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 for EvaMist. 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. KV Pharmaceutical will also assume all additional expenses and liabilities associated with EvaMist.
Marc Hermelin, KV’s chairman of the board and CEO, said: “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 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 said that it intends to 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.