Pharmacia Trelstar Depot Approval Gives Company Prostate Cancer Therapy
Executive Summary
Pharmacia will add a prostate cancer therapy to its oncology products portfolio following approval of Trelstar Depot June 15.
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Pharmacia will add a prostate cancer therapy to its oncology products portfolio following approval of Trelstar Depot June 15. Trelstar (triptorelin) was approved for the palliative treatment of prostate cancer. Pharmacia licenses the lutenizing hormone-releasing hormone agonist product from the Swiss firm Debio Recherche Pharmaceutique, which will manufacture the product. Pharmacia markets Camptosar (irinotecan) for colorectal cancer, Ellence (epirubicin) and Aromasin (exemestane) for breast cancer and Celebrex (celecoxib) for prevention of familial adenomatous polyposis. Trelstar is the fourth product approved in the LHRH market in the U.S. TAP's Lupron Depot (leuprolide acetate) held approximately 80% of the market in 1999, while AstraZeneca's Zoladex (goserelin acetate) held the remaining 20%, according to IMS Health. Two more products are also nearing market entry. Alza's Viadur (leuprolide acetate) was approved in March and is expected to be launched in early 2001; the product is administered as a once-yearly implant (1 (Also see "Alza Considering Viadur Marketing Partner For Late 2000 Launch" - Pink Sheet, 13 Mar, 2000.)). Praecis plans to submit an NDA for abarelix depot by the fourth quarter (2 (Also see "Praecis/Amgen Abarelix-Depot Spares Patients Initial Testosterone Surge" - Pink Sheet, 29 May, 2000.)). Abarelix is expected to spare patients the initial testosterone surge associated with LHRH agonists. Trelstar's labeling contains a warning about "a transient increase in serum testosterone levels" experienced by some patients during the first weeks of treatment. It is administered once a month. In a trial of 277 men with prostate cancer, 91.2% patients receiving Trelstar achieved castration levels of testosterone by day 29 and 96.4% maintained castration levels of serum testosterone from day 57 through day 253, labeling notes. In addition to higher testosterone levels in the first week, adverse events included hot flushes, headache and skeletal pain. NDA 20-715 was originally submitted in 1996 and received an "approvable" letter in 1997. Target Research Associates, a New Jersey-based contract research organization, resubmitted the application in December 1999. |