• A.P. Pharma Inc., of Redwood City, Calif., submitted a protocol to the FDA for a single pivotal Phase III trial with APF530. The proposed trial will compare the safety and efficacy of APF530 with palonosetron to treat acute and delayed chemotherapy-induced nausea and vomiting in patients receiving either moderately or highly emetogenic chemotherapy. The company hopes to begin enrollment of 1,200 patients in April.

• Accentia Biopharmaceuticals Inc., of Tampa, Fla., said its subsidiary, Biovest International Inc., reported follow-up data to a Phase II trial, showing that its cancer vaccine, BiovaxID, yielded an 89 percent survival rate in mantle cell lymphoma patients, with a median follow-up of 3.8 years. BiovaxID is designed to stimulate the immune system to seek out and destroy tumor cells. The results were published in Nature Medicine.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., intends to publicly offer about 5 million shares of common stock pursuant to a shelf registration statement. Alnylam also intends to grant an option to the underwriters to purchase up to 767,394 additional shares of common stock to cover over-allotments. All of the shares are being sold by Alnylam.

• Amgen Inc., of Thousand Oaks, Calif., said it intends to invest more than $1 billion in Cork, Ireland, on new process development, bulk manufacturing and fill and finish facilities. The company also plans to add a manufacturing plant in Puerto Rico, and to expand existing research and development operations in Cambridge, Mass.; San Francisco; Seattle; and Cambridge, UK. It also plans to build a development center in Uxbridge, UK. Amgen moved its European headquarters from Lucerne to Zug, Switzerland, and formed Amgen International, to improve access to its drugs for patients in Central and Southeast Asia, Africa and Latin America.

• Array BioPharma Inc., of Boulder, Colo., and AstraZeneca plc, of London, selected an additional clinical candidate for their small-molecule cancer program, triggering a $1 million milestone payment to Array. The companies began collaborating in December 2003 to use the oncology portion of Array's MEK program, and lead compound ARRY-142886 for co-development and commercialization. That compound is in Phase Ib development. (See BioWorld Today, Dec. 19, 2003.)

• Avicena Group Inc., of Palo Alto, Calif., said findings from a Phase I/II study of its Huntington's disease drug candidate HD-02 showed safety and tolerability at a dose of 8 grams/day. Patients receiving HD-02 also experienced elevated serum and brain levels of creatine. These results were published in Neurology.

• Axonyx Inc., of New York, completed the ascending single-dose Phase I trial with Posiphen, which is in clinical development for Alzheimer's disease progression. The double-blind, placebo-controlled study in healthy men and women showed Posiphen is well tolerated at single doses up to and including 80 mg. No serious adverse events were reported at any dose level.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, signed a cooperative research and development agreement with the National Institutes of Health relating to small-agonists of the A(3) adenosine receptor created at the NIH. The A(3)AR is the prime target of Can-Fite's drug development efforts. The collaboration will focus on identifying agonists with potential against autoimmune inflammatory diseases and cancer.

• Caprion Pharmaceuticals Inc., of Montreal, entered a research collaboration with Berlex Inc., a U.S. affiliate of Schering AG, of Berlin. The collaboration will use Caprion's CellCarta proteomics platform to support biomarker discovery. Caprion will identify pharmacodynamic biomarkers in plasma resulting from the administration of Berlex compounds in preclinical development.

• Chiron Corp., of Emeryville, Calif., said the European Commission granted marketing approval for Cubicin (daptomycin), a first-in-class IV antibiotic. The marketing approval was granted in the 25 member states of the European Union, Iceland, Liechtenstein and Norway. Cubicin is indicated for the treatment of complicated skin and soft-tissue infections caused by Gram-positive bacteria. It is expected to become available in the UK and the Netherlands within the next few weeks, followed by additional European countries. Cubicin was approved in the U.S. in September 2003, and also is approved in Israel and Argentina.

• Ciphergen Biosystems Inc., of Fremont, Calif., said that the Nasdaq Listing Qualifications Panel informed the company that it has complied with the requirements for continued listing on The Nasdaq National Market, and that the "E" that has been appended to the company's ticker symbol was removed.

• Cresset BioMolecular Discovery Ltd., of Hertfordshire, UK, a drug discovery technology company, and Bayer CropScience, of Monheim, Germany, entered a collaboration to exploit Cresset's molecular field technology for the discovery of new agrochemicals. Bayer will apply Cresset's FieldScreen software to identify early stage active compounds to progress through their development pipeline.

• Cue Biotech Inc., of Evanston, Ill., entered a collaboration with H. Lundbeck A/S, of Copenhagen, Denmark, to discover and develop small-molecule therapeutics targeting G-Protein Coupled Receptors, or GPCR, for disorders and diseases of the central nervous system (CNS). The companies will apply Cue Biotech's Cue-Quest screening technology to multiple GPCR targets in their efforts to identify and develop small molecules that allosterically modulate important CNS targets.

• Cytogen Corp., of Princeton, N.J., said Blood published online preclinical data from studies involving the use of Quadramet (samarium Sm-153 lexidronam) both as a monotherapy and in combination with the first-in-class proteasome inhibitor bortezomib (Velcade, Millennium Pharmaceuticals Inc.) to treat multiple myeloma. Quadramet demonstrated broad and synergistic activity when administered in combination with bortezomib in a murine myeloma model. The anticancer activity was characterized by prolonged median survival, reduced clonogenicity of bone-marrow resident 5TGM1 cells, slowed elevation of serum myeloma-associated paraprotein levels and longer-term preservation of bone mineral density.

• Cytori Therapeutics Inc., of San Diego, received the CE Mark for its Celution System, a device aimed at processing adult stem cells from adipose tissue. The approval triggered an $11 million milestone payment from Olympus-Cytori Joint Venture, formed in November as part of Cytori's regenerative medicine collaboration with Olympus Corp., of Tokyo. (See BioWorld Today, Nov. 7, 2005.)

• Erimos Pharmaceuticals Inc., of Raleigh, N.C., began patient dosing of its lead product, EM-1421, for the treatment of refractory and metastatic solid tumors that are unresponsive to conventional therapy. In addition to safety, the 30-patient study is expected to find the maximum tolerated dose and assess antitumor activity. EM-1421 was derived semi-synthetically from a desert plant, and it is designed to target abnormal tumor cells while causing little or no toxicity to healthy cells.

• Eurand International SpA, of Milan, Italy, signed research agreements with the University of Milan and the University of Sassari to evaluate a new class of analgesic compounds. The new class of compounds is expected to be comparable to opioids in terms of efficacy, but not to possess the major drawbacks of tolerance and dependence which limits the use of opioids.

• Genta Inc., of Berkeley Heights, N.J., said the first patients have entered a new clinical study that will evaluate the bioactivity and safety of Genasense (oblimersen sodium) injection. The study employs a new formulation of Genasense that is fivefold more concentrated than material used in clinical trials. The program will evaluate a range of single doses, followed by repeated dosing schedules, in order to optimize use for future studies.

• Halozyme Therapeutics Inc., of San Diego, completed enrollment of a clinical trial of subcutaneous hydration (hypodermoclysis) with Hylenex, a liquid injectable formulation that includes recombinant human hyaluronidase, which is FDA approved for use as a spreading agent to increase the absorption and dispersion of other injected drugs. Subcutaneous hydration is the introduction of fluids under the skin to replace inadequate intake or excessive loss of water and electrolytes during illness or operation. The double-blind, randomized, placebo-controlled study has reached its target enrollment of 50 evaluable subjects.

• Immtech International Inc., of Vernon Hills, Ill., appointed Eric Sorkin CEO. He also will continue as chairman of the company's board. Stephen Thompson will hold a position as Immtech's president in charge of operations.

• LAB International Inc., of Laval, Quebec, said its asthma product, LAB CGRP (calcitonin gene related peptide) was demonstrated safe with no serious adverse events reported at all doses tested in a Phase I trial. The study was carried out on 10 healthy volunteers. The company expects to move into a Phase II trial. LAB International also appointed Jean-Marie Pomerleau to its board.

• Metabolex Inc., of Hayward, Calif., said preclinical findings demonstrated that metaglidasen provided glycemic control and lipid-lowering activity equivalent to the rosiglitazone and pioglitazone with a significantly improved side-effect profile, including less weight gain and edema. Metaglidasen is an oral insulin sensitizer in clinical development for Type II diabetes.

• Nuvelo Inc., of San Carlos, Calif., plans to offer 5.5 million shares of common stock in an underwritten public offering made through its shelf registration statement. The underwriters, JP Morgan Securities Inc., Deutsche Bank Securities Inc. and Lehman Brothers Inc., will have an overallotment option to purchase up to an additional 825,000 shares. Nuvelo's pipeline includes alfimeprase in Phase III for thrombotic-related disorders, and rNAPc2 in Phase II for acute coronary syndrome.

• Open Biosystems Inc., of Huntsville, Ala., reported the availability of its lentiviral microRNA-adapted short hairpin RNA library. This resource is designed to enable investigators to inhibit expression of specific genes within the human genome.

• Organon NV, of Oss, the Netherlands, a business unit of Akzo Nobel, and Shanghai Genomics Inc., a China-based affiliate of GNI, agreed to a two-year collaboration on Organon's program for identifying selective steroid hormone receptor modulators. Research will focus on the areas of rheumatoid arthritis, atherosclerosis and oncology. Financial terms were not disclosed.

• Phosphogenics Ltd., of Melbourne, Australia, said it will begin animal studies later this month with its cancer compound. The drug, GTP-0805, is a phosphorylated variant of gamma-tocopherol. Laboratory tests thus far found that the compound induced a greater than 90 percent reduction in breast and prostate cancer cells.

• Proacta Inc., of San Diego, began treating cancer patients in its Phase I study of PR-104, a hypoxia targeted small-molecule prodrug aimed at improving the outcomes of existing treatment regimens, such as chemotherapy and radiotherapy. PR-104 is designed to be activated in the low oxygen environment of hypoxic tumors, and preclinical studies have demonstrated its ability to cause the death of hypoxic tumor cells, while distributing to surrounding tumor cells. The company also reported additional Series A funding from Alta Partners, which joined lead investor GBS Ventures in Australia, along with Endeavour i-Cap and NO8 Ventures, both of New Zealand, and early investors Genentech Inc. and F. Hoffmann-La Roche Ltd. The company's Series A brought in a total of $12 million. David Mack, director at Alta Partners, joined Proacta's board.

• Prolong Pharmaceuticals Inc., of Monmouth Junction, N.J., signed an agreement for Rockville, Md.-based Omnia Biologics Inc. to provide Prolong with sterile fill-finish services. Prolong's core technology is an FDA-approved delivery system for protein-based biopharmaceuticals known as PEGylation. Financial terms were not disclosed.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said that Nasdaq has agreed to continue the listing of the company's securities, provided that the company files its amended Form 10-Q for the quarter ended March 31, and all required restatements, by Jan. 26.

• Serono SA, of Geneva, said the Japanese Ministry of Health, Labour and Welfare approved Gonal-f 75 IU and Gonal-f 150 IU (follitropin alfa recombinant) subcutaneous injection for co-administration with Profasi 5000 IU (chorionic gonadotropin) for the induction of spermatogenesis in men with hypogonadotropic hypogonadism. The company plans to continue working with Japanese authorities to register the product in female infertility. It will be marketed in Japan under the brand name Gonalef.

• Tripos Inc., of St. Louis, implemented its work force reduction, cutting 76 positions at its Discovery Research business based in Bude, UK. The company also plans to close a 6,000-square-foot laboratory building in Bude, as part of the company's plan to streamline and refine its Discovery Research business following the completion of a four-year project with New York-based Pfizer Inc.

• Vical Inc., of San Diego, granted nonexclusive, academic licenses for its broad DNA delivery technology patent estate to three of the nation's top research institutions, Stanford University, Harvard University and Yale University. The licenses are intended to encourage commercial use of Vical's technologies in the development of new antibodies, vaccines, therapeutic proteins and diagnostics. University researchers can use the technology free of charge for educational and internal, non-commercial research purposes. Vical will have the option to exclusively license from the universities potential commercial applications that result.

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