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Vivus sells off erectile dysfunction drug

Vivus has sold its Muse (transurethral alprostadil) erectile dysfunction drug business to Meda in a deal potentially worth $23.5m
Vivus has sold its Muse (transurethral alprostadil) erectile dysfunction drug business to Meda in a deal potentially worth $23.5m.  

Under the deal, Meda has acquired Muse assets including US and foreign patents, existing inventory and the New Jersey manufacturing facility for the product. It has also taken on most of the Vivus employees who worked in the Muse business, including the field sales force for the product. 

The deal included an upfront cash payment of $22m plus potential one-time $1.5m milestone tied to future sales of the erectile dysfunction drug. Meda has been the European distributor of Muse since 2002, and the two companies agreed to the asset acquisition deal in early October of this year. 

Vivus said the sale would allow the company to focus on the approval and commercialisation of its obesity drug candidate Qnexa (phentermine/topiramate) and the development of the new erectile dysfunction therapy avanafil. 

The company is currently working on preparing a written reply to a Complete Response Letter that it received from the US Food and Drug Administration (FDA) in late October stating that the marketing application for Qnexa cannot be approved in its current form. Part of that response will include the final study report from a recently completed trial showing significant and sustained weight loss of more than 10 percent over two years, according to the company.  

The FDA has also requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential, including a risk-management plan regarding the use of the drug in women of childbearing age. 

In addition, the agency has asked for data to prove that an elevation in heart rate that is associated with phentermine/topiramate does not increase the risk for major adverse cardiovascular events. 

Qnexa is also in phase II development for the treatment of type 2 diabetes and obstructive sleep apnea. Vivus' PDE5 inhibitor avanafil is in phase III studies for erectile dysfunction. 

9th November 2010

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