The Abbott-Takeda (TAP) product Lupron (leuprolide acetate) is targeted at a submarket of prostate cancer patients of about 65,000 patients, or approximately 75% of the 86,000 patients diagnosed with the disease each year. FDA clearance of the injectable synthetic LHRH analog was announced on April 12, less than two weeks after consideration of the drug by FDA's Oncologic Drugs Advisory Cmte. The approved indication for "palliative treatment of advanced prostatic cancer" states that the drug "offers an alternative treatment of prostatic cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient." The drug inhibits the production of testosterone by suppressing gonadotropin secretion through regulation of gonadotropic releasing hormone. Lupron is the first approval for the Abbott-Takeda joint venture. The product was rated a 1-A "important therapeutic gain" entity by FDA. The agency quickly approved the application following the advisory cmte. discussion of appropriate labeling on March 29. The approved indication is similar to what FDA's Oncologic Drugs Advisory Cmte. recommended. The cmte. unanimously agreed that leuprolide labeling should state that the drug is an "alternative" to DES or surgical castration ("The Pink Sheet" April 1, T&G-1). The drug is intended for once-daily subcutaneous injection. It is designed to be patient-administered and is packaged in kits to last two weeks. The projected daily cost to the patient is $10, according to TAP VP Sales and Marketing Richard McMahon. First shipments of Lupron from TAP's North Chicago plant are expected to begin in May. TAP has a separate sales force from Abbott. A TAP sales force will detail the product to oncologists and urologists. The product will be distributed through whslrs. According to a TAP press release, Lupron is "the result of a collaborative research program between Abbott and Takeda which started in 1972." The 1977 joint venture, TAP, is headed by Ira Ringler, PhD, formerly VP-R&D in Abbott's Pharmaceutical Div. The firm's Exec VP is Kunio Takeda, a direct descendant of the family that founded Takeda Chemical Industries in 1781. TAP has three other NDAs pending for U.S. marketing: two cephalosporins, Cefmax (cefmenoxime HCl) and Cefonomil (cefsulodin sodium), and a sleep disorder product, estazolam.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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