LYCOS RETRIEVER 
Merck: Vaccines
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"Merck has been a leader in the field of hepatitis B prevention since we introduced the first recombinant vaccine, Recombivax HB(R), in 1986," said Margaret G. McGlynn, president, Merck vaccines and infectious disease. "Through this collaboration with Dynavax, we have now gained rights to HEPLISAV, and as a result, have the potential to add another important advance to Merck's broad portfolio of vaccines."
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The advance by Merck exploits a relatively new understanding of the interaction between the virus and the human immune system that has emerged from numerous labs in the past few years. Based on these findings, researchers are convinced that a vaccine protective against HIV, the AIDS virus, must stimulate the release into the bloodstream of a very specific kind of white blood cell. These so-called CD8 or killer T-cells can seek out cells infected by HIV and destroy them, thereby squelching the virus's ability to replicate and spread. The excitement about the Merck vaccine, and several of the others like it, is that in test tube and animal experiments they all trigger in varying degrees a muscular assault by killer T-cells.
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The Merck facility, a pharmaceutical plant located in West Point, Pa., houses pharmaceutical and vaccine research as well as the manufacturing of pharmaceutical products and vaccines. The facility consists of approximately 400 acres, 110 buildings employing approximately 8,500 employees. Merck discharges pollutants from this facility to the Upper Gwynedd Township Publicly Owned Treatment Works (UGT POTW). The treated effluent is discharged into the Wissahickon Creek, a tributary of the Schuylkill River.
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Merck generated its best results by first "priming" the animals' immune system with the naked DNA containing the gag gene, and following that with a booster shot of adenovirus-containing gene. Merck's human trials, being conducted in several U.S. medical centers, are designed to see if the double inoculation is safe and has the ability to set off a similar killer-cell reaction. If all goes well, Merck will conduct similar safety tests of vaccines containing the other two genes, too. Eventually, it plans to build a vaccine with all three genes.
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"The Merck study highlights the importance of clinical trials in vaccine development," said Dr. Harriet Robinson, Chief Scientific Advisor for GeoVax. "The volunteers who participate in these trials are Heroes of Vaccine Development and make it possible for products that are safe and effective to be identified and licensed for human use. GeoVax salutes the volunteers who participated in the Merck trials and the volunteers that are participating in the GeoVax trials. These are people who care and have volunteered for the greater good of humanity."
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Under the terms of the agreement, Merck receives worldwide exclusive rights to HEPLISAV, will fund future vaccine development, and be responsible for commercialization. Dynavax will receive an initial payment of $31.5 million, and will be eligible to receive up to $105 million in development and sales milestone payments, and double-digit tiered royalties on global sales of HEPLISAV.
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