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Vivus licenses US, Canadian Stendra rights to Auxilium under $300-million deal


Vivus signed a licensing agreement potentially worth up to $300 million giving Auxilium Pharmaceuticals exclusive rights to market the erectile dysfunction (ED) therapy Stendra (avanafil) in the US and Canada, the companies reported Friday. «We believe Stendra complements our current portfolio of testosterone replacement therapy and ED products, further broadening our men’s health care franchise," remarked Auxilium CEO Adrian Adams.

Stendra, an oral phosphodiesterase type 5 (PDE5) inhibitor, wasapproved by the FDA for the treatment of ED in April last year. Auxilium said it expects to launch the product by the end of 2013, with shipments beginning in December and promotional activities starting in early January 2014. «We look forward to working with Auxilium as they prepare for launch," commented Vivus CEO Seth H. Z. Fischer.

Under the deal, Vivus will receive payments from Auxilium based on certain regulatory and sales milestones, including an upfront licensing fee of $30 million, in addition to royalties. The drugmakers also signed a supply agreement pursuant to which Vivus will be initially responsible for the manufacture and supply of Stendra to Auxilium.

The companies also noted that Vivus is entitled to receive a $15 million payment contingent upon a potential label amendment regarding onset-of-action. Under the agreement, Vivus will continue to be responsible for Stendra’s post-approval requirements in the US, including the potential label amendment based on results of the TA-501 study, which is designed to assess the efficacy of the drug in approximately 15 minutes.

Vivus licensed global rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries, from Mitsubishi Tanabe Pharma. The drug was approved earlier this year under the name Spedra in Europe, where Vivus granted rights to Menarini. Vivus noted that it is in talks with other companies for marketing rights in its remaining territories.

Sources: firstwordpharma.com

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