• Alpha Therapeutic Corp., of Los Angeles, named Claude Miller president and CEO, a promotion from his position as chief operating officer. Edward Colton has assumed the position of vice chairman. In his new role, Miller will be responsible for the day-to-day operations and focusing on strategic planning and future business development for the company, which develops plasma-derived biopharmaceuticals.

• Altair Nanotechnologies Inc., of Reno, Nev., entered a testing agreement with a second pharmaceutical company for in vivo evaluation of RenaZorb, its new pharmaceutical candidate for phosphate control in kidney dialysis patients. Both Altair and the company doing the testing will own data collected from the evaluation.

• Amgen Inc., of Thousand Oaks, Calif., said an arbitrator determined it to be the prevailing party in a recent arbitration with Johnson & Johnson, of New Brunswick, N.J., ordering the latter to pay four years' worth of Amgen's costs and reasonable attorney fees. Three months ago the arbitrator found that J&J breached its license agreement with Amgen by promoting its brand of Epoetin alfa, Procrit, into Amgen's reserved dialysis market. As a result, the arbitrator ordered J&J to pay Amgen $150 million in damages. Separately, Amgen named two Rhode Island and five California teachers as recipients of the 2003 Amgen Award for Science Teaching Excellence as part of a program for science education. The kindergarten through 12th-grade educators each will receive an $10,000 award.

• Antex Biologics Inc., of Gaithersburg, Md., received FDA approval of its investigational new drug application for its Helivax vaccine. Antex said it is planning patient enrollment for a pair of Phase II trials scheduled for the first half of 2003 to study Helivax, an inactivated, multivalent, whole-cell vaccine designed to prevent and treat infections caused by Helicobacter pylori.

• Beckman Coulter Inc., of Fullerton, Calif., said ProteomeLab PF 2D and ProteomeLab PA-800 Protein Characterization are available. The instruments are systems for protein discovery and are the first introductions in Beckman Coulter's ProteomeLab initiative, the company said.

The Bill & Melinda Gates Foundation reported a $200 million grant to establish the Grand Challenges in Global Health initiative, a new effort and partnership with the National Institutes of Health in Bethesda, Md. The initiative will identify scientific challenges in global health and increase research of diseases that cause millions of deaths in the developing world, the foundation said. Gates revealed the initiative at the World Economic Forum's annual meeting in Davos, Switzerland.

• CancerVax Corp., of Carlsbad, Calif., said the FDA granted fast-track designation to its Canvaxin therapeutic cancer vaccine for the post-surgical treatment of patients with metastatic melanoma. It is being evaluated in two international, randomized, double-blind, placebo-controlled Phase III trials, though both are on partial clinical hold for the enrollment of new patients while CancerVax develops certain information requested by the FDA related to the production, characterization and testing of Canvaxin. CancerVax stressed that the hold is not the result of any clinical practice or safety concerns.

• Crucell NV, of Leiden, the Netherlands, and Aventis Pasteur SA, of Lyon, France, signed a license agreement for manufacturing technology related to viral vaccines. The agreement allows Aventis Pasteur to use Crucell's cell-based vaccine manufacturing technology to develop and commercialize next-generation vaccines. Crucell will receive up-front payments, milestone payments and royalties on future product sales.

• Cytogen Corp., of Princeton, N.J., said Friday it provided Draximage Inc., of Mississauga, Ontario, the radiopharmaceutical subsidiary of Draxis Health Inc., with notice of termination for its license and distribution agreement and its product manufacturing and supply agreement with respect to both of Draxis' BrachySeed I-125 and BrachySeed Pd-103 products. Cytogen said it took this action as a result of Draxis' failure to consistently supply the BrachySeed products at quantities, activity levels and schedules amenable to commercial sales. On Monday, Draximage said it disputes that there is any basis for either of Cytogen's claims or that Cytogen is entitled to terminate the agreements. Draximage said it notified Cytogen on Friday that it was exercising its rights to terminate Cytogen's exclusivity with regard to the marketing and distribution of BrachySeed implants in the U.S., which prompted Cytogen's notice to terminate.

• Dendreon Corp., of Seattle, reported in the current issue of Human Immunology that it developed a novel assay that enables the use of animal models to characterize its therapeutic prostate cancer vaccine, Provenge, as well as other cancer immunotherapies. The publication describes the use of cell lines derived from transgenic mice to measure immune stimulation induced by Provenge, a vaccine against prostatic acid phosphatase, a protein found at high levels on a majority of prostate cancer cells. Dendreon said that to date such approaches have been limited due to differences between human immune cells and the immune systems of animals.

• Ecopia BioSciences Inc., of Montreal, disclosed the first two compounds discovered using its drug discovery platform. One of the compounds, ECO-02301, is a potential antifungal agent. The second, ECO-04601, is a potential anticancer agent. Patent applications have been filed for both. ECO-02301 represents a new structural class of antifungal agent, the company said. It is a polyketide possessing unique structural features that distinguish it from other antifungal compounds. ECO-02301 has shown activity against a broad spectrum of pathogenic yeasts including strains resistant to currently used antifungal drugs. Ecopia's stock (TSE:EIA) gained C21 cents Monday, or 45.7 percent, to close at C67 cents.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., entered a license agreement with the University of California at San Francisco, providing Elixir with access to discoveries in age-related genetics research made by Elixir's founder, Cynthia Kenyon, a university professor, including the life span-extension discoveries around the DAF-2/insulin/IGF-1 signaling pathway in nematode worms. Specifically, Elixir obtained access to novel biological reagents created in Kenyon's laboratory, as well as current and, for a period of two years, a limited option to future related intellectual property that is dominated by the licensed patent rights. Financial terms were not disclosed.

• Epigenomics AG, of Berlin, gained access to two new technologies through a licensing agreement with Johns Hopkins University in Baltimore, and an option agreement with Australia's Commonwealth Scientific and Industrial Research Organization Division of Molecular Science in Sydney, for the early detection of solid tumors. The agreements are designed to enhance Epigenomics' work in the field of DNA methylation and its role in disease detection and monitoring. As part of the agreements, representatives from both institutions joined Epigenomics' scientific advisory board. Financial terms were not disclosed.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, reported data from a Phase I safety study of FM-VP4, results establishing the safety and tolerability of the cholesterol transport inhibitor over the dose ranges studied. Subjects were administered single doses of FM-VP4 ranging from 100 mg to 2,000 mg. After receiving medication, each was monitored for 24 hours and periodically over the following seven days. All 30 subjects completed the trial.

• Genmab A/S, of Copenhagen, Denmark, received FDA approval to begin two Phase II open-label studies using HuMax-CD4 to treat cutaneous T-cell lymphoma. One study will focus on refractory patients and the other will be for patients with persistent early stage disease. In both studies patients will receive a 280 mg dose of HuMax-CD4 once a week for 16 weeks. Patients will be followed for at least four weeks after the end of treatment or until disease progression. Both 12-patient studies, which will run concurrently, aim to determine the efficacy and safety of HuMax-CD4 in treating the disease.

• KuDOS Pharmaceuticals Ltd., of Cambridge UK, and MerLion Pharmaceuticals Pte. Ltd., of Singapore, entered a two-year discovery and preclinical research collaboration. The collaboration will bring together MerLion's library of natural product compounds and KuDOS' validated targets to select lead candidates in the area of HPV-induced cervical cancer. MerLion will be responsible for identifying and characterizing active substances from its library against KuDOS assays, and KuDOS will then progress the compounds through initial pharmacological screening. Financial terms were not disclosed.

• Matritech Inc., of Newton, Mass., said Nasdaq has granted preliminary approval of its application to return to trading its common stock on the Nasdaq SmallCap Market. Matritech requested the change because of changes during the second half of 2002 in a number of standards for continued listing on the Nasdaq National Market. Matritech said it does not meet one such requirement, which changed from requiring minimum net tangible assets of $4 million to at least $10 million of shareholders' equity (including intangible assets). Matritech said the transfer would take effect on Jan. 27.

• MitoKor Inc., of San Diego, said it sold its Australian subsidiary, Mimotopes Pty. Ltd., to Fisher Scientific International Inc., of Hampton, N.H., as part of its plans for accelerating the preclinical and clinical development of its lead compounds. Financial terms were not disclosed, though MitoKor said it would continue to access Mimotopes' chemistry capabilities.

• Molecular Staging Inc., of New Haven, Conn., and Eli Lilly and Co., of Indianapolis, entered a clinical proteomics research collaboration. MSI will use its clinical proteomics platform and bioinformatics to identify biomarkers in the rapid progression of sepsis. The goal is to identify opportunities for earlier intervention and improved patient outcomes.

• MorphoSys AG, of Munich, Germany, entered an agreement with Lonza Biologics plc, of Slough, UK, for production and supply of clinical-grade antibody drugs derived from MorphoSys' HuCAL technology within the next five years. The agreement regulates access to Lonza's process development and manufacturing capacity for future antibody projects for both MorphoSys' own and partnered therapeutic antibody projects. Financial terms were not disclosed.

The National Institutes of Health in Bethesda, Md., reported in this week's online edition of the Proceedings of the National Academy of Sciences that it has discovered insight into how Group A Streptococcus can evade destruction by the immune system. The National Institute of Allergy and Infectious Diseases called the study the first genome-scale investigation of Group A Streptococcus genes that are differentially expressed during interaction with the human innate immune system.

• SomaLogic Inc., of Boulder, Colo., and Merial Ltd., of Duluth, Ga., entered a collaboration to develop aptamer-based diagnostics for bovine spongiform encephalopathy. SomaLogic's technology is based on aptamers, single-stranded DNA molecules that bind target molecules. Financial terms were not disclosed.

• SynGenix Ltd., of Cambridge, UK, acquired Dallas Burston Ltd., of Northampton, UK. SynGenix completed the acquisition by issuing new shares. The deal gives SynGenix a pipeline of products based on delivery through the mucosa of the mouth. Financial details were not disclosed. SynGenix focuses on treating the conditions of the nervous system.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said a class action lawsuit has been brought against it and its CEO in the United States District Court for the District of Massachusetts. The complaint alleges securities fraud from Jan. 4, 2001, to Jan. 14, 2003, stating the company made false and misleading statements and failed to disclose material information concerning the status and progress of its product, Replagal, designed to treat Fabry's disease. TKT said it believes it has "highly meritorious defenses" and intends to defend itself. On Jan. 14, an FDA advisory panel voted 15-0 that TKT failed to provide substantial evidence of efficacy of Replagal (agalsidase alfa) in the treatment of Fabry's disease. (See BioWorld Today, Jan. 15, 2003.)

• Tularik Inc., of South San Francisco, began a Phase I trial to evaluate the safety and pharmacokinetic profile of T131, a candidate to treat Type II diabetes. T131 activates PPARgamma (peroxisome proliferator-activated receptor gamma), a target involved in the body's ability to respond to insulin. The randomized, double-blind, dose-escalation trial is being conducted in healthy adult volunteers in the UK.

• Unigene Laboratories Inc., of Fairfield, N.J., said it received a $1 million milestone payment from GlaxoSmithKline plc, of London, following the performance demonstrated by Unigene's oral parathyroid hormone (PTH) formulation in animal studies. In addition, Unigene is producing PTH in order to meet all of GlaxoSmithKline's requirements for its preclinical and Phase I studies to treat osteoporosis under the terms of a recently concluded supply agreement between the parties.

• Valentis Inc., of Burlingame, Calif., said it received stockholder approval for its proposed capital restructuring and that the restructuring activities have been completed. Specifically, it effected the conversion of all outstanding shares of its Series A convertible redeemable preferred stock into common stock and, immediately thereafter, a reverse stock split of its common stock at a ratio of 1-for-30.

• Vion Pharmaceuticals Inc., of New Haven, Conn., began a multicenter Phase II trial of Triapine as a single agent in patients with advanced hormone-refractory prostate cancer. Vion now has two ongoing Phase II studies of Triapine as a single agent, and also is planning to study Triapine in combination with gemcitabine in Phase II trials in non-small-cell lung and pancreatic cancers. Vion said it expects to begin the combination trials in the next few months.