February 23, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, presents the fourth in a series of Q&A interviews with Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). Mr. Simes updates the investment community on recent milestones for its leading product in development, LibiGel (testosterone gel).
The first introductory Q&A can be found here:
http://www.investorideas.com/CO/BPAX/news/9211.asp
In this follow up, Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals discusses recent developments with LibiGel (testosterone gel).
Interview
Q: Investorideas.com
Stephen, can you give us a quick summary of some of the company's recent milestones?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The most recent milestone regarding LibiGel is a very positive LibiGel safety data update. We reported that the safety study's independent Data Monitoring Committee (DMC) took its fifth unblinded look at adverse events reported in the LibiGel safety study. For the fifth time, the DMC recommended continuing the LibiGel safety study as per FDA-agreed protocol without modification. This is a positive outcome since the DMC did not express to us any concern to date about the safety of LibiGel.
Q: Investorideas.com
Your company just recently announced t hat there has been positive safety data in your ongoing LibiGel Phase III clinical trials. Your news release states "with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent." With those positive safety results how much closer to FDA approval does that make LibiGel?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We are making excellent progress toward FDA approval in that our three LibiGel Phase III clinical studies are proceeding as per our plan. Our hope is to submit a new drug application (NDA) to the FDA for a LibiGel approval and launch in 2012. This is on the near-term horizon for us.
Q: Investorideas.com
Your company recently presented data at an International conference showing Female Sexual Dysfunction is a significant unmet medical need. Can you give us a summary of some the physician stats to back that up?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
To start, it is important to point out that there is no FDA-approved pharmaceutical product for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Well over 80 percent of surveyed physicians told us that there is a need or a great need for an FDA-approved product for the treatment of female sexual dysfunction, a full 13 years after Viagra was approved for men. In fact, over 90 percent of surveyed physicians report that they currently prescribe products off-label (that is, products not FDA-approved) for the treatment of FSD. Interestingly the average gynecologist hears 37 non-solicited complaints about FSD per month. The unmet medical need is dramatic.
Q: Investorideas.com
You recently stated. "LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD". Can you comment in more detail on the significance of that?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As I mentioned, there is no FDA-approved pharmaceutical product for the treatment of HSDD. LibiGel is the only product in the world in Phase III clinical development for this indication. Therefore, we expect to be the first product to be FDA approved for HSDD!
Q: Investorideas.com
As the biotech sector is heating up again for investors, your company has received substantial media attention recently, in particular following your company reporting positive safety data from your late-stage study. The company plans to submit an application for LibiGel's approval to the Food and Drug Administration in 2012 - so what key developments are in the pipeline for investors and media to watch for from now to then?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
In the very near-term, we hope to announce completion of enrollment in our LibiGel efficacy trials. In addition, we will continue to report on data from our LibiGel safety study, even though we remain blinded to which therapy, LibiGel or placebo, the women in the study are taking. LibiGel is the main driver of value for BioSante in 2011, however, we also expect to update the public about our other products in development including Bio-T-Gel, our male testosterone gel, already licensed to TEVA, as well as our cancer vaccines in development.
About LibiGel®
LibiGel® is a gel formulation of testosterone in development that is quickly absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials that are underway are randomized, doubleblind, placebo-controlled trials which will enroll approximately 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante 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.
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Or the company website www.biosantepharma.com to learn more about BioSante.
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Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For info about BioSante Pharmaceuticals, Inc
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
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Source - Investorideas.com
Wednesday, February 23, 2011
Tuesday, February 22, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) to Present at Citi Global Health Care Conference
LINCOLNSHIRE, Ill. - February 22, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will be presenting at the 2011 Citi Global Health Care Conference. The conference will take place March 1-3, 2011 at the Hilton Hotel in New York City, New York.
Stephen M. Simes, BioSante�s president & CEO, will speak Tuesday, March 1, 2011 at 2:30 pm EST. He will provide an overview of the company, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/citigroup/healthcare2011/88112623.cfm. A webcast replay will be available one hour after conclusion of the presentation and will expire June 1, 2011.
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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Stephen M. Simes, BioSante�s president & CEO, will speak Tuesday, March 1, 2011 at 2:30 pm EST. He will provide an overview of the company, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/citigroup/healthcare2011/88112623.cfm. A webcast replay will be available one hour after conclusion of the presentation and will expire June 1, 2011.
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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Friday, February 18, 2011
Biotech/Pharma Stock News; Regulatory Process Is an Ongoing Challenge for Xoma & BioSante (NASDAQ: BPAX)
NEW YORK, NY - February 18, 2011 (Investorideas.com newswire) There is plenty of optimism surrounding the Biotech industry as firmer pricing and new products have improved sales and earnings trends. Meanwhile, more speculative biotech firms such as XOMA and BioSante continue to garner significant attention with potential blockbuster drugs working their way through the regulatory process.The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on XOMA, Ltd. (NASDAQ:XOMA) and BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX). Access to the full company reports can be found at: www.bedfordreport.com/2011-02-XOMA www.bedfordreport.com/2011-02-BPAX
A recent study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice as likely to gain approval than more traditional chemical drugs.
The study found that drugs moving from early stage Phase I clinical trials to FDA approval is roughly ten percent, down from around 20 percent in reports involving earlier years.The report adds that approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval -- though only half were approved on initial review.
The Bedford Report releases regular market updates on the Biotechnology Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Earlier this month BioSante reported positive late stage safety data for its potential blockbuster drug, "LibiGel". LibiGel is designed as a possible treatment for sexual dysfunction in menopausal women. BioSante's senior vice president of medical affairs, Michael C. Snabes, argues that "The need for an FDA-approved treatment to cope with this condition is astonishing."
The Bedford Report provides Analyst Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
A recent study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice as likely to gain approval than more traditional chemical drugs.
The study found that drugs moving from early stage Phase I clinical trials to FDA approval is roughly ten percent, down from around 20 percent in reports involving earlier years.The report adds that approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval -- though only half were approved on initial review.
The Bedford Report releases regular market updates on the Biotechnology Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Earlier this month BioSante reported positive late stage safety data for its potential blockbuster drug, "LibiGel". LibiGel is designed as a possible treatment for sexual dysfunction in menopausal women. BioSante's senior vice president of medical affairs, Michael C. Snabes, argues that "The need for an FDA-approved treatment to cope with this condition is astonishing."
The Bedford Report provides Analyst Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Tuesday, February 15, 2011
Biotech/Pharma Stock News; BioSante Presents Data Showing Female Sexual Dysfunction is a Significant Unmet Medical Need
LINCOLNSHIRE, Ill. - February 15, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a pharmaceutical company developing products for the treatment of female sexual health, presented critical female sexual dysfunction market data at the ISSWSH (The International Society for the Study of Women�s Sexual Health) annual meeting. The data presented include results of a survey of over 100 Obstetrician/Gynecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).
There are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 percent) reported that they prescribe off-label testosterone for women to treat FSD, however, these physicians are dissatisfied with the non-FDA approved, off-label alternatives. The physicians indicated that they hear an average of 37 unsolicited inquiries per month from women regarding sexual dysfunction. Nationally, it is estimated that 4.1 million off-label testosterone prescriptions are filled annually.
"The need for an FDA-approved treatment to cope with this condition is astonishing, as stated by the physicians surveyed. This position also was strongly supported by the attendees at the ISSWSH meeting," said Michael C. Snabes, M.D., Ph.D., BioSante�s senior vice president of medical affairs. "It has been more than a decade since the FDA approved Viagra for the treatment of male sexual dysfunction; it is time women have a safe and effective option for the treatment of their sexual health." BioSante is developing LibiGel® (testosterone gel) for the treatment of HSDD in menopausal women. LibiGel is currently in three Phase III clinical studies to prove its safety and efficacy.
The physicians in the survey were asked their reaction to an unnamed therapeutic that fit LibiGel�s profile. An overwhelming 94% responded favorably, as long as it is proven to be safe. To that end, BioSante is conducting a Phase III multicenter cardiovascular and breast cancer safety study. BioSante reported at the ISSWSH meeting that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
The survey, conducted independently for BioSante by Campbell Alliance Group, Inc., revealed sexual dysfunction to be one of the most common complaints received in these doctors� offices. The physicians described themselves as dissatisfied with the current lack of therapeutic options for HSDD, a loss of libido or sexual desire.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
There are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 percent) reported that they prescribe off-label testosterone for women to treat FSD, however, these physicians are dissatisfied with the non-FDA approved, off-label alternatives. The physicians indicated that they hear an average of 37 unsolicited inquiries per month from women regarding sexual dysfunction. Nationally, it is estimated that 4.1 million off-label testosterone prescriptions are filled annually.
"The need for an FDA-approved treatment to cope with this condition is astonishing, as stated by the physicians surveyed. This position also was strongly supported by the attendees at the ISSWSH meeting," said Michael C. Snabes, M.D., Ph.D., BioSante�s senior vice president of medical affairs. "It has been more than a decade since the FDA approved Viagra for the treatment of male sexual dysfunction; it is time women have a safe and effective option for the treatment of their sexual health." BioSante is developing LibiGel® (testosterone gel) for the treatment of HSDD in menopausal women. LibiGel is currently in three Phase III clinical studies to prove its safety and efficacy.
The physicians in the survey were asked their reaction to an unnamed therapeutic that fit LibiGel�s profile. An overwhelming 94% responded favorably, as long as it is proven to be safe. To that end, BioSante is conducting a Phase III multicenter cardiovascular and breast cancer safety study. BioSante reported at the ISSWSH meeting that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
The survey, conducted independently for BioSante by Campbell Alliance Group, Inc., revealed sexual dysfunction to be one of the most common complaints received in these doctors� offices. The physicians described themselves as dissatisfied with the current lack of therapeutic options for HSDD, a loss of libido or sexual desire.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Monday, February 14, 2011
Biotech/ Pharma Stock Trading Alert; BioSante Pharmaceuticals Inc up on News
Point Roberts, WA. –February 14, 2011 (Investorideas.com Energy stocks Newswire) -
www.InvestorIdeas.com and its leading Biotech investor portals, announces a technical stock
trading alert for BioSante Pharmaceuticals Inc (NASDAQ:BPAX). The stock is trading at $2.41,
up 0.10 (4.33%), trading as high as $2.53 in morning trading.
Recent News: BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Positive LibiGel Safety
Data in Phase III Program
“LINCOLNSHIRE, Ill. - February 14, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX),
presented positive safety data in its ongoing LibiGel Phase III clinical development program, at
the annual meeting of ISSWSH on February 12, 2011.
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure
in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17
adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately
0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27
percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-
agreed protocol, without modifications including continued enrollment of new subjects. This was
the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th
unblinded review of all study safety data. 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.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02142.asp
Recent News: BioSante Pharmaceuticals, Inc. To Present LibiGel®
Safety Study Update At BIO CEO & Investor Conference
“LINCOLNSHIRE, Illinois (February 14, 2011) – BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the
Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take
place February 14-15, 2011 at the Waldorf-Astoria in New York.
Stephen M. Simes, BioSante’s president & CEO, will speak today, Monday February 14, 2011
at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel®
(testosterone gel) Phase III clinical development program including safety data. A live audio
webcast of Mr. Simes’ remarks may be accessed at: http://www.veracast.com/webcasts/bio/
ceoinvestor2011/16113289.cfm .”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02141.asp
More info: 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.
Sign up for the free investor news letter and get stock alerts in leading
sectors! http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://
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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 mining and gold stocks, in addition
to global markets including China, India, the Middle East and Australia. Investorideas.com is
known for its comprehensive stock directories in each sector and sector specific newswires.
About our Biotech investor portal: www.biotechindustrystocks.com
BiotechIndustryStocks.com is a global meeting place for investors and industry following the
sector, within Investorideas.com. Global visitors use the site daily to research the latest news,
articles, audio, research reports and our stock directories.
Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
Investorideas.com Disclosure, Disclaimer/ BPAX is a paid advertising client on
Investorideas.com. (one thousand per month)
Disclaimer: The following news is paid for by BPAX (three thousand per month)
Investorideas.com is a third party publisher of news and research .Our sites do not make
recommendations, but offer information portals to research news, articles, stock lists and
recent research. Nothing on our sites should be construed as an offer or solicitation to buy or
sell products or securities. This site is currently compensated by featured companies, news
submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com to become a biotech showcase stock or research biotech stocks
800 665 0411 cvanzant@investorideas.com
www.InvestorIdeas.com and its leading Biotech investor portals, announces a technical stock
trading alert for BioSante Pharmaceuticals Inc (NASDAQ:BPAX). The stock is trading at $2.41,
up 0.10 (4.33%), trading as high as $2.53 in morning trading.
Recent News: BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Positive LibiGel Safety
Data in Phase III Program
“LINCOLNSHIRE, Ill. - February 14, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX),
presented positive safety data in its ongoing LibiGel Phase III clinical development program, at
the annual meeting of ISSWSH on February 12, 2011.
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure
in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17
adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately
0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27
percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-
agreed protocol, without modifications including continued enrollment of new subjects. This was
the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th
unblinded review of all study safety data. 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.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02142.asp
Recent News: BioSante Pharmaceuticals, Inc. To Present LibiGel®
Safety Study Update At BIO CEO & Investor Conference
“LINCOLNSHIRE, Illinois (February 14, 2011) – BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the
Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take
place February 14-15, 2011 at the Waldorf-Astoria in New York.
Stephen M. Simes, BioSante’s president & CEO, will speak today, Monday February 14, 2011
at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel®
(testosterone gel) Phase III clinical development program including safety data. A live audio
webcast of Mr. Simes’ remarks may be accessed at: http://www.veracast.com/webcasts/bio/
ceoinvestor2011/16113289.cfm .”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02141.asp
More info: 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.
Sign up for the free investor news letter and get stock alerts in leading
sectors! http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://
www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized
in sector investing, covering leading industry sectors including mining and gold stocks, in addition
to global markets including China, India, the Middle East and Australia. Investorideas.com is
known for its comprehensive stock directories in each sector and sector specific newswires.
About our Biotech investor portal: www.biotechindustrystocks.com
BiotechIndustryStocks.com is a global meeting place for investors and industry following the
sector, within Investorideas.com. Global visitors use the site daily to research the latest news,
articles, audio, research reports and our stock directories.
Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
Investorideas.com Disclosure, Disclaimer/ BPAX is a paid advertising client on
Investorideas.com. (one thousand per month)
Disclaimer: The following news is paid for by BPAX (three thousand per month)
Investorideas.com is a third party publisher of news and research .Our sites do not make
recommendations, but offer information portals to research news, articles, stock lists and
recent research. Nothing on our sites should be construed as an offer or solicitation to buy or
sell products or securities. This site is currently compensated by featured companies, news
submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com to become a biotech showcase stock or research biotech stocks
800 665 0411 cvanzant@investorideas.com
Biotech/Pharma Stock News; BioSante Pharmaceuticals Reports Positive LibiGel Safety Data in Phase III Program
LINCOLNSHIRE, Ill. - February 14, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), presented positive safety data in its ongoing LibiGel Phase III clinical development program, at the annual meeting of ISSWSH on February 12, 2011.
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. 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.
"Once again, the DMC 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. In addition, 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. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete. The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum."
Subjects have been enrolled in this study for an average of 12.5 months. More than 1,000 subjects have been enrolled in the study for more than a year and over 550 subjects 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. BioSante's objective is to submit the LibiGel NDA for a product launch in 2012.
"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. "We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future," Mr. Simes continued. "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 enrolled 2,869 women, with a maximum of 4,000 patients to be enrolled. 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 an average of 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). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �potential,� �could,� �can,� �believe,� �intends,� �continue,� �plans,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. 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.
"Once again, the DMC 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. In addition, 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. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete. The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum."
Subjects have been enrolled in this study for an average of 12.5 months. More than 1,000 subjects have been enrolled in the study for more than a year and over 550 subjects 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. BioSante's objective is to submit the LibiGel NDA for a product launch in 2012.
"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. "We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future," Mr. Simes continued. "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 enrolled 2,869 women, with a maximum of 4,000 patients to be enrolled. 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 an average of 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). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �potential,� �could,� �can,� �believe,� �intends,� �continue,� �plans,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present LibiGel Safety Study Update at BIO CEO & Investor Conference
LINCOLNSHIRE, Ill. - February 14, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take place February 14-15, 2011 at the Waldorf-Astoria in New York.
Stephen M. Simes, BioSante�s president & CEO, will speak today, Monday February 14, 2011 at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel� (testosterone gel) Phase III clinical development program including safety data. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/bio/ceoinvestor2011/16113289.cfm
A webcast replay will be available for 90 days beginning one hour after conclusion of the live event.
About The BIO CEO & Investor Conference
Now in its thirteen year, the BIO CEO & Investor Conference 2011 is the largest investor conference focused on the biotechnology industry. The conference provides a forum for public and private equity investors, research analysts, investment bankers and senior-level industry executives to learn about and discuss investment trends and investment opportunities in the biotechnology industry. This year�s conference will feature corporate presentations from more than 120 companies, workshops featuring leading experts on specific therapeutic and technology topics, plenary and panel sessions on timely business issues and industry trends, many opportunities to schedule one-on-one meetings, as well as numerous networking opportunities. For more information, visit www.ceo.bio.org.
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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Stephen M. Simes, BioSante�s president & CEO, will speak today, Monday February 14, 2011 at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel� (testosterone gel) Phase III clinical development program including safety data. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/bio/ceoinvestor2011/16113289.cfm
A webcast replay will be available for 90 days beginning one hour after conclusion of the live event.
About The BIO CEO & Investor Conference
Now in its thirteen year, the BIO CEO & Investor Conference 2011 is the largest investor conference focused on the biotechnology industry. The conference provides a forum for public and private equity investors, research analysts, investment bankers and senior-level industry executives to learn about and discuss investment trends and investment opportunities in the biotechnology industry. This year�s conference will feature corporate presentations from more than 120 companies, workshops featuring leading experts on specific therapeutic and technology topics, plenary and panel sessions on timely business issues and industry trends, many opportunities to schedule one-on-one meetings, as well as numerous networking opportunities. For more information, visit www.ceo.bio.org.
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.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
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