VIVUS Announces Sale of MUSE Assets to Meda
MOUNTAIN VIEW, Calif., Oct. 4 /PRNewswire-FirstCall/ — VIVUS, Inc. (Nasdaq: VVUS) today announced that it has entered into an asset purchase agreement with Meda – an international specialty pharma company – for MUSEÃ‚®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey. As part of the transaction, the existing VIVUS employees that are MUSE dedicated, including the field sales force, are expected to join Meda. VIVUS will retain all of the liabilities associated with the pre-closing operations of the MUSE business.
“We have been business partners with Meda in Europe for MUSE since 2000 and the acquisition of MUSE fits with their expansion plans,” stated Leland Wilson, chief executive officer of VIVUS. “The divestiture of MUSE to Meda will allow us to focus on our commercialization efforts for QNEXA for obesity and development of avanafil for erectile dysfunction. I appreciate all the efforts from those employees that have been involved with MUSE since its approval in late 1996. As part of the Meda urology portfolio, we expect MUSE to continue to meet the needs of ED patients and their providers for years to come.”
The acquisition price is $23.5 million, which includes an upfront cash payment of $22 million. VIVUS is eligible to receive a one-time milestone payment of $1.5 million based on future sales of MUSE. The transaction is subject to standard closing requirements and conditions. The transaction is expected to close on or before November 15, 2010.
In 1997, VIVUS commercially launched MUSE in the United States. MUSE was the first minimally invasive therapy for erectile dysfunction approved by the FDA. With MUSE, an erection is typically produced within 15 minutes of administration and lasts approximately 30 to 60 minutes. Alprostadil is the active pharmacologic agent used in MUSE. Alprostadil is the generic name for the synthetic version of prostaglandin E1, a naturally-occurring vasodilator present in the human body and at high levels in seminal fluid.
MUSE is designed to overcome the limitations of other available therapies through its unique product attributes. Because therapeutic levels of drug are delivered locally to the erectile tissues with minimal systemic drug exposure, MUSE is a relatively safe, local treatment that minimizes the chances of systemic interactions with other drugs or diseases. Because it mimics the normal vasoactive process, MUSE produces an erection that is more natural than those resulting from needle injection therapy, vacuum constriction devices or penile implants.
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead product in clinical development, QNEXAÃ‚®, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.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; 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 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, 2009 and periodic reports filed with the Securities and Exchange Commission.
CONTACT: -------- VIVUS, Inc. Investor Relations: Timothy E. Morris The Trout Group Chief Financial Officer Brian Korb 650-934-5200 646-378-2923
SOURCE VIVUS, Inc.