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| |  VIRAMUNE Now Commercially Available for the Treatment of HIV COLUMBUS, Ohio, Aug. 7, 1996-- Roxane Laboratories today announced that distribution has begun for VIRAMUNE(R) (nevirapine), the first drug in a new class of compounds called non-nucleoside reverse transcriptase inhibitors (NNRTI's). NNRTI's have a unique mechanism of action and a distinct side effect profile from nucleoside analogues and protease inhibitors, the other two classes of agents approved to treat HIV. VIRAMUNE(R) was granted accelerated approval by the Food and Drug Administration on June 21, 1996, for use in combination with nucleoside analogues for the treatment of HIV infected adults who have experienced clinical and/or immunologic deterioration. The wholesale acquisition cost for VIRAMUNE(R) is $6.88 per day, for the standard maintenance dose of one 200 mg tablet taken twice daily. "We have worked closely with the AIDS community throughout the development of VIRAMUNE(R), which included establishing the appropriate price for the drug," said Ed Tupa, Vice President for marketing at Roxane Laboratories. "This price, when compared to the currently approved protease inhibitors which range from $12-$18 per day, is significantly lower." Dr. Maureen Myers, Director of Clinical Virology at Boehringer Ingelheim Pharmaceuticals Inc. said, "VIRAMUNE(R) should be considered as a reasonable alternative to a protease inhibitor in triple combination regimens. It is potent, generally well-tolerated, simple to take, and more economical." Since March of this year, VIRAMUNE(R) has been available to patients through an Expanded Access program. There will be a transition period for those patients enrolled in the Expanded Access program to ensure that those patients will have no interruption in treatment. Roxane Laboratories also announced that it will establish a Reimbursement Hotline to assist physicians and patients in securing reimbursement for VIRAMUNE(R). The company is working with Medicaid, State ADAP programs and other third parties to establish adequate reimbursement for VIRAMUNE(R). For patients without adequate insurance coverage, Roxane Laboratories has established a comprehensive Patient Assistance Program. Roxane Laboratories Inc., of Columbus, Ohio, a subsidiary of Boehringer Ingelheim Corporation, is a leader in palliative care therapy. Roxane Laboratories now manufactures a broad range of pharmaceuticals, including treatments for pain in AIDS and cancer, an antinauseant for cancer chemotherapy, and an appetite stimulant for AIDS. Boehringer Ingelheim Corporation is a member of the Boehringer Ingelheim Worldwide group of companies, based in Ingelheim, Germany. A privately-held company founded in 1885, Boehringer Ingelheim is a major pharmaceutical, chemical, animal health, and bakery products manufacturer with operations in more than 100 countries around the world. VIRAMUNE(R) is a product of original research done at Boehringer Ingelheim Pharmaceuticals Inc., located in Ridgefield, CT., which is a sister company of Roxane Laboratories, Inc.
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