BioSante Pharmaceuticals Inc has signed a development and license agreement with Teva Pharmaceuticals USA Inc, a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd, under which Teva USA and BioSante will collaborate on the development of a hormone therapy product for the U.S. market.

Upon signing the U.S. development and license agreement, BioSante received an upfront payment of $1.5 million. In addition, Teva will pay BioSante development and sales-related milestone payments plus royalties on sales of the product commercialized in this collaboration. Teva also will be responsible for continued development, regulatory filings and all manufacturing and marketing associated with the product.

"We are extremely excited by this agreement and the opportunity to work with Teva," said Stephen M. Simes, president and chief executive officer of BioSante. "Since we continue to make progress in development of our hormone therapy gel products, our objective was to fund our work in a way that maximizes stockholder value. Teva is impressive since they are a multinational pharmaceutical company with an excellent track record of sales and marketing in the U.S. and collaborations with U.S. companies. With this Teva license agreement, we can continue to fund development and be ready to capture significant market share on introduction of any product we jointly develop."

"We are pleased to be working with BioSante in the field of hormone therapy," said George Barrett, president of Teva Pharmaceuticals USA. "We are impressed with BioSante's technologies as well as its management team, which has a successful track record in the development of hormone therapy products. The product resulting from this collaboration will complement Teva's broad basket of products which we offer to the U.S. pharmaceutical market."

BioSante currently is developing several hormone therapy products, including Bio-T-Gel, bio-identical testosterone gel for men; Bio-E- Gel, bio-identical estradiol gel for women; and LibiGel, bio-identical testosterone gel for treatment of female sexual dysfunction, as well as combinations of these hormones. In addition, a combination hormone therapy gel product containing estradiol and progestin is being developed under a license with Solvay Pharmaceuticals, B.V. The U.S. market for hormone therapy products is approximately $2.5 to $3.0 billion in annual sales.