• AnorMED Inc., of Vancouver, British Columbia, filed an investigational new drug application to begin a clinical program for its stem cell mobilizer, AMD3100, in cardiac patients. The company said it hopes to initiate the first study this year to evaluate the product's safety in heart attack patients. AMD3100 is AnorMED's lead product and is in ongoing Phase III studies for stem cell transplant in cancer patients.

• Callisto Pharmaceuticals Inc., of New York, received an $885,641 biodefense partnership grant from the National Institute of Allergy and Infectious Diseases to develop a monoclonal antibody and vaccine against bacterial superantigen toxins. Callisto's lead monoclonal antibody and antagonist peptide are being developed to provide broad-spectrum protection against a variety of toxins, such as Staphylococcal and Streptococcal bacterial strains.

• Cellular Dynamics International, of Madison, Wis., a new drug screening company, began constructing laboratory facilities at University Research Park in Madison. The company was founded by James Thomson, Craig January and Timothy Kamp, researchers at the University of Wisconsin-Madison and Tactics II Ventures LP. CDI will focus initially on developing and providing stem cell and HEK cell-based screening services to the pharmaceutical and biotechnology industries.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, is reducing its work force from 46 to 23 employees as part of a restructuring effort to conserve cash and focus resources on its cell-line engineering business. The company plans to close its office in Seattle and consolidate operations in Burnaby. In addition, Chromos will delay the initiation of its planned clinical trial until sufficient funds are available. Restructuring expenditures are expected to cut the company's burn rate to about $450,000 per month for 2005, though Chromos said it will have to work on completing additional financings and other transactions to extend its operations beyond May 2005. The company reported a net loss of $7.8 million for 2004, with research and development expenses nearly doubling from 2003, to $4.1 million. Cash resources at the end of the year totaled $1.6 million, with another $1.1 million brought in during a private placement offering in January.

• Critical Therapeutics Inc., of Lexington, Mass., submitted a supplemental new drug application to the FDA for its asthma drug Zyflo Filmtab (zileuton tablets). The company anticipates launching its version of the drug in the second half of this year. The FDA approved Zyflo in 1996, and Critical Therapeutics in-licensed worldwide rights to the product in March 2004. The commercial supply was depleted in early 2004 and Critical Therapeutics submitted the sNDA because it changed the manufacturing process and transferred production of zileuton and the tablet formulation to third-party sites.

• Crucell NV, of Leiden, the Netherlands, said its partner, Sanofi Pasteur, the vaccines business of the Sanofi-Aventis Group, of Paris, was awarded a $97 million contract by the U.S. Department of Health and Human Services to accelerate the licensure in the U.S. of a PER.C6-based cell-culture influenza vaccine and vaccine manufacturing facility. Crucell will be a subcontractor for the program. Terms of the agreement between Crucell and Sanofi Pasteur were not disclosed. The project is part of the U.S. government's effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency. Separately, Crucell said the Netherlands Authority for the Financial Markets has notified Crucell that its investigation into the exercise of options and the subsequent sale of shares on Jan. 18 by certain members of Crucell's management and supervisory boards was completed. The investigation indicated that insider trading did not occur.

• Curis Inc., of Cambridge, Mass., said Genentech Inc., of South San Francisco, filed an investigational new drug application to start trials of a drug candidate for the topical treatment of basal-cell carcinoma. The candidate is an antagonist of the Hedgehog signaling pathway, which was discovered by Curis and is being co-developed with Genentech. The companies established a collaboration in 2003 to develop a set of technologies based on inhibition of the Hedgehog signaling pathway.

• Cytos Biotechnology AG, of Zurich, Switzerland, and Medarex Inc., of Princeton, N.J., expanded the scope of their agreement for new drug targets. Medarex will acquire the exclusive rights to develop and commercialize monoclonal antibody therapeutics against the collaboration targets. Medarex also will receive a first right of negotiation for use of those targets in small-molecule drug discovery and as protein therapeutics. Cytos will receive an up-front payment and has the opportunity to earn license fees, milestones and royalties on net sales of products that are brought to market.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, initiated the first in a series of Phase I trials with Neumune, its immune-regulating hormone to treat acute radiation syndrome. The study is being conducted in the Netherlands. The company expects to file an investigational new drug application with the FDA in the first half of the year.

• ImaRx Therapeutics Inc., of Tucson, Ariz., said Phase I/II results of SonoLysis in clotted dialysis grafts indicated no safety issues. Most patients showed improvements in both endpoints of declotting of the graft and increased blood flow after 30 minutes. SonoLysis combines external ultrasound and ImaRx's nanobubbles and is designed to clear blood clots more quickly and without the use of surgery or lytic drugs. The data is being presented at the Society of Interventional Radiology 30th Annual Scientific Meeting in New Orleans.

• Inncardio Inc., of New York, announced a definitive agreement to acquire Cengent Therapeutics, a privately held company based in San Diego. Inncardio, which is focused on developing therapies for cardiovascular diseases, will add to its technology Cengent's drug discovery efforts that focus on targeting signal transduction for the treatment of obesity/diabetes. Cengent's recent development efforts have results in the discovery of orally active PTP-1B inhibitors Type II diabetes and obesity. Financial terms of the acquisition were not disclosed.

• Invitrogen Corp., of Carlsbad, Calif., completed its acquisition of Dynal Biotech, of Oslo, Norway, with a cash transaction totaling about NOK2.5 billion (US$391 million). Invitrogen acquired Dynal from majority owner Nordic Capital and a co-investor. Dynal is the industry leader in magnetic bead technologies that are used in cell separation and purification, cell stimulation, protein research, nucleic acid research and microbiology. (See BioWorld Today, Feb. 9, 2005.)

• Inyx Inc., of New York, completed its acquisition of certain assets and business of Aventis Pharmaceuticals Puerto Rico Inc. from Aventis Pharmaceuticals Inc., a member of the Paris-based Sanofi-Aventis Group. Inyx gains a pharmaceuticals development and production center. The $19.7 million acquisition price was financed through non-dilutive, asset-based funding provided by Westernbank Business Credit Division of Westernbank, Puerto Rico. Inyx secured total funding of $46 million and received 10-year and five-year asset-based term loans bearing an interest of 2 percent above prime. Funding also will be used to replace Inyx's debt financings through Laurus Funds.

• Osiris Therapeutics Inc., of Baltimore, received FDA clearance to begin enrollment in the first human trial for a stem cell therapy targeted at injured tissue in knee surgery patients. Chondrogen, a formulation of adult mesenchymal stem cells, will be evaluated in a 48-patient study to determine the safety and efficacy of the stem cell treatment for the regeneration of meniscus.

• PPD Inc., of Wilmington, N.C., has relocated its Phase I clinic and Phase I-III central lab in Austin, Texas, to a new facility in Austin. The company said increased demand for comprehensive management of early phase studies prompted the move.

• Proteome Systems, of Sydney, Australia, achieved a milestone under an agreement from the U.S.-based High Q Foundation for the discovery of biomarkers for monitoring the progression of Huntington's disease and the effectiveness of treatments in clinical trials. The milestone, involving proteomic analysis of diseased and normal individuals, was reached four months into the 18-month agreement and involved identification of the first candidate biomarkers for HD in clinical samples of plasma and cerebrospinal fluid. The milestone payment was $300,000.

• Sepracor Inc., of Marlborough, Mass., said the final rule that will designate eszopiclone as a Schedule IV controlled substance will be published in the April 4 edition of the Federal Register. Sepracor will then commence a full-scale commercial launch of Lunesta brand eszopiclone, which received FDA approval in December for insomnia. About 1,250 sales representatives will promote Lunesta to primary care doctors, psychiatrists and sleep specialists in the U.S. (See BioWorld Today, Dec. 17, 2004.)

• Solvay Pharmaceuticals Inc., of Marietta, Ga., is examining its options and plans to discuss future steps with the FDA after receiving a not-approvable letter last month for cilansetron in irritable bowel syndrome with diarrhea predominance in men and women. The letter requested additional trials.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., submitted a new drug application to the FDA on March 31 to market lubiprostone, a compound for the treatment of chronic idiopathic constipation and associated symptoms in adults. Administered orally, the agent has been shown to work locally in the gastrointestinal tract by activating specific chloride channels on cells lining the small intestine, increasing intestinal fluid secretion.

• TheraQuest Biosciences LLC, of Blue Bell, Pa., said TQ-1015 produced dose-dependent reversal of tactile hyperesthesia and thermal hyperalgesia in an inflammatory pain study. The product, an abuse deterrent opioid agonist, retained its antinociceptive potency in the presence of inflammation and was more potent than morphine, with a high degree of efficacy. The data were presented at the American Pain Society Annual Scientific Meeting in Boston.