To: wvalx who wrote (21575 ) 5/4/1999 10:12:00 AM From: Joe Reich Read Replies (1) | Respond to of 23519
This is the only thing to come over the wire this morning: TAP Pharmaceuticals' Male Erectile Drug Shows Promise /FROM PR NEWSWIRE CHICAGO 888-776-6551/ TO MEDICAL AND BUSINESS EDITORS: TAP Pharmaceuticals' Male Erectile Drug Shows Promise -- Three Phase III Studies Presented -- DEERFIELD, Ill., May 4 /PRNewswire/ -- Data from three Phase III studies presented today at the American Urological Association meeting in Dallas, Texas, suggest that TAP's dopamine receptor agonist, UPRIMATM (apomorphine HCL tablets) sublingual, can increase the number of successful intercourse attempts. UPRIMA is a central initiator that works by stimulating an erection through mechanisms originating in the brain. TAP anticipates utilizing these data in supporting a New Drug Application in mid-1999. "The results of this study are promising and provide hope for the approximately 30 million Americans who suffer from some form of erectile dysfunction," says Harin Padma-Nathan, M.D., director, The Male Clinic, Beverly Hills, Calif., and an investigator in the studies. Erectile dysfunction is defined as the inability to obtain and maintain an erection sufficient for intercourse. The three studies were multicenter, double-blind studies where patients were randomized to four treatment arms of UPRIMA versus placebo -- 2 mg, 4 mg, 5 mg and 6 mg. The studies measured the number of attempts resulting in an erection firm enough for intercourse. Dr. Padma-Nathan presented the following: The first presentation consisted of data from a study that evaluated 520 male erectile dysfunction patients and found that the UPRIMA doses demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo (2 mg group -- 44 percent vs. 38 percent; 4 mg group -- 58 percent vs. 37 percent; 5 mg group -- 53 percent vs. 29 percent and 6 mg group -- 61 percent vs. 29 percent; respectively). Ronald Lewis, M.D., chief of neurology, Medical College of Georgia, presented the following: The second presentation consisted of data from two studies and found similar results in hypertension patients. Hypertension is associated with erectile dysfunction. The study evaluated 977 patients, of which 236 were hypertensive, and found that the UPRIMA doses also demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo (2 mg group -- 42 percent vs. 32 percent; 4 mg group -- 51 percent vs. 28 percent; 5 mg group -- 46 percent vs. 30 percent; and 6 mg group -- 63 percent vs. 33 percent; respectively). The most common adverse event reported in these studies was nausea, mostly mild-to-moderate. "TAP is encouraged by these results, particularly because there are limited options available for men who suffer from erectile dysfunction," says Thomas Watkins, president, TAP Pharmaceuticals Inc. TAP Holdings Inc., the parent company of TAP Pharmaceuticals Inc., is a joint venture between Abbott Laboratories (NYSE: ABT), headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd. of Osaka, Japan. Abbott and Takeda will jointly develop and co-market apomorphine in the countries outside of the United States and Canada. TAP also markets Lupron Depot(R) (leuprolide acetate for depot suspension) and PREVACID(R) (lansoprazole). SOURCE TAP Holdings, Inc. /CONTACT: Kim Modory of Abbott Labs, 847-236-2461, or pager,800-759-8888, PIN 1252283/ /Company News On-Call: prnewswire.com or fax,800-758-5804, ext. 110328/ /Web site: abbott.com May-04-1999 08:48 GMT Symbols: US;ABT Source PRN PR NewsWire Categories: NWR/IL NWR/TX NWI/MTC NWS/PDT