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Biotech / Medical : Barr Laboratory BRL -- Ignore unavailable to you. Want to Upgrade?


To: Mel Spivak who wrote (122)9/2/1998 12:53:00 PM
From: rkrw  Read Replies (1) | Respond to of 207
 
This is a solid drug for BRL. Big market for this type of contraceptive in Europe. Naturally none of the big pharmas will touch it here. If its marketed well, $50M in sales should be easy. Nice move today, stock was way oversold. Note that this is in JV with Gynetics, a privately held company.

Here's the release.

Wednesday September 2, 11:48 am Eastern Time

Company Press Release

SOURCE: Barr Laboratories, Inc.

Barr's First Proprietary Product
Receives FDA Approval; Contraceptive Product
Co-Developed with Gynetics, Inc.

POMONA, N.Y., Sept. 2 /PRNewswire/ -- Barr Laboratories, Inc. (NYSE: BRL - news) today announced that the first product from its proprietary product development program -- a contraceptive co-developed with Gynetics, Inc. -- has been approved by the U.S. Food & Drug Administration (FDA). The product, the PREVEN(TM) Emergency Contraceptive Kit, is the first FDA-approved product specifically designed to prevent pregnancy within 72 hours of sex.

Barr helped to develop and submit the new product application to the FDA and will manufacture the oral contraceptive tablets that are part of the PREVEN Kit in its New York area facilities. Gynetics will be responsible for marketing the product in the United States when it becomes available by prescription through healthcare professionals in the next few weeks.

''The approval of PREVEN marks a significant milestone for women's reproductive health and for our Company,'' said Bruce L. Downey, Barr's Chairman, President and CEO. ''Together with Gynetics, we have answered the FDA's call for a safe and effective contraceptive option that can help prevent the incidence of unwanted pregnancies and reduce abortions.'' The contraceptive tablets included in the PREVEN Kit are similar to those sold under brand names and routinely used for birth control. The tablets will have no effect on an existing pregnancy.

''We have made a commitment to build a strong line of female healthcare pharmaceuticals, including generic and proprietary therapies,'' Downey continued. ''This is our first NDA product and a model for the types of partnerships we are creating to leverage our drug development skills and expertise with hormonal agents into proprietary products that answer targeted healthcare needs. Our new
drug development efforts, launched less than 18 months ago, are already producing encouraging results.'' The Company currently has four additional proprietary products in various stages of
development.