• Acusphere Inc., of Watertown, Mass., initiated more than half the projected number of clinical sites in the pilot phase of its Phase III program for AI-700, an ultrasound contrast agent designed for detecting coronary artery disease. Its efforts are focused on training new sites in the U.S. and Europe. Over the next several months, the company said it would initiate sites in both the pilot study and the pivotal studies, which consist of two concurrent international trials. During the first half of next year, Acusphere expects to initiate all pivotal sites necessary to meet its enrollment plan for the program.

• AEterna Laboratories Inc., of Quebec City, Quebec, said its updated plan for the clinical development of Neovastat includes the continuation of the Phase III trial in non-small-cell lung cancer sponsored by the National Cancer Institute in Bethesda, Md., with which AEterna renewed the agreement for a period of two years. AEterna also said it is ceasing all activities related to renal cell carcinoma, resulting in a work force reduction. The company is eliminating 63 jobs, or 20 percent of its staff at AEterna and its subsidiaries.

• Bio Sidus SA, of Buenos Aires, Argentina, said it settled an arbitration proceeding with Avant Immunotherapeutics Inc., of Needham, Mass., related to contractual issues between the parties, including issues surrounding a contract for the clinical manufacture of a vaccine product. Bio Sidus manufactures biological products in the Latin American market. Details of the settlement were not disclosed.

• BioMicro Systems Inc., of Salt Lake City, released the MAUI Mixer HT, a micro-volume hybridization chamber optimized for high-temperature microarray hybridizations using the company's MAUI Hybridization System. The disposable hybridization chambers are optimized for temperatures of about 50 degrees C to 65 degrees C.

• Chiron Corp., of Emeryville, Calif., granted a nonexclusive license to hepatitis C virus drug targets to Boehringer Ingelheim International GmbH, of Ingelheim, Germany. In exchange for rights related to research, development and commercialization of small-molecule therapeutics against the targets, Boehringer Ingelheim will pay up-front license fees, milestone payments and royalties on products. More specific financial terms were not disclosed.

• Cytokinetics Inc., of South San Francisco, entered an exclusive collaboration with AstraZeneca plc, of London, to develop automated imaging-based cellular phenotyping and analysis technologies for the in vitro prediction of hepatotoxicity. AstraZeneca will fund technology development activities at Cytokinetics over a two-year research term. The agreement further provides for a milestone payment and annual licensing fees to be paid to Cytokinetics upon the Cytometrix Hepatotoxicity Module achieving certain agreed-upon performance criteria. More specific financial terms were not disclosed.

• Dynavax Technologies Corp., of Berkeley, Calif., said the U.S. Patent and Trademark Office declared an interference to resolve first-to-invent disputes between a patent application filed by The Regents of the University of California, which is exclusively licensed to privately held Dynavax, and an issued U.S. patent owned by Coley Pharmaceutical Group Inc., of Wellesley, Mass., relating to immunostimulatory DNA sequences. The declaration of interference indicates that an application filed by the university was filed prior to an application owned by Coley that led to an issued patent, and if successful, the interference would establish Dynavax's founders as the inventors, Dynavax said.

• FibroGen Inc., of South San Francisco, began an open-label Phase I trial of FG-3019, its lead investigational antifibrotic agent, in patients with idiopathic pulmonary fibrosis. The dose-escalating study is expected to enroll up to 27 patients to evaluate the compound's safety, tolerability, pharmacokinetics and immunogenicity. Licensed from Medarex Inc., of Princeton, N.J., FG-3019 is designed to delay or halt the progression of fibrotic disease by blocking connective tissue growth factor, a protein that plays a key role in fibrosis.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., licensed its HAP Technology to Novo Nordisk A/S, of Bagsvaerd, Denmark, for use in a drug development program. The agreement calls for Novo Nordisk to pay Genaissance license and service fees, including fees for genotyping clinical samples. Genaissance will have certain rights to develop and commercialize specified diagnostic products and services. More specific financial terms were not disclosed.

• Generex Biotechnology Corp., of Toronto, hired Kinexum LLC to assist in completing Generex's Phase IIb trials of Oralin, and begin Phase III trials when authorized by the FDA and other regulatory authorities. The life sciences consulting firm's initial responsibilities will be to establish a team of clinical and regulatory personnel to assist Generex in a global development and registration program for the oral insulin spray product.

• Genome Therapeutics Corp., of Waltham, Mass., filed a registration statement with the SEC related to a proposed offering of 11 million common shares to fund its combined operations with Genesoft Pharmaceuticals Inc., of South San Francisco. The companies agreed to an $80 million all-stock merger last month. J.P. Morgan Securities Inc. will serve as the offering's lead placement agent. (See BioWorld Today, Nov. 19, 2003.)

• GenoMed Inc., of St. Louis, entered an agreement with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to test the company's compounds in tissue culture assays to evaluate potential activity against influenza, West Nile virus and severe acute respiratory syndrome. GenoMed's universal vaccine method involves blocking angiotensin II.

• Human Genome Sciences Inc., of Rockville, Md., said it would receive a one-time undisclosed license fee from Pfizer Inc., of New York, which acquired nonexclusive worldwide rights to research, develop and commercialize products based on gene sequences from Staphylococcus aureus, for potential human and animal use. The agreement amends a 1996 agreement with Pharmacia & Upjohn Inc., now a part of Pfizer, which was relieved of any other obligation under the prior agreement.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said that as a result of its recent corporate reorganization, Nasdaq changed its stock-trading symbol to "ICRA." In November, Incara completed a corporate reorganization that consisted of the merger of Incara into one of its wholly owned subsidiaries. Incara common stock was converted into common stock of the merged company and will continue to trade as Incara Pharmaceuticals Corp. on the Over-the-Counter Bulletin Board, with the symbol changed to ICRA.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reached its goal for patient enrollment in its Phase III study of Xibrom. A topical, twice-daily, nonsteroidal anti-inflammatory solution, Xibrom is initially being developed for the treatment of ocular inflammation following cataract surgery. Pending the results of the trial, ISTA plans to file a new drug application for Xibrom with the FDA in early 2004. ISTA acquired the rights to commercialize Xibrom in the U.S. in May 2002. (See BioWorld Today, May 7, 2002.)

• Large Scale Biology Corp., of Vacaville, Calif., reported plans to commercialize through a wholly owned subsidiary, Eclipse Diagnostics Inc., a new diagnostic product called BAMF Technology that is designed to enable detection of cancer and other diseases through noninvasive, serum-based tests. BAMF is a pattern recognition discovery platform that detects key proteins found in blood, known as biomarkers, which act as biological fingerprints to classify life-threatening disease such as cancer. Life Scale Biology's stock (NASDAQ:LSBC) rose 99 cents Thursday, or 70.7 percent, to close at $2.39.

• Merck KGaA, of Darmstadt, Germany, said it would receive $300 million through the sale of its 50 percent stake in the BioMer CV European orthopedics joint venture to Biomet Inc., of Warsaw, Ind. The transaction is expected to be completed in the first quarter. Merck said its decision stems from a plan to better focus on its core businesses, which include diabetes and oncology.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., said the FDA granted orphan drug designation to PhotoPoint MV2101, Miravant's drug candidate for the prevention of hemodialysis access graft disease in patients with new vascular grafts. PhotoPoint PDT is a minimally invasive medical procedure using a light-activated drug to selectively target diseased cells and blood vessels.

• NanoBio Corp., of Ann Arbor, Mich., formed a new company, NanoCure Corp. NanoBio said it is a strategic action being taken to support the product development of the dendrimer-based drug delivery and imaging nanotechnology. Dendrimer drug delivery and imaging platforms are a nanotechnology developed at the University of Michigan Center for Biologic Nanotechnology and exclusively licensed to NanoBio, it said.

• Novacea Inc., of South San Francisco, reached the target enrollment of 232 patients in a Phase II/III trial evaluating its lead product, DN-101. DN-101 is an experimental, oral cancer drug containing an active form of vitamin D, known as calcitrol. DN-101 is being tested in combination with Taxotere (docetaxel) as a potential treatment for androgen-independent prostate cancer.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said a study conducted by researchers at the University of Manitoba showed that treatment of meat with the company's NXC-4720 product reduced E. coli O157:H7 contamination.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., received a $15 million creditable milestone-based payment from Bayer Pharmaceuticals Corp., a unit of Bayer AG, of Leverkusen AG. The payment results from the ongoing development of BAY 43-9006, a cancer compound being co-developed by the companies that entered Phase III testing two months ago. Onyx received a $5 million payment upon beginning Phase II, and can achieve two $10 million milestones upon the filing of a new drug application and approval in either the U.S., Germany, Italy, Spain or the UK. (See BioWorld Today, Oct. 28, 2003.)

• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., signed a nonexclusive license agreement with SRL Inc., of Tokyo, to develop and commercialize cancer diagnostic tests in Japan. The tests will be based on Panacea's HAAH oncology program, which targets the enzyme human aspartyl (asparaginyl) beta-hydroxylase (HAAH). Panacea received an up-front payment, could receive milestone payments for further development and Japanese regulatory approval, and would receive sales royalties. Panacea also will provide technical support and reagents under the agreement's service provision.

• Pharmion Corp., of Boulder, Colo., reported that New Zealand's Minister of Health approved Thalidomide Pharmion for the treatment of multiple myeloma after the failure of standard therapies, as well as for the treatment of a complication of leprosy. The New Zealand approval follows the Australian registration for the same indications by the Therapeutic Goods Administration in October.

• Protometrix Inc., of Branford, Conn., reported the publication of a new study in the December issue of Nature Biotechnology describing an approach using the company's Yeast ProtoArray to yield for the first time proteome-wide knowledge about antibody-protein interactions. The protein microarray technology is designed to help accelerate development of medical, diagnostic and research antibodies and to improve the speed and success rates of antibody-based drugs.

• Quark Biotech Inc., of Fremont, Calif., said findings published in the Dec. 19, 2003, edition of Science describe a study of mice that contain virtually no cholesterol. The mouse strain was created by disrupting the gene Dhcr24, which encodes the enzyme called desmosterol reductase and appears to be responsible for the last step in the biosynthesis of cholesterol, a sterol that is a structural block of cells and their membranes and plays a role in signal transduction. The study was conducted together with the Karolinska Institute in Sweden and the Sackler School of Medicine in Israel.

• Sangamo BioSciences Inc., of Richmond, Calif., gained an exclusive license to oncolytic adenovirus vector technology belonging to Onyx Pharmaceuticals Inc., also of Richmond. Sangamo initially plans to develop an Armed Therapeutic Virus (ATV) to express zinc finger DNA-binding protein transcription factors (ZFP TFs) designed to up-regulate the expression of granulocyte macrophage colony-stimulating factor, an immune system activator shown to augment antitumor immune responses. Sangamo will have full rights and responsibility for research and commercial development of the ZFP TF ATV. Onyx could receive milestone payments as well as royalties.

• Seattle Genetics Inc., of Bothell, Wash., filed a shelf registration statement with the SEC to sell up to $75 million of common stock from time to time. The company said it does not have immediate plans for an offering. Seattle Genetics develops monoclonal antibody-based therapeutics to treat cancer and other diseases.

• SemBioSys Genetics Inc., of Calgary, Alberta, executed a development agreement with Martek Biosciences Corp., of Columbia, Md., to co-develop specialty oil products with potential pharmaceutical and nutraceutical applications. SemBioSys will use its Safflower biotechnology capabilities to develop plant-based DHA products for Martek in return for up to $10 million in research payments and milestone payments as well as undisclosed royalties on new product sales.

• Sepracor Inc., of Marlborough, Mass., said it began Phase IIIb studies of Estorra brand eszopiclone to evaluate the compound in treating insomnia in patients suffering from depression, as well as rheumatoid arthritis patients and women who experience symptoms of perimenopause. The company said it is conducting the studies to provide further clinical information on Estorra's effects in the treatment of insomnia in such patient populations.

• System Biosciences Inc., of Mountain View, Calif., launched its GeneNet Lentiviral siRNA Transduction System based on the feline immunodeficiency virus. The company said researchers armed with the delivery and expression system for short interfering RNA can permanently inhibit the expression of any gene in almost any mammalian cell or organism.

• Tranzyme Inc., of Research Triangle Park, N.C., agreed to merge with Neokimia Inc., of Sherbrooke, Quebec, combining the former's functional biology with the latter's chemistry platform. In connection with the merger, the new company received $6 million through the sale of convertible notes, producing capital to finance operations and preclinical development of lead compounds. It also plans to seek additional funding next year to eventually accelerate candidates into Phase II trials. The combined company's portfolio will include drug candidates in late-stage lead optimization, with expectations of generating two compounds in clinical development in 2005. Tranzyme focuses on the discovery of therapeutics for diseases of the neurosensory system, including the eye, ear and the brain. Neokimia has a medicinal chemistry platform for the synthesis and optimization of small cyclic compounds and has developed several lead compounds directed towards gastrointestinal disorders and metabolic diseases. The combined company will maintain the North Carolina facility for its functional biology program, and will continue drug discovery operations at the Canadian chemistry facility. In addition to internal programs, the new company has partnerships for HIV, cancer and cystic fibrosis.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., entered an agreement to collaborate on the discovery and development of therapies for undisclosed diseases with the Oregon Health & Science University in Portland. Over the next three years, the company will fund scientific research projects at the university in areas of mutual interest. In addition, Vertex will establish a fellowship stipend for selected graduate researchers.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., filed its marketing authorization application for anidulafungin for the treatment of esophageal candidiasis with the European Medicines Evaluation Agency. Anidulafungin belongs to the echinocandin class, the first new class of antifungal agents introduced in more than 40 years. It is a naturally occurring molecule that has been significantly improved through chemical modification, the company said.

• ViroPharma Inc., of Exton, Pa., discovered antiviral compounds active against a group of potential bioterrorism viruses called hemorrhagic fever viruses. Several series of compounds from ViroPharma's chemical library have been identified that have antiviral activity in laboratory tests against the group of viruses called the New World arenaviruses. The viruses are classified as Category A viruses by the National Institutes of Health in Bethesda, Md., and the Centers for Disease Control and Prevention in Atlanta and represent the most serious of the bioterrorism threat agents, the company said.

• VirXsys Corp., of Gaithersburg, Md., said a third patient would be treated in its Phase I trial of VRX496 modified T cells following a recommendation by an independent data safety monitoring board that reviewed initial safety data from the first two patients. The planned five-patient trial is the first to use a new class of genetic vectors, lentiviral vectors, in humans. It involves the use of an HIV-based lentiviral vector where a muted form of the virus is genetically engineered to inhibit HIV replication and spread.

• XOMA Ltd., of Berkeley, Calif., and Alexion Pharmaceuticals Inc., of Cheshire, Conn., entered a collaborative agreement to develop a rationally designed human c-MPL agonist antibody to treat chemotherapy-induced thrombocytopenia. The preclinical compound was discovered at Alexion's wholly owned subsidiary, Alexion Antibody Technologies. The parties will share development and commercialization expenses, as well as revenues, generally on a 70-30 basis, with Alexion retaining the larger portion. In addition, Alexion will receive payments tied to initiation of the collaboration and achievement of a regulatory milestone. XOMA will be entitled to royalty payments and milestones related to its bacterial expression technology. Separately, XOMA and Millennium Pharmaceuticals Inc., of Cambridge, Mass., began a Phase I trial of MLN2222 (also called CAB-2), a complement inhibitor being developed to reduce the incidence of death and heart attacks in patients undergoing procedures involving the use of cardiopulmonary bypass.

• Zonagen Inc., of The Woodlands, Texas, reduced the number of common shares in its previously announced modified Dutch Auction tender offer to up to about 8.6 million shares, rather than 9.8 million, at a per-share purchase price no greater than $2.10 nor less than $1.83. Pursuant to the amendment, Zonagen will now purchase all shares tendered up to the new reduced limit of about 8.6 million shares, subject to the odd lot preference and possible pro-ration described in prior releases and Zonagen's ability under SEC rules to purchase up to a number of additional shares equal to 2 percent of its outstanding common stock. The company extended the expiration date of its offer to Jan. 7.

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