Investors Seeing the Upside in BioSante Pharmaceuticals (NasdaqGM: BPAX) Following News of LibiGel® Positive Data

Point Roberts, WA - October 14, 2011- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for specialty pharmaceutical company, BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). The stock closed Thursday at $2.4, up 0.13 (5.56%) on just over 1 Million shares.

The stock has a 52-week high of $4.02 and has analysts confident with a 12 -month price target price of $5.00.
The Company reported news this week of positive LibiGel® safety data review in the Phase III program. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no current FDA-approved product.
The LibiGel® l NDA is currently targeted for the end of 2012. Rodman & Renshaw's analyst covering the stock, Elemer Piros, predicts sales of $500 million annually by 2021.
The Company stated in its release this week, "The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased that the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
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.
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 its future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," other words of similar meaning, derivations of such words and 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:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
azachary@harrisdmckinney.com
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Biotech/Pharma stocks News; BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Positive LibiGel® Safety Data Review in Phase III Program

LINCOLNSHIRE, Ill. - October 11, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the seventh unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.

BioSante reported that with 3,656 women enrolled and over 4,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 29 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.60 percent. In the same population of subjects, there have been 17 breast cancers reported, a rate of approximately 0.35 percent, which is in line with the ages of the subjects enrolled in the study.
"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased that the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
Subjects have been enrolled in this study for an average of 15.7 months. More than 2,000 subjects have been enrolled in the study for more than a year and over 770 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante�s president & CEO. "With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
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.
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 its future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," other words of similar meaning, derivations of such words and 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:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
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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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Biotech and Pharma News; Aethlon (OTCBB: AEMD) Announces Hemopurifier® and HER2osome™ Cancer Therapy Presentation

SAN DIEGO � October 5, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the Aethlon Hemopurifier® and HER2osome™ cancer therapy will be the subject of a presentation at the Exosomes and Microvesicles 2011 conference on October 17th. The event is being held at the Wyndham Lake Buena Vista Resort located in Walt Disney World, Florida. Dr. Annette Marleau, Director of Tumor Immunology at Aethlon Medical will give the presentation. Both the Aethlon Hemopurifier® and HER2osome™ represent novel exosome-targeted strategies to improve cancer treatment outcomes. Exosomes released by cancers have recently emerged to become therapeutic targets in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes assist tumors in evading the response of the immune system.

About HER2osome™
HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. HER2osome™ is a novel medical device, whose goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer. Research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin® (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to fill an unmet medical need and enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks.
About the Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. Aethlon recently expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma.
To support the advancement of its therapeutic candidates, Aethlon has developed a diagnostic assay known as ELLSA™ that is able to identify and quantify the presence of exosomes in blood and other fluids. Aethlon plans to license or sell this technology to an organization already established in the research diagnostics field.
The Aethlon Hemopurifier® and HER2osome™ were both developed from the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides the foundation for a new class of therapeutics that selectively target the clearance of harmful agents from the entire circulatory system without the loss of essential blood components. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technology as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics. As Aethlon advances its current pipeline of therapies toward market, the company will market the ADAPT™ system to government agencies and organizations representing the pharmaceutical, biotechnology and medical device industry. On September 30, 2011, Aethlon was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device from the ADAPT™ system that would reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit www.aethlonmedical.com.
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 ability to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it 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
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com

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Biotech/Pharma Investor Alert; BioSante (NASDAQ: BPAX) Trading up over 10% on News of Top LibiGel efficacy trial results

Point Roberts, WA; LINCOLNSHIRE, Ill - October 4, 2011 - Investorideas.com, a leader in sector stock research for independent investors , issues a trading alert for specialty biotech/ pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), following news released from the Company October 4th.
The stock has bounced back as high as $2.25 in today's trading and is up 10.94% on news of completion of its two pivotal LibiGel (testosterone gel) efficacy trials.
According to reports on Seeking Alpha, "5 Stocks Trading Under $10 That Could Surge Higher", there is more upside for the stock.

News Excerpt: Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Completes Both Pivotal LibiGel® Efficacy Trials
"LINCOLNSHIRE, Ill. - October 4, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced completion of its two pivotal LibiGel (testosterone gel) efficacy trials, required for the company's anticipated LibiGel new drug application (NDA). The final visit of the last subject enrolled in the second of the two pivotal LibiGel Phase III efficacy trials occurred at the end of September. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
Data are being collected from the 141 investigative sites in the U.S. and Canada that participated in the two trials, and BioSante expects to announce top-line LibiGel efficacy results during this quarter. Both efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA). The third and last pivotal study for the LibiGel clinical development program is the ongoing LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of 3,656 subjects. The primary analysis of safety data is targeted for third quarter of 2012. The LibiGel NDA submission will include data from the two efficacy trials as well as the safety study and is targeted for the fourth quarter of 2012."
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/10041.asp
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), 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 using BioSante patented technology. Additional information is available online at: www.biosantepharma.com .
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 BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
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About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Biotech and Pharma stocks News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Completes Both Pivotal LibiGel® Efficacy Trials

LINCOLNSHIRE, Ill. - October 4, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced completion of its two pivotal LibiGel (testosterone gel) efficacy trials, required for the company's anticipated LibiGel new drug application (NDA). The final visit of the last subject enrolled in the second of the two pivotal LibiGel Phase III efficacy trials occurred at the end of September. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.

Data are being collected from the 141 investigative sites in the U.S. and Canada that participated in the two trials, and BioSante expects to announce top-line LibiGel efficacy results during this quarter. Both efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA). The third and last pivotal study for the LibiGel clinical development program is the ongoing LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of 3,656 subjects. The primary analysis of safety data is targeted for third quarter of 2012. The LibiGel NDA submission will include data from the two efficacy trials as well as the safety study and is targeted for the fourth quarter of 2012.
"We are delighted to have completed both LibiGel Phase III efficacy trials. We appreciate the diligence of the investigative sites and their care of the subjects in the trials, and we also thank the participating subjects," noted Joanne Zborowski, BioSante's vice president of clinical development. "There were over 1,100 subjects enrolled in the two efficacy trials, and we look forward to analyzing the data and announcing the results later this year."
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 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 a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from HSDD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 4,800 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 the safety study and efficacy trials, 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) 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 its future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as �anticipates,� �expects,� �will,� �continue,� �could,� �believes,� �intends,� �estimates,� �may,� other words of similar meaning, derivations of such words and 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:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
azachary@harrisdmckinney.com
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Pharma/Biotech Stock (OTC: AEMD) Doubles During Monday's Trading Following Report of $6.8 Million DARPA Contract

Point Roberts, WA - October 4, 2011 - Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, reports Aethlon Medical (OTCBB: AEMD) stock traded up over 100% , as high as $0.12 in yesterday's trading session following news of a $6.8 Million DARPA contract.

The stock traded significant volume and was one of the top ten percentage gainers on OTCBB throughout the day’s trading session on larger than normal trading volume. (See 5-day chart)
The Company reported yesterday that it has been 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. The contract program will utilize the Aethlon ADAPT™ system as a core technology component underlying an extracorporeal blood purification device that selectively clears multiple sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The resulting device, which is being advanced under DARPA's Dialysis Like Therapeutics (DLT) program, is expected to dramatically decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States each year. Under the DLT program, Aethlon will also introduce a novel blood pump strategy to reduce or eliminate the systemic administration of anticoagulants normally required during extracorporeal device therapies. Worldwide, more than 18 million cases of sepsis are reported every year, with more than six million resulting in death.
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. Aethlon's ADAPT™ platform provides the technology foundation 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 Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C. For more information, please visit www.aethlonmedical.com.
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Biotech Stock News Alert; (OTC: AEMD) Trading Up 50.88% on News of $6.8 million Contract from Defense Advanced Research Projects Agency (DARPA)

Point Roberts, WA - October 3, 2011 - Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, report Aethlon Medical (OTCBB: AEMD), a pioneer in developing therapeutic filtration devices is trading up at $0.0860, up 0.0290 (50.88%) on over 1.3 million shares in early morning trading.
The Company reported news that it has been 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. The contract program will utilize the Aethlon ADAPT™ system as a core technology component underlying an extracorporeal blood purification device that selectively clears multiple sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The resulting device, which is being advanced under DARPA's Dialysis Like Therapeutics (DLT) program, is expected to dramatically decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States each year. Under the DLT program, Aethlon will also introduce a novel blood pump strategy to reduce or eliminate the systemic administration of anticoagulants normally required during extracorporeal device therapies. Worldwide, more than 18 million cases of sepsis are reported every year, with more than six million resulting in death.
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. Aethlon's ADAPT™ platform provides the technology foundation 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 Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C. 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
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Disclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) is a paid advertising client ($one thousand five hundred per month, $five thousand per month in 144 stock)