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VERTEX/MITSUBISHI TO DEVELOP HCV ORAL PROTEASE INHIBITOR.


Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX An earlier real time operating system for embedded systems from Mentor Graphics, Wilsonville, OR (www.mentor.com). VRTX was the progenitor of the VxWorks OS from Wind River and was superseded by Nucleus OS.

VRTX - Virtual Real-Time Executive.
), Cambridge, Mass., and Mitsubishi Pharma Corporation have signed an agreement to develop and commercialize VX-950,

Vertex's investigational oral protease inhibitor protease inhibitor (prō`tē-ās'), any of a class of drugs that interfere with replication of the AIDS virus (HIV), by blocking an enzyme (protease) necessary in the late stages of its reproduction.  for the treatment of hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
 (HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
) infection, in Japan and certain Far East countries.

As part of the agreement, Mitsubishi will make pre-commercial payments to

Vertex to support clinical development of VX-950. Additionally, Mitsubishi will pay royalties to Vertex on commercial sales of VX-950 in Mitsubishi's territories. Vertex will retain exclusive development and marketing rights to VX-950 in the rest of the world, including North America and Europe.

"Vertex has selected hepatitis C Hepatitis C Definition

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild.
 as an important and rapidly growing therapeutic area in which to pursue independent development of its drug candidates in North America," stated Joshua Boger, Ph.D., chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Vertex. "This regional partnership provides financial support for the global development of this important product, recognizes the breakthrough potential of VX-950 as a direct antiviral therapy and provides important downstream opportunities for Vertex in one of the largest hepatitis C populations in the world."

"Current treatment alternatives for chronic hepatitis Chronic hepatitis
Long lasting inflammation of the liver due to viruses or other causes.

Mentioned in: Tube Compression of the Esophagus and Stomach

chronic hepatitis 
 C infection provide

limited benefit to patients," said Akihiro Tobe, Ph.D., Executive Managing Officer, Division Manager of Strategic Planning at Mitsubishi Pharma Corporation. "Through this partnership with Vertex, a leader in the discovery and development of HCV protease inhibitors Protease Inhibitors Definition

A protease inhibitor is a type of drug that cripples the enzyme protease. An enzyme is a substance that triggers chemical reactions in the body.
, we hope to accelerate the advancement of novel therapeutics for hepatitis C infection, and we are pleased to add VX-950 to our pipeline of innovative drugs in development."

Under the terms of the agreement, Mitsubishi will have exclusive rights to develop and commercialize VX-950 in Japan and certain Far East countries.

Vertex expects that Mitsubishi will make pre-commercialization payments to Vertex of up to $33 million under the agreement, consisting of license fees, a significant contribution to drug development costs through Phase II clinical development, and clinical milestone payments. Vertex anticipates that it could recognize the majority of these pre-commercial payments by the end of 2006. Further cost-sharing beyond Phase II clinical development will be determined by the parties based on the design of registration studies for VX- 950. Vertex will also receive royalties on VX-950 product sales by Mitsubishi and retains an option to supply bulk drug material to Mitsubishi for commercialization in its territories.

About VX-950

VX-950 is Vertex's lead oral HCV protease inhibitor and one of the most advanced of a new class of antivirals in development for HCV. Preclinical data have shown that VX-950 significantly reduces levels of HCV RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 in both the replicon rep·li·con
n.
A genetic element that undergoes replication as an autonomous unit.
 system and infectious virus assays within days. Preclinical pharmacokinetic studies completed to date have indicated that VX-950 is orally bioavailable and achieves excellent exposure in the liver, the target organ target organ
n.
A tissue or organ that is affected by a specific hormone.


target organ,
n the organ or body part whose activity levels demonstrate change in the course of biofeedback.
 

for HCV treatment. In early June 2004, Vertex initiated a Phase I clinical

trial for VX-950 in healthy volunteers.

Clinical Need and Market Opportunity in HCV Infection Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 2.7 million people in the United States. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver Cirrhosis of the liver
A type of liver disease, most often caused by chronic alcohol abuse. It is characterized by scarring of the liver, which leads to an increase in the blood pressure in the portal veins.

Mentioned in: Bleeding Varices
 resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Worldwide, the disease strikes as many as 185 million people. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV.

The current standard of care in HCV treatment is a treatment combination of pegylated interferon (peg-IFN), an injectable agent, and ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon . This combination therapy provides a sustained viral response for only 40 to 50 percent of patients chronically infected with genotype 1 HCV, the most difficult viral strain to treat and the most common form in the U.S.

Vertex's drug development portfolio includes two different approaches for advancing the future standard-of-care in HCV. In addition to VX-950, Vertex is developing merimepodib in combination with pegylated interferon alpha Pegylated interferon alpha can refer to:
  • Pegylated interferon-alpha-2a
  • Pegylated interferon-alpha-2b
 (peg-IFN) and ribavirin. The goal of combining merimepodib with standard therapy is to enhance antiviral efficacy and to increase the proportion of patients who

achieve a sustained response to treatment. Vertex owns worldwide development and commercialization rights for merimepodib.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for

serious diseases. The company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical partners. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the new HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  protease inhibitor, Lexiva(TM), with GlaxoSmithKline.

About Mitsubishi

Mitsubishi Pharma Corporation was founded by the merger between former Welfide Corporation and Mitsubishi-Tokyo Pharmaceuticals, Inc., on October 1, 2001. The company is a global research-driven pharmaceutical company targeting the therapeutic areas of psychiatric and central nervous system diseases, cardiovascular and metabolic diseases, immunological and respiratory diseases, and cancer and hepatic disease. Mitsubishi Pharma Corporation has established a strong drug discovery infrastructure to engage in the development of innovative new drugs.

For more information, visit http://www.vrtx.com or call 617/444-6108.
COPYRIGHT 2004 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Worldwide Biotech
Geographic Code:9JAPA
Date:Aug 1, 2004
Words:861
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