To: Tom Latham who wrote (29729 ) 12/17/1998 9:36:00 AM From: Rock_nj Read Replies (2) | Respond to of 119973
VVUS Receives European Approval: Thursday December 17, 7:31 am Eastern Time Company Press Release VIVUS' MUSE European Approval Triggers Country Licenses and Milestone Payments From ASTRA AB MUSE Also Approved in Australia MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 17, 1998--VIVUS, Inc. (Nasdaq:VVUS - news) today announced the approval of MUSE® (alprostadil) by the European Agency for the Evaluation of Medicinal Product (EMEA). This approval triggers the individual country licensing process. Licenses are expected during the first and second quarters of 1999 and MUSE launches by ASTRA AB into these countries are anticipated shortly after licensing. Upon receiving the licenses for MUSE in Italy, France, Spain and Germany, ASTRA AB will pay VIVUS a $2 million milestone payment for each license. VIVUS also announced today the approval of MUSE in Australia, bringing the number of countries in which MUSE has been approved to 33. ''ASTRA will launch MUSE throughout the European Union and Australia with the same excitement that led to the successful launches in the UK and Sweden. We are pleased to provide a safe alternative therapy for men seeking treatment for erectile dysfunction,'' said Jim Cuttle, Vice President, Marketing at ASTRA. VIVUS CEO Leland Wilson also commented on the Company's partnering strategy, ''In June, VIVUS suggested a time frame of six months in order to complete our partnering negotiations for MUSE in the United States. Although we are not prepared at this time to announce a partner, we have made significant progress in these negotiations. We believe that our position in these negotiations has been strengthened due to positive Company developments. Most recently, we announced the success of the MUSE launch in the Canadian marketplace. This news, combined with today's announcement of Australian and European Union approvals, demonstrates the progress the Company has made and the enthusiasm with which the product is being welcomed around the globe. Also adding strength to our negotiating position is the MUSE safety data that the Company reported on in November 1998. At that time, VIVUS released data demonstrating that there is no apparent increase in cardiovascular risk with renewed sexual activity in men using MUSE.'' Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. VIVUS has pioneered a novel therapy for erectile dysfunction known as MUSE® (alprostadil). This therapy consists of a proprietary, non-invasive drug delivery system that delivers pharmacologic agents via the urethra. Note to editors and investors: Additional written materials, recent releases and Company information are available through a variety of sources, including the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719). Contact: VIVUS Nina W. Ferrari, 650/934-5200 IR@VIVUS.COM