AEGiS-PRn: VX-175/GW433908, Vertex and Glaxo Wellcome HIV Protease Inhibitor In Clinical Development, Receives Fast Track Designation from U.S. FDA PRNewswireImportant note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Click here to return to PRNewswire main menu
DonateNow


VX-175/GW433908, Vertex and Glaxo Wellcome HIV Protease Inhibitor In Clinical Development, Receives Fast Track Designation from U.S. FDA

PRNewswire - December 16, 1999


CAMBRIDGE, Mass., Dec. 16 /PRNewswire/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its partner Glaxo Wellcome has received fast track designation for the HIV protease inhibitor VX-175/GW433908 from the United States Food and Drug Administration. Fast track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. VX-175/GW433908 is a prodrug of amprenavir that is designed to provide more compact dosing for patients. In connection with development progress for VX-175/GW433908, which is in Phase II clinical testing in patients with HIV, Vertex has received a $1.0 million milestone payment from Glaxo Wellcome.

"The clinical advancement of VX-175/GW433908 underscores both the productivity of our partnership with Glaxo Wellcome, and the power of Vertex's integrated research and development strategy," said Joshua Boger, Ph.D., Chairman, President, and CEO of Vertex. "Vertex's pipeline features seven product candidates in Phase II clinical development in four different therapeutic areas -- viral disease, cancer, autoimmune/inflammatory disease, and neurological disease -- that we have brought forward both independently and in collaboration with other companies."

Vertex Receives Milestone for VX-175/GW433908

Vertex will realize the milestone payment related to VX-175/GW433908 development as collaborative revenue in the fourth quarter of 1999. VX-175/GW433908 is the second product to be advanced through development as part of an ongoing collaboration between Vertex and Glaxo Wellcome. Vertex will receive additional milestone payments from Glaxo Wellcome as VX-175/GW433908 progresses through development towards commercialization.

VX-175/GW433908 was first synthesized at Vertex as part of a collaboration between Glaxo Wellcome and Vertex to research and develop HIV protease inhibitors for the treatment of HIV infection and AIDS. Glaxo Wellcome is developing VX-175/GW433908 in the United States, Europe, and other countries outside the Far East. Glaxo Wellcome will market VX-175/GW433908, and Vertex will have an option to co-promote VX-175/GW433908 in the United States and the European Union, and will receive royalties on sales of VX-175/GW433908.

HIV Program

Vertex also provided an update on ongoing development and commercial activities within Vertex and Glaxo Wellcome's HIV protease inhibitor program, including an update on the commercial and regulatory status of Agenerase(TM) (amprenavir). In the United States, more than 10,000 patients are currently taking Agenerase as part of combination therapy for the treatment of HIV infection. Agenerase has received approval in the United States, Brazil, Mexico, Uruguay, Argentina, Israel, and Switzerland. Agenerase has been submitted for approval in other markets worldwide, including the European Union (EU). In the EU, the application review process is ongoing, and approval of Agenerase is anticipated in mid- to late 2000. Agenerase was discovered at Vertex and licensed to partner Glaxo Wellcome for development. Vertex co-promotes Agenerase in the United States and plans to co-promote Agenerase in the EU.

Vertex also reported that partner Kissei Pharmaceutical Co., Ltd. has begun a Phase II/III clinical trial of amprenavir in Japan, which is required by the Ministry of Health and Welfare in Japan as part of that country's fast track approval process. Kissei received approval for amprenavir in Japan in September 1999 and has launched the drug under the trade name Prozei(TM).

Vertex Pharmaceuticals Incorporated discovers, develops and markets small molecule drugs that address major unmet medical needs. The Company has nine drug candidates in clinical development to treat viral diseases, inflammation, cancer, autoimmune diseases and neurological disorders. Vertex has created its pipeline using a proprietary approach, information-driven drug design, that integrates multiple technologies in biology, chemistry and biophysics aimed at increasing the speed and success rate of drug discovery. Vertex's first approved product is Agenerase(TM) (amprenavir), an HIV protease inhibitor, which Vertex co-promotes with Glaxo Wellcome.

There can be no assurance that clinical trials will continue, that initial clinical trial results will be predictive of any future results, that drugs under development by the Company 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.

Vertex's press releases are also available by fax-on-demand at (800) 758-5804 - Code: 938395

SOURCE Vertex Pharmaceuticals Incorporated

CONTACT: Michael Partridge, Manager, Product Communications, 617-577-6108 or Michele Karpf, Manager, Product Communications, 617-577-6259 both of Vertex Pharmaceuticals/

Web Site: http://www.vpharm.com/
991216
PR991224


Copyright © 1999 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019  http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 1999. 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, 1999. 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. .