• American BioScience Inc., of Santa Monica, Calif., the privately held parent company of American Pharmaceutical Partners Inc., said the U.S. Court of Appeals for the Federal Circuit in Washington unanimously ruled that ABI is the true and rightful owner of a patent on three next-generation taxane anticancer compounds (the '653 patent), overturning a lower court decision in a lawsuit brought in 1998 by Florida State University and Taxolog Inc. The suit claimed FSU and Taxolog were the true inventors of the compounds. ABI said the ruling clears the way for developing the taxane compounds in further clinical trials.

• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said trial results published on exenatide, in development for the treatment of Type II diabetes, demonstrated reduced fasting and postprandial glucose concentrations in patients through the coordination of several mechanisms of action. An article containing the study results appears in the July 2003 issue of the Journal of Clinical Endocrinology and Metabolism. The article includes results from two studies showing exenatide achieved glucose-lowering effects by stimulating the body to produce insulin only in response to elevated levels of glucose, by suppressing the release of glucagon and by slowing the rate at which nutrients are absorbed into the bloodstream.

• Aphton Corp., of Miami, said the European Union granted orphan drug status for its anti-gastrin immunogen G17DT, also known as G17(9)DT, for treatment of both pancreatic cancer and gastric cancer indications. That status in the EU confers up to 10 years of marketing exclusivity, among other things. Aphton reported in July 2002 that the FDA granted orphan drug status to G17DT for both pancreatic cancer and gastric cancer indications.

• Arexis AB, of Gothenburg, Sweden, initiated a Phase II trial in the area of lipid metabolism. The study will be completed before the end of the year. Further details will be released shortly, the company said. Arexis AB said it pioneered the use of genetics in selected disease models to pinpoint specific genes involved in multifactorial metabolic and inflammatory diseases.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., was awarded a Phase I Small Business Innovation Research Advanced Technology grant from the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The $600,000 grant supports BioCryst's efforts to develop its preclinical product candidates for the treatment of hepatitis C. BioCryst's research has been directed toward the design, evaluation and synthesis of active site-directed inhibitors of hepatitis C polymerase.

• Bionaut Pharmaceuticals Inc., of Cambridge, Mass., said it expanded its Series A financing to $6.8 million and appointed Kees Been CEO. Been joins Bionaut from Biogen Inc. to lead the company's discovery and development of small-molecule drug candidates. Bionaut uses its Sentinel Pathway Reporter System to correlate genetic activity in disease pathways directly with disease modulation in living cells, it said. Collinson, Howe & Lennox, of Stamford, Conn., and HealthCap Venture Capital, of Stockholm, Sweden, were among the investors in the round. Proceeds will be used to expand its cancer and inflammation cell lines and to develop a pipeline of drug candidates, it said.

• Celsion Corp., of Columbia, Md., said it raised $5.1 million through the exercise of outstanding common stock purchase warrants since May 28, resulting in the issuance of about 11.9 million shares. And it expects to realize gross proceeds of $4.5 million in a private placement of its common stock and warrants that was expected to close Tuesday. The proceeds will be used to complete the commercial development and regulatory approval process for the Microfocus BPH 800 Microwave Urethroplasy System, among other things. Celsion focuses on treatment systems for cancer and other diseases using focused-heat technology delivered by microwave technology.

• Epimmune Inc., of San Diego, said Immuno-Designed Molecules SA, of Paris, exercised its option to a nonexclusive license to certain cancer epitopes for use in IDM's ex vivo cell therapy program. Epimmune received a license fee in connection with IDM exercising the option and is entitled to receive pre-commercialization milestones and royalties on product sales if IDM develops products using the Epimmune technology. From a deal signed in October, IDM had the right to evaluate the epitopes and exercise its option to license certain patented and nonpatented rights to Epimmune's universal cancer epitope packages for use in connection with its own ex vivo dendritic cells technology. The territory is worldwide except for Japan, where IDM maintains an additional option for a license.

• Genedata AG, of Basel, Switzerland, and the National Cancer Centre Singapore (NCCS) entered a collaboration in gene expression analysis for cancer research. As part of the agreement, the NCCS licensed the Genedata Expressionist system for the analysis of microarrays.

• Genome Therapeutics Corp., of Waltham, Mass., said Ramoplanin was highlighted in a peer-reviewed supplement to the Journal of Antimicrobial Chemotherapy for the antibiotic's ability to prevent infections caused by an increasing incidence of vancomycin-resistant enterococci (VRE). Researchers pointed to decolonization of the gastrointestinal tract, the primary reservoir of VRE, as a potential approach to preventing VRE infections, and called Ramoplanin a promising agent for gastrointestinal decolonization. The drug is being studied in a Phase III trial for bloodstream infections caused by VRE and a Phase II study for Clostridium difficile-associated diarrhea. Genome's stock (NASDAQ:GENE) gained 40 cents Tuesday, or 15.9 percent, to close at $2.92.

• GenPath Pharmaceuticals Inc., of Cambridge, Mass., and Array BioPharma Inc., of Boulder, Colo., reported a drug discovery collaboration to identify small-molecule drugs that target a tumor maintenance gene discovered in GenPath's genetic model systems. Array will receive research funding and be entitled to receive milestone payments based on the selection and progress of a development candidate. Other terms of the agreement were not disclosed.

• Illumina Inc., of San Diego, said it sold BeadLab, a production-scale single nucleotide polymorphism genotyping laboratory, to an undisclosed research institution. BeadLab is designed for large-scale genotyping projects.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., intends to offer, subject to market and other conditions, about $50 million in convertible senior notes due 2008. The offering will be made to qualified institutional buyers. The notes will be convertible into Indevus common stock, at the option of the holder, at a price to be determined by negotiations between Indevus and the initial purchasers. Indevus expects to grant purchasers an option to purchase up to an additional $10 million of notes. Indevus intends to use the proceeds for continued development and premarketing activities for its lead product, trospium, clinical development of its other product candidates, acquiring and developing new product candidates, and for working capital and general corporate purposes. Trospium is on file with the FDA for overactive bladder. (See BioWorld Today, April 29, 2003.)

• Invitrogen Corp., of Carlsbad, Calif., paid about $2 million for product lines and technology rights, including tools and methods for ultra-sensitive signal generation and detection, from privately held Genicon Sciences Corp., of San Diego. Invitrogen said the acquisition improves its position as a partner in disease research and drug development projects, as the Genicon technology allows for the application of nanotechnology to life sciences. The platform technology, Resonance Light Scattering, uses gold and silver nanoparticles for the detection of nucleic acids and proteins in its system. In partnership with Qiagen NV, of Venlo, the Netherlands, it has been commercially available for a year for DNA microarray experiments. Invitrogen said it would continue to co-promote and distribute the DNA microarray toolkit products with Qiagen, but retain exclusive, worldwide commercialization rights for other research uses, including protein-related applications.

• Millenium Biologix Inc., of Kingston, Ontario, and Procter & Gamble Co., of Cincinnati, formed a research agreement in which P&G Pharmaceuticals will evaluate the therapeutic potential of Millenium's synthetic BCSP (Bone and Cartilage Stimulating Peptides) growth factors to treat diseases of bone and cartilage. BCSP synthetic growth factors are the result of work at MBI to develop active, tissue-specific, growth-promoting small molecules that target bone and cartilage. Millenium has granted P&G Pharmaceuticals an option for the compounds and the companies signed a letter of intent outlining the terms for a worldwide license to P&G Pharmaceuticals. Financial terms were not disclosed.

• Neurion Pharmaceuticals Inc., of Pasadena, Calif., entered an alliance with Eli Lilly and Co., of Indianapolis, to discover small-molecule drugs targeting ion channels for various central nervous system indications. The collaboration will combine Neurion's Precision Neurochemistry Platform technology with Lilly's discovery resources. Privately held Neurion, which bills itself as an ion channel drug discovery company targeting central nervous system diseases, will receive cash payments for its work while Lilly retains an option to negotiate development and marketing rights to compounds identified by Neurion. More specific financial terms were not disclosed.

• Northwest Biotherapeutics Inc., of Bothell, Wash., said it was planning a Phase I trial to evaluate DCVax-Direct as a possible treatment for prostate cancer, at the H. Lee Moffitt Cancer Center in Tampa, Fla. In addition to assessing the product's safety, the study will measure patients' immune responses in order to determine the potential for DCVax-Direct to impact disease progression. The approach uses a company formulation for the activation of dendritic cells that are injected directly into solid tumors.

• Nuvelo Inc., of Sunnyvale, Calif., filed a shelf statement with the SEC to offer up to $50 million worth of common or preferred stock, or debt securities, from time to time. The company, formally called Hyseq Pharmaceuticals Inc., said it would use net proceeds for general corporate purposes, including capital expenditures and to meet working capital needs.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said research on its Permeation Enhancing Peptide compound was reviewed in the July 2003 issue of The Lancet Oncology. The PEP compound is part of the vasopermeation enhancement agents (VEA) class of compounds, and is a protein fragment derived from the cancer immunotherapy drug interleukin-2, believed to enhance the uptake of chemotherapeutic agents and monoclonal antibodies by solid tumors. The VEA technology has been exclusively licensed from the University of Southern California to Peregrine.

• Pluristem Life Systems Inc., of Haifa, Israel, said it reached a milestone in its stem cell expansion technology by implanting stromal cells into its bioreactors, creating an environment that will encourage stem cells to self-renew without differentiation. Company researchers used an original plug-flow bioreactor system that mimics the 3-dimensional structure of bone to support the growth and maintenance of stromal cells, which are essential to supporting the expansion without differentiation of hematopoietic stem cells found in cord blood.

• Point Therapeutics Inc., of Boston, enrolled the first patient in a Phase I/II trial investigating combination therapy of PT-100 and Rituxan for B-cell hematologic malignancies, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia. The study will include patients whose disease has relapsed following chemotherapy and/or prior Rituxan treatment. The Phase I portion is a multicenter, dose-escalation trial to determine the maximum tolerated dose to be studied in Phase II and will include up to 24 patients. It is expected to be completed by the first half of 2004.

• Progen Industries Ltd., of Brisbane, Australia, reported the completion of the PI-88 Phase II trial in multiple myeloma and achievement of the study's primary efficacy endpoints. The primary endpoint was to investigate clinical efficacy in patients who had exhausted other treatment options. A clinical response was prespecified as patients remaining stable or experiencing a decrease in blood levels of paraprotein. That endpoint was achieved in 39 percent of patients in the study.

• Protein Design Labs Inc., of Fremont, Calif., intends to offer, subject to market and other conditions, up to $200 million of convertible subordinated notes due 2023 (plus an additional amount up to $40 million) in a private placement. The notes would be convertible into PDL's common stock at the option of the holder. PDL may use up to $155 million to redeem outstanding convertible notes and intends to use the remaining net proceeds for acquisition of products and technologies, working capital and other general corporate purposes, which includes the current expansion of manufacturing facilities. A portion of the proceeds will be used to collateralize the first three years of interest payments on the notes.

• Qiagen NV, of Venlo, the Netherlands, and Intradigm Corp., of Rockville, Md., entered an agreement to provide research and development of small interfering RNA (siRNA) for drug discovery and siRNA therapeutic products. Qiagen will manufacture and provide Intradigm with siRNA agents for its ongoing research programs in several disease areas, including oncology, arthritis and severe acute respiratory syndrome coronavirus infection. Financial terms were not disclosed.

• Quark Biotech Inc., of Cleveland, expanded operations in the U.S., relocating three main business units from Pleasanton, Calif., to Fremont, Calif., with plans to add personnel in the clinical development division. Three business units - microarray technologies, product development and business development - will be placed in one 20,000-square-foot facility in Fremont.

• RJV Networks Inc., of Bellevue, Wash., said it mutually rescinded its proposed merger agreement with BioKinetix Research Inc., and instead acquired global access to all Super-Antibody, anticancer technologies owned by BioKinetix. RJV, which plans to change its name to ProtoKinetix Inc., said the quickest way to effect the transaction was to terminate and rescind the merger, and instead opt for an asset acquisition type of transaction. Financial terms were not disclosed.

• The Institute for OneWorld Health, of San Francisco, licensed a class of compounds from Yale University and the University of Washington in Seattle. The agreement gave OneWorld Health, a nonprofit company, the exclusive license to develop azole compounds to treat parasitic diseases in the developing world. OneWorld initially will focus on the use of the azoles in Chagas disease, the leading cause of heart failure in Latin America. The licensing agreement also creates a dual market opportunity in which the universities could seek a pharmaceutical partner to develop the same compounds for fungal infections in industrialized countries.

• Valentis Inc., of Burlingame, Calif. said its wholly owned subsidiary, PolyMASC Pharmaceuticals plc, settled its patent infringement litigation against ALZA Corp., a unit of Johnson & Johnson, of New Brunswick, N.J. PolyMASC will receive $6.5 million and grant a worldwide license to ALZA under its PEG-liposome patents. The agreement settles pending patent infringement litigation in the U.S. and Germany, as well as opposition proceedings in Japan and before the European Patent Office. PolyMASC initiated infringement proceedings against ALZA in the U.S. in April 2001 related to ALZA's manufacturing and selling of Doxil and Caelyx.

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