Agouron and The Immune Response Corporation to Collaborate on Commercialization of REMUNE(TM)
PR Newswire, Thursday, June 11, 1998 at 16:23
LA JOLLA, Calif., and CARLSBAD, Calif., June 11 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. (NASDAQ:AGPH) and The Immune Response Corporation (Immune Response) (NASDAQ:IMNR) today announced they have agreed to collaborate on final development and commercialization of REMUNE(TM), 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 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 at a 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 made the decision to aggressively pursue this opportunity with Immune Response after a comprehensive review of clinical data on 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 small 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."
"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 Immune Response.
An important recent goal in 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 2500 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 complete in April 1999. More than 300 patients have been enrolled in two other clinical studies which are evaluating the effect of REMUNE in combination with antiretroviral drugs on virologic and immunologic markers in adults. A smaller study 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 that play key roles in cancer, AIDS, and other serious diseases.
VIRACEPT is indicated for the treatment of HIV infection when
antiretroviral therapy is warranted. This indication is based on analyses of surrogate marker changes in patients who received VIRACEPT in combination with nucleoside analogs or alone for up to 24 weeks. At present, there are no results from controlled trials evaluating the effect of therapy with VIRACEPT on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections.
The most commonly observed adverse event of moderate or greater severity in clinical trials of VIRACEPT was diarrhea, which was generally controlled with over-the-counter medications. New onset or exacerbation of diabetes mellitus and hyperglycemia, as well as increased bleeding in patients with hemophilia types A and B, have been reported with protease inhibitors.
This press release may contain forward-looking statements or predictions. These statements represent our judgment as of this date and are subject to risks and uncertainties (including those associated with regulatory approvals and the impact of competitive products) that could cause the actual results to differ materially. Important factors concerning these risks are discussed in our Form 10-K for the fiscal year ended June 30, 1997 currently on file with the Securities and Exchange Commission. Agouron undertakes no obligation to publicly release the result of any revisions to such forward-looking statements which may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
For more information on Agouron or Immune Response Corporation, you may visit the Agouron Web Site at agouron.com or The Immune Response Corporation website at imnr.com.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc. REMUNE(TM) is a trademark of The Immune Response Corporation.
SOURCE Agouron Pharmaceuticals, Inc.
-0- 06/11/98
/CONTACT: Investors: Donna Nichols, Vice President, Head of Corporate
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