¿ Amylin Pharmaceuticals Inc., of San Diego, said it plans to conduct the additional clinical trials requested by the FDA in its approvable letter, received in October, for Symlin, its product for Type I or insulin-using Type II diabetics. The company said the trials should lead to the filing of an amendment to the new drug application in the second half of 2002. Amylin filed its original NDA in December 2000. (See BioWorld Today, Oct. 15, 2001.)
¿ BioTransplant Inc., of Charlestown, Mass., said a Phase I/II trial with its AlloMune System demonstrated encouraging antitumor results in a majority of patients afflicted with end-stage refractory lymphoma. AlloMune uses BioTransplant¿s antibody MEDI-507 in combination with nonmyeloablative allogeneic bone marrow transplantation. The trial involved patients who were believed to have no other therapeutic options following failure to respond to chemotherapy, and in some cases, radiation and autologous bone marrow transplantation.
¿ Exelixis Inc., of South San Francisco, and Genomica Corp., of Boulder, Colo., said the exchange ratio of shares of Genomica common stock into shares of Exelixis common stock will be 0.28306, as part of their merger that was valued at $110 million. The initial offering period for the exchange offer made by Exelixis for shares of common stock of Genomica will expire at midnight today. The exchange offer, if successful, will be followed by a merger in which Exelixis will acquire, at the same exchange ratio, the remaining shares of common stock not previously acquired in the exchange offer. (See BioWorld Today, Nov. 21, 2001.)
¿ Genaera Corp., of Plymouth Meeting, Pa., said results of its Phase I trial of squalamine in advanced cancer patients were published in the December 2001 issue of Clinical Cancer Research. The study was designed to investigate the safety of squalamine as a single agent, at increasing doses and over multiple courses of treatment. Of the 19 patients treated with squalamine, transient tumor responses were observed in a patient with synovial cell sarcoma and a patient with breast cancer with cutaneous metastases. Dose-limiting toxicity was encountered beginning at doses of 384 mg/m2/day and 538 mg/m2/day and consisted of grade 3 liver transaminase elevations that resolved three to 11 days after ceasing squalamine infusion.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., established a long-term research-scale antisense inhibitor supply agreement with Integrated DNA Technologies Inc. IDT will manufacture antisense inhibitors and research reagents to Isis¿ specifications. Isis will pay IDT $5 million toward Isis¿ future purchase of antisense inhibitors. Isis also expanded its licensing agreement with IDT on certain patents, allowing Isis to exclusively sublicense the intellectual property for functional genomics purposes. Isis will pay IDT $4.9 million for the broadened IP license.
¿ MedImmune Inc., of Gaithersburg, Md., completed enrollment in two previously announced clinical trials for Synagis (palivizumab), a product that prevents serious respiratory syncytial virus in certain high-risk infants, and siplizumab, a drug being developed as a psoriasis treatment. For Synagis, 1,287 infants under 24 months of age with congenital heart disease have been enrolled in a Phase III study, dosing for which is expected to be completed in the second quarter of 2002. For siplizumab, 420 psoriasis patients have been enrolled in a Phase II study. Dosing is projected to be completed during the first quarter of 2002.
¿ Ortec International Inc., of New York, said it will use a dedicated sales force provided by PDI Inc., of Upper Saddle, N.J., to target the burn market. Ortec¿s OrCel, a biologically active wound agent, will be launched in the United States during 2002¿s first quarter. PDI is a sales and marketing company focused on the pharmaceutical, biotechnology and the medical devices and diagnostics industries.
¿ SkyePharma PLC, of London, withdrew its Nov. 20 notice to terminate all agreements with Bioglan Pharma PLC, of Hertfordshire, UK, concerning the product Solaraze for marketing in Europe, the U.S., Canada and Mexico. Bioglan agreed to pay SkyePharma $12.5 million in settlement for the sales and marketing of Solaraze in the U.S., Canada and Mexico. Solaraze is a U.S.- and European-approved topical treatment for actinic keratosis, a precancerous skin condition that arises from excessive sun exposure.
¿ Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel, said its drug Copaxone (glatiramer acetate for injection) and Betaseron (interferon beta-1b), a Berlex Laboratories Inc. and Chiron Corp. product, significantly reduced the mean annualized number of relapses compared to an untreated group of relapsing-remitting multiple sclerosis patients, according to a study published in the December 2001 issue of Multiple Sclerosis. The 18-month prospective, non-randomized, open-label study¿s primary endpoint was to determine the differences in the mean annualized relapse rate of patients with relapsing-remitting MS treated with Copaxone, Betaseron and Avonex (interferon beta-1a; Biogen Inc.) compared with those not choosing an immunomodulating therapy. Teva said the Avonex group did not show a statistically significant reduction.
¿ Zonagen Inc., of the Woodlands, Texas, reported that a response to questions on the marketing authorization application for Vasomax was provided by Schering-Plough Corp., of Madison, N.J., to the Medicines Control Agency in the UK. Vasomax is Zonagen¿s oral therapy to treat erectile dysfunction. Schering-Plough is the exclusive licensee worldwide for commercialization of the product. The submission includes responses to the questions and comments posed in 1999, along with data from studies completed since the submission in 1998 as well as several reports including efficacy and cardiovascular safety evaluations.