• Active Biotech AB, of Lund, Sweden, signed an agreement with Strathmann Biotec AG, of Hamburg, Germany, involving process development and manufacturing of Active Biotech's cancer product TTS (Tumor-Targeted Superantigens) CD3, for the treatment of non-small-cell lung cancer. Strathmann will take an active part in the project and share a part of the financial risk, reducing Active Biotech's initial development costs for the project, it said. In return, Strathmann is entitled to a limited royalty on Active Biotech's income from future milestones and sales. The total potential royalty to be paid is €10 million.

• Active Pass, of Vancouver, British Columbia, promoted David MacDonald to president and CEO. He succeeds Peter Reiner, who was named chairman. Prior to working at Active Pass, he was general manager of Biovail Contract Research, a clinical contract research organization in Toronto. Active Pass is developing drugs that target ABC transporters, a class of targets for diseases.

• Beckman Coulter Inc., of Fullerton, Calif., entered an exclusive licensing agreement with Althea Technologies Inc., of San Diego, for the eXpress Profiling technology. Beckman plans to integrate the technology into its GenomeLab suite of genetic analysis solutions to speed drug discovery. Researchers in genetic, cancer or medical research institutions will have access to a high-speed, highly sensitive approach to tracking disease-relevant gene targets and pathways.

• Celera Diagnostics, a joint venture between Applied Biosystems Group, of Foster City, Calif., and Celera Genomics Group, of Rockville, Md., reported data linking genetic variations in two genes with increased risk for myocardial infarction at the International Vascular Biology Meeting in Toronto. The genetic markers include a single nucleotide polymorphism in the aquaporin 10 gene (AQP10), which is associated with a twofold increased risk for myocardial infarction. The second is in KIAA1462, a gene of unknown function. Celera conducted the study in collaboration with researchers from the Cleveland Clinic Foundation and the University of California at San Francisco.

• Crucell NV, of Leiden, the Netherlands, received Israeli regulatory approval to market a West Nile virus veterinary vaccine for geese. Developed with the Israeli Kimron Veterinary Institute, the vaccine is based on Crucell's PER.C6 human cell line technology. The approval follows a safety trial involving 1,875 geese, with no vaccine-related adverse reactions, as well as various efficacy trials.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., agreed to a worldwide development and commercialization license of an investigational monoclonal antibody belonging to XTL Biopharmaceuticals Ltd., of Rehovot, Israel. Known as HepeX-B, the product is in a Phase IIb study for the prevention of re-infection by the hepatitis B virus in liver transplant patients. The companies will continue the ongoing international study and, if successful, will continue late-stage clinical development. Cubist will fund HepeX-B's development costs going forward, and will be solely responsible for the product's worldwide registration and commercialization. In exchange, it will pay XTL collaboration support and an up-front payment totaling $3 million over the next two years, and might pay an additional $3 million upon certain regulatory milestones. Cubist also committed to pay XTL a tiered royalty that ranges from 10 percent to 17 percent of net sales.

• Enzo Biochem Inc., of Farmingdale, N.Y., said it rejected the latest cash offer by Roche Diagnostics GmbH, a division of Basel, Switzerland-based F. Hoffmann-La Roche Ltd., to settle Enzo's claims of alleged breach of contract and misappropriation of assets. Roche Diagnostics and Roche Molecular Systems Inc. filed suit in the U.S. District Court of the Southern District of New York against Enzo and Enzo Life Sciences Inc. Enzo said the action reflects Roche's concern that certain products and technologies funneled to Roche by Affymetrix Inc., of Santa Clara, Calif., rightfully belong to Enzo under an agreement with Affymetrix. Enzo terminated that deal and filed suit against Affymetrix last October alleging breach of agreement.

• Eyetech Pharmaceuticals Inc., of New York, completed a secondary offering of about 4.4 million shares of its common stock, which includes 579,000 shares sold upon full exercise of the underwriters' overallotment option. All of the shares were sold by selling stockholders at $38.50 per share. Eyetech did not sell any shares and will not receive proceeds. Eyetech specializes in the development and commercialization of therapeutics to treat diseases of the eye.

• Gamida-Cell Ltd., of Jerusalem, said an article was published in the June issue of Experimental Hematology. The article describes the research that laid the foundation for Gamida-Cell's preclinical stem cell expansion studies and the company's investigational new drug Phase I/II study of StemEx for the treatment of leukemia, now in progress in the U.S. StemEx is a unit of an expanded population of stem cells. Gamida-Cell also will begin a Phase I/II cardiac trial in 2004 or early 2005.

• Genentech Inc., of South San Francisco, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said The New England Journal of Medicine published previously reported Phase III data showing that the addition of Avastin (bevacizumab) to the IFL-chemotherapy regimen (5-FU/Leucovorin/CPT-11) significantly extended survival in patients with first-line metastatic colorectal cancer. The findings, first disclosed a year ago at the American Society of Clinical Oncology meeting, were the first positive results from a Phase III trial of an anti-angiogenesis therapy. Avastin was approved earlier this year. (See BioWorld Today, Feb. 27, 2004.)

• Genitope Corp., of Redwood City, Calif., closed its sale of about 7 million common shares, including 914,823 shares as part of an overallotment option granted to the underwriters, at $8.50 apiece for estimated net proceeds of about $55.5 million. WR Hambrecht + Co. was the offering's lead underwriter, with co-management from Punk, Ziegel & Co., Brean Murray & Co. Inc. and Stanford Group Co. (See BioWorld Today, May 28, 2004.)

• GenoMed Inc., of St. Louis, expanded its antiviral trials to include viruses that cause hemorrhagic fever. The company's treatment will be used against Dengue virus in Venezuela, Crimea-Congo hemorrhagic fever and Rift Valley fever in Iran, as well as for West Nile virus. The company has a goal to eliminate the threat of West Nile virus from the general population on the 50th anniversary of the 1954 polio field trials that ended the threat of polio in the U.S.

• Hemosol Corp., of Toronto, gained a license to the Cascade technology developed by ProMetic Biosciences Inc., a subsidiary of ProMetic Life Sciences Inc., of Montreal, and the American Red Cross for the separation of therapeutic proteins from human plasma. Cascade integrates technologies to improve the yield and product recovery of therapeutic proteins isolated from human plasma, such as intravenous immunoglobulins, alpha-1 antitrypsin, anti-hemophilic Factor VIII and others. Hemosol intends to sell resulting products to customers, including the Red Cross. In exchange, it will pay a staged license fee of C$15.5 million (US$11.4 million) and issue 1 million shares to ProMetic, which also will receive royalties on products that use Cascade.

• ILEX Oncology Inc., of San Antonio, said the FDA accepted the filing of its new drug application for clofarabine to treat refractory or relapsed acute leukemia in children. The NDA has been granted a priority review, and previously received fast-track and orphan drug designation. If approved, it would become the company's second marketed product, in addition to Campath. Clofarabine is a next generation of the drug class purine nucleoside analogues, which inhibit DNA production necessary for cancer cell growth. The company completed the rolling NDA submission in March. Bioenvision Inc., of New York, sub-licensed ILEX the right to develop and market clofarabine for human cancer indications in the U.S. and Canada, in return for milestone payments and royalties.

• Introgen Therapeutics Inc., of Minneapolis, presented clinical data suggesting that Advexin has a good safety and tolerability profile and demonstrates clinical activity when administered as a single agent or in combination with chemotherapy or radiation in patients with several types of cancer. Advexin provides high levels of the tumor suppressor called p53 that is abnormal in many tumors. The therapy also does not appear to increase the toxicities of chemotherapy or radiation. The data were collected from 445 cancer patients treated with Advexin in 14 clinical trials. Advexin is in two Phase III trials for recurrent squamous-cell cancer of the head and neck.

• Lipid Sciences Inc., of Pleasanton, Calif., sold real estate notes receivable totaling $5.4 million. The sale is another transaction in the company's two-year-long asset-liquidation program designed to provide working capital to fund the advancement of its delipidation process and delivery system. At the time of the merger between Lipid Sciences and NZ Corp. in late 2001, the fair-market value of NZ's real estate portfolio was estimated to be $61.4 million. To date, sales of the real estate assets have generated $66.9 million in working capital.

• Meridian Bioscience Inc., of Cincinnati, said its wholly owned subsidiary Viral Antigens Inc. entered a collaboration with Viral Therapeutics Inc., of Ithaca, N.Y., to support the clinical and commercial development needs of biopharmaceutical partners. Viral Antigens has expertise in process development and clinical-stage manufacturing, while Viral Therapeutics is knowledged in the development of recombinant proteins and production optimization.

• Micrologix Biotech Inc., of Vancouver, British Columbia, entered a 60-day, exclusive negotiation period to license MBI-226 (omiganan pentahydrochloride 1 percent gel), an antimicrobial cationic peptide in Phase III development for catheter-related infections, to an unnamed U.S.-based specialty pharmaceutical company. Micrologix will receive a nonrefundable fee for suspending licensing discussions with other parties during the exclusivity period, though further terms were not disclosed. Micrologix, which also met with the FDA regarding MBI-226's regulatory path, said it has several options for advancing the program toward market approval. The FDA encouraged Micrologix to complete a confirmatory Phase III trial using, as the primary endpoint, statistically significant data on local catheter site infections from an initial Phase III study completed in July. The agency also indicated an opportunity for the company to submit a new drug application for catheter-related bloodstream infections based on statistically significant data from that study.

• Mirus Bio Corp., of Madison, Wis., announced the development of Pathway IV gene delivery, a method to deliver therapeutic genes to muscle via the bloodstream. The technique could lead to therapies for diseases such as muscular dystrophy, peripheral vascular ischemia, arthritis, anemia and cancer. With blood flow in an arm or leg temporarily occluded by a tourniquet or blood pressure cuff, a plasmid DNA (pDNA) solution is rapidly injected intravenously, elevating the pressure within the occlusion zone, making the blood vessel wall more permeable and allowing the pDNA to migrate.

• Nucleonics Inc., of Malvern, Pa., acquired an exclusive worldwide license from the University of California to intellectual property covering a class of promoters for transcribing expressed interfering RNAs. The company gained rights to use all eukaryotic RNA Pol III promoters, including human promoters, within the field of expressed interfering RNA for any human therapeutic indication. The license also covers delivery of the promoters by either plasmid DNA or viral vectors, and allows Nucleonics to sublicense the technology to other parties.

• OXIS International Inc., of Portland, Ore., secured a $1.2 million loan from its major investor, Axonyx Inc., of New York. The loan, in the form of a one-year secured note, will be used to continue the advancement of the company's oxidative stress programs and other working capital purposes. OXIS is focused on developing technologies and products to research, diagnose, treat and prevent diseases associated with damage from free-radical and reactive-oxygen species, or diseases of oxidative stress.

• QLT Inc., of Vancouver, British Columbia, entered a Cooperative Research and Development Agreement with the National Eye Institute (NEI) in Bethesda, Md., to study the effects of preservative-free triamcinolone acetonide (PFTA), as an adjunct to Visudyne therapy in patients with wet age-related macular degeneration. QLT will provide funding for the trial and assume responsibility for manufacturing. In return it will gain the option to an exclusive license for certain rights to PFTA in combination with Visudyne therapy. The NEI will be responsible for the clinical trial with scientific input from a joint committee representing both QLT and the NEI.

• Senesco Technologies Inc., of New Brunswick, N.J., reported results of two preclinical studies involving its Eukaryotic Initiation Factor 5A1 gene. In the first study, the levels of myeloperoxidase, an enzyme linked to inflammation and cardiovascular disease, were reduced. In the second, the number of immune system thymocyte cells from the thymus gland that were killed in the presence of inflammatory toxin was reduced.

• Solbec Pharmaceuticals Ltd., of Perth, Australia, said its lead compound, SBP002, destroys existing tumors and boosts immunity against mesothelioma. The drug is derived from a native weed called Devil's Apple. Studies conducted by the University of Western Australia confirmed its ability to positively activate the immune system, effectively destroying the tumors in animals, without destroying lymphocytes.

• Stratagene Corp., of La Jolla, Calif., said that following the completion of its merger with Hycor Biomedical Inc., of Garden Grove, Calif., it has satisfied the Nasdaq National Market's initial listing requirements. The company's common stock began trading on the exchange Thursday under the ticker symbol "STGN."

• Target Discovery Inc., of Palo Alto, Calif., entered a product technology collaboration with Acton, Mass.-based Groton Biosystems LLC, a subsidiary of Groton Technology Inc. The companies will develop and market new capillary electrophoresis analysis systems, incorporating Target's technology and products into Groton's online and laboratory process-monitoring solutions for protein production applications. Details and financial terms were not disclosed.

• Titan Pharmaceuticals Inc., of South San Francisco, said a pilot clinical study evaluating Probuphine to treat opiate addiction demonstrated that all 12 patients had maintenance of therapeutic benefit for a period of six months following a single treatment. The treatment also was safe and well tolerated, with no significant adverse events. Probuphine is designed to provide the drug buprenorphine at therapeutic blood levels continuously for six months.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., entered an agreement to apply its technologies to certain investigational and marketed product development programs of Abbott Laboratories, of Abbott Park, Ill. TransForm's scientists will conduct crystallization and formulation studies of select Abbott compounds as part of a collaborative effort to enhance compound attributes, such as speed of onset, bioavailability, dosing regimen, delivery options, stability and storage requirements. The work will start immediately. Financial terms were not disclosed.

• Trimeris Inc., of Durham, N.C., and Array BioPharma Inc., of Boulder, Colo., renewed their agreement to discover small-molecule entry inhibitors directed against HIV. Trimeris will screen small-molecule compounds created by Array against HIV entry inhibitor targets. Array will be entitled to receive research funding and milestone payments, as well as potential royalties. The original agreement was signed in August 2001.

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