LINCOLNSHIRE, Ill. - November 16, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011. The pK study results indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 grams daily, the same dose as included in the two LibiGel pivotal safety and efficacy trials and safety study. The mean free testosterone level at baseline was 1.4 pg/ml. During the study, subjects in the pK study demonstrated a mean free testosterone of approximately 3.5 pg/ml on day 14, and 4.1 pg/ml on day 21 (at the end of study period 1) and approximately 4.5 pg/ml on study day 42 (at the end of 21 days of transdermal estradiol co-therapy in period 2). During study period 3, the mean free testosterone level was approximately 3.7 pg/ml. Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued.
The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase II efficacy trial which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively. In a recent publication, it was shown that serum testosterone concentrations in normally cycling 30-year-old pre-menopausal women range from 1.2 pg/ml to 6.4 pg/ml. However, generally, blood levels are not compared between studies because different studies performed at different times with different assays can produce varying testosterone blood levels.
In the LibiGel Phase III clinical studies, baseline testosterone levels, although collected, are not an inclusion or exclusion criterion, per FDA suggestion, since therapy for HSDD is meant for symptomatic treatment of HSDD and not testosterone levels. BioSante plans to present the full pK study results at an upcoming medical meeting. The LibiGel pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. The completed efficacy trials were conducted according to an FDA-agreed 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 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 over 5,100 women-years of exposure, to date. 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 demonstrate 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 efficacy trials and the safety study, BioSante intends to submit an NDA to the FDA, requesting approval of LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter 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), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to 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. 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.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
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Wednesday, November 16, 2011
Medical Technology Stock Alert: U.S FDA Clears PositiveID's (OTCBB:PSID) iglucose System for Diabetes Management
DELRAY BEACH, Fla. - November 16, 2011 (Investorideas.com Newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual's data-capable glucometer to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan.
The iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes.; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose and receive insurance reimbursement; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual's data-capable glucometer to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan.
The iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes.; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose and receive insurance reimbursement; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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Tuesday, November 15, 2011
Biotech News Alert; Investor Update for BioSante Pharmaceuticals (NasdaqGM: BPAX); Jefferies Initiating at Buy: Positive Ahead of Phase III LibiGel Data
Point Roberts, WA - November 15, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues an investor update for BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). Jefferies & Company, Inc. has initiated a buy rating on the stock with a price target of $5.00, driven by Phase III LibiGel testosterone gel.
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under an FDA-agreed 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.
About BioSante Pharmaceuticals, Inc. (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), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to 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. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.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.
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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.
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Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under an FDA-agreed 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.
About BioSante Pharmaceuticals, Inc. (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), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to 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. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.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.
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Source - Investorideas.com 800-665-0411
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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Thursday, November 3, 2011
Biopharmaceutical Stock Alert: Medivation, Inc. (NASDAQ: MDVN) Trades up over 100% on News of Positive Results of Phase 3 AFFIRM Trial
Point Roberts, WA - November 3, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for Medivation, Inc. (NASDAQ: MDVN) following news of �Positive Survival Data From Interim Analysis of Phase 3 AFFIRM Trial of MDV3100 in Men With Advanced Prostate Cancer.
The stock is trading up at $35.37, up 18.85 (113.97%) 11:09AM EDT.
This morning, Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. announced that the Independent Data Monitoring Committee (IDMC) has informed the companies of positive results from a planned interim analysis of the Phase 3 AFFIRM trial of MDV3100 in men with advanced prostate cancer previously treated with chemotherapy. MDV3100, the first androgen receptor signaling inhibitor, successfully met the study's pre-specified interim efficacy stopping criteria, demonstrating a clinically meaningful and statistically significant (p < 0.0001) improvement in overall survival compared to placebo. As a result, the IDMC recommended that AFFIRM be stopped early and men who received placebo be offered MDV3100.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer's disease. For more information, please visit us at www.medivation.com.
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Source - www.Investorideas.com
The stock is trading up at $35.37, up 18.85 (113.97%) 11:09AM EDT.
This morning, Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. announced that the Independent Data Monitoring Committee (IDMC) has informed the companies of positive results from a planned interim analysis of the Phase 3 AFFIRM trial of MDV3100 in men with advanced prostate cancer previously treated with chemotherapy. MDV3100, the first androgen receptor signaling inhibitor, successfully met the study's pre-specified interim efficacy stopping criteria, demonstrating a clinically meaningful and statistically significant (p < 0.0001) improvement in overall survival compared to placebo. As a result, the IDMC recommended that AFFIRM be stopped early and men who received placebo be offered MDV3100.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer's disease. For more information, please visit us at www.medivation.com.
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
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Monday, October 31, 2011
Biotech Stock Alert; Aethlon Medical (OTC: AEMD) Trading Up over 19%
Point Roberts, WA- October 31, 2011- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for Aethlon Medical (OTCBB: AEMD), a Company developing therapeutic filtration devices to address infectious disease and cancer .The stock is trading up at $0.0810, up 0.0130 (19.12%), with a morning high of $0.0870 (up 27%) on over 1.2 Million shares.
The Company reported news at the beginning of October that it was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
On October 18th, the Company reported that it will begin accepting orders for its Enzyme Linked Lectin Specific Assay (ELLSA™) from researchers that require a highly sensitive diagnostic tool to detect the presence of exosomes in cell culture, ascites, and other biological fluids, including blood.
Biotech Investor Snapshot for Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source – www.Investorideas.com
The Company reported news at the beginning of October that it was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
On October 18th, the Company reported that it will begin accepting orders for its Enzyme Linked Lectin Specific Assay (ELLSA™) from researchers that require a highly sensitive diagnostic tool to detect the presence of exosomes in cell culture, ascites, and other biological fluids, including blood.
Biotech Investor Snapshot for Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Visit the AEMD showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get biotech news and stock alerts
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Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.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.
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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
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source – www.Investorideas.com
Wednesday, October 26, 2011
Trending Investor Searches; (TSX: YLO), (NYSE:SD), (NASDAQ:BPAX), (NASDAQ:HGSI) Top Four Searched Stocks
Water Stocks, Renewable Energy Stocks Lead Sector Searches
POINT ROBERTS, October 26, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on this weeks trending top ten investor searches. The top four most searched stocks on the site included (TSX: YLO), (NYSE:SD), (NASDAQ:BPAX) and (NASDAQ:HGSI).
Sandridge Energy Inc. (NYSE: SD ) made the top four searches following Investorideas.com commentary on the Mississippian Play entitled “Horizontal Drilling Plans for the Mississippian ;( OTCBB: OEDV), (NasdaqGM: RAM), (NYSE: RRC), (NYSE: SD)”
http://www.investorideas.com/news/2011/energy/10241.asp
Specialty biopharmaceutical company, BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX ) made the top ten searches for the second week, with news out on positive data on LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Investorideas.com released an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals, Inc.
http://www.investorideas.com/CO/BPAX/news/2011/10241.asp
Leading sectors searched by investors included water stocks and renewable energy stocks.
Investorideas.com Top Investor Searches…
1. TSX: YLO
2. NYSE:SD
3. NASDAQ:BPAX
4. NASDAQ:HGSI
5. TSX: SU
6. NASDAQ:JASO
7. Water stocks
8. Renewable energy stocks
9. TSX: LUN
10. NASDAQ:FSLR
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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.
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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. BPAX is a paid showcase stock on Investorideas.com – six thousand five hundred for 3 months
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Source – Investorideas.com
800-665-0411
POINT ROBERTS, October 26, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on this weeks trending top ten investor searches. The top four most searched stocks on the site included (TSX: YLO), (NYSE:SD), (NASDAQ:BPAX) and (NASDAQ:HGSI).
Sandridge Energy Inc. (NYSE: SD ) made the top four searches following Investorideas.com commentary on the Mississippian Play entitled “Horizontal Drilling Plans for the Mississippian ;( OTCBB: OEDV), (NasdaqGM: RAM), (NYSE: RRC), (NYSE: SD)”
http://www.investorideas.com/news/2011/energy/10241.asp
Specialty biopharmaceutical company, BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX ) made the top ten searches for the second week, with news out on positive data on LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Investorideas.com released an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals, Inc.
http://www.investorideas.com/CO/BPAX/news/2011/10241.asp
Leading sectors searched by investors included water stocks and renewable energy stocks.
Investorideas.com Top Investor Searches…
1. TSX: YLO
2. NYSE:SD
3. NASDAQ:BPAX
4. NASDAQ:HGSI
5. TSX: SU
6. NASDAQ:JASO
7. Water stocks
8. Renewable energy stocks
9. TSX: LUN
10. NASDAQ:FSLR
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.
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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. BPAX is a paid showcase stock on Investorideas.com – six thousand five hundred for 3 months
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Source – Investorideas.com
800-665-0411
TSX Biotech Stock News Alert; Verisante's (TSX.V: VRS) Aura™ has ability to revolutionize the way skin cancer is diagnosed
October 26, 2011 - Investorideas.com, a leader in sector research for independent investors issues an investor snapshot for TSX biotech stock, Verisante (TSX-V: VRS) following its October 19 th news, receiving Health Canada's approval for their innovative skin cancer detection device. The stock immediately moved up to over $1.00 on significant volume once the news was disseminated.
Verisante Receives Health Canada Approval for Verisante Aura(TM)!
VANCOUVER, BRITISH COLUMBIA -(10/19/11)- Verisante Technology, Inc. (TSX-V: VRS) (OTCQX: VRSEF.PK)(PINK SHEETS: VRSEF) a leader in cancer imaging technology, announced today that it has obtained a license from Health Canada to market and sell the Verisante Aura™, an innovative, non-invasive medical device for the early detection of skin cancer.
"Obtaining a license from Health Canada means we are now able to begin marketing and selling Verisante Aura™ in Canada. This is a defining milestone for our Company," said President and CEO Thomas Braun. " Our technology has the ability to revolutionize the way skin cancer is diagnosed, saving lives and costs. Verisante Aura™ will aid healthcare professionals in assessing skin lesions, reducing patient wait times and decreasing healthcare costs by detecting skin cancer at an early and most easily treatable stage."
Verisante Technology, Inc Key Facts:
Revolutionary, patent-protected, platform technology!
Verisante Technology, Inc. is a medical device company committed to commercializing innovative systems for the early detection of cancer. The Company's device for skin cancer detection, Aura™, is approved for sale in Canada. Approval in Europe and Australia is expected by the end of 2011. Verisante's AuraTM and Core™ (for lung, colon and cervical cancer detection) devices utilize a proprietary cancer detection platform while the operating software and probe technology are unique to each device. This exclusive platform technology allows Verisante to develop compact, non-invasive cancer detection devices that offer immediate results for many of the most common cancers. Visit www.verisante.com
Company Contact
Verisante Technology, Inc.
306 - 2309 West 41st Avenue
Vancouver BC V6M 2A3
Tel 604 605 0507
Fax 604 605 0508
info@verisante.com
verisante.com
TSX-V: VRS
OTCQX: VRSEF
FRANKFURT: V3T
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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, stocklists 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 .
Disclosure: Investorideas.com has been compensated one thousand to advertise Verisante technology and distribute news releases and content on their behalf by a third party IR firm. All information in this report is within the public domain and previously released by the company. All investment involves risk and possible loss of investment.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
Source - www.Investorideas.com
Verisante Receives Health Canada Approval for Verisante Aura(TM)!
VANCOUVER, BRITISH COLUMBIA -(10/19/11)- Verisante Technology, Inc. (TSX-V: VRS) (OTCQX: VRSEF.PK)(PINK SHEETS: VRSEF) a leader in cancer imaging technology, announced today that it has obtained a license from Health Canada to market and sell the Verisante Aura™, an innovative, non-invasive medical device for the early detection of skin cancer.
"Obtaining a license from Health Canada means we are now able to begin marketing and selling Verisante Aura™ in Canada. This is a defining milestone for our Company," said President and CEO Thomas Braun. " Our technology has the ability to revolutionize the way skin cancer is diagnosed, saving lives and costs. Verisante Aura™ will aid healthcare professionals in assessing skin lesions, reducing patient wait times and decreasing healthcare costs by detecting skin cancer at an early and most easily treatable stage."
Verisante Technology, Inc Key Facts:
Revolutionary, patent-protected, platform technology!
- Applicable to several forms of cancer
- Clear regulatory pathway that will result in significant early revenue
- Imaging device for the safe detection of skin cancer now approved for sale in Canada
- Strategic alliances with leading institutions
- World class scientific capability
- Project management led by experienced, award-winning pioneers
- Medical and technical team led by renowned experts
- Highly qualified management, and Strong, independent board
- Raised $8.7 million in 2011, ensuring sufficient funding through commercialization
Verisante Technology, Inc. is a medical device company committed to commercializing innovative systems for the early detection of cancer. The Company's device for skin cancer detection, Aura™, is approved for sale in Canada. Approval in Europe and Australia is expected by the end of 2011. Verisante's AuraTM and Core™ (for lung, colon and cervical cancer detection) devices utilize a proprietary cancer detection platform while the operating software and probe technology are unique to each device. This exclusive platform technology allows Verisante to develop compact, non-invasive cancer detection devices that offer immediate results for many of the most common cancers. Visit www.verisante.com
Company Contact
Verisante Technology, Inc.
306 - 2309 West 41st Avenue
Vancouver BC V6M 2A3
Tel 604 605 0507
Fax 604 605 0508
info@verisante.com
verisante.com
TSX-V: VRS
OTCQX: VRSEF
FRANKFURT: V3T
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