Partnerships between the Pharmaceutical Industry and Patient Groups: A Company Example
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PARTNERSHIPS BETWEEN THE PHARMACEUTICAL INDUSTRY AND PATIENT GROUPS: A COMPANY EXAMPLE LARRYK. Pow Department Director, Global Medical Affairs, Rhhe-Poulenc Rorer, Collegeville, Pennsylvania
This paper discusses the development of the partnership between RhSne-Poulenc Rorer (RPR) and two patient groups that are dedicated to the care of patients with amyotrophic lateral sclerosis ( A M ) or (Lou Gehrig disease): the ALS Association (ALSA) and the Muscular Dystrophy Association (MDA). This partnership covered the preapproval, approval, and postapproval periods in the drug development of Rilutek" (riluzole), which was approved by the Food and Drug Administration (FDA) to treat patients with ALS in 1995. The partnership between RPR and the patient group associations continues to evolve. Key Words: RhBne-Poulenc Rorer; Amyotrophic lateral sclerosis (ALS); Rilutek" (nlu-
zole)
INTRODUCTION
der that affects mainly voluntary motor activities (1). The onset is characterized by muscle weakness with death usually occurring within five years of diagnosis due to respiratory compromise. About 50000 to 60000 people worldwide are afflicted with this condition. While there are numerous theories as to what causes A L S , there is no clear understanding of its etiology. One theory that has gained momentum is an accumulation of the excitatory neurotransmitter glutamate that may play a major role in the disease process. Hence, we have the excitotoxic hypothesis. Preclinical studies demonstrating that Rilutek' inhibits the release of glutamate help validate the excitotoxic hypothesis. In part, this hypothesis may help explain the role of Rilutek' in the treatment of this dreaded disease.
THE PURPOSE OF THIS paper is to discuss the development of the partnership between RPR, a pharmaceutical firm, and the patient groups that are dedicated to the care of patients with A L S or Lou Gehrig disease. This partnership was initiated based on the clinical development of Rilutek@(riluzole). Preliminary review of the clinical results from the first survival study suggested that this drug could improve the health care of patients with ALS. With the completion of the second survival study RPR filed its dossier for market registration in the United States. In December 1995, Rilutek" became the first FDA-approved therapeutic agent to receive the indication to treat patients with ALS. Briefly, ALS is a neurodegenerativedisor-
A PROFILE OF RILUTEK@ Reprint address: Larry K. Powe, Director, Clinical Research, Amgen, 1 Amgen Center Drive, Mailstop 17-2-B, Thousand Oaks, CA 91320.
Rilutek' belongs to the chemical class of benzathiazoles. It comes in 50 mg tablets 83
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Larry K. Powe
and is rapidly absorbed. While it appears to possess neuroprotective properties, its mechanism of action is complex. Based on experimental data, Rilutek@is believed to affect pre- and post
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