• Barrier Therapeutics Inc., of Princeton, N.J., completed the sale of about 5.5 million shares in a registered direct offering priced at $5.75 per share, for gross proceeds of about $31.9 million. The funding strengthens the firm's balance sheet as it continues partnering discussions for some of its pipeline products, including Hyphanox, pramiconazole and Rambazole. J.P. Morgan Securities acted as the exclusive placement agent, while Pacific Growth Equities LLC served as financial advisor.

• Basilea Pharmaceuticals Ltd., of Basel, Switzerland, submitted a marketing authorization application to Swissmedic for alitretinoin in severe refractory chronic hand eczema. The company previously filed for marketing approval in various European Union member states. In other news, the company also appointed Hans Christian Rohde as global head of commercial operations.

• Biomira Inc., of Edmonton, Alberta, is changing its name to Oncothyreon Inc., as part of its plan to reincorporate in the U.S. The name is derived from the Greek words for "tumor" and "shield" and is intended to describe the company's goal to develop therapies that protect against the effects of cancer. Upon approval of the change, the company intends to trade on Nasdaq under the symbol "ONTY," and on the Toronto Stock Exchange under "ONY."

• Cangene Corp., of Toronto, said it completed delivery of the initial order for botulinum toxin immune globulin (heptavalent botulism antitoxin), and the drug has been formally received into the U.S. Strategic National Stockpile. Cangene now can invoice for the remaining two-thirds of the previously disclosed $18 million to $22 million. Those revenues will be recognized in the company's first quarter 2008 earnings.

• Celera Group, of Rockville, Md., an Applera Corp. business, received a $2 million milestone payment from Whitehouse Station, N.J.-based Merck & Co. Inc. under the companies' cathepsin K inhibitor collaboration. The payment was triggered by Merck's advancement of odanacatib (MK-0822), an oral, selective inhibitor of the cathepsin K enzyme, into a Phase III trial in osteoporosis patients. Celera will receive additional milestones and potential royalties upon successful commercialization.

• Crucell NV, of Leiden, the Netherlands, reported the discovery of a set of 21 human monoclonal antibodies against H5N1. All were found to be able to neutralize the H5N1 virus of avian influenza, with the most potent shown to neutralize a broad range of H5N1 strains that emerged between 1997 and 2004. In addition, that antibody prevents flu, in preclinical models when given 24 hours before a challenge with a lethal dose of H5N1 virus. Those findings were presented at the bird flu meeting in Las Vegas.

• CSL Ltd., of Parkville, Australia, received FDA approval Friday for Afluria, a seasonal influenza vaccine for the immunization of people ages 18 and older. Afluria is intended to protect adults from influenza type A and type B flu viruses. The approval brings to six the number of seasonal influenza manufacturers licensed for the U.S. market. Afluria was approved using the FDA's accelerated approval pathway for serious or life-threatening diseases, which reduces the time for needed medical products to become available to the public. As part of the accelerated approval process, CSL will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination.

• CV Therapeutics Inc., of Palo Alto, Calif., submitted a supplemental new drug application seeking expansion of the product labeling for Ranexa (ranolazine extended-release tablets) to include first-line treatment of chronic angina and cautionary language, based on substantial data from the MERLIN TIMI-36 study. Ranexa currently is indicated to treat chronic angina in patients who have not achieved an adequate response with other anti-anginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.

• ExSar Corp., of Monmouth Junction, N.J., received a $400,000 FDA grant to support Phase I studies of EXR-101, the company's first clinical candidate for treating adult Tay-Sachs and Sandhoff diseases. Half of that is intended to support first-year activities, with the remaining $200,000 to be awarded in the second year following a progress review. EXR-101 is a small-molecule chaperone of hexosaminidase A, the mutant enzyme at the core of Tay-Sachs and Sandhoff diseases, and is designed to work by facilitating the folding and trafficking of HexA to the lysosome where HexA is responsible for catabolizing GM2 ganglioside.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., purchased all of the equity of Symphony GenIsis at the prenegotiated price of $120 million. Symphony GenIsis, a financing vehicle established last year by Isis and Symphony Capital Partners LP, held rights to three Isis compounds in exchange for providing $75 million in funding for those programs. Isis retained the option of reacquiring those programs upon achieving proof-of-concept data. But the firm decided to buy back its programs sooner than expected, after securing a metabolic disease collaboration with Ortho-McNeil Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, in mid-September. That deal, worth a potential $440 million, included the licensing of two of the drugs previously held by Symphony GenIsis, ISIS 325568 and ISIS 377131, which target the glucagon receptor and the glucocorticoid receptor. Isis reacquired full ownership of the third Symphony program, ISIS 301012, a cholesterol-lowering drug targeting apolipoprotein B-100. As part of the $120 million purchase price, Isis paid Symphony Capital $80.4 million in cash and about 3.4 million shares, for an aggregate value of $39.6 million based on a 60-day average closing price prior to Isis exercising its repurchasing option. (See BioWorld Today, April 11, 2006, and Sept. 14, 2007.)

• Keygene NV, of Wageningen, the Netherlands, signed an agreement with UK-based D1 Oils plc for molecular genetics research in Jatropha curcas, an oilseed tree that grows in tropical and subtropical regions and produces high yields of inedible vegetable oil that can be refined into high-quality biodiesel. The two-year deal provides D1 with exclusive rights on applied contract research and molecular services carried out by Keygene.

• Macroflux Corp., of Fremont, Calif., changed its name to Zosano Pharma Inc., which represents a combination of "sano," meaning to heal or to cure, and "zo," for zone. The company develops the Macroflux transdermal microprojection delivery system to provide benefits, such as needle-free administration with room temperature stability for various therapeutic peptides, proteins, small molecules and vaccines.

• Matritech Inc., of Newton, Mass., and Sysmex Corp., of Kobe, Japan, mutually agreed to terminate their 2002 agreement under which Sysmex was granted an exclusive, worldwide license to Matritech's NMP 179 cervical cancer technology for automated, non-slide-based laboratory instruments. The development of an automated process of screening cervical cell specimens by combining that technology with flow cytometry also was discontinued, and all rights licensed in the deal revert to Matritech. The move follows last month's news that Inverness Medical Innovations Inc., of Waltham, Mass., will acquire Matritech's assets for $36 million in stock.

• Metabolix Inc., of Cambridge, Mass., received a $2 million Advanced Technology Program grant from the National Institutes of Standards and Technology to develop a commercially viable process for producing bio-based chemicals from renewable agricultural products, rather than from fossil hydrocarbons such as oil or coal. The award will fund the company's Integrated Bio-Engineered Chemicals program, which is starting development of clean, sustainable solutions for widely used four-carbon industrial chemicals.

• Par Pharmaceutical Companies Inc., of Woodcliff Lake, N.J., has established Strativa Pharmaceuticals, a specialty pharmaceuticals division to bring the company's innovative pharmaceuticals to market. Strativa's current focus will be on supportive care products, including the marketed Megace ES for anorexia, cachexia and/or unexplained weight loss in HIV patients, as well as three in-licensed development-stage products: Zensana (ondansetron HCl), which is partnered with South San Francisco-based Hana Biosciences Inc., for preventing chemotherapy-induced nausea and vomiting; Loramyc (miconazole Lauriad), with Paris-based BioAlliance Pharma SA, for oropharyngeal candidiasis, an opportunistic infection in cancer and HIV patients; and pafuramidine maleate, which is partnered with New York-based Immtech Pharmaceuticals Inc., as an antimicrobial drug for pneumocystic pneumonia in AIDS patients.

• Solazyme Inc., of South San Francisco, received a $2 million Advanced Technology Program award from the National Institutes of Standards and Technology to develop a biopetroleum derived from marine microorganisms. Under the program, Solazyme will accelerate development of a renewable, domestically produced light sweet crude oil, which is fully compatible with the vast existing petroleum industry infrastructure that refines, distributes and markets petroleum products for transportation, heating, power generation and petrochemical applications.

• Velcura Therapeutics Inc., of Ann Arbor, Mich., received a $2 million Advanced Technology Program grant from the National Institutes of Standards and Technology to support the development of improved, or second-generation, molecules for use in bone diseases requiring long-term therapy, such as rheumatoid arthritis or osteoporosis. Velcura's pipeline includes small molecules that possess characteristics of dual-action therapies, both stimulating bone formation and inhibiting loss. The company also is investigating those compounds in cancer and expects to start Phase I testing of its lead program, VEL-0230, in multiple myeloma patients early next year.

No Comments