KV Pharmaceutical Company has completed its previously announced transaction with Vivus, Inc. for the sublicense of exclusive rights and purchase of assets related to EvaMist.
Under the terms of the all-cash transaction, KV agreed to pay $10 million at closing and to make an additional payment of approximately $140 million at the time of final approval from the US Food and Drug Administration. There are also two, one-time milestone payments tied to the net sales of the product. $10 million will be paid if the product achieves $100 million in net sales in a market year and up to $20 million will be paid if the product achieves $200 million in net sales in a market year.
EvaMist, which has completed phase III clinical trials, is a patented estradiol transdermal spray that offers a novel approach to the treatment of vasomotor symptoms associated with menopause. Upon approval, EvaMist is expected to significantly augment the women's health offerings of KV's branded subsidiary, Ther-Rx Corporation. With a PDUFA action date of July 29, 2007 from the FDA, KV currently expects that the product may be approved and launched during the second half of its fiscal 2008 which began April 1, 2007.
The product targets an annual $1.3 billion estrogen replacement market (Source: IMS NSP Audit, January 2006-December 2006) where physicians and patients are seeking an effective and safe, low-dose estrogen product. The company estimates EvaMist's US market potential to be approximately $125 million in peak, annual net sales with gross margins consistent with those currently being achieved by Ther-Rx Corporation. KV believes EvaMist will offer therapeutic effectiveness with estradiol dosing that is among the lowest available for this indication in a manner that is also cosmetically appealing for women.
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 next-generation therapeutic products addressing obesity and sexual health.