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Instead, Thompson Join to Move HIV Microbicide to Market

PharmaManufacturing.com
08/10/2006

La Jolla, Calif.-based Instead Inc. and former Health and Human Services Administrator Tommy Thompson announced Aug. 1 that they have formed a new company called Instead Sciences, Inc. to complete the final stage of clinical trials, product development and market launch of its promising microbicide Amphora (clinically known as Acidform).

"Amphora — which already has FDA safety clearance for human use — is in the best position to be the first approved microbicide that will be available over-the-counter to protect women from HIV/AIDS," Thompson said. "By forming a company to focus exclusively on its testing and development, we think we can be to market first."

Worldwide, the market for a woman-controlled, over-the-counter microbicide/contraceptive is estimated to be $10 billion, according to a report commissioned by the European Union Commission on HIV/AIDS and presented at the Geneva World AIDS Conference in 1998. The report estimated that the U.S. market would be $900 million.

"Up until now, all of the research and development costs have been funded by government and private foundation grants," explained Instead President Joe Pike. "Now we are going to raise private capital so we can coordinate the final steps required to bring the product to market."

Last month, leading researchers from the South African Medical Research Council announced at the bi-annual International AIDS Microbicide Conference in Cape Town, South Africa that a microbicide to prevent AIDS could be available for use by women as early as 2010.

Pike noted, "Because of the favorable reports about our technologies that were presented at the Conference, we believe they were referring to our products. Apparently Thompson feels the same way.

"We have the only product reviewed at the Conference that already has FDA clearance, and we will certainly be in the market before 2010," he continued. "Instead Sciences will first focus on finalizing a six-month contraceptive study showing Amphora's spermicidal properties," he said. "We plan to replicate an earlier clinical study showing that Amphora is as effective as Nonoxynol-9 — the only topical contraceptive currently approved by the FDA--then immediately apply for FDA approval for Amphora as a contraceptive."

Pike noted that Thompson worked with the World Health Organization to develop the six-month protocol for the study.

Subsequent research is planned to prove Amphora's microbicidal properties as well. The research includes a 2007 trial in Madagascar by the U.S. Centers for Disease Control and Prevention, the United States Agency for International Development, the Contraceptive Research and Development, and the University of North Carolina at Chapel Hill that will evaluate Amphora's effectiveness in preventing N. gonorrhoeae and chlamydia infections, while also monitoring pregnancy and HIV data.

Additionally, the National Institutes of Health has agreed to provide funding for an HIV/HSV prevention clinical trial to begin later this year. Amphora has already been shown to have anti-viral potential against herpes and HIV in studies conducted at Mount Sinai School of Medicine.

"Since leaving office, I have followed the research and development of Instead's Amphora gel, and believe the company is in the best position to bring to market the first microbicide that may protect women from HIV/AIDS," said Thompson. "In this role, I intend to participate in the global launch of Amphora as well as pursue funding from individuals and organizations around the world that are committed to stopping the spread of HIV and improving reproductive health care worldwide."

Thompson will participate in the global launch of the product working with Ministries of Health as well as pursuing funding from organizations that are committed to stopping the spread of HIV and improving reproductive health care worldwide.

Amphora is a bio-adhesive "acid-buffering" gel that coats the vaginal wall and cervix, helping maintain a woman's natural pH level between 3.8 and 4.2, a level that has been proven in early clinical testing to render sperm immobile and inactivate most STI-causing organisms, including gonococci, herpes, chlamydia, HPV and HIV.

Originally developed by the Topical Prevention of Conception and Disease (TOPCAD) Program, Amphora was licensed to Instead in 2002, and patent protection was granted in March 2004. Shortly thereafter, Amphora was granted clearance for use as a personal lubricant by the FDA.

More information about Instead and Amphora is available at www.amphoragel.com.