VIVUS Enters Into 30 Million Dollars Funding Collaboration For The Phase 3 Studies Of Avanafil For Erectile Dysfunction
"The collaboration with Deerfield allows us to move avanafil into the phase 3 clinical trials on a timely basis. The funding collaboration provides us with financial flexibility and allows us to leverage the MUSE franchise for the benefit of avanafil development. Deerfield is a well-respected healthcare investment organization. Their interest in avanafil for ED and in becoming a shareholder of VIVUS is significant," commented Leland Wilson, President and Chief Executive Officer. "The market for ED therapies continues to grow. In 2007, sales of all PDE5i's exceeded $3 billion, an increase of 15% over the previous year. Given the profile of avanafil and the results seen to date, we believe that if approved, avanafil could offer patients suffering from ED a satisfying treatment alternative."
"Avanafil has a proven mechanism of action and a unique and attractive profile," said Howard Furst, M.D., a partner at Deerfield Management. "We are pleased to have entered into this collaboration with Vivus that provides full funding for phase 3 while avoiding significant shareholder dilution."
Under the terms of the Royalty and Funding Agreement, Deerfield will provide VIVUS $20 million of funding in the first 18 months of the collaboration. In consideration for the funding, Deerfield will receive a royalty on product sales of MUSE and if approved, product sales of avanafil. VIVUS and Deerfield have also entered into an Option and Put Agreement that allows VIVUS to purchase the royalty stream from Deerfield and allows Deerfield, under certain conditions, to require VIVUS to purchase the royalty stream from Deerfield. VIVUS, entirely at its discretion, can buy back the royalty stream at any time in the first three years of the collaboration for $25 million. In the fourth year, the purchase price increases to $28 million. For this purchase right, VIVUS will make a $2 million upfront payment to Deerfield which will be credited to the purchase price if VIVUS exercises its purchase option. Beginning the fourth year, Deerfield will have the right to sell its interests to VIVUS for a minimum of $17 million. Under certain circumstances, including a change in control, the right to sell the interests back to VIVUS held by Deerfield accelerates at amounts consistent with the VIVUS purchase rights. Once the royalty stream has been acquired by VIVUS, no additional royalty payments will be made to Deerfield.
About the Phase 2 Studies of Avanafil
VIVUS previously reported the results of the phase 2 study of avanafil in men with erectile dysfunction (ED) were positive. The phase 2 study was a multicenter, double-blind, randomized, parallel-design study conducted to assess the safety and efficacy of different doses of avanafil for the treatment of ED. Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. Results showed that up to 84% of avanafil doses resulted in erections sufficient for vaginal penetration, as compared to placebo (p
VIVUS intrã în 30 de milioane de dolari de finantare Colaborare Pentru Faza 3 studii de Avanafil Pentru disfuncþie erectilã - VIVUS Enters Into 30 Million Dollars Funding Collaboration For The Phase 3 Studies Of Avanafil For Erectile Dysfunction - articole medicale engleza - startsanatate