GenVec in major drug accord Warner-Lambert pact on diseases of heart valued at $100 million


September 10, 1997|By Mark Guidera | Mark Guidera,SUN STAFF

Rockville-based GenVec Inc. and consumer health care giant Warner-Lambert Co. said yesterday that they have struck a deal worth an estimated $100 million to jointly develop a gene therapy product to treat common cardiovascular diseases.

The deal with Warner-Lambert's Parke-Davis pharmaceutical division is the first collaboration GenVec has struck with a major pharmaceutical house, and it is a sign of growing recognition among some major drug companies that gene therapy may have promising medical applications.

Privately held GenVec, launched in 1993, is developing gene therapies for cancer, cystic fibrosis and cardiovascular diseases, the nation's No. 1 killer.

Under the agreement, Parke-Davis, based in Morris Plains, N.J., will take an equity stake in GenVec and have the option to buy additional shares should GenVec go public.

It will also fund a five-year research effort aimed at bringing a product called BioByPass to market by early in the next decade.

The agreement includes an undisclosed signing payment to GenVec. The company will receive additional payments upon achieving specific research and development milestones, said Dr. Paul Fischer, GenVec's president and chief executive officer.

Parke-Davis gets the rights to market BioByPass worldwide, except in Asia. GenVec retains manufacturing rights.

The companies did not disclose how much of an equity position Parke-Davis is taking or how much money has been pledged to further research and development of BioByPass.

"The terms of this deal reflect a very large product opportunity," Fischer said.

According to an annual survey of hospitals nationwide, 990,000 people in the United States undergo surgical procedures to relieve blocked coronary arteries.

An estimated 6 million others suffer symptoms considered early warning signs of blocked arteries. GenVec officials believe BioByPass may also hold promise for treating the millions of diabetics suffering from vascular problems, a common complication of their disease.

Wendell Wierenga, senior vice president for worldwide pre-clinical research development and technologies at Parke-Davis, said the company has high hopes for BioByPass.

"We are very excited about the broad potential applicability of this novel therapeutic approach for a variety of important medical needs," Wierenga said.

The focus of the deal involves Parke-Davis and GenVec jointly developing BioByPass, a promising new way to treat heart and vascular diseases stemming from a condition known as ischemia.

Ischemia primarily results when oxygen-carrying blood flow is blocked by fat buildup in arteries, according to medical experts. The condition can be painful.

BioByPass, which GenVec has tested on pigs, is a genetically altered virus loaded with a gene that stimulates the body to produce a protein known as vascular endothelial growth factor, or VEGF. It is responsible for triggering new blood vessel growth.

The treatment is designed to be injected into a diseased area and to trigger blood vessel growth locally.

Other biotechnology companies are attempting to develop cardiovascular disease drugs to stimulate VEGF and blood vessel growth. One hurdle: how to localize a drug's effect.

In animal testing, Fischer said, BioByPass has been shown to stimulate blood vessel growth locally.

The approach, Fischer said, is based on the body's natural response to ischemia -- forming new blood vessels to carry oxygen and nutrients to the heart and other areas of the body where blood flow is blocked by arteries dammed by fat deposits.

Fischer said he envisions BioByPass being used in conjunction with surgery and to treat patients who are too sick with blocked arteries to be candidates for surgery.

The companies expect to seek Food and Drug Administration approval late this year to start human trials early in 1998 to assess the safety of the therapy, Fischer said. Larger human trials may be launched in 1999, he said, if all goes well in the early trials.

Coronary heart disease and coronary artery disease today are typically treated with surgical procedures, such as angioplasty and bypass surgery.

Development of new drugs and therapies for cardiovascular diseases is one of Parke-Davis' top research priorities, said Jeff Blaum, a spokesman for the company.

Parke-Davis has about 15 research alliance agreements with emerging biotechnology companies, though the GenVec agreement is the company's first deal involving genetic therapy.

While there are a number of gene therapy products in clinical trials, mostly for cancers, hurdles to development have been high.

The BioByPass product differs from most of the other gene therapies in development in that it does not seek to alter or replace a defective gene triggering a disease.

It seeks, instead, to use a gene to further stimulate the body's natural responses to disease.

Pub Date: 9/10/97

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