BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced on the close yesterday that its top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials. Initial analysis of the data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences in the endpoints, all results were in the appropriate directions. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product. BioSante is trading down at $0.4801, down 1.6399 (77.35%) 12:28PM EST.
Antares' partnership with BioSante includes LibiGel® transdermal testosterone gel in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD).
"Antares Sell-Off is a Holiday Gift"- Josh Levine
"After the market close yesterday, Antares Pharma (AIS) partner Biosante reported results from two Phase III efficacy trials for Libigel, which is used to treat hypoactive sexual desire disorder in post-menopausal women. Here's the bottom line: While Libigel was extremely effective and reinforced previous studies, the placebo group fared nearly as well. The failure appears to have been due to a surprisingly high placebo effect. The impact on Biosante is devastating, but it's only a minor bump in the road for Antares. Today's 30%-plus drop in AIS shares is an overreaction and the stock will rebound fully in time."
He also noted, "Libigel, if successful, would have only begun contributing revenues to Antares in 2015."
About Josh Levine and Levine's MicroCap Investorwww.levinesmicrocapinvestor.com
Josh Levine has 25 years of senior-level experience in analyzing technology trends and investing in top-performing micro- and small-cap stocks.
About Antares Pharma, Inc. (NYSE Amex: AIS)
Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include VIBEX™ disposable pressure-assisted auto injectors, disposable multi-use pen injectors and Vision™ reusable needle-free injectors distributed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In the injector area, Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH) and a partnership with Ferring that includes Zomacton® hGH. In the gel-based area, the Company's FDA approved product is Anturol® gel, an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder) which has been licensed to Watson Pharmaceuticals, Inc. for the U.S. and Canada. Antares' partnership with BioSante includes LibiGel® transdermal testosterone gel in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® estradiol gel indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has two facilities in the U.S. The Parenteral Products Division located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company's reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted auto injector and pen injector systems. The Company's corporate offices and Pharma Division are located in Ewing, New Jersey, where pharmaceutical products are developed utilizing both the Company's transdermal systems and drug/device combination products.
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