Printer Friendly

MGI PHARMA ACQUIRES RIGHTS TO POTENTIAL NEW DRUG FOR CHRONIC DRY MOUTH; PRODUCT IN EARLY STAGE OF DEVELOPMENT

 MINNEAPOLIS, Jan. 14 /PRNewswire/ -- MGI Pharma, Inc. (NASDAQ: MOGN), a specialty pharmaceutical company, has acquired the rights to a patent issued in June 1991 that covers a new chemical entity that could potentially be more potent and have a longer lasting effect than Salagen(TM). Salagen is a drug that MGI Pharma has studied as a treatment for dry mouth caused by radiation used to treat head and neck cancers. The company submitted a New Drug Application (NDA) for Salagen to the Food and Drug Administration (FDA) in February 1992 and is currently awaiting approval.
 The new compound is a synthetic agent which has activity resembling the natural form of pilocarpine used in Salagen. Because it is a new chemical entity, this agent will be subjected to a full set of laboratory, animal and human studies before it can be submitted to the FDA for approval. These studies, which could take several years to complete, would be designed to determine whether the new agent offered a therapeutic advantage over Salagen.
 Kenneth F. Tempero, MGI Pharma's chairman and chief executive officer, stated "We are pleased with the long term opportunities this new drug provides us in continuing to develop meaningful and effective drugs for critically and chronically ill patients. We will begin conducting additional laboratory tests and animal studies in the near future. However, our immediate focus remains on supporting the current NDA for Salagen and successfully bringing that product to market. Should the new compound be developed in the future, it could prove to be an exciting alternative for dry mouth sufferers."
 Chronic dry mouth can be very severe and debilitating. It is caused by a variety of treatments and conditions, including radiation to treat head and neck cancer and an autoimmune disease called Sjogren's syndrome. Chronic dry mouth creates a great deal of pain, makes talking, eating and sleeping difficult, and causes rapid tooth decay. Patients' mouths are often so dry that the membranes crack, bleed and become infected. Currently available treatments are limited to saliva substitute products that act as wetting agents. These products have not been well received and most patent simply sip water constantly. Salagen, which is taken in tablet form, works by stimulating damaged salivary glands to produce more natural saliva.
 MGI Pharma has been actively involved in the development of treatments for chronic dry mouth. In addition to having completed the clinical studies and FDA application for Salagen as a treatment for radiation-induced dry mouth, the company is conducting Phase III clinical studies with Salagen to treat the dry mouth and dry eyes caused by Sjogren's syndrome.
 Salagen has been designated an orphan drug when used to treat both radiation-induced dry mouth and Sjorgen's syndrome. Orphan drug status provides the drug with seven years of market exclusivity following its approval from the FDA. Analysts have estimated the markets for each of these indications to be more than $50 million annually in the United States alone. As previously announced, the European marketing rights to Salagen have been licensed to EuroCetus B.V., Amsterdam, The Netherlands, a unit of Chiron Corporation (NASDAQ: CHIR).
 MGI Pharma acquires, develops and markets pharmaceuticals prescribed and recommended by physician specialists. Its initial focus is on developing products that improve the quality of life for critically and chronically ill patients. It currently sells DIDRONEL(R) I.V. Infusion and Oratect(R) Gel to cancer specialists throughout the United States. MGI Pharma is awaiting approval from the FDA for Salagen and has several additional products in various stages of clinical development.
 -0- 1/14/93
 /CONTACT: Lori Weiman of MGI Pharma, 612-939-4666/
 (MOGN)


CO: MGI Pharma, Inc. ST: Minnesota IN: MTC SU: PDT

DS -- MN004 -- 4771 01/14/93 10:09 EST
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:Jan 14, 1993
Words:620
Previous Article:MGI PHARMA EXPANDS PRODUCT PORTFOLIO WITH POTENTIAL CHEMOTHERAPY PRODUCTS; PRODUCTS HAVE LONG TERM FOCUS
Next Article:NORTHWEST AIRLINK TO BEGIN SERVICE BETWEEN THUNDER BAY AND MINNEAPOLIS/ST. PAUL
Topics:


Related Articles
MGI PHARMA'S SALAGEN(TM) DESIGNATED ORPHAN DRUG FOR SJOGREN'S SYNDROME
MGI PHARMA REPORTS FIRST QUARTER 1993 RESULTS
MGI PHARMA ACQUIRES NEW CHEMOTHERAPEUTIC TO TREAT NEOPLASTIC MENINGITIS
MGI PHARMA ANNOUNCES ACQUISITION OF NEW ANTI-ESTROGENIC CANCER AGENTS AT 1993 ANNUAL MEETING
MGI PHARMA'S SALAGEN(R) TABLETS "APPROVABLE" BY FDA; PRODUCT TREATS RADIATION-INDUCED DRY MOUTH IN HEAD AND NECK CANCER PATIENTS
MGI PHARMA's SALAGEN(R) TABLETS CLEARED FOR MARKETING BY FDA; PRODUCT TREATS RADIATION-INDUCED DRY MOUTH IN HEAD AND NECK CANCER PATIENTS
MGI PHARMA'S SALAGEN TABLETS NOW AVAILABLE THROUGHOUT UNITED STATES
MGI PHARMA ANNOUNCES ITS SAMPLING PROGRAM IS IMPACTING INITIAL PIPELINE DRAW DOWN OF SALAGEN TABLETS, LEADING TO LOWER THIRD QUARTER SALES
Positive Results from Clinical Studies with Salagen Tablets in Sjogren's Syndrome Patients Presented at International Dry Eye Conference
MGI Pharma Announces 1996 and Fourth Quarter Results; 1996 Product Sales Increase 40 Percent Over 1995

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