KV Pharmaceutical Company announced that Vivus, Inc. has received US Food & Drug Administration (FDA) approval for the marketing of Evamist, for which KV recently acquired exclusive US marketing rights from Vivus.
This approval marks the FDA's first approval of an estradiol transdermal spray. KV will market the product as part of its Ther-Rx Corporation subsidiary's women's health product line. Evamist is a metered dose transdermal estradiol spray for the treatment of moderate to severe vasomotor symptoms due to menopause.
The company previously announced the agreement with Vivus for the grant of a sublicense of exclusive rights and sale of assets related to Evamist in March 2007. Under the terms of the transaction, Vivus is eligible to receive a $140 million cash payment upon the approval of its New Drug Application (NDA) for Evamist. The payment is expected five days after the transfer of the NDA to KV. The transaction also calls for two one-time success milestone payments of up to $30 million which would be payable to Vivus after stepped milestone annual sales levels are achieved.
Marc S. Hermelin, chairman of the board and chief executive officer of KV stated, "We are extremely pleased that VIVUS was successful in obtaining FDA approval on what we consider to be an exciting new product opportunity for our branded subsidiary, Ther-Rx Corporation. We believe our existing presence in the women's health market and our specialized focus on the OB/GYN community through our dedicated sales force will allow us to successfully promote the benefits of Evamist to physicians and patients. We look forward to launching this product during the second half of fiscal 2008 and to its contribution to the growth of our branded business moving forward."
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures and markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products.
Vivus, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health. Vivus has three investigational products that are positioned to enter phase 3 clinical trials.