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U.S. District Court defers immediate action in Berlex Laboratories suit against the U.S. Food and Drug Administration.

WAYNE, N.J.--(BUSINESS WIRE)--April 30, 1996--Berlex Laboratories Inc. was prepared for the action of the U.S. District Court in denying a temporary restraining order in the company's suit against the U.S. Food & Drug Administration.

Berlex was pleased that the court recognized the need to maintain the lawsuit and only denied the temporary restraining order because the FDA has not yet taken any action on the Biogen filing.

With this suit, Berlex seeks to protect the Orphan Drug exclusivity awarded to BETASERON(R) (interferon beta-1b) by the FDA in 1993. The case is highly technical and legally complex, involving issues of public health and the viability of the Orphan Drug Act. Berlex expects a preliminary injunction hearing to be set pending any FDA action; the company is looking forward to this kind of hearing which will provide a better opportunity to present the merits of the case.

Berlex introduced BETASERON(R), the first therapeutic treatment for multiple sclerosis (MS), into the U.S. market in July 1993. This therapy was developed under the Orphan Drug Act, and Berlex was granted marketing exclusivity through July 2000. More than 5-years of clinical trial data, and experience treating more than 40,000 patients attest to the safety and efficacy of BETASERON(R) for the treatment of MS.

While the company remans confident that BETASERON(R) is the superior therapy for treatment of MS, Berlex is fully prepared to endorse the availability of additional treatment approaches. Berlex has pointed out to the FDA the fact that the pivotal data presented by Biogen in the December 4, 1995 Advisory Panel were produced using Rentschler Biotechnologie's interferon beta. Berlex therefore had suggested to the FDA that the agency give approval to Rentschler Biotechnologie's beta interferon and to the Biogen product if that product proves to be identical to that tested in the pivotal clinical trial. This solution would have given MS patients access to all three therapies and would have promoted healthy competition between the two CHO-cell products and BETASERON(R).

The FDA has not accepted this Berlex proposal. Additionally, the FDA seems intent upon granting approval of the Biogen product. If this approval were connected to separate orphan drug exclusivity, there would be the risk that the Rentschler product, which is the original CHO-cell beta interferon, would be barred from the market for 7 years even though existing clinical data is entirely based on the Rentschler product. This result would have serious consequences because it would undermine the Orphan Drug ACT provisions which encourage companies to develop new medications for rare diseases.

CONTACT: Berlex Laboratories Inc.

Wendy Neininger, 201/292-8043
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Publication:Business Wire
Date:Apr 30, 1996
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