vivus sells evamist rights

VIVUS Agrees to Sell EvaMist Rights to KV Pharmaceutical
Friday March 30, 9:00 am ET
VIVUS Eligible to Receive $150 Million in Cash Payments Through NDA Approval


MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--VIVUS, Inc. (NASDAQ: VVUS - News) today announced that it had executed an agreement to transfer its exclusive rights and assets related to EvaMist(TM), an investigational metered dose transdermal estradiol spray for the treatment of menopause symptoms, to KV Pharmaceutical Company (the "Transaction"). The closing of the Transaction is expected to occur by mid 2007 following the satisfaction of various closing conditions as well as the completion of a review by the Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the Transaction, VIVUS is eligible to receive an upfront payment of $10 million upon the closing and an additional $140 million upon the approval of the New Drug Application ("NDA") for EvaMist currently under review by the Food and Drug Administration. VIVUS may also receive milestone payments of up to $30 million based on sales of EvaMist through the term of the agreement.

Upon the closing of the Transaction, KV Pharmaceutical will be responsible for the manufacturing, selling, marketing and regulatory requirements once the product is approved. VIVUS previously submitted the NDA for EvaMist on September 29, 2006. The PDUFA date is July 29, 2007. KV Pharmaceutical will also assume all additional expenses and liabilities associated with EvaMist.

"KV, with its strong women's health franchise, is the ideal company to maximize EvaMist's potential in the US," said Leland F. Wilson, President and Chief Executive Officer for VIVUS. "If approved, EvaMist will provide an important new treatment option for women suffering with the symptoms of menopause, and we are pleased to be able to have a company such as KV, with an exceptional infrastructure already in place, including 285 sales representatives and sales management personnel in their Ther-Rx division, to quickly bring the benefits of EvaMist to patients."

Marc S. Hermelin, KV's Chairman of the Board and Chief Executive Officer stated, "EvaMist is a great strategic fit with our Ther-Rx women's health franchise, an area in which we are devoting significant R&D resources to expand our footprint. EvaMist targets a new and compelling market for Ther-Rx with great growth potential, menopause, with an innovatively delivered drug that is designed to promote patient compliance. Upon approval, we will be able to leverage the promotion of this product through our current branded sales force, focusing on the specific targets of OB/GYN and select primary care physicians that write for Estrogen Replacement Therapy. EvaMist has the potential to be one of Ther-Rx's largest products in terms of revenue."

In clinical trials, EvaMist has been shown to reduce the number and severity of hot flashes in post-menopausal women. Once approved, KV will promote EvaMist to the OB/GYN community that currently treats postmenopausal women. In 2006, sales of all prescription estrogen products were approximately $1.5 billion, with the transdermal segment of the market approaching $300 million.