Berlex Laboratories files suit against FDA.WAYNE, N.J.--(BUSINESS WIRE)--April 26, 1996--On April 26 Berlex Laboratories Introduction Berlex Laboratories, Incorporated is a research-based pharmaceutical company headquartered in Montville, New Jersey with operations in Wayne, New Jersey; Bothell, Washington; Seattle, Washington; and Richmond, California. Inc. filed suit in the U.S. District Court for the District of Columbia District of Columbia, federal district (2000 pop. 572,059, a 5.7% decrease in population since the 1990 census), 69 sq mi (179 sq km), on the east bank of the Potomac River, coextensive with the city of Washington, D.C. (the capital of the United States). against the U.S. Food and Drug Administration to prevent the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. from granting marketing approval for a drug that is intended to treat multiple sclerosis (MS) but that has not been tested in MS patients. The product in question is Avonex, an interferon beta interferon beta Fibroblast interferon IFN-β A 20 kD anti-viral protein with 30% 'homology' with IFN alpha, encoded on chromosome 9, produced by fibroblasts in response to viruses or polyribonucleotides manufactured by Biogen Inc. Berlex Laboratories Inc. has brought this lawsuit to protect its rights and those of Rentschler Biotechnologie, a German company. This lawsuit was necessary because the FDA has departed from its prior practice and apparently intends to approve Biogen's product even though the pivotal clinical trial on which Biogen relies was conducted using Rentschler's original interferon beta product, and not the product that Biogen is seeking to market. Berlex has an October 1994 licensing agreement with Rentschler on that original interferon beta product. Berlex has attempted to work with the FDA to ensure that the original drug product, the one that was tested in MS patients, is the drug made available to patients with MS. Additionally, if the FDA approves the Biogen product, it will wrongfully take away from Berlex the marketing exclusivity for Betaseron(R), which was granted under the Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Act enacted by Congress in 1983. By taking away orphan drug exclusivity, the FDA would be effectively gutting the incentive that Congress provided to encourage the development of safe and effective drugs for rare diseases. At this time, Berlex Laboratories cannot comment further on pending litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . CONTACT: Berlex Laboratories Inc. Wendy Neininger, 201/292-8043 or Dr. Jeffrey Latts, 510/262-5036 |
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