Healthcare Industry News: estradiol gel
News Release - June 12, 2007
BioSante Pharmaceuticals Announces Reinitiation of Product Development With TevaLINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (AMEX: BPA ) announced today that it and a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA ), have signed an amendment to their development and license agreement under which Teva and BioSante will reinitiate their collaboration on the development of a male testosterone therapy product for the U.S. market. Effective immediately, Teva has withdrawn its previous notice of its desire to terminate the license agreement and will reinitiate funding and development of the product.
Teva has agreed to pay BioSante certain milestone payments plus royalties on sales of the product, if and when commercialized. BioSante's product is owned by BioSante with no royalty or milestone obligations to any other party. Teva also will be responsible under the revised agreement for continued development of the product, including required clinical trials, regulatory filings and all manufacturing and marketing associated with the product.
"We are extremely excited by this amendment and the opportunity again to work closely with Teva," said Stephen M. Simes, president and chief executive officer of BioSante. "We are pleased with our continued progress in the development of our hormone therapy gel products, having received U.S. Food and Drug Administration (FDA) approval of Elestrin(TM), our estradiol gel for the treatment of hot flashes in menopausal women, and having initiated Phase III clinical development of LibiGelŪ, our transdermal testosterone gel for the treatment of female sexual dysfunction. Our objective with respect to all of our products is to fund their development and commercialization in a way that maximizes stockholder value. Teva is an exceptional partner - it is a multinational pharmaceutical company with an impressive track record of sales and marketing in the U.S. This amended agreement with Teva will permit us to continue the co-development of our male testosterone hormone therapy product, which we believe, if and when commercialized, will have the potential to capture significant market share."
BioSante's Hormone Therapy Products in Development
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bio-identical estradiol and testosterone. Among those products in development are Bio-T-Gel(TM), a testosterone gel for the treatment of male hypogonadism, and an oral contraceptive using BioSante's patented technology. BioSante's lead products include Elestrin(TM) (estradiol gel) developed through FDA approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and expected to be commercially launched shortly by Bradley Pharmaceuticals, Inc. (NYSE: BDY ) in the U.S., and LibiGelŪ (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD).
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 76 percent of Teva's sales are in North America and Europe.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bio-identical estradiol and testosterone. BioSante's lead products include Elestrin(TM) (estradiol gel) developed through FDA approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and expected to be commercially launched shortly by Bradley Pharmaceuticals, Inc. in the U.S., and LibiGelŪ (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel(TM), a testosterone gel for male hypogonadism, and an oral contraceptive using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration. Additional information is available online at www.biosantepharma.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes," "plans," "hopes," or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed in BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements 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.
Source: BioSante Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.