Biotech breakups
by Kevin DeGeeter
Posted 06:20 PM EST, Jul-10-2001
The majority of new drugs are developed under research agreements between big drug companies and biotechnology startups. Pharmaceutical companies typically promise to market the drug after regulatory approval and provide periodic cash infusions in exchange for a large slice of future profits.
The following companies are seeking new partners after their pharmaceutical collaborators abandoned still-promising drug candidates. The decision to discontinue the partnership may have been prompted by disappointing scientific data or a change in strategy.
Each company plans to continue clinical studies, but needs marketing infrastructure, regulatory expertise or capital infusions to bring the drug to market.
The list includes collaborations terminated in past month.
Immune Response/ Pfizer
Agouron Pharmaceuticals Inc., a subsidiary of Pfizer Inc., returned North American and European marketing rights for Remune to Carlsbad, Calif.-based Immune Response Corp. after the HIV drug failed to lower viral load or increase CD4+ T-cell count in Phase 2 studies.
Pfizer hoped Remune would boost CD4+ T-cells that protect cells from infectious agents. HIV lowers CD4+ cell count, leading to death from opportunistic diseases.
Since 1998, Immune Response has received $47 million from Pfizer and Agouron. Pfizer relinquished marketing rights in the U.S., Europe, Japan and certain other countries.
In June Trinity Medical Group USA Inc. said preliminary Remune studies showed higher CD4+ count. The Rancho Santa Margarita, Calif.-based company owns rights to market Remune in Southeast Asia.
Inspire Pharmaceuticals/ Genentech
South San Francisco-based Genentech Inc. returned worldwide marketing rights for two P2Y2 agonists to Durham, N.C.-based Inspire Pharmaceuticals Inc.
In April the companies suspended enrollment for a Phase 2 study of INS365, a therapy for chronic bronchitis. The program's future will be evaluated after Inspire reviews data from the truncated trial.
The other drug, INS37217, helps the body break down mucus. The cystic fibrosis drug is in Phase 1/2 trials and has been granted orphan-drug status by the Food and Drug Administration.
Phase 1 studies of INS37217 in patients with sinusitis, more commonly known as a sinus infection, are scheduled to begin in the third quarter.
Genentech has pumped $16 million into the program since December 1999. However, the collaboration with Inspire was less attractive, the company said, than "competing priorities."
Biosearch Italia/ IntraBiotics Pharmaceuticals
Italian drug researcher Biosearch Italia S.p.A. will reacquire North American marketing right to Ramoplanin oral powder, an antibiotic for vancomycin-resistant enterococci bacterial infections. The blood-borne infection is common among hospitalized patients with catheters.
Under terms of separation agreement, IntraBiotics Pharmaceuticals Inc. will fund clinical development until August 31.
Biosearch Italia plans to complete Phase 3 studies. After unexpectedly slow enrollment in the 950-person study, final results are expected by the end of 2002. IntraBiotics will receive royalties from sales of Ramoplanin in North America.
Biosearch Italia is looking for partners to market Ramoplanin in North America. On May 31 IntraBiotics cut 70% of its work force to conserve cash.
The company's remaining funds are earmarked for Phase 3 study of Iseganan, a therapy for oral mucositis in cancer patients.
Peregrine Pharmaceuticals/ Schering
German drug maker Schering AG relinquished worldwide marketing rights for Oncolym to Peregrine Pharmaceuticals Inc.
The injectable antibody-radioactive isotope conjugate binds to surface protein of non-Hodgkin's lymphoma cells and administers a localized dose of radiation. Under terms of agreement, Phase 1/2 clinical trials for high-grade non-Hodgkin's lymphoma will be transferred Peregrine.
Schering cited changing "strategic needs" for discontinuing the collaboration.
Tustin, Calif.-based Peregrine is searching for new development partners.
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