Printer Friendly

MEDIMMUNE AND NEW YORK BLOOD CENTER ANNOUNCE FILING WITH FDA FOR MARKETING APPROVAL OF INTRAVENOUS IMMUNE GLOBULIN PRODUCT

 GAITHERSBURG, Md., Oct. 29 /PRNewswire/ -- MedImmune, Inc. (NASDAQ-NMS: MEDI) and the New York Blood Center today announced the filing by the New York Blood Center of a Product License Application (PLA) with the United States Food and Drug Administration (FDA) for MelGAM(TM). MelGAM(TM) is a liquid intravenous immune globulin (IVIG) treated with a patented solvent/detergent process to inactivate viruses in plasma proteins. MelGAM(TM) was developed by Melville Biologics, a division of the New York Blood Center. As previously announced in September 1993, MedImmune signed a letter of intent to acquire Melville Biologics, including rights to MelGAM(TM). MedImmune and the New York Blood Center expect to complete the transaction later this year.
 "We are pleased with the progress Melville continues to make in developing blood derived therapies," said Wayne T. Hockmeyer, Ph.D., Chief Executive Officer. "We believe that MelGAM(TM) has the potential to be an important addition to MedImmune's product portfolio."
 The PLA is seeking approval to market MelGAM(TM) for primary humoral immunodeficiencies and for idiopathic thrombocytopenic purpura (ITP). If and when approved for marketing by the FDA, MelGAM(TM) will compete with several existing intravenous immune globulin products which together comprise a market in the U.S. estimated to exceed $250 million.
 In addition to the MelGAM(TM) PLA, the New York Blood Center filed a PLA in February 1993 for MelPLAS(TM), a virally inactivated fresh frozen plasma for transfusion product. Rights to MelPLAS(TM) will be included in the sale of Melville Biologics to MedImmune. MedImmune also filed a PLA in December 1992 for the Respivir(TM) product, a polyclonal antibody product for prevention of respiratory syncytial virus infection in certain high risk infants. The PLAs for MelGAM(TM), and Respivir(TM) are currently under review for marketing approval by the FDA.
 New York Blood Center, a not for profit corporation, is the largest independent blood collection agency in the United States. The Blood Center provides blood and blood products for the 18 million people in the New York/New Jersey metropolitan area.
 MedImmune, Inc. was formed in 1988 to develop manufacture and market therapeutics and vaccines for the treatment and prevention of certain infectious diseases and cancers. MedImmune's corporate headquarters are in Gaithersburg, Md.
 -0- 10/29/93
 /CONTACT: David M. Mott, Vice President, Business Development and Planning of MedImmune, 301-417-0770, or Anthony J. Russo, Ph.D., or Rhonda Chiger of Noonan/Russo Communications, Inc., 212-696-4455/
 (MEDI)


CO: MedImmune, Inc.; New York Blood Center ST: Maryland, New York IN: MTC SU:

TS-RW -- NY029 -- 8479 10/29/93 11:52 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Oct 29, 1993
Words:431
Previous Article:CALIFORNIA FEDERAL BANK OFFERS ASSISTANCE TO VICTIMS OF SOUTHERN CALIFORNIA FIRES
Next Article:TOREADOR UPDATES EXPLORATION ACTIVITY
Topics:

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