Healthcare Industry News: estradiol
News Release - May 16, 2007
VIVUS Closes EvaMist Transaction with KV PharmaceuticalVIVUS Receives Initial Payment of $10 Million
MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--VIVUS, Inc. (NASDAQ: VVUS ) today announced that it has closed the previously announced transaction with KV Pharmaceutical Company ("KV") for the grant of a sublicense of exclusive rights and sale of assets related to EvaMist(TM), an investigational metered dose transdermal estradiol spray for the treatment of menopause symptoms (the "Transaction"). At the closing, VIVUS received a cash payment of $10 million. All of the closing conditions set forth in the Transaction have been satisfied. The waiting period required by the Federal Trade Commission expired on May 14, 2007 at 11:59 pm eastern time.
Under the terms of the Transaction, VIVUS is also eligible to receive an additional $140 million cash payment upon the approval of the New Drug Application ("NDA") for EvaMist. The NDA for EvaMist is currently under review by the Food and Drug Administration ("FDA"). VIVUS may also receive certain one-time milestone payments of $10 million to 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.
KV Pharmaceutical will be primarily responsible for the manufacturing, selling, and marketing. VIVUS will maintain responsibility for regulatory affairs related to the NDA through its approval by the FDA, at which time regulatory responsibilities will transfer to KV. VIVUS previously submitted the NDA for EvaMist on September 29, 2006. The PDUFA date is July 29, 2007.
"It is rewarding for us to reach this important milestone of closing the transaction with KV," said Leland F. Wilson, President and Chief Executive Officer for VIVUS. "We are very pleased to have KV as a partner and we believe they are making great progress towards market launch. It is rewarding to share the vision with our partner of the potential of this unique product."
EvaMist is a patent protected, estradiol spray investigational product that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin for the treatment of vasomotor symptoms (hot flashes) associated with menopause. EvaMist is placed gently against the skin and an actuator button is pushed, releasing a light spray containing a proprietary formulation of estradiol. estradiol is designed to be released into the blood stream on a sustained basis over 24 hours. EvaMist is fast drying, non-irritating and invisible after application.
Approximately two million American women turn 50 each year. Women naturally enter into menopause usually between the ages of 45 and 55; however, surgical menopause may happen at any age. Menopausal symptoms occur when the ovaries stop producing estrogen. Symptoms include hot flashes, discomfort or pain during sexual intercourse due to vaginal atrophy (thinning of the vagina), and changes in skin and hair.
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three investigational products that are positioned to enter Phase 3 clinical trials, and one investigational product currently under NDA review by the FDA. The investigational pipeline includes: Qnexa(TM), for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS®, for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist(TM), for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; and avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE® is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
About KV Pharmaceutical Company
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. The Company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. For further information about KV Pharmaceutical Company, please visit the Company's corporate website at www.kvpharmaceutical.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; the pivotal trial design, the number of patients required and cost estimates to complete all the necessary studies of Qnexa and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the EvaMist NDA submission will be approved in a timely basis, or at all. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2006 and periodic reports filed with the Securities and Exchange Commission.
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