¿ Alexion Pharmaceuticals Inc., of Cheshire, Conn., said it began a Phase II trial in lupus nephritis patients with its humanized monoclonal antibody C5 complement inhibitor, 5G1.1. The trial is expected to enroll about 40 patients at four U.S. sites and will test 5G1.1¿s safety and efficacy for up to six months. Separately, Alexion said it completed a Phase I pilot safety trial in psoriasis patients with 5G1.1. It has completed the preliminary analysis and said 5G1.1 appears to be safe and well tolerated, although drug administration did not influence the clinical outcome as measured by Psoriasis Area and Severity Index score. Alexion released its third-fiscal-quarter results as well, showing a pro forma net loss of about $5.6 million. Its stock (NASDAQ:ALXN) fell $3.77 Thursday, or about 13.5 percent, to close at $24.12.
¿ Arqule Inc., of Woburn, Mass., appointed Ariel Elia nonexecutive chairman of the board. Elia joined Arqule¿s board in October 2000. He has 17 years of experience at Merck & Co. Inc., of Whitehouse Station, N.J., and spent 12 years at American Home Products Corp., of Madison, N.J.
¿ Bristol-Myers Squibb Co., of New York, said it has a definitive agreement to purchase DuPont Pharmaceuticals Co., a wholly owned subsidiary of DuPont, of Wilmington, Del., for $7.8 billion in cash. The agreement is expected to close Dec. 31. Last year, DuPont Pharmaceuticals realized sales of $1.5 billion.
¿ Celgene Corp., of Warren, N.J., filed an investigational new drug application with the FDA to initiate a Phase I trial of SPC8490, an orally available selective estrogen receptor modulator-alpha for the treatment of breast cancer. A Phase I study in healthy, postmenopausal volunteers was initiated in the United Kingdom as well. Also, Celgene formed license agreements with the New York University School of Medicine, the Research Foundation of the State University of New York and the Toronto Hospital for Sick Children for the identification, validation and use of ligases for drug discovery. Separately, Celgene gave preliminary results of its Phase I safety trial of Revimid, its immunomodulatory drug for the treatment of solid tumors. The data showed encouraging drug tolerability and indications that the drug may be active in treating melanoma, Celgene said.
¿ Centocor Inc., of Malvern, Pa., and its product Remicade (infliximab) got potentially good psoriasis news from a report in the June 9, 2001, issue of The Lancet. The report said infliximab, used currently as a treatment for rheumatoid arthritis and Crohn¿s disease, could have a role in treating psoriasis, based on research done at the University of Medicine and Dentistry of New Jersey.
¿ Cephalon Inc., of West Chester, Pa., presented data from two new studies demonstrating that patients receiving Provigil Tablets, for the treatment of the excessive daytime sleepiness associated with narcolepsy, experienced a sustained treatment response and that the response may be related to the drug dosage. The data were presented at the 15th Annual Meeting of the Associated Professional Sleep Societies in Chicago.
¿ Chromos Molecular Systems Inc., of Burnaby, British Columbia, said a paper reporting the development of a unique and rapid screening technique to quantify delivery of intact artificial chromosome expression systems (ACes) was published in the June 2001 issue of Cytometry. This is the first report describing the use of flow cytometry for the direct quantification of chromosome transfer in mammalian cells, Chromos said.
¿ Geron Corp., of Menlo Park, Calif., entered an option agreement to license its nuclear transfer technology to Viragen Inc., of Plantation, Fla. Viragen has the option to license, on a nonexclusive worldwide basis, Geron¿s nuclear transfer patent portfolio for the field of avian nuclear transfer. Geron will receive cash and Viragen stock in exchange for the option rights. If the option is exercised, additional cash and stock and a percentage of future revenues will go to Geron.
¿ Hemispherx Biopharma Inc., of Philadelphia, will begin a research trial with The Orange County Center for Special Immunology, of Fountain Valley, Calif., involving a new approach to treating HIV infection. The study will use immune-based therapy with Ampligen in combination with strategic therapeutic interruptions of antiviral medications.
¿ LaunchCyte LLC, of Pittsburgh, created Morewood Molecular Inc. to commercialize proteomics technology licensed from the University of Pennsylvania in Philadelphia. LaunchCyte is providing seed capital and management services to the new company. The proteomics technology addresses the need for rapid measurement of enzyme activity in biological samples.
¿ MediChem Life Sciences, of Chicago, and Elitra Pharmaceuticals Inc., of San Diego, entered a three-year joint research program to discover and develop drug candidates against microbial infections. The companies will commit resources and share rights to the program. Elitra will reimburse MediChem for research conducted. Elitra may purchase MediChem¿s rights to drug candidates from the collaboration, in exchange for milestone payments and royalties. No further financial details were disclosed.
¿ Oxigene Inc., of Watertown, Mass., completed the transition of its scientific, administrative and financial functions to its Watertown, Mass., offices. The transition is intended to increase Oxigene¿s presence in the United States, the company said.
¿ Synsorb Biotech Inc., of Calgary, Alberta, was granted an additional 200,000 shares of BCY LifeSciences Inc., of Toronto. Synsorb now owns 1.3 million shares, or about 11.5 percent of the outstanding shares of BCY. The shares were delivered as a milestone, triggered by BCY completing the fractionation of a low-molecular-weight dextran and the bioassay of these fractions. An additional 600,000 shares may be issued to Synsorb upon completion of other predetermined milestones.
¿ Vitro Diagnostics Inc., of Aurora, Colo., said the FDA completed its initial evaluation of Vitro¿s plan to seek FDA approval of Vitropin, a purified human urinary FSH. Vitro plans to seek approval through a ¿paper¿ new drug application, using information submitted by other FSH manufacturers. Vitro is also developing a platform technology to immortalize human cells.
¿ Waratah Pharmaceuticals Inc., of Montreal, reached an agreement with the Massachusetts General Hospital (MGH) to amend and restructure its license agreement covering 50 percent of Waratah¿s Islet Neogenesis Therapy. Waratah proposed a specific timetable to MGH for the development of the Islet Technology that MGH agreed to. Waratah owns the remaining 50 percent of the Islet technology.