The Immune Response Corporation and Agouron Pharmaceuticals, Inc. Announce Collaboration to Commercialize REMUNE(TM)
PR Newswire - June 11, 1998 16:16
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CARLSBAD, Calif. and LA JOLLA, Calif., June 11 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) and Agouron Pharmaceuticals, Inc. (Nasdaq: AGPH) today announced that they have agreed to collaborate on the final development and commercialization of REMUNE, an immune-based therapy for the treatment of HIV infection. REMUNE was discovered by Immune Response and is currently the subject of several clinical trials, including a large Phase III clinical endpoint trial. The two companies will endeavor to complete the development and apply for registration of REMUNE in 1999.
Immune Response will manufacture commercial supplies of REMUNE, and Agouron will have exclusive rights to market REMUNE in North America, Europe and certain other countries. Under the agreement, subject to certain rights of termination by Agouron, Immune Response may receive as much as $77 million over the next two years, including license and milestone payments of $45 million, payments to support development of $18 million and the purchase of $14 million of Immune Response common stock priced at premium to market. Of the $77 million, Immune Response initially will receive a $10 million license fee and Agouron has purchased 118,256 shares of newly issued Immune Response common stock for $2 million. In addition, the two companies will share all profits from the commercialization of REMUNE on a 50/50 basis.
"We welcome this collaboration with one of the world leaders in the treatment of HIV. Agouron's experienced development and marketing team will be invaluable when we transition our focus from the development of REMUNE to making it commercially available to those infected with HIV," said Dennis J. Carlo, Ph.D., president and chief executive officer of The Immune Response Corporation.
"We made the decision to aggressively pursue this opportunity with Immune Response after a comprehensive review of clinical data of REMUNE from a number of studies, which convinced us of the unique potential of this product to make a powerful contribution to the treatment of HIV infection and AIDS," said Peter Johnson, Agouron's president and chief executive officer. "Prominent among these data were encouraging preliminary results from a study of REMUNE taken in combination with highly active antiretroviral drugs -- results that will be presented at the upcoming 12th World AIDS Conference in Geneva later this month. Given the intense recent interest in REMUNE on the part of companies committed to the field of HIV therapy, we are very gratified that Agouron has been selected by Immune Response as its commercial partner for major markets."
An important recent goal in the treatment of HIV infection is to combine such highly active drugs as HIV protease inhibitors, capable of halting replication of HIV, with agents capable of directly enhancing recovery of the immune system. As part of the collaboration, Agouron will sponsor a new surrogate marker trial of REMUNE taken in combination with highly active drug regimens containing Agouron's marketed protease inhibitor VIRACEPT(R) (nelfinavir mesylate).
REMUNE is an immune-based therapy, derived from HIV itself, which has been shown to elicit an HIV-specific immune response. In May 1997, enrollment was completed at 74 centers in the United States for a pivotal Phase III clinical endpoint trial in which approximately 2,500 patients were randomized to receive conventional antiretroviral drug therapy with or without REMUNE administered as an intramuscular injection every three months. This trial is expected to be completed in April 1999. More than 300 patients have been enrolled in two other clinical trials which are evaluating the effect of REMUNE in combination with antiretroviral drugs on virologic and immunologic markers in adults. A smaller trial of REMUNE for treatment of HIV infection in children is in progress at the National Institutes of Health.
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T cell responses for the treatment of HIV, autoimmune diseases and cancer. The company is conducting clinical trials for its immune-based therapies for HIV, rheumatoid arthritis, psoriasis, multiple sclerosis, colon cancer and brain cancer and preclinical studies for melanoma and prostate cancers. In addition, the company is developing a targeted delivery technology for gene therapy which is designed to enable the intravenous injection of genes for delivery directly to the liver. The company's gene therapy program is currently focused on diseases of the liver and is in preclinical studies for the treatment of hemophilia and hepatitis.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical company committed to the discovery, development, manufacturing, and marketing of innovative therapeutic products engineered to inactivate proteins which play key roles in cancer, AIDS, and other serious diseases.
NOTE: The Immune Response Corporation news releases are available at no charge through the company's automated attendant 800 number at 800-491-0153. News releases are also available through PR Newswire's Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain these numbers for future reference. Company information can also be located on the Internet Web Site: imnr.com.
This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including whether REMUNE will be successfully developed and registration applied for by 1999, whether REMUNE will be approved for marketing by regulatory authorities, whether any profits will be derived from REMUNE even if it is successfully developed and approved for marketing, whether Immune Response will receive any payments beyond the initial payment made under the agreement with Agouron, the uncertainty of successful completion of clinical trials, and those risks set forth from time to time in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended December 31, 1997. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc.
REMUNE(TM) is a trademark of The Immune Response Corporation
SOURCE The Immune Response Corporation
/CONTACT: Debra L. Altman, Manager, Investor Relations, or Charles J.
Cashion, Senior Vice President of Immune Response Corporation, 800-491-0153/
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