Friday, May 18, 2012

BioSante to seek in-licensing of products

December 15, 2011 by · Leave a Comment 

BioSante Pharmaceuticals (NASDAQ: BPAX) plans to actively seek to in-license new products in an attempt to rebuild the value of the company, CEO Stephen Simes said in a telephone interview with BioTuesdays.com.

Stephen M. Simes

“We are in the enviable position of having $56 million in cash at a time when there are products out there that deserved to be developed for want of funding. So, perhaps we can rebuild the value of BioSante by bringing in other products and doing what we do best, which is product development.”

Mr. Simes made his comments following results of two pivotal efficacy trials with its LibiGel testosterone gel that failed to meet co-primary and secondary endpoints. LibiGel is in development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder in postmenopausal women, for which there is no FDA-approved product.

“We are evaluating the efficacy studies of LibiGel to see if there is any subgroup of patients that might indicate better efficacy,” Mr. Simes said. Assuming there is, the company plans to maintain an ongoing Phase 3 cardiovascular and breast cancer study.

If the company is unable to find a subset of women who “can respond so that we can show in a clinical trial a separation from placebo, we would then stop the safety study,” he said. “That’s a decision we hope to make in the relative near-term and I’m not sure if its weeks or months, but it will be very soon.”

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