• AstraZeneca plc, of London, is making a labeling change to Iressa (gefitinib tablets). Based on the FDA's assessment of available data, including the lack of survival benefit in the Phase III trial comparing Iressa to placebo in advanced recurrent non-small-cell lung cancer, the revised label indicates that the drug is to be used only in patients who previously have taken and have benefited from Iressa. The new label will be implemented Sept. 15. (See BioWorld Today, Dec. 20, 2004.)

• Bioniche Life Sciences Inc., of Belleville, Ontario, said data from a study using its mycobacterial cell wall-DNA complex (MCC) against peritoneal cancer in rats showed that the product demonstrated anticancer activity against PROb cells by inhibiting proliferation and inducing apoptosis. The data were presented at the 7th World Congress on Gastrointestinal Cancer in Barcelona, Spain. MCC, trademarked Urocidin, is in development as an intravesical treatment for urinary bladder cancer.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said the U.S. District Court in New York denied its motion seeking a temporary restraining order and a preliminary injunction to stop the sale of generic equivalents of Periostat. The company said it intends to continue its lawsuits and efforts to seek compensation for any lost profits.

• Generex Biotechnology Corp., of Toronto, signed an agreement with the holders of its 6 percent secured convertible debentures for the issuance of additional debentures and warrants for an aggregate purchase price of $2 million. Generex said it intends to use the proceeds from the transaction to fund the initial launch of commercial sales of Oral-lyn, an oral, insulin buccal spray product, as well as accelerate further clinical development activities and add to its working capital.

• Maxygen Inc., of Redwood City, Calif., is reducing its staff by about 16 percent and is consolidating its organization to move the focus from research to product development. The staff reductions will come from the company's research and administrative functions, and are expected to result in annual cost savings of about $3 million in 2006 and beyond. Maxygen expects to record a one-time termination cost of $1 million. The company, which uses its MolecularBreeding platform to generate protein therapy candidates, said it expects to file two investigational new drug applications next year.

• MediciNova Inc., of San Diego, initiated a second Phase I study of MN-029 in patients with solid tumors. MN-029 is a vascular-targeting agent (VTA) that in preclinical studies demonstrated greater potency with a potential for less toxicity to the cardiovascular and central nervous system than first-generation VTAs. The company is nearing completion on a Phase I trial of MN-029 started in September in patients with solid tumors.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., saw its shares jump 13.8 percent Friday. Reports, by Reuters and others, linked the stock jump to validating Velcade data published Thursday in the New England Journal of Medicine, as well as rumors that the company might be a candidate for acquisition. Also, Millennium said Friday it added to its board Robert Friel, the executive vice president and chief financial officer of PerkinElmer Inc., a global health services and industrial sciences firm with annual revenues of $1.8 billion. Millennium's stock (NASDAQ:MLNM) closed at $9.41, up $1.14, with nearly 53 million shares traded, more than 11 times its average volume.

• Prolysis Ltd., of Oxford, UK, and Essential Science Ltd., of Glasgow, UK, agreed to extend their collaboration for the commercialization of Prolysis' antibiotic development programs. In the year since the companies began working together, they said they have validated Prolysis' approach to anti-infectives through an investment from Tokyo-based Astellas Pharma Inc. The extended agreement will focus on opportunities to out-license Prolysis' research technologies and programs or in-license development candidates.

• Provid Pharmaceuticals Inc., of North Brunswick, N.J., entered an agreement with Immune Control Inc., of West Conshohocken, Pa., for the development of lead compounds for diseases with immunological causes. Provid said it will use structure-based design, peptide mimetics technology and medicinal chemistry to develop the compounds. Financial terms were not disclosed.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., filed a shelf registration statement to allow the sale of up to $60 million of its common stock and warrants to purchase common stock. RegeneRx said in its prospectus that proceeds from any sales will be used to explore additional clinical trials for myocardial infarctions, ophthalmic indications and for general corporate purposes.

• Revotar Biopharmaceuticals AG, of Brandenburg, Germany, said the European Medicines Agency granted orphan drug designation to bimosiamose disodium, its pan-selectin antagonist for the treatment of acute lung injury. The designation provides Revotar with 10 years of marketing exclusivity if its drug is approved in the European Union.

• Senesco Technologies Inc., of New Brunswick, N.J., said results of a series of mouse experiments comparing its Factor 5A technology to two approved drugs - dexamethasone and Amgen Inc.'s Enbrel - showed its siRNA product was comparable to corticosteroids and anti-TNF therapies in decreasing levels of inflammatory cytokines. Relative to a control group, mice injected with LPS to induce an inflammatory response showed a 90 percent reduction in cytokine levels with dexamethasone and a 75 percent decrease with Senesco siRNA. Against Enbrel, Senesco's drug decreased interleukin-1-alpha by 35 percent compared to Enbrel's 50 percent. Enbrel decreased interleukin-6 by 98 percent, while Senesco siRNA showed an 82 percent decrease, and interferon-gamma decreased 93 percent with Enbrel and 87 percent with Senesco's product.

• Southern Research Institute in Birmingham, Ala., received a three-year, $11.6 million grant from the National Institutes of Health to support drug discovery and to operate the Southern Research Molecular Libraries Screening Center. SRI is one of nine U.S. research centers included in a nearly $90 million grant program to establish a collaborative network that will use robotic high-throughput screening methods to identify small-molecule probes as tools for drug discovery.

• Tercica Inc., of South San Francisco, said it, along with co-plaintiff, Genentech Inc., also of South San Francisco, filed a request to withdraw its motion for a preliminary injunction against Richmond, Va.-based Insmed Inc. and Santa Clara, Calif.-based Celtrix Inc., filed in U.S. District Court. Tercica said the decision was based on the FDA's extension of Insmed's PFUFA date to Oct. 3, which will come after Tercica's PDUFA date set for Aug. 31. The injunction motion had been seeking to prevent Insmed from making and selling SomatoKine, a growth hormone therapy, and to compel Insmed to grant Tercica joint exclusivity in any orphan drug marketing right if SomatoKine were approved before Tercica's growth hormone drug, Increlex.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Merck & Co. Inc., of Whitehouse Station, N.J., started an additional Phase I study with VX-680, a small-molecule inhibitor of Aurora kinases. The trial will evaluate safety and tolerability when administered over a five-day treatment cycle to patients with hematologic cancers. Other studies are ongoing to evaluate VX-680 in patients with recurrent or non-responsive solid tumors, and cancers for which there are no standard therapies.

• XOMA Ltd., of Berkeley, Calif., granted Whitehouse Station, N.J.-based Merck & Co. Inc. a nonexclusive worldwide license for its antibody-related intellectual property. Under the agreement, Merck receives a license to use XOMA's bacterial cell expression property for phage display with the potential use in the discovery of antibody products. XOMA will receive an undisclosed access fee, milestones and royalties on future sales of any products, and Merck has an option to use the bacterial cell expression IP to manufacture antibodies upon additional payments to XOMA. Further terms were not disclosed.