PRNewswire - Monday September 21, 1998

The early access program for Agenerase will be open to begin enrollment of patients on September 21 and will include three options for obtaining the drug. One option will be to enroll in an open-label clinical trial to determine the effect of Agenerase on lipid metabolism (hyperlipidemia and lipodystrophy) in subjects experiencing these adverse effects and who are not failing current antiretroviral therapy. A second option will be to enroll in an open-label clinical trial which will evaluate Agenerase, or Agenerase together with a second protease inhibitor, in multi-drug regimens for patients who have failed a protease-containing combination. A third option is for patients who are failing their current therapies and need Agenerase to try to create a viable treatment regimen to meet their individual needs.

Regardless of which option physicians and patients opt for, patients need to have received prior treatment with at least one protease inhibitor in addition to fulfilling other standard criteria. Patients will also be strongly encouraged to start at least one other anti-HIV agent that they have not previously used.

"It is our hope that making Agenerase available through this early access program will enable patients who have failed previous treatment to construct alternative regimens which will fight the virus," said Lynn Smiley, M.D., vice president of HIV and OI clinical research at Glaxo Wellcome, the company that is developing Agenerase. "Furthermore, by taking this unique approach to an early access program, we hope to capture some clinical information regarding Agenerase that might help guide future antiretroviral treatment decisions."

Patients can be considered for inclusion in the early access program for Agenerase by having their physicians call 1-800-248-9757 on or after September 21, 1998. Details of each option, including enrollment criteria, will be provided to physicians seeking to enroll patients into the program.

Those patients who qualify for and are enrolled in any one of the three options will be provided Agenerase free of charge during the early access program through their physicians and will be counseled regarding dosing, compliance and adverse event reporting.

To date, data collected on more than 700 patients receiving Agenerase have suggested that the drug is generally well tolerated with few treatment- limiting adverse events. The most commonly reported adverse events in clinical trials of Agenerase have included nausea, headache, vomiting, rash and perioral parasthesia. Agenerase is dosed twice daily, once in the morning and once in the evening. In clinical trials, Agenerase was dosed without regard to food or water.

"This early access program for Agenerase will provide treatment experienced patients with a new protease inhibitor to which other investigational compounds can be added in hopes of creating a viable treatment regimen," said Jeffrey Goodgame, M.D., Associate Professor, University of Florida, Central Florida Research Initiative, Maitland, Fl.

Agenerase was discovered by scientists at Vertex Pharmaceuticals of Cambridge, Massachusetts. Glaxo Wellcome has been responsible for product formulation, manufacture of Agenerase, design and implementation of all clinical trials, as well as the regulatory submissions to the U.S. Food and Drug Administration. Glaxo Wellcome will also lead the commercialization efforts for Agenerase. Glaxo Wellcome Inc. is the pharmaceutical industry leader in HIV research and therapies. The company currently manufactures and markets Retrovir(R) (zidovudine, AZT) and Epivir(TM) (lamivudine, 3TC), as well as Combivir(R) (lamivudine/zidovudine) which combines Epivir and Retrovir into one tablet. The company also has submitted an application to the FDA to market the investigational new drug Ziagen(TM) (abacavir, formerly known as 1592), which is currently available through a separate expanded access program.

SOURCE: Glaxo Wellcome Inc.
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