EDEX Granted Approvable Letter by FDA; Schwarz Pharma Provides New Product for Impotence Treatment.

MEQUON, WI--(HealthWire)--November 20, 1996--Schwarz Pharma today announced the receipt of an approvable letter from the United States Food and Drug Administration (FDA) for EDEX(TM) (alprostadil for injection). EDEX was developed to treat erectile dysfunction, which affects more than 10 million American men and their partners. In guidelines issued earlier this month, the American Urological Association noted intracavernous injection of alprostadil as a safe and effective treatment for impotence. Schwarz Pharma plans to begin marketing EDEX following final FDA marketing clearance.

With self-injection of EDEX, 97% to 99% of patients with erectile dysfunction who chose at-home treatment achieved erections sufficient for intercourse. More than 15,400 self-injections were performed, and more than 90% delivered satisfactory responses, ultimately providing both patient and partner satisfaction. EDEX has an excellent safety profile, determined through clinical trials involving 1,065 patients with erectile dysfunction. The most common side effect experienced by patients was penile pain reported by 31% of EDEX patients versus 9% of placebo patients. EDEX will be marketed in four convenient dosage strengths of 5, 10, 20 and 40 mcg, and EDEX does not require refrigeration.

"We are extremely pleased that the FDA has issued an approvable letter for EDEX," said Klaus Juelicher, President of Schwarz Pharma. "Schwarz Pharma is committed to patient health care needs and to providing high quality products at the best price. EDEX proudly continues the Schwarz Pharma tradition." Schwarz Pharma is a pioneer in the research of PGE1 with an emphasis on erectile dysfunction.

"I have had extensive experience working with EDEX during the product's clinical trials, and am pleased with the results," said Irwin Goldstein, MD, Professor of Urology at Boston University's Department of Urology. "My patients have found EDEX to be effective, and easy to use. EDEX offers an important new option in the treatment of impotence."

Schwarz Pharma's current relationship with Urologists with it's Levsin family of products will be expanded to all those managing erectile dysfunction now and in the future. "We have a long standing relationship with Urologists worldwide that we are very proud of," noted Juelicher. "Our commitment is to help physicians and other healthcare professionals support patients by providing innovative medication and information through education."

Schwarz Pharma, Inc. is a member of the Schwarz Pharma USA family of companies (Schwarz Pharma, USA). Schwarz Pharma USA is a fully integrated pharmaceutical company based in Mequon, Wisconsin, with over 700 employees and sales of approximately $200 million. Schwarz Pharma USA is owned by Schwarz Pharma AG, an international pharmaceutical company headquartered in Monheim, Germany.

CONTACT: Schwarz Pharma

Dave Eddy, Manager, Drug Information

1-800-558-5114 or [e-mail]

or

Burns McClellan

Scott Storbo

[phone] or [e-mail]