• Aastrom Biosciences Inc., of Ann Arbor, Mich., received a staff determination letter from Nasdaq indicating that the firm has not regained compliance with the minimum $1 bid price requirement for continued listing. The stock would be subject to delisting Oct. 13, 2009, though Aastrom said it intends to request a hearing before the panel, which would stay the delisting.

• Amarillo Biosciences Inc., of Amarillo, Texas, agreed to a partnership with Intas Pharmaceuticals Ltd., of Ahmedabad, India, under which Intas will sponsor clinical trials in India of ABI's orally administered interferon-alpha lozenges for influenza. The objective of the studies is to determine the efficacy of low-dose oral interferon in reducing the severity of infection with influenza viruses such as H1N1. Intas will pay ABI a royalty on net sales after marketing approval is obtained in India.

• Asuragen Inc., of Austin, Texas, received more than $3.8 million in new grant funding for 2009 from the Small Business Innovative Research, Small Business Technology Transfer and American Recovery and Reinvestment Act initiatives for further development of molecular diagnostics for oncology and genetic disease.

• Baxter International Inc., of Deerfield, Ill., said the European Commission granted marketing authorization for Celvapan H1N1 pandemic vaccine using the firm's Vero cell technology. Celvapan H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union.

• BioMarker Strategies LLC, of Baltimore, said it was awarded a fast-track Small Business Innovation Research contract from the National Cancer Institute to develop the SnapPath live-tumor-cell testing system, which the firm is developing to enable oncologists to determine the most effective drug treatment for patients with cancer. Under the contract, the company will receive an initial award of $254,000 and be eligible to receive an additional $2 million when the first phase of work is completed.

• Cardiokine Inc., of Philadelphia, Pa., named Amber Salzman president and CEO and a member of the board. She most recently served as senior vice president for operations for medicines development at GlaxoSmithKline plc.

• Clinical Genomics Pty Ltd., of Sydney, Australia, and CSIRO entered into a new phase in their collaboration to develop improved diagnostics for cancers of the colon and rectum. The companies will use their technologies to research and develop a clinical test aimed at testing patient blood and stool for the early detection of bowel cancer. If that research is successful, those assays will be commercially developed and delivered by Clinical Genomics.

• DelSiTech Ltd., of Turku, Finland, signed a collaboration agreement with Orion Corp., of Espoo, Finland, allowing Orion to apply DelSiTech drug delivery technology in combination to develop its drug molecules for different therapeutic purposes. DelSiTech will receive fully allocated payments for project work and milestone payments, as well as an option for licensing and further collaboration.

• Gen-Probe Inc., of San Diego, said it signed a definitive agreement to acquire Prodesse Inc., of Waukesha, Wis., for $60 million in cash. Gen-Probe said its purchase price could increase to up to $85 million if Prodesse achieves certain financial and regulatory milestones in 2010 and 2011.

• Labopharm Inc., of Laval, Quebec, said the FDA notified Rome-based Gruppo Angelini, the manufacturer of the active pharmaceutical ingredient for Labopharm's trazodone formulation, that the company has addressed all deficiencies cited by regulators during an inspection of the company's manufacturing facility in June and July. The FDA classified the facility as acceptable. Labopharm received a complete response letter from the FDA on July 17 indicating that the firm's new drug application for its trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier's manufacturing facility. The letter did not raise any efficacy or safety issues. (See BioWorld Today, July 21, 2009.)

• Odyssey Thera Inc., of San Ramon, Calif., said it will receive undisclosed milestone payments from Pfizer Inc., of New York, under an August 2006 multiyear alliance. Odyssey said the milestones are the fourth and fifth to be earned for the advancement of specific drug candidates, and they follow other technology development milestones previously achieved in the alliance.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., established an antiviral research group in its R&D organization to coordinate, expand and leverage the company's multiple external collaborations, either under way or planned, for assessing the potential utility of Peregrine's phosphatidylserine-targeting antibody platform for the prevention and treatment of a broad range of serious infectious diseases, including viral hemorrhagic fevers and other biodefense threats, HIV, influenza, cytomegalovirus, leishmaniasis and malaria.

Published: October 8, 2009