FIRST REGULATORY APPROVAL FOR THYMOSIN ALPHA 1
FIRST REGULATORY APPROVAL FOR THYMOSIN ALPHA 1 WASHINGTON, May 15 /PRNewswire/ -- Alpha 1 Biomedicals, Inc.
(NASDAQ: ALBM) has been informed by its Italian licensee, Sclavo, S.P.A. (Siena, Italy), that Thymosin alpha 1 has received approval from the Italian Ministry of Health for the primary imunodefiencies and as an adjuvant for influenza vaccine in renal dialysis patients. This is the first regulatory approval in any country for Thymosin alpha 1. Prior to actual sales in Italy, the Italian government must establish a public price for Thymosin alpha 1.
Dr. Vincent F. Simmons, president and chief executive officer of Alpha 1 Biomedicals, Inc., stated "The regulatory approval of Thymosin alpha 1 in Italy is a major turning point for Alpha 1 Biomedicals. We are beginning the evolutionary process of changing from a development stage company into an operating company. Sclavo anticipates pricing approval in the near future but expects initial sales to be modest. Alpha 1 Biomedicals will manufacture and supply bulk Thymosin alpha 1 to Sclavo for commercial sales and will receive both manufacturing revenue and royalties." One of the approved indications is treatment of primary immune- deficiencies which are congenital or inherited abnormalities which result in impaired T-cell function. As a consequence, the infants and young children who have these diseases suffer from recurring, antibiotic-resistant infections that are life-threatening. Among the diseases in this category are DiGeorge Syndrome, Ataxia Telangiectasia and Mucocutaneous Candidiasis. The second indication is an influenza vaccine adjuvant for use in immune depressed patients undergoing renal dialysis. In the United States, Alpha 1 Biomedicals is conducting a randomized, double-blind, multi-center trial using Thymosin alpha 1 for the treatment of chronic hepatitis B. The results of the U.S. trial are not expected to be available until the latter half of 1993. Thymosin alpha 1 is also being evaluated in a U.S. trial in combination with interferon for the treatment of chronic active hepatitis C. Alpha 1 Biomedicals, Inc. is a Washington, D.C.-based company engaged in the development of pharmaceutical products for the treatment of human immune disorders. -0- 5/15/92 /CONTACT: Judith A. Hautala of Alpha 1 Biomedicals, 202-628-9898, or Anita Monteith-Dixon of Long Ridge Associates, 203-790-0647, for Alpha 1 Biomedicals/ (ALBM) CO: Alpha 1 Biomedicals, Inc. ST: District of Columbia IN: MTC SU:
SH-0TQ -- NY013 -- 0615 05/15/92 09:27 EDT
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|Date:||May 15, 1992|
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