• Affymetrix Inc., of Santa Clara, Calif., said scientists at the Broad Institute of MIT and Harvard in Cambridge, Mass., will use the new GeneChip High Throughput system to perform pioneering research projects in RNA expression analysis, SNP genotyping and DNA resequencing. The institute plans to use the GeneChip HT system to undertake large-scale genomic and genetics projects.

• Applied Biosystems Group, of Foster City, Calif., introduced the LS LIMS Software, a new workflow-management and process-automation solution designed to increase productivity, improve data quality and integrate data from different sources for genomics and proteomics laboratories.

• BioMarin Pharmaceutical Inc., of Novato, Calif., revised its financial guidance based on reduced 2004 revenue expectations for the pediatric asthma product Orapred that it acquired in May. Revisions reflect larger-than-anticipated levels of Orapred inventory held by distributors prior to BioMarin's acquisition of the product. Louis Drapeau, BioMarin's acting CEO, said Orapred remains the top-selling product in its class, and has had a 9 percent increase this year in prescriptions from physicians, compared to 2003. Inventory is expected to normalize in the fourth quarter and should not affect 2005 sales. BioMarin revised its 2004 GAAP net loss guidance of $112 million to $114 million to the new range of $137 million to $140 million. The ending cash, cash equivalent and restricted cash balance of $85 million to $90 million has been revised to $70 million to $75 million. The revised guidance also reflects $2.9 million paid to BioMarin's former chairman and CEO upon his resignation in August. The company's stock (NASDAQ:BMRN) fell 15.2 percent Wednesday, or 93 cents, to close at $5.21.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said data from its Phase II study showed treatment with LibiGel (transdermal testosterone gel) increased satisfying sexual activity in surgically menopausal women suffering from female sexual dysfunction. Specific results showed that LibiGel increased the number of satisfying sexual events by 238 percent vs. baseline (p<0.0001) in the 46-patient trial, and the increase also was significant vs. placebo (p<0.05). LibiGel also produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. The product uses transdermal delivery gel technology belonging to Antares Pharma Inc., of Exton, Pa.

• Biovitrum AB, of Stockholm, Sweden, acquired rights to obesity-focused drug candidates from BioFocus plc, of Chesterford Research Park, UK. The research project, which is at the end of the lead-generation phase, focuses on blocking signaling through a G protein-coupled receptor that is believed to be relevant to weight reduction. It has been developed within a joint venture between the companies, which began in 2001. The new agreement calls for Biovitrum to gain full rights to a lead program that contains compounds that inhibit the specific receptor. Biovitrum said it would continue to develop the compounds, while in return, BioFocus will receive an up-front payment, milestones and royalties.

• CancerVax Corp., of Carlsbad, Calif., completed enrollment of 1,118 patients in its Phase III trial of Canvaxin to treat patients with Stage III melanoma. The trial is designed to evaluate the ability of Canvaxin to extend the survival of patients following surgical resection of their tumors. The company will continue to enroll new patients in its ongoing Phase III trial of Canvaxin to treat patients with Stage IV melanoma. The trial was re-started in April 2003, after the company resolved some manufacturing issues. (See BioWorld Today, April 16, 2003.)

• Cerus Corp., of Concord, Calif., said preclinical data published in the Sept. 21, 2004, issue of the Proceedings of the National Academy of Sciences shed light on the efficacy and safety of its cancer immunotherapy technology. The research showed that experimental vaccines based on an attenuated Listeria strain, engineered to express tumor antigens, elicited therapeutic antitumor responses, including prolonged survival and tumor regression, following vaccination of tumor-bearing mice. Also, the Cerus strain demonstrated a more than 1,000-fold increase in safety when compared to unmodified Listeria. The company's stock (NASDAQ:CERS) gained 38 cents Wednesday, or 18 percent, to close at $2.49.

• Corgentech Inc., of South San Francisco, plans to start a Phase I/II trial in the first half of 2005 in eczema with NF-Kappa-B Decoy (NF-KB Decoy), an inhibitor of immune and inflammatory responses. The trial will treat about 60 patients with mild to moderate eczema. The company also said preclinical studies of its Hypoxia-Inducible Factor Decoy (HIF Decoy) showed down-regulation of VEGF and tumor growth inhibition as monotherapy and an additive effect in combination with Avastin (Genentech Inc.) and 5-Fluorouracil.

The Dana-Farber Institute and Brigham and Women's Hospital, both in Boston, and their researchers said they have prolonged the lives of mice with a rare blood disorder by using an experimental drug that blocks signals promoting runaway growth of blood cells. The researchers also tested the drug, PKC412, in a patient with myeloproliferative disease, and saw her symptoms improve. PKC412 is a highly specific targeted drug that disables a switch in cancer cells that has become jammed in the "on" position because of a genetic mutation.

• Galapagos Genomics NV, of Mechelen, Belgium, created a new business unit for its viral-based discovery and validation service. The unit will operate under the name Galadeno from the Galapagos facility in Leiden, the Netherlands. The drug discovery business will be conducted from the Mechelen facility and continue to trade under the name Galapagos. Galadeno will offer individual adenoviral-based siRNA and full-length gene reagents for drug target discovery and validation.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said the Microbicide Development Programme, a partnership set up to develop vaginal microbicides for the prevention of HIV transmission, selected Indevus' PRO 2000 to be tested in clinical trials expected to start next year in several African nations. PRO 2000 is a microbicide under development to prevent sexual infection of HIV. The trials are expected to enroll 12,000 women and begin enrollment in April.

• Inhibitex Inc., of Atlanta, said Canadian authorities approved the clinical trial application for Veronate, allowing the company to enroll patients in its ongoing Phase III trial at neonatal intensive care units in Canada. Veronate is being developed to prevent hospital-associated infections in premature, very-low-birth-weight infants. In June, the company commenced enrollment in a 2,000-patient Phase III pivotal trial for Veronate, planning to conduct the trial at between 70 and 100 sites in the U.S., Canada and Europe.

• Matritech Inc., of Newton, Mass., presented preliminary serum-based data for its NMP66 proteins for the detection of breast cancer at the 4th annual European Conference: Perspectives in Breast Cancer, held in Madrid, Spain. Researchers tested 50 blood samples using an immunoassay and a recently developed qualitative reverse-transcription polymerase chain reaction (RT-PCR) procedure. The RT-PCR test detected the presence of the NMP66 protein complex in 30 of the 50 samples, or 13 out of 14 serum samples from cancer patients and in 19 out of 36 samples from patients with benign or no detectable disease. Seven of the 14 samples from cancer patients were positive by the NMP66 protein immunoassay as were nine of 35 samples from the patients free of cancer.

• Maxim Pharmaceuticals Inc., of San Diego, was named a defendant in a class-action lawsuit filed in a federal district court. The complaint alleges that the defendants artificially inflated the price of Maxim shares by issuing a series of false and misleading statements about the utility of Ceplene in the treatment of malignant melanoma. Earlier this week, the company's stock lost about half its value following news of a Phase III failure. (See BioWorld Today, Sept. 21, 2004.)

• MGI Pharma Inc., of Minneapolis, reported the closing of the stock-purchase agreement pursuant to which MGI Pharma purchased $40 million of Dublin, Calif.-based SuperGen Inc. common stock at $10 per share and received exclusive worldwide rights to the development, manufacture, commercialization and distribution of SuperGen's Dacogen (decitabine). The transaction, first reported on Sept. 1, was subject to certain closing conditions. (See BioWorld Today, Sept. 2, 2004.)

• Neurologix Inc., of Fort Lee, N.J., appointed Michael Sorell CEO. Sorell also was appointed to the board, bringing the total number of directors to six. Since 1996, Sorell has been managing member of MS Capital Advisors LLC. Neurologix develops treatments for disorders of the brain and central nervous system using gene therapy and other therapies.

• Northeastern University in Boston opened the New England Inflammation and Tissue Protection Institute, which will focus on understanding the underlying causes and molecular mechanisms of inflammation and developing treatments for immunological diseases. Northeastern endowed chair and professor of immunophysiology and pharmaceutical biotechnology Michail Sitkovsky will serve as director. Envisioned as a consortium of researchers, doctors and industry, the institute is expected to play a role in research geared toward the pathogenesis of inflammatory diseases.

• Pain Therapeutics Inc., of South San Francisco, said it plans to offer about 8 million shares of common stock pursuant to its effective shelf registration statement. The company intends to grant the underwriters of the offering a 30-day option to purchase an additional 1.2 million shares of common stock to cover overallotments. Citigroup Global Markets Inc. and UBS Securities LLC are lead underwriters. CIBC World Markets Corp. and Rodman & Renshaw Inc. will serve as co-managing underwriters.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., submitted an investigational new drug application to the FDA for Tarvacin. The study will enroll up to 28 patients at up to three clinical centers. The study will be open to patients with advanced solid tumors that no longer respond to standard cancer treatments, regardless of tumor type. Tarvacin is a chimeric monoclonal antibody that binds to the phospholipid, phosphatidylserine.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., filed an investigational new drug amendment with the FDA requesting permission to initiate a Phase II trial to test its drug, Thymosin beta-4 (TB4), in chronic pressure ulcers. Unless otherwise instructed by the FDA, RegeneRx could initiate the trial 30 days after submission of the amendment. The Phase II trial is set up to test several doses of TB4. The drug will be topically administered to each patient over a period of several weeks. The study should be completed and analyzed in about 12 months, the company said.

• Sequenom Inc., of San Diego, launched its new "Assays by Sequenom" service, which provides custom-designed assays for users of the company's MassArray system, the company said.

• Switch Biotech AG, of Neuried, Germany, filed for insolvency on Sept. 3. Due to an unexpected outflow of funds at the end of August, the financial reach of the liquid funds was reduced substantially, the company said. Considering the current difficult climate at the European venture capital markets, it said, the remaining financial reach was too short to close the anticipated round of financing in time. During the insolvency process, Switch Biotech will focus on certain dermatological disease areas, such as psoriasis and vitiligo, and will restructure the organization accordingly, with the intention to further advance those activities in a new company. Assets, such as the patent portfolio in the area of diabetic foot ulcers, will be divested to third parties, the company said.

• The Medicines Co., of Parsippany, N.J., received marketing authorization from the European Commission for Angiox (bivalirudin) as an anticoagulant in patients undergoing percutaneous coronary interventions. Angiox now is authorized for marketing in all 25 member states of the European Union. Angiox will be marketed in Europe by Nycomed Group and Grupo Ferrer. Angiox, which is sold in the U.S. as Angiomax, is a direct thrombin inhibitor with a naturally reversible mechanism of action.

• Yale University School of Medicine-Howard Hughes Medical Institute in New Haven, Conn., and Weill Cornell Medical College in New York said its researchers believe they now have a better understanding of how synaptic transmission works. Their findings, to be published in the Sept. 23, 2004, issue of Nature, focus on the role of a lipid found on the plasma membrane of brain cells, called PI(4,5)P(2). In the absence of a sufficient supply of that lipid, synaptic transmission slows, as does neurological function, the researchers found.

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