. 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 stocks, reports on new trends in the healthcare sector where the industry is
reporting that medical technology is on the rise, and the development of new drugs may be
slowing down. The cost to bring a new drug to market, and the success rates may be a factor
in why some of the leading companies are looking at advancement in medical technology and
devices.
“In our case, we are leveraging our Hemopurifier® device to provide therapeutic capabilities
that target to improve infectious disease and cancer drug therapies,” stated Jim Joyce, CEO of
Aethlon Medical (OTCBB: AEMD).
Partnering technology to advance delivery of drugs is also a key to the future of healthcare. Eli
Lilly and Company (NYSE:LLY) and Medtronic, Inc. (NYSE:MDT) recently announced they have
entered into a collaboration to research and develop a new approach to treating Parkinson's
disease that involves delivering a potential new medicine to the brain using an implantable
drug delivery system. The goal of the collaboration is to develop a therapeutic approach for
Parkinson's disease that combines the strengths of Lilly's biologic, a modified form of glial
cell derived neurotrophic factor (GDNF), with Medtronic's implantable drug infusion system
technology.
As technology plays a key role in healthcare , new players enter the market from within the tech
sector including Apple’s (NasdaqGS: AAPL ) iPad, predicted to potentially revolutionize the
health-care universe.
Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at $ 0.0911 - 0.10
Apple Inc.(NasdaqGS: AAPL ) trading at $348.69, down 1.73 (0.49%) 11:40AM EDT
Eli Lilly and Company (NYSE: LLY ) trading up at$ 37.10, up 0.28 (0.76%) 11:41AM EDT
Medtronic Inc.(NYSE: MDT ) trading at $41.38, up 0.14 (0.34%) 11:42AM EDT
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Recent article; Are Medical Devices the New Drugs? QMed.com
Published: April 20, 2011
w.qmed.com/mpmn/blog/44335/are-medical-devices-new-drugs
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase profile at Investorideas.com
http://www.investorideas.com/CO/AEMD/
Recent News:
About the Company:
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
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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
Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at the Deutsche Bank Annual Health Care Conference
LINCOLNSHIRE, Ill. - April 27, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will present at the 36th Annual Deutsche Bank Health Care Conference to be held at the InterContinental Hotel, Boston from May 2-4, 2011.
Phillip B. Donenberg, BioSante's senior vice president, finance & CFO, will speak on Tuesday May 3, 2011 at 4:10 pm EDT. He will provide an overview of the company, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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," "potential," "could," "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 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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Phillip B. Donenberg, BioSante's senior vice president, finance & CFO, will speak on Tuesday May 3, 2011 at 4:10 pm EDT. He will provide an overview of the company, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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," "potential," "could," "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 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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
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