Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - November 5, 2001
"We are delighted that Merck's HIV vaccine program has advanced and that Vical's naked DNA technology remains a key component in Merck's latest efforts," said Vical President and Chief Executive Officer Vijay Samant. "Merck's scheduled payment is a welcome sign of its continuing interest in the pursuit of therapeutic vaccines based on our technology. Developing a vaccine against a complex target such as HIV is a challenging undertaking, but we believe our confidence in Merck's abilities is well-placed and well-founded."
Merck is using Vical's naked DNA vaccine technology to develop vaccines that would prevent and treat HIV infections. Naked DNA is Vical's patented method of delivering genetic material into cells in the body without using a virus.
Under terms of a licensing agreement for Vical's naked DNA technology first signed in 1997, Merck originally made a $5-million investment in Vical common stock at a premium over fair market value. Merck extended the agreement in 1999 with an additional $2-million payment. If Merck successfully develops products using the Vical technology, Vical may receive additional milestone payments plus royalties on product sales. In addition, Vical may have the option under certain conditions to co-promote the products in the United States.
A number of investigators are currently testing vaccine candidates that employ prime-boost strategies that use Vical's naked DNA delivery method to prime the immune system along with a range of secondary approaches to boost the immune response. Other vaccine development programs have combined a naked DNA prime vaccine with boost vaccines using modified pox, vaccinia, adeno- and adeno-associated viruses. In contrast to conventional vaccine approaches, which induce only an antibody immune response, Vical's naked DNA technology has demonstrated the ability to induce a cellular immune response. This cellular immune response is considered a crucial element in vaccines that are meant to challenge infectious disease targets.
Vaccines are generally recognized as the most cost-effective approach for infectious disease health care. However, the technical limitations of conventional vaccine approaches have limited the development of effective vaccines for many diseases. These limitations include the inability of traditional preventative vaccines to counteract random changes in the strains of various infectious agents and the need for safe formulations that boost an antibody response or cause sufficient killer T-cell responses.
Vical's naked DNA vaccine technology has the potential to overcome these deficiencies. Moreover, possible vaccine products based on the Vical technology should be easier to manufacture than vaccines made using conventional techniques, which tend to be cumbersome and labor-intensive and generally involve difficult tissue culture procedures and live viruses.
Vical Incorporated, The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma, Human Genome Sciences, Centocor Inc., Merial and Boston Scientific Corporation. Allovectin-7(R), which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with head and neck cancer. Leuvectin(TM), which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with prostate cancer. If you are interested in any of Vical's clinical trials, please see our website at http://www.vical.com, or contact Cherie Smith by phone at 858-646-1177 or by e-mail at csmith@vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the company's focus, collaborative partners, product candidates, and developmental status. Risks and uncertainties include whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
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