MADISON, N.J., Dec. 1 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, the pharmaceutical division of Wyeth (NYSE: WYE - News), has been awarded a five-year, $32 million contract from the Division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the development of therapeutic HIV vaccines in conjunction with researchers at the University of Pennsylvania, Duke University, and Beth Israel/Deaconess Hospital in New York City. Through the HIV Vaccine Design and Development Teams (HVDDT) program, Wyeth will develop and clinically evaluate novel adjuvant-enhanced plasmid DNA (pDNA) and peptide based vaccines for use in a prime-boost therapeutic regimen to help treat HIV infection.
Previously, the NIH had awarded Wyeth two five-year contracts to evaluate two separate preventative HIV vaccine strategies.
NIH will provide the funding for direct costs associated with the design, manufacture and release of the clinical trial materials. Wyeth will contribute a minimum of $23 million of in-kind services.
"The Wyeth HIV vaccine program is focused on the identification and clinical evaluation of vaccine approaches capable of eliciting robust and sustained anti-HIV immunological responses," says Emilio A. Emini, Ph.D., Executive Vice President, Wyeth Vaccines Research & Development. "We look forward to continuing our work with the NIH on a program that has been a very gratifying scientific partnership."
The previous two five-year contracts through the HVDDT program totaled more than $37 million. The first contract, awarded in April 2000, focused on adjuvant-enhanced plasmid DNA (pDNA) and peptide-based vaccines. The second contract, awarded in May 2002, supported the study of vesicular stomatitis virus (VSV) as a potential immunization vehicle for the delivery of HIV immunogens. Extensive preclinical evaluations of the VSV vector system are ongoing.
Wyeth successfully completed the first contract by developing and manufacturing novel adjuvant-enhanced plasmid DNA (pDNA) and peptide-based vaccines. These prototype vaccines, which contain only a limited number of HIV antigens, are currently being evaluated in Phase I clinical studies. The HIV Vaccines Trial Network (HVTN), supported by NIAID, is conducting studies in HIV-negative subjects as a first step towards determining the potential of this vaccine approach to prevent HIV infection.
In parallel, Wyeth will evaluate the vaccine approach in Phase 1 clinical trials for their potential therapeutic benefit in HIV-infected individuals.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Wyeth
