¿ NewBiotics Inc., of San Diego, said Michael Shepard, its chief scientific officer and co-founder, was named president. Previously, Shepard was chief scientific officer and vice president of research at Canji Inc.
¿ Abgenix Inc., of Fremont, Calif., added 10 antigen targets to its eight-year human antibody collaboration with Pfizer Inc., of New York, raising the alliance's potential product candidates to 15. Abgenix receives an undisclosed fee to extend the agreement, begun in December 1997. This is the second expansion in the $30 million deal, originally for up to three antibodies developed with Pfizer targets. The first was last March. Abgenix also said it extended its research collaboration with Amgen Inc., of Thousand Oaks, Calif. The extension calls for Abgenix to use its XenoMouse technology to generate fully human monoclonal antibodies to antigen targets provided by Amgen over the collaboration's five-year term. Amgen and Abgenix entered the original agreement in April 1999. (See BioWorld Today, March 1, 2000, and April 27, 1999.)
¿ AeroGen Inc., of Sunnyvale, Calif., said its AeroDose albuteral inhaler entered Phase II trials in moderate to severe asthmatic patients. AeroGen plans to introduce the inhaler to the market in 2003.
¿ Alteon Inc., of Ramsey, N.J., said it received about $1.55 million from the sale of its net operating loss carryovers under the state of New Jersey's Technology Business Tax Certificate Transfer Program. Alteon may participate in the program again in 2001, and the amount of tax credit the company will actually receive is dependent on the allocation among qualified companies of an annual pool established by the state.
¿ Andrex Corp., of Fort Lauderdale, Fla., initiated a basic research program in Alzheimer's disease and other dementias. Initial results of the program indicate that physiologic concentrations of an active metabolite of lovastatin can decrease the production of beta amyloid protein in cultured cells.
¿ Antex Biologics Inc., of Gaithersburg, Md., said a recently completed Phase II trial of Campyvax, its Campylobacter infection vaccine, indicated the compound produces significant immune responses that correlate with protection against disease. The company will proceed with development of the vaccine, which is supported through Phase III testing by the U.S. Department of Defense.
¿ Aurora Bioscience Corp., of San Diego, entered an agreement with Allergan Inc., of Irvine Calif., for ion channel drug discovery for ophthalmic indications. Aurora will develop primary and secondary functional cell-based assays using its Voltage Sensor Probe technology and voltage ion probe reader for a novel ion channel target identified by Allergan. The agreement includes an up-front payment to Aurora and additional payments upon achievement of certain research performance milestones. Aurora also will receive development milestone payments and royalties on resulting products.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said its double-blind, placebo-controlled Phase I trial of its CETP vaccine in adult volunteers indicated the compound is well tolerated. The company said the compound met the objectives of the safety study. CETi-1 is under development for management of patients with low levels of HDL cholesterol.
¿ Aviron Inc., of Mountain View, Calif., said it received a $10 million payment from American Home Products Corp., of Madison, N.J., to support commercial manufacturing and inventory buildup of FluMist for a potential 2001-02 influenza season launch. The payment is an advance for payments American Home products owes Aviron under the companies' global collaboration agreement for FluMist.
¿ AxCell Biosciences Corp., of Princeton, N.J., a subsidiary of Cytogen Corp., also of Princeton, said it mapped all of the interactions of the known proteins found in one of the 60 to 80 protein domain families in the human body using advanced robotic screening technologies and data from the Human Genome Project. The company said it's the first domain map to be completed in the effort to develop a chart of all the human protein pathways. Cytogen's stock (NASDAQ:CYTO) jumped 27 percent Tuesday to close at $3.375.
¿ Biogen Inc., of Cambridge, Mass., said it expects the number of drug candidates in its clinical pipeline to double this year. The development company focused on treatments for inflammatory, neurological and autoimmune disease, cancer, neurological disorders, fibrosis and congestive heart failure currently has 20 potential therapeutics in development.
¿ BioVex Ltd., of London, established GenTest, a business dedicated to target validation. GenTest entered into an agreement with an unnamed U.S. biopharmaceutical company, BioVex said, for the discovery of small-molecule and biotherapeutic products.
¿ Charles River Laboratories International Inc., of Wilmington, Mass., completed its acquisition of Pathology Associates International Corp., of Frederick, Md., for $37 million. The purchase included a cash consideration of $25 million, and the remainder, $12 million, was paid as a convertible note carrying a two-year term and a 2 percent interest rate convertible into shares of Charles River Laboratories at $23.38 per share.
¿ Dendreon Corp., of Seattle, received clearance from the FDA to begin trials of its therapeutic breast, ovarian and colon cancer vaccine, APC8024. The candidate is designed to induce an immune response against tumor cells that show increased amounts of the protein antigen Her-2/neu, which is overexpressed in about 25 percent of metastatic breast cancers, ovarian, pancreatic and colon cancers.
¿ Esperion Therapeutics Inc., of Ann Arbor, Mich., initiated a Phase IIa large unilamellar vesicles (LUV) program designed to evaluate the safety, tolerability, dose level and pharmacokinetics of LUV in individuals with atherosclerosis and low HDL-C. The company also said that Phase I data for LUV indicated a dose-dependent increase in plasma phospholipid followed by an increase in plasma-free cholesterol, a clinically relevant mobilization of cholesterol in normal volunteers.
¿ Gene Logic Inc., of Gaithersburg, Md., and Sumitomo Pharmaceuticals Co. Ltd., of Tokyo, entered an agreement granting Sumitomo access to segments of Gene Logic's GeneExpress Suite for use in drug discovery efforts. Financial terms of the agreement were undisclosed.
¿ Genencor International Inc., of Palo Alto, Calif., said it successfully created the first in vivo model that contains genetically linked DQ2 and DR3 genes as a part of its transgenic mouse program. The mouse line expressing the human HLA DR3 gene locus will be used to build an in vivo celiac disease model. The HLA class II haplotype DQ2:DR3 expressed in humans predisposes individuals to several autoimmune diseases, including celiac disease, diabetes, multiple sclerosis, lupus, thyroiditis and myasthenia gravis.
¿ Genmab A/S, of Copenhagen, Denmark, initiated a Phase II trial of HuMax-CD4 in patients with severe psoriasis. The multicenter, dose-ranging, placebo-controlled study is designed to provide researchers with safety and efficacy data as well as dosing information.
¿ Genomics Collaborative Inc., of Cambridge, Mass., and NetGenics Inc., of Cleveland, entered a joint development collaboration to create and develop the first application of the Genotypic DataMart, a data retrieval and mining application. The companies will apply the DataMart to analysis and mining of annotated, genotypic data derived from GCI's repository of human genetic samples to aid drug target identification.
¿ Genzyme Transgenics Corp., of Framingham, Mass., agreed to expand the production capacity it developed for production of CTLA4Ig fusion protein for Bristol-Myers Squibb Co., of New York. The expansion will enable Genzyme to produce CTLA4Ig fusion protein in amounts sufficient to supply bulk products for human trials.
¿ Geron Corp., of Menlo Park, Calif., and Clontech Laboratories Inc., of Palo Alto, Calif., said the launch of the hTERT-HME1 human mammary epithelial cell line marks the third cell type offered in the Infinity family of telomerase-immortalized cells, cells that express human telomerase reverse transcriptase. Clontech and Geron entered the marketing agreement in March 1999.
¿ GPC Biotech AG, of Martinsried, Germany, entered an alliance with Boehringer Ingelheim International GmbH, of Ingelheim, Germany, to use GPC's technology platform to identify novel targets and their molecular pathways associated with human papillomavirus. The research and license agreement includes an undisclosed up-front license fee, research funding and development milestones in addition to royalties on product sales from the collaboration for GPC. The deal could add up to $30 million, excluding royalties.
¿ ILEX Products Inc., of San Antonio, Texas, filed an investigational new drug application for NM-3, an angiogenesis inhibitor. The compound is scheduled to begin Phase I testing in the U.S. in the first half of this year.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., said its offer to acquire Bradford Particle Design plc, of Bradford, UK, a supercritical fluid processing company, has become unconditional in all respects. Inhale made the offer in December to acquire Bradford for 3.75 million newly issued Inhale shares and about $20 million in cash.
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., initiated Phase III trials for its P2Y(2) receptor agonist, INS365 Ophthalmic treatment, in patients with dry eye. The two trials will enroll about 1,000 patients at 60 sites. Both studies are designed as double-masked and placebo-controlled, and each will evaluate the compound's efficacy at different concentrations.
¿ Labopharam Inc., of Laval, Quebec, said a Phase II study on solid oral dosage forms of Xopenex (levalbuterol HCL) in treatment of asthma demonstrated significant improvement in breathing compared to placebo in moderate and severe patients, dose-dependant efficacy, bioequivalence with existing treatments and pharmacokinetics results that duplicated those in an earlier trial with healthy volunteers. Labopharm conducted the trial in conjunction with its Xopenex marketing partner, Sepracor Inc., of Marlborough, Mass.
¿ Ligand Pharmaceuticals Inc., of San Diego, said development partner Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corp., of Madison, N.J., elected to continue development of TSE-424 as a hormone replacement therapy for prevention and treatment of osteoporosis in postmenopausal women. The decision triggered an undisclosed milestone payment to Ligand.
¿ Lorus Therapeutics Inc., of Toronto, said its lead anticancer drug, Virulizin, demonstrated better antitumor activity in mice with human breast cancer tumor cells than Taxol, one standard-of-care treatment. Even better antitumor activity was found when the drugs were used in combination therapy, Lorus said.
¿ Medarex Inc., of Princeton, N.J., and Novo Nordisk A/S, of Copenhagen, Denmark, entered an alliance to develop fully human antibody therapeutics. The alliance will combine Medarex's UltiMAb Human Antibody Development System and T-12 Development with Novo Nordisk's fusion protein expertise to create antibodies to multiple Novo Nordisk disease targets. Novo Nordisk will develop and commercialize any resultant human antibody products, and Medarex will receive up-front payments, as well as milestones and royalties on commercial sales.
¿ Microcide Pharmaceuticals Inc., of Mountain View, Calif., amended its research and license agreement with The R.W. Johnson Pharmaceutical Research Institute and Ortho McNeil Pharmaceutical Inc., both of Raritan, N.J., and both Johnson & Johnson companies, to cover preclinical research by Microcide to develop an orally active cephalosporin with similar spectrum and potency to the paternal compounds currently under development by the J&J companies. Microcide will receive an up-front license fee and one year of "substantial" funding, it said, for research to optimize newly discovered leads. Microcide also will receive multiple milestone payments for each product resulting from the new research as well as royalties on worldwide sales.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Wyeth-Ayerst Research, of Rodman, Pa., a division of American Home Products Corp., identified a preclinical candidate compound that demonstrated safety and efficacy in animal models of life-threatening bacterial infections. The companies said they will move forward with the submission of an investigational new drug application upon further validation.
¿ NaPro BioTherapeutics Inc., of Boulder, Colo., said it received marketing approval in Israel for Biotax, its version of the anticancer agent paclitaxel. NaPro established an exclusive supply and distribution agreement with Tzamal Pharma, of Israel, for the therapeutic.
¿ Peregrine Pharmaceuticals Inc., of Tustin, Calif., said data from its Phase II trial of Cotara, its tumor necrosis therapy drug, in patients with recurrent or unresectable malignant glioma indicated a median time to progression of about 14 weeks, a 75 percent increase over historical data for the 16 evaluable patients. The company plans to present the completed analysis of the trial's results in scientific publications and at upcoming scientific meetings.
¿ Pharamcyclics Inc., of Sunnyvale, Calif., said its pivotal, randomized, placebo-controlled Phase III trial of lead product Xcytrin (motexafin gadolinium) Injection for treatment of brain metastases reached 90 percent enrollment. In addition, the company reported that analysis of the trial's interim data from 341 randomized patients by an independent Data Safety Monitoring Board indicated the compound is safe, and it recommended the trial continue as designed.
¿ Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said an article published in The Journal of Virology concerning its HIV entry inhibitor PRO 140 details a study that demonstrated "impressive antiviral properties" associated with PRO 140. Progenics said the compound demonstrated potent broad-spectrum activity against more than 40 genetically diverse primary HIV viruses.
¿ Sangamo BioSciences Inc., of Richmond, Calif., and Renessen LLC, of Bannockburn, Ill., signed an agreement to apply Sangamo's proprietary gene regulation technology to enhance the value of certain crops for the animal feed and processing industries. Sangamo will receive certain payments, including research funding and royalties on the sales of any commercialized products. Renessen will receive a worldwide exclusive license to Sangamo's technology for the sale and use of certain enhanced crops.
¿ Stressgen Biotechnologies Corp., of Victoria, British Columbia, said it has initiated a Phase II trial to investigate HspE7 as an immunotherapeutic for genital warts caused by the human papilloma virus. The study will involve 52 patients at multiple study centers in the United States.
¿ Tecan Group Ltd., of Hombrechtikon, Switzerland, established Tecan Proteomics GmbH and devoted more than 20 percent of its 2001 research and development budget to fund the venture. Tecan plans to develop the proteomics company using its resources, and acquired Dr. Weber GmbH, of Munich, a developer and commercializer of proprietary free-flow electrophoresis fractionation technology, in support of the venture for an undisclosed consideration.
¿ Telik Inc., of South San Francisco, entered a collaboration with the Arizona Cancer Center at the University of Arizona to apply Telik's TRAP chemogenomics technology to identify small-molecule compounds active against multiple cancer targets provided by university researchers. Telik will have exclusive worldwide rights to develop and commercialize compounds arising from the collaboration.
¿ Theratechnologies Inc., of Saint-Laurent, Quebec, said it filed two additional investigational new drug applications with Health Canada's Therapeutic Products Programme for its ThGRF 1-44 peptide - a growth hormone-releasing factor analogue - to begin a second Phase II trial in sleep disorders and a Phase I trial in hip fractures.
¿ Versicor Inc., of Fremont, Calif., and Biosearch Italia S.p.A., of Gerenzano, Italy, expanded their anti-infective product leads development partnership known as BIOCOR. The expansion calls for the formation of a dedicated medicinal and combinatorial chemistry research team devoted exclusively to BIOCOR projects. Biosearch will contribute selected microbial library compounds, fermentation extracts and high-throughput screening beyond the scope of the original agreement, and Versicor will provide additional selected targets and assays for screening purposes.