PRNewswire - Monday November 2, 1998

Agenerase is a protease inhibitor, a class of anti-HIV medicines that, in combination with two new nucleoside reverse transcriptase inhibitors, has been associated with significant improvement in clinical outcomes in the management of HIV infection. Agenerase is well-tolerated and, unlike most existing protease inhibitors, provides a twice daily dosing regimen which can be important in improving patient adherence. In clinical trials, Agenerase was dosed without regard to food or water intake.

Peter Young, Vice President Therapeutic Development, HIV and Opportunistic Infections said, "The Agenerase submissions made in the European Union, USA and Canada follow the international submissions for Ziagen(TM)(abacavir), made earlier this summer. Together, they reflect the company's commitment to making innovative anti-HIV medicines available to people with HIV/AIDS and demonstrate its sustained leadership in this field."

"Agenerase was designed to address key issues of HIV therapy, and the expanding use of protease inhibitors in Europe is an encouraging sign that Agenerase will be adopted as an important new drug for use against HIV infection," commented Dr. Joshua Boger, Chairman, President, and CEO of Vertex. "A number of key studies involving Agenerase have taken place in Europe, and this firsthand clinical experience should contribute to a broad base of support for the drug among European physicians who treat HIV patients."

The highly significant benefits of Agenerase were demonstrated by preliminary phase III clinical trial data which were presented recently at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, 24 to 27 September 1998. These showed that, in an intent-to-treat analysis (considered to be the most conservative and stringent statistical analysis), 59 percent of adult trial participants in the arm containing Agenerase in combination with Retrovir(R) (zidovudine; AZT) and Epivir(R)(lamivudine; also known as 3TC(R)) had plasma levels of HIV RNA reduced to less than 400 copies/ml at 16 weeks. By contrast, in the control arm of Epivir and Retrovir alone, 17 percent of participants had less than 400 copies/ml at 16 weeks. A separate as-treated analysis (which included only patients who remained on study medication) showed that 88 percent of patients who received Agenerase+Retrovir+Epivir had plasma levels of HIV RNA reduced to less than 400 copies/ml at 16 weeks compared to 19 percent of patients who received Epivir+Retrovir.

Over 1,200 people around the world are currently being treated with Agenerase through clinical trials and expanded access in the United States. Agenerase is dosed as 1200 mg (eight 150 mg capsules) twice daily and, in clinical trials, was taken without regard to food or water. The dose studied in children has been 20 mg/kg of body weight twice daily. A 50 mg pediatric formulation and an oral solution of Agenerase have also been developed and are included in the marketing application. An oral solution of Agenerase has now also been included in the application for market approval in the United States.

Glaxo Wellcome is a research-based company bringing innovative medicines and services to patients throughout the world and to the healthcare providers who serve them. Besides Agenerase, Glaxo Wellcome has a broad portfolio of anti-HIV medicines including the already marketed treatments Combivir, Epivir, Retrovir, as well as Ziagen, a new nucleoside reverse transcriptase inhibitor for which regulatory submissions were made in June 1998 in the United States, European Union and Canada. In 1997 the Company spent 1.2 billion pounds sterling on research and development which included an extensive basic research program for HIV, embracing virology and vaccines.

Agenerase was discovered by scientists at Vertex Pharmaceuticals and developed by Glaxo Wellcome under a license agreement.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - news) is engaged in the discovery, development and commercialization of novel, small molecule pharmaceuticals for the treatment of diseases for which there are currently limited or no effective treatments. The Company is a leader in the use of structure-based drug design, an approach to drug discovery that integrates advanced biology, biophysics and chemistry. The Company is concentrating on the discovery and development of drugs for the treatment of viral diseases, multidrug resistance in cancer, autoimmune and inflammatory diseases, and neurodegenerative diseases.

There can be no assurance that clinical trials will continue, that initial results will be predictive of any future results, that drugs under development by Vertex or its partners will receive marketing approval from the U.S. Food and Drug Administration or other regulatory authorities, or that drugs, if any, which receive such approval will be marketed successfully. Investors are also directed to consider other risks and uncertainties discussed in Vertex documents filed with the Securities and Exchange Commission.

Additional Vertex Contacts: Michael Partridge, Manager, Product Communications 617-577-6108 Justine Schultz, Corporate Communications Specialist 617-577-6619 Vertex's press releases are also available by fax-on-demand at (800) 758-5804 Code 938395.

Combivir, Epivir, Retrovir, Ziagen and Agenerase are trademarks of the Glaxo Wellcome Group of companies.

Glaxo Wellcome Contacts: Martin Sutton (U.K.) 011-44-171-493-4060 Nancy Pekarek (U.K.) 011-44-171-493-4060 Jennie Younger (U.K.) 011-44-171-493-4060 Joan Toohill (U.K.) 011-44-171-493-4060 Duncan Learmouth (U.K.) 011-44-171-493-4060 Frank Murdolo (U.S.) 212-308-5185

SOURCE: Vertex Pharmaceuticals
981102
PR981101

Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .