• Abgenix Inc., of Fremont, Calif., and Sosei Corp. Ltd., of Tokyo, formed an agreement focusing on fully human monoclonal antibody therapies against CRTH2, a receptor expressed on human T-helper-type cells linked to the immune response in certain allergic reactions such as asthma. Financial details of the agreement were not disclosed. The companies will co-develop antibodies against CRTH2 and additional target antigens that might be contributed. The companies intend to share development and manufacturing costs for antibody products. Abgenix will use its XenoMouse technology to generate, screen and characterize human monoclonal antibodies. Abgenix has responsibility for manufacturing monoclonal antibodies for use in clinical trials, and might offer early commercial manufacturing for antibodies stemming from the collaboration. Sosei will be responsible for commercialization in Japan, while Abgenix would lead commercialization in the U.S. Future profits resulting from the collaboration would be shared equally on a worldwide basis.

• Alkermes Inc., of Cambridge, Mass., reported that it completed enrollment of more than 600 patients in its pivotal Phase III trial of Vivitrex, a formulation of naltrexone based on Alkermes' Medisorb injectable, an extended-release technology designed to provide once-monthly dosing for the treatment of alcohol dependence. Following a six-month treatment period, patients may enter an extension study that will collect safety data for an additional 12 months. More than 180 patients have entered the extension study to date. Alkermes reported that it started the study in April 2002. (See BioWorld Today, April 2, 2002.)

• Alteon Inc., of Ramsey, N.J., reported results from the full data analyses of the Phase IIa Diamond trial of Alteon's lead compound, ALT-711, in diastolic heart failure patients. The new data, presented at The Society of Geriatric Cardiology's Ninth Annual Scientific Sessions in Chicago, strengthen and broaden the positive findings from a preliminary analysis in January that showed a statistically significant reduction in left ventricular mass and a marked improvement in left ventricular diastolic filling, the company said. In the study, 21 patients who received ALT-711 for 16 weeks experienced the reduction (p=0.0364).

• AnorMED Inc., of Vancouver, British Columbia, filed an investigational new drug application with the FDA for approval to begin its clinical program for AMD-070 for the treatment of HIV infection. AMD-070 is designed to target the CXCR4 cell receptor and prevent HIV from entering and infecting healthy cells, the company said. AnorMED plans to start the program in 2003 and also is exploring partnering opportunities for use of AMD-070 in combination with other HIV therapeutics.

• Axcan Pharma Inc., of Mont-Saint-Hilaire, Quebec, said it filed a preliminary base shelf prospectus in Canada and a related registration statement in the U.S. to register the resale by holders of the previously issued $125.0 million aggregate principal amount of 4.25 percent convertible subordinated notes due 2008 and the common shares issuable upon their conversion. Axcan said it received about $120.8 million from the offering and said it would use the funds for general corporate purposes. Axcan focuses on the field of gastroenterology.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said the FDA formally acknowledged BioMarin and partner Cambridge, Mass.-based Genzyme Corp.'s joint response to remaining items outlined in the complete response letter received Jan. 28, 2003, related to the marketing application for Aldurazyme. The FDA classified the response as complete and intends to take action on the resubmission by April 30. Aldurazyme (laronidase) is an enzyme replacement therapy designed to treat mucopolysaccharidosis I. (See BioWorld Today, Jan. 30, 2003.)

• Cephalon Inc., of West Chester, Pa., filed a lawsuit in the U.S. District Court in New Jersey against four generic drug companies for infringement of Cephalon's U.S. patent No. RE37516, which covers the pharmaceutical compositions of the form of modafinil contained in Provigil tablets and does not expire until 2014. The suit names Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Ranbaxy Pharmaceuticals Inc. and Barr Laboratories Inc. and is based on abbreviated new drug applications filed with the FDA for a generic equivalent of modafinil.

• Cerus Corp., of Concord, Calif., reported that the FDA concurred with expanding the inclusion criteria for patients in the pivotal Phase III trial for Intercept red blood cells for chronic transfusion support. The Intercept system, being jointly developed by Cerus and subsidiaries of Deerfield, Ill.-based Baxter International Inc., is a pathogen-inactivation system designed to protect patients against transmission of infectious diseases through transfusions. In addition, the companies reached agreement with the FDA to revise the informed consent form signed by patients of the study.

• Cyclacel Ltd., of Dundee, UK, entered a collaboration with Cancer Research Technology Ltd. and the University of Cambridge to develop RNA interference technology for target validation and drug discovery. The parties have combined intellectual property. The collaboration is aimed at improving RNAi technology in mammalian cells to allow the generation of new disease models and systems for analyzing mammalian gene expression. Financial terms were not disclosed.

• Enodar Biologic, of Seattle, reported the availability of True Discovery Genomic Data Analysis Services. Using a combination of processes, methods and patent-pending tools, Enodar Biologic's services are designed to help pharmaceutical and biotechnology companies speed the process of identifying predictive biomarker targets from large genomic, proteomic and SNP data sets.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application for XL784, a small-molecule cancer compound. XL784 is directed at a cell surface protease involved in cleavage of growth factors. The company plans to initiate a Phase I program by late spring, once the IND is cleared, it said.

• FeRx Inc., of San Diego, presented results at the 28th annual meeting of the Society of Interventional Radiology in Salt Lake City from clinical and preclinical studies using the company's Magnetic Targeted Carrier drug delivery platform. A Phase I/II study looked at hepatic intra-arterial delivery of doxorubicin hydrochloride absorbed to magnetic-targeted carriers in patients with hepatocellular carcinoma. Tumor localization of MTC-DOX was achieved in 31 of 33 patients and measurements of doxorubicin in plasma were undetectable or low.

• Gyros AB, of Uppsala Science Park, Sweden, reported that users of Gyrolab Maldi can now employ the latest chemically assisted fragmentation when preparing protein digests for peptide sequencing by Maldi mass spectrometry. Maldi MS is a technique used for protein identification in proteomics. Gyrolab offers a miniaturized and integrated process for sample preparation prior to Maldi MS that is designed to increase the success rate of protein identification, particularly when working with low-abundance proteins.

• Heska Corp., of Fort Collins, Colo., reported the publication of research describing a vaccine based on Heska technology to protect animals from plague. The article, titled "Recombinant Raccoon Pox Vaccine Protects Mice Against Lethal Plague," appeared in the March issue of Vaccine. Plague, caused by the bacterium Yersinia pestis, is a disease of rodents transmitted by fleas.

• ImClone Systems Inc., of New York, is postponing its financial results for the fourth quarter and year ended Dec. 31, as well as delaying the filing of its annual report on Form 10-K with the SEC. The company expects to do both by April 15. It is delaying due to a need to restate its 2001 and later financial statements and possibly certain of its financial statements for earlier periods to reflect the impact of a potential withholding tax liability on the exercise of company stock options and warrants issued to its former president and CEO due to his nonpayment of New York state income taxes and potential nonpayment of federal income taxes. The company is in discussions with both the IRS and the New York State Department of Taxation and Finance regarding the extent of its liability and any interest or penalties that might be assessed. Also, it is reviewing certain other options and warrants to determine the extent, if any, of potential withholding tax liabilities associated with the exercise of those warrants and options that were held by current and former officers, directors and employees, including its former president and CEO. ImClone's stock (NASDAQ:IMCL) fell $1.82 Monday, or 10 percent, to close at $16.54.

• InterMune Inc., of Brisbane, Calif., presented a review of the company's recent research on the antiviral effects of its interferons, Infergen (interferon alfacon-1) and Actimmune (interferon gamma-1b) at the Cytokines and Beyond conference in San Diego. The highlight of the presentation was the finding of synergistic antiviral effects of combination use of Infergen and interferon gamma-1b in cell-based models of hepatitis C virus, the company said.

• Invitrogen Corp., of Carlsbad, Calif., and Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed the sale of products and technology rights of Vertex's PanVera LLC subsidiary to Invitrogen for about $95 million in cash. PanVera provides products and services for drug discovery. The acquisition was announced in February. (See BioWorld Today, Feb. 5, 2003.)

• Iomai Corp., of Gaithersburg, Md., raised an additional $2 million in its Series C, bringing the total for the round to $56 million. The $2 million was provided by AIG Global Investment Corp., the investment unit of American International Group Inc. AIG joins a syndicate co-led by New Enterprise Associates and Essex Woodlands Health Ventures. Iomai focuses on delivering vaccines through the skin.

• Keryx Biopharmaceuticals Inc., of New York, reported the implementation of its restructuring program. The program resulted in an approximate 70 percent reduction in staff and a refocus of the company's efforts toward the development of its lead compound, KRX- 101, which has completed a Phase II trial in diabetic nephropathy. The company expects to pursue acquisitions of additional clinical-stage drug candidates. As of Dec. 31, it reported cash, cash equivalents, interest receivable and investment securities of $24.1 million. In August, the company said it would reduce staff by 45 percent and cut pay for the rest of the staff by 5 percent to 10 percent.

• La Jolla Pharmaceutical Co., of San Diego, said additional analyses of data from its Phase III and Phase II/III studies of Riquent for the treatment of lupus renal disease demonstrated statistically significant correlations between reductions in antibodies to double-stranded DNA (dsDNA) and a reduced risk of renal flare in lupus patients (Phase III: p<0.0001, Phase II/III: p=0.0004). The Phase III results demonstrated that Riquent lowers levels of antibodies to dsDNA in a statistically significant manner (p < 0.0001), although the trial did not reach statistical significance for its primary endpoint, time to renal flare. Those results were presented at the Biomarkers for the Assessment of Systemic Lupus Erythematosus Conference in Bethesda, Md. Data from the trial were originally released in February, dropping La Jolla's stock about 72 percent. Its stock (NASDAQ:LJPC) rose 21 cents Monday, or 14.2 percent, to close at $1.69. (See BioWorld Today, Feb. 19, 2003.)

• Medicure Inc., of Winnipeg, Manitoba, and Duke Clinical Research Institute announced results from a Phase II MEND-1 study of Medicure's lead drug, MC-1, at the 52nd Annual Scientific Sessions of the American College of Cardiology in Chicago. The trial enrolled 60 patients undergoing percutaneous coronary intervention and was designed to show MC-1 was safe and effective as a cardioprotective treatment to reduce damage to the heart associated with acute ischemic and reperfusion injury. The primary endpoint was periprocedural infarct size, which was reduced by about 33 percent in the MC-1 treatment group, Medicure said.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., and Volcano Therapeutics Inc., of Laguna Hills, Calif., said results were reported at the 52nd Annual Scientific Sessions of the American College of Cardiology and the VP Symposium in Chicago of a study to explore the diagnosis and treatment of atherosclerotic vulnerable plaque. In the preclinical study conducted at Washington Hospital Center in Washington D.C., Volcano's thermography catheter was used to identify inflamed plaques in artery walls, followed by treatment with Miravant's intravascular PhotoPoint PDT. The preclinical study provided evidence to support the combined technologies.

• Nanosyn Inc., of Menlo Park, Calif., said it delivered its 100,000 purified characterized compound to Amphora Discovery Corp., of Research Triangle Park, N.C. In late 2001, the companies entered a partnership to construct a screening library. Nanosyn focuses on the design, synthesis and analysis of small organic compounds.

• Nexia Biotechnologies Inc., of Montreal, signed a memorandum of understanding with Defence R&D Canada-Suffield in Alberta to research and test Protexia, formerly NEX-91, a protein designed to protect people against the toxic effects of nerve gas and other organophosphate agents. Protexia is Nexia's recombinant version of butyrylcholinesterase. Financial terms were not disclosed. Nexia's stock (TSE:NXB) rose C28 cents, or 20 percent, to close at C$1.69.

• Oncolytics Biotech Inc., of Calgary, Alberta, reported that Don Morris of the Alberta Cancer Board and the University of Calgary presented results from an interim assessment of the first six completed patients of a clinical study to evaluate the efficacy and safety of Reolysin in T2 prostate cancer. There was evidence of viral activity in five of six patients and there were no safety concerns, the company said. The results were presented Friday at the Oncolytic Viruses As Cancer Therapeutics conference in Banff, Alberta.

• Orphan Medical Inc., of Minneapolis, obtained a revolving line of credit with Silicon Valley Bank. The credit can be used at Orphan Medical's discretion to obtain working capital and provides the lesser of $3.5 million or 75 percent of qualifying assets and carries an interest rate on borrowings at the prime rate plus 2 percent. A five-year warrant to purchase 15,000 shares of Orphan Medical common stock at the market price was included. The company has an approved product, Xyrem (sodium oxybate) oral solution, designed to treat cataplexy associated with narcolepsy.

• Pharmacyclics Inc., of Sunnyvale, Calif., said preclinical studies involving treatment with the company's texaphyrins, motexafin lutetium (Antrin Injection) and motexafin gadolinium, demonstrate their potential use to reduce the number of macrophages and stabilize vulnerable plaque in atherosclerotic blood vessels. The company presented the data at the 52nd Annual Scientific Session of the American College of Cardiology in Chicago.

• Pyrosequencing AB, of Uppsala, Sweden, and Thomas Jefferson University in Philadelphia entered a sponsored research agreement to analyze genes and develop applications for inflammatory bowel disease. The university recently purchased a PSQ HS 96A system, Pyrosequencing's genotyping platform, to advance clinical molecular genetics research, including inflammatory bowel disease.

• SangStat Medical Corp., of Fremont, Calif., appointed Richard Murdock chairman, president and CEO. Murdock has served as interim CEO since last fall, and he has served as a board member since October 1993. SangStat focuses on autoimmune, hematology/oncology and immunosuppression areas.

SuperGen Inc., of Dublin, Calif., said data from a follow-up of a Phase I study of decitabine, as part of a combination preparative regimen given to leukemia patients prior to stem cell transplants, was published in Cancer (Vol. 97, No. 5, pp. 1242- 1247). The study enrolled 23 patients diagnosed with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelomonocytic leukemia or chronic myelogenous leukemia between November 1995 and July 1999. Each patient received decitabine, cyclophosphamide and busulfan prior to undergoing an allogeneic blood or bone marrow transplant. Decitabine was administered at three increasing dose levels. All but one patient also received a tacrolimus-based graft-vs.-host-disease prophylaxis regimen. Twenty-one patients were engrafted and achieved disease remission. Six of the 23 patients were alive and disease free as of May 2002 at a median of 3.3 years after transplantation. The median survival for the entire group was 17.2 months and disease-free survival for the group was 8.9 months.

• The Medicines Co., of Parsippany, N.J, presented at the 52nd Annual Scientific Sessions of the American College of Cardiology conference in Chicago a pre-specified, protocol-directed cost-of-care analysis of the Replace-2 clinical trial. The Replace-2 trial in coronary angioplasty compared The Medicines Co.'s Angiomax (bivalirudin) with the prior standard of care - heparin given with intravenous platelet inhibitors. It was reported that analysis of the 4,651 patients treated in the U.S. demonstrated statistically significant cost advantages for Angiomax, driven by savings in drug acquisition costs and reductions in hospital resource consumption related to reduced bleeding and thrombocytopenia.

• Vion Pharmaceuticals Inc., of New Haven, Conn., initiated a Phase I trial of Triapine in combination with cytarabine in patients with advanced leukemia. Cytarabine is a cytotoxic drug that is used alone and in combination for the treatment of leukemia. Triapine is designed to be an inhibitor of ribonucleotide reductase, the company said.

• Vivus Inc., of Mountain View, Calif., said results from its at-home, dose-ranging study of Alista for female sexual arousal disorder showed the 400 mg dose produced a statistically significant improvement in the primary endpoint of satisfactory sexual arousal and/or orgasm. Results in the 200 mg and 800 mg dose groups demonstrated positive trends for the primary endpoint but did not reach statistical significance. Alista is a formulation of alprostadil applied locally to the female genitalia. Vivus' stock (NASDAQ:VVUS) fell 60 cents Monday, or 15 percent, to close at $3.40.