Point Roberts, WA - June 27th, 2011 - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features a sector snapshot of biotech/ pharma stocks in the sexual dysfunction and sexual health markets.
NYSE: PFE)'s Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc (NYSE: PFE) is battling it out in court with Teva Pharmaceutical (Nasdaq: TEVA) and Watson Pharmaceuticals (NYSE: WPI) for generic versions of Viagra. Teva (NASDAQ: TEVA) has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires.
More info http://www.fiercepharma.com/story/pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13
Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals (NASDAQ: BPAX), recently commented in an Investorideas.com interview, “We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.”
Investor Spotlight forBioSante Pharmaceuticals (NASDAQ: BPAX) :
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. www.biosantepharma.com.
Recent News for LibiGel Product: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
LINCOLNSHIRE , Ill. - May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
Updates from the LibiGel Brochure:
Progress and Plans in Phase III: Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials, which are underway and have completed enrollment of subjects, are randomized, double-blind, placebocontrolled trials of over 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway and in which enrollment of subjects is complete. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of approximately 3,600 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, BioSante intends to submit a LibiGel NDA for review and potential approval by FDA by the end of 2012.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in 3,550 women enrolled comprising approximately 3,800 women-years of exposure, there have been only 22 adjudicated cardiovascular events, even though the safety study has enrolled women with a higher risk of cardiovascular events. Enrollment in the LibiGel safety study is complete at approximately 3,600 subjects
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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