• Aeolus Pharmaceuticals Inc., of Laguna Nigel, Calif., announced Wednesday that a new report published in Nature Genetics showed that Aeolus' lead compound, AEOL 10150, can improve survival in fruit flies genetically lacking the neurofibromatosis-1 (NF1) gene. Researchers concluded that the increased mitochondrial Reactive Oxygen Species production resulting from NF1 mutations could be an important factor in the generation of neurofibromas. Thus, treatment with catalytic antioxidants such as AEOL 10150 could reduce NF1, as well as other cancers. AEOL 10150 has been shown to be safe and well-tolerated in single and multi-dose Phase I studies. In animal models, the compound has shown promise in treatment of ALS, Parkinson's disease, stroke and neurofibromatosis. In addition, it protected healthy cells from radiation therapy. Aeolus currently is in the process of planning and securing the financial resources to support a Phase II study to test the efficacy of AEOL 10150 in humans.

• Avexa Ltd., of Victoria, Australia, completed formalization of the licensing and collaboration agreement with TargetDrug, of Shanghai, China, for a CCR5 HIV drug program. The companies already began the collaborative phase of the agreement aimed at identification of improved clinical candidates from the program. Under the agreement, Avexa has worldwide marketing rights, excluding China, to any drugs that result from the collaboration and retains an exclusive option to license TargetDrug's lead CCR5 inhibitor, nifeviroc. If Avexa exercises that option, it will pay TargetDrug clinical development and sales-based milestones and royalties. Specific terms were not disclosed.

• BioSeek Inc., of Burlingame, Calif., has been awarded a contract of up to $12.8 million from the Environmental Protection Agency to use its BioMAP Systems technology to profile the toxic effects of compounds in the agency's ToxCast program. BioSeek will analyze chemical compounds in the ToxCast program with its primary human cell-based systems biology technology, BioMAP Systems. Compounds will be profiled in systems designed to model human tissue and disease states with endpoints including inflammatory responses, cell proliferation, cell death and tissue remodeling.

• Biosite Inc., of San Diego, said Inverness Medical Innovations Inc., of Waltham, Mass., has provided copies of revised commitment letters from Inverness' proposed financing sources connected to the Inverness acquisition proposal for $90 per share in cash. The revised commitment letters identify conditions to the financing and are being filed today with the SEC. Biosite said it will review and evaluate the new information. Inverness made a bid to buy Biosite after Beckman Coulter, of Fullerton, Calif., had made a cash tender offer of $85 per share. That offer expires April 27.

• Cell Therapeutics Inc., of Seattle, agreed to pay the U.S. $10.5 million to resolve allegations of illegal marketing of the anticancer drug Trisenox (arsenic trioxide). The government's complaints include promotion for cancer indications other than for its approved use in second-line acute promyelocytic leukemia (APL) as well as kickbacks to physicians through sham consulting agreements. CTI sold Trisenox to Cephalon Inc., of Frazer, Pa., about two years ago, and the government said Cephalon halted the illegal sales tactics. (See BioWorld Today, June 14, 2005.)

• Cepheid, of Sunnyvale, Calif., received clearance from the FDA to market its Xpert MRSA test, which runs on the GeneXpert System, for the rapid detection of Methicillin-resistant Staphylococcus aureus. Xpert MRSA results identify carriers of the potential pathogen in about an hour and enable health care organizations to implement the proper infection control measures. Cepheid currently is working with VA hospitals across the country to potentially deploy Xpert MRSA in compliance with a VA directive that all patients be tested for MRSA.

• CytoDyn Inc., of Santa Fe, N.M., is adjusting the seasonal components of its pre-flu vaccine to accommodate the recent recommendations of the World Health Organization. WHO reports that it expects the Solomon Islands strain of H1N1 influenza A and the Wisconsin strain of H3N2 Influenza A to predominate during the 2008 flu season, replacing the New Caledonia Strain of H1N1 and Panama Strain of H3N2. The adjustment is expected to delay manufacturing of CytoDyn's trivalent, DNA-based pre-flu vaccine by about six weeks. The bird flu component of the company's trivalent product is unaffected by the anticipated shift.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., and Valera Pharmaceuticals Inc., of Cranbury, N.J., have announced the completion of their merger. Trading in Valera common stock was discontinued Wednesday. Under the terms of the merger agreement, each holder of Valera's common stock will receive 1.1337 shares of Indevus common stock for each share of Valera common stock. In addition, Valera stockholders will receive three contingent stock rights for each of their shares of Valera common stock. The contingent stock rights will become convertible into common stock upon the achievement of particular milestones for three Valera product candidates in development - Supprelin-LA, a ureteral stent and VP003 (octreotide implant).

• Lexicon Genetics Inc., of The Woodlands, Texas, presented data regarding the use of an ophthalmic-specific screening platform within its Genome5000 drug discovery program at IBC Life Sciences meeting in Boston. The screening identified new targets that produce anti-angiogenic effects similar to those caused by blocking vascular endothelial growth factor (VEGF) as well as proteins involved in retinal degeneration, glaucoma, dry eye and ocular inflammation.

• MediGene AG, of Munich, Germany, announced that regulatory authorities in Germany, Austria and Spain have accepted the marketing authorization application for Polyphenon E Ointment for review. MediGene expects approval and market launch of the product in those countries during the first six months of 2008. The active substance in Polyphenon E Ointment is a concentrate of catechines that can be applied to genital warts. The drug was approved in the U.S. in October 2006. MediGene's marketing and development partner, Bradley Pharmaceuticals, of Fairfield, N.J., is expected to launch the product in the U.S. in the last six months of 2007.

• MultiCell Technologies Inc., of San Diego, has entered into an agreement with Merck KGaA & Co., of Spittal/Drau, Austria, to formulate and supply one of the active components of MCT-125, MultiCell's Phase IIb drug for chronic fatigue in patients with multiple sclerosis. In a 138-patient, multi-center, double-blind, placebo-controlled Phase II clinical trial conducted in the UK, MCT-125 demonstrated efficacy in significantly reducing the levels of fatigue in all three types of MS patients enrolled in the study. Financial details were not disclosed.

• Shire plc, of Basingstoke, UK, successfully completed its tender offer for the outstanding shares of common stock of New River Pharmaceuticals Inc., of Radford, Va. Shire intends to complete the acquisition through a short-form merger without a vote or meeting of New River's shareholders, after which New River will immediately become an indirect wholly owned subsidiary of Shire. Shire is paying $64 per share, or $2.6 billion, for its former partner on the recently approved ADHD drug, Vynase. (See BioWorld Today, Feb. 21, 2007.)

• Trimeris Inc., of Morrisville, N.C., said partner F. Hoffman-La Roche Ltd., of Basel, Switzerland, reported $64.3 million in worldwide net sales of the anti-HIV fusion inhibitor Fuzeon for the first quarter of 2007, up 16 percent from $55.4 million in the first quarter of 2006. Trimeris attributed the slight downturn from the record $73.3 million in sales seen in the fourth quarter of 2006 to a normalization of wholesaler purchasing after increased end-of-year stocking. Trimeris' shares (NASDAQ:TRMS) rose 15.4 percent, or $1.04, to close at $7.78 on Wednesday.

• ValiRx plc, of London, announced that its subsidiary, Cronos Therapeutics Ltd., completed experiments demonstrating that the gene-silencing technology GeneICE binds to its predicted genetic target. The preclinical research, which is part of an effort to confirm the drug's mechanism of action, was conducted in collaboration with ATDBio Ltd., of Southampton, UK.

• Vasogen Inc., of Toronto, has formed a collaboration with Grupo Ferrer Internacional SA, of Barcelona, Spain, a European pharmaceutical and medical devices company, to commercialize Vasogen's Celacade technology in chronic heart failure in the European Union and in certain Latin American countries. Under the agreement, Vasogen will receive 45 percent of Celacade revenues generated by Ferrer for five years after the first commercial sale on a country-specific basis, and will receive 42 percent of revenues thereafter. Ferrer will be responsible for the costs of the launch and marketing in Europe and Latin America. Vasogen also will receive milestone payments based on Ferrer's first commercial sales, and on reaching sales thresholds. Ferrer also has the right of first negotiation with respect to the remaining countries of the EU. Ferrer expects to begin the initial commercialization phase in the second half of 2007. Shares of Vasogen (NASDAQ:VSGND) closed up 34 cents, or 9.3 percent Wednesday, to close at $3.99.

• Viragen Inc., of Plantation, Fla., and its majority-owned subsidiary, Viragen International Inc., completed a licensing agreement with Swedish Orphan International AB granting exclusive marketing rights to Multiferon (multi-subtype, human alpha interferon) for the European Union, excluding previously licensed member states. Under the terms, Viragen received about $2 million up front and will serve as sole manufacturer for the product. Swedish Orphan International will pay Viragen for Multiferon at an agreed upon sales price, and, in addition, Viragen will receive double-digit royalties on net sales. Multiferon is approved for malignant melanoma and other diseases in Sweden, and the parties will collaborate on registration throughout the European Union, with regulatory approvals expected by early 2008.

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