• Abbott Laboratories, of Abbott Park, Ill., said patients with active Crohn's disease who have ceased responding to Remicade (infliximab, Centocor Inc.) might respond to Humira (adalimumab), according to a new study in the January 2005 issue of the American Journal of Gastroenterology. The study found that 11 of 13 Crohn's patients who had experienced a reduction or loss of response to infliximab experienced a reduction in disease activity with Humira.

• ArQule Inc., of Woburn, Mass., closed its previously announced registered direct offering. The company sold about 5.8 million shares of its common stock at $5.25 per share, for aggregate proceeds of about $30 million. The small group of investors included both existing and new shareholders. ArQule is engaged in research and development of next-generation small-molecule cancer therapeutics based on its Activated Checkpoint Therapy platform. (See BioWorld Today, Jan. 26, 2005.)

• Callisto Pharmaceuticals Inc., of New York, opened two additional cancer sites for the Phase I/IIa trial of Atiprimod, which is Callisto's lead drug candidate for the treatment of multiple myeloma. Among the secondary objectives for the trial is the screening of surrogate markers to explore any potential drug effect in multiple myeloma patients.

• Cellectricon AB, of Gothenburg, Sweden, opened Cellectricon Inc., a wholly owned subsidiary to be headquartered in Gaithersburg, Md. Peter Tunon was retained as the company's president and Thomas Guiel as its chief operating officer. Cellectricon Inc. will provide sales and technical support and further expand the company's presence in the U.S. and Canada.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, said the underwriters of its recent initial public offering exercised in full their overallotment option and purchased about 2.4 million shares at the IPO price of C$1 (US$.80) a share. After giving effect to the sale of the overallotment shares, a total of 18.4 million shares were offered and sold by the company in the IPO for gross proceeds of C$18.4 million. (See BioWorld Today, Jan. 4, 2005.)

• Cortex Pharmaceuticals Inc., of Irvine, Calif., reported the FDA accepted the company's CX717 investigational new drug application to initiate pilot Phase II trials in the U.S. CX717 is being developed in cognitive dysfunction that can arise from a variety of neuropsychiatric conditions, including Alzheimer's disease and attention deficit hyperactivity and sleep disorders. The first study will use positron emission tomography imaging to determine the response of patients with Alzheimer's disease with CX717.

• Flamel Technologies SA, of Lyon, France, entered an agreement with Bristol-Myers Squibb Co., of New York, which resolves all outstanding matters with respect to the former licensing agreement between the companies for Flamel's formulation of long-acting human insulin, Basulin. Flamel will receive a cash payment, as well as clear title to certain data produced in connection with the relationship between the parties, including the results of a Phase IIa study of Basulin. The deal originally was signed in August 2003 and valued at up to $165 million. (See BioWorld Today, Aug. 28, 2003.)

• GeneGo Inc., of St. Joseph, Mich., said that GlaxoSmithKline plc, of London, licensed MetaBase, GeneGo's database of human biology and medicinal chemistry. GSK intends to apply MetaBase in applications in preclinical drug discovery and to integrate MetaBase content with their internal informatics systems.

• ICOS Corp., of Bothell, Wash., and Marietta, Ga.-based Solvay Pharmaceuticals Inc. entered a co-promotion agreement for AndroGel, (testosterone gel) 1 percent CIII. Under the agreement - which covers the U.S. and extends through 2006 with a renewal option - ICOS will provide promotional support for AndroGel through physician details and will be paid a service fee per detail, as well as fees based on achievement of specified sales goals. AndroGel is approved in the U.S. for replacement therapy in males suffering from conditions associated with a deficiency or absence of testosterone.

• Joslin Diabetes Center in Boston said its researchers discovered why excess weight leads to low-grade inflammation, which hampers the body's ability to use insulin. They found that the "master switch" of the inflammation is activated in the liver by weight gain. And they showed it can be turned off by salicylates, a class of drugs that includes aspirin. The Joslin study was published in the February issue of Nature Medicine.

• Lynx Therapeutics Inc., of Hayward, Calif., said its Massively Parallel Signature Sequencing whole-genome expression technology will be used by the University of Southern California College of Letters, Arts & Sciences, through a research grant from the National Science Foundation. Researchers will study oyster larval development. Under terms of the agreement, Lynx will receive payment for the genome-wide transcriptome sequencing services it will perform on oyster samples. The company said the agreement builds on a previous contract aimed at understanding the factors involved in growth of oysters.

• Medicago Inc., of Quebec City, entered a product agreement with Bayer CropScience LP, the U.S. business of Monheim, Germany-based Bayer CropScience AG, to assess the feasibility of using Medicago's Proficia Protein Technology for the production of an undisclosed human therapeutic protein. The goal is to further cooperation between the companies in the area of plant-made pharmaceuticals. Further details were not disclosed. Medicago develops and uses an alfalfa-based protein production platform for the commercialization of biopharmaceutical proteins.

• Medicis Pharmaceutical Corp., of Scottsdale, Ariz., amended its alliance, signed in June 2002, with aaiPharma Inc., of Wilmington, N.C., to allow for the immediate transfer of the project's management and development to Medicis, and provides that aaiPharma will continue to assist Medicis with development of an undisclosed dermatologic product on a fee-for-service basis. The agreement states that Medicis will have no future financial obligations on milestone payments, but the company will incur a $9 million research and development expense this quarter associated with the project. In addition, Medicis will pay aaiPharma $1 million upon approval of an alternate facility for manufacturing the product and upon product approval.

• Medicure Inc., of Winnipeg, Manitoba, acquired the exclusive worldwide licensing rights from the University of Manitoba and University of Ottawa Heart Institute for a technology platform focused on the development of lipid-lowering therapeutics for the treatment of cardiovascular diseases.

• The Michael J. Fox Foundation for Parkinson's Research in New York awarded grants totaling nearly $1 million to four researchers through its Cell Line II program, "Cell Replacement Therapy: Developing Dopaminergic Cell Lines With Long-Lasting Functional Impact in Transplant Models of Parkinson's Disease." The program seeks to address obstacles in achieving the therapeutic potential of cell replacement, including poor survival and function of stem cell-derived dopaminergic neurons after transplantation into the brain.

• Morphotek Inc., of Exton, Pa., was awarded a developmental project grant from the Network for Translational Research in Optical Imaging Consortium of the National Cancer Institute. Morphotek said the grant will support research to generate antibodies with enhanced antibody-dependent cellular cytotoxicity activity derived from genetically evolved cell lines generated using the company's Morphodoma technology. The program involves generating in vitro and in vivo high-throughput assays to screen and identify genetically optimized antibody-producing cell clines for therapeutic development.

• Noven Pharmaceuticals Inc., of Miami, said the FDA denied pending citizen petitions intended to prevent or delay the approval of Noven's generic versions of New Brunswick, N.J.-based Johnson & Johnson's Duragesic (fentanyl transdermal system) product. Petitions had been filed by ALZA Corp., of Mountain View, Calif.; Drs. Brookoff and Voth; London & Mead; and Dr. Steven L. Shafer. An abbreviated new drug application for Noven's patch, for the management of chronic pain, is pending at the FDA. The company previously granted marketing rights in the U.S. and Canada to Endo Pharmaceuticals Inc., of Chadds Ford, Pa., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. Noven's stock (NASDAQ:NOVN) jumped $2.82 Monday, or 18.3 percent, to close at $18.22.

• Osiris Therapeutics Inc., of Baltimore, received fast-track designation from the FDA for Prochymal, an adult stem cell product formulated for the treatment of acute graft-vs.-host disease. Osiris said the FDA's decision makes the company the first to receive fast-track designation for a pre-formulated stem cell drug.

• Palatin Technologies Inc., of Cranbury, N.J., presented data from preclinical studies that indicates its small-molecule melanocortin receptor subtype-4 (MC4) selective agonist reduced food intake and body weight and improved metabolic parameters in rodent models of obesity. The data were presented at the 2005 Keystone Symposia on Obesity: Molecular Physiology and Genetics of the Control of Body Weight. The research was presented in a poster titled "Regulation of Body Weight in Diet-Induced Obese Mice by a Small Molecule Melanocortin-4 Receptor Agonist."

• Sanofi-Aventis Group, of Paris, presented preliminary results of two large prospective trials evaluating the safety and efficacy of Eloxatin (oxaliplatin for injection)-based regimens in metastatic colorectal cancer at the Gastrointestinal Cancers Symposium, co-sponsored by the American Society of Clinical Oncology, the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology. TREE-2 is the first study to assess the safety of Eloxatin-based regimens combined with Avastin (bevacizumab, Genentech Inc.) for the first-line treatment of metastatic colorectal cancer. Preliminary efficacy results suggested that adding bevacizumab improved the response rate of all Eloxatin-based regimens. Researchers from the Eastern Cooperative Oncology Group also reported results of the E3200 study, which demonstrated a 26 percent reduction in the risk of death for patients receiving Eloxatin-based chemotherapy (FOLFOX4) plus bevacizumab compared to those who received FOLFOX4 alone.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., acquired worldwide exclusive rights to RenaZorb (two second-generation lanthanum-based phosphate-binding agents) from Altair Nanotechnologies Inc., of Reno, Nev. The non-aluminum, non-calcium phosphate binders, which use Altair's lanthanum nanomaterial technology, have the potential to treat hyperphosphatemia. Spectrum will pay Altair an up-front payment of 100,000 shares of restricted common stock and will make an equity investment of $200,000 for 38,314 shares of Altair common stock. Spectrum's shares (NASDAQ:SPPI) rose 40 cents Monday to close at $6.34.

• TyRx Pharma Inc., of Monmouth Junction, N.J., said it has received an equity investment from Boston Scientific Corp., of Natick, Mass. TyRx is focused on developing a family of bioresorbable drug-eluting polymers for use in combination medical devices and specialty pharmaceuticals. Terms of the agreement were not disclosed.

• VaxGen Inc., of Brisbane, Calif., expects to file all of its outstanding periodic reports with the SEC and apply for a relisting of its common stock on Nasdaq no later than in the third quarter. The company expects to be relisted on Nasdaq six to eight weeks after it files its periodic reports, if its listing application is approved. The company said it believes it meets Nasdaq's listing requirements.

• YM BioSciences Inc., of Mississauga, Ontario, has partnered with Shin Poong Pharmaceutical Co., of Seoul, South Korea, to expand the development program of its lead drug, tesmilifene, in gastric cancer. The companies will form a joint development team, and Shin Poong will fund development costs and provide an undisclosed up-front fee, as well as milestone and royalty payments. In addition, Shin Poong will begin a study in the local population this year to allow the breast cancer indication under study by YM to be launched in Korea and other Asian countries.

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