Printer Friendly

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
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:May 15, 1992
Words:392
Previous Article:STAGE II APPAREL RESUMES CASH DIVIDEND
Next Article:ALL CHILDREN'S HOSPITAL WING DEDICATED TO AMOCO DEALERS AND JOBBERS
Topics:


Related Articles
ALPHA 1 BIOMEDICALS COMPLETES ACQUISITION OF U.S. RIGHTS TO THYMOSIN ALPHA 1 FROM HOFFMANN-LA ROCHE
ALPHA 1 BIOMEDICALS RECEIVES THE FIRST COMMERCIAL ORDER FOR THYMOSIN ALPHA 1
THYMOSIN ALPHA 1 TO BE EVALUATED IN CLINICAL TRIAL IN MEXICO
SCHERING-PLOUGH LICENSES FROM SCICLONE POTENTIAL HEPATITIS TREATMENT IN JAPAN
SCICLONE PHARMACEUTICALS ANNOUNCES CLINICAL DEVELOPMENT/COMMERCIALIZATION AGREEMENT WITH SCHERING-PLOUGH K.K.
SCICLONE PHARMACEUTICALS ANNOUNCES APPROVAL TO BEGIN CLINICAL TRIALS IN JAPAN FOR THYMOSIN ALPHA 1
ALPHA 1 BIOMEDICALS APPOINTS MARTIN ROSE SENIOR VICE PRESIDENT, CLINICAL AND REGULATORY AFFAIRS
ALPHA 1 BIOMEDICALS ANNOUNCES MANUFACTURING AGREEMENT FOR THYMOSIN ALPHA 1
ALPHA 1 BIOMEDICALS SIGNS DEFINITIVE MERGER AGREEMENT
ITALIAN RESEARCHERS REPORT PROMISING RESULTS IN PHASE III STUDY OF THYMOSIN ALPHA 1 AS IMMUNE SYSTEM ENHANCER

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters