• Acadia Pharmaceuticals Inc., of San Diego, said the U.S. Adopted Names Council approved the nonproprietary name "pimavanserin tartrate" for the selective 5-HT2A inverse agonist, ACP-103. The company plans to begin the first of two planned Phase III trials of the drug in Parkinson's disease psychosis during the first half of 2007 and recently reported positive data from a Phase II trial in schizophrenia, causing its share price to double. (See BioWorld Today, March 20, 2007, and April 6, 2007.)

• Allon Therapeutics Inc., of Vancouver, British Columbia, released preclinical data it said confirmed the robust oral bioavailability of AL-309. Data also showed Al-309 enters the brain, and that effective concentrations can be detected for an extended time. AL-309, which will be developed in neuroprotective indications, is a 9-amino-acid fragment of activity-dependent neurotrophic factor.

• Astex Therapeutics, of Cambridge, UK, granted a non-exclusive, worldwide license to its cytochrome P450 intellectual property to London-based GlaxoSmithKline plc in exchange for an unspecified up-front fee. New York-based Pfizer Inc. obtained a similar license last year to patents on the drug-metabolizing enzymes. Astex also develops targeted cancer drugs and has two in the clinic.

• Cepheid Inc., of Sunnyvale, Calif., signed an exclusive agreement with clinical diagnostics company Instrumentation Laboratory, of Lexington, Mass. Under the deal, Cepheid will develop a line of hemostasis tests to be used on its GeneXpert System, which Instrumentation Laboratory will market. The first tests will allow hospital and independent clinical laboratories to detect Factor II G202210A (FII) and Factor V Leiden (FV) genetic variations associated with increased risk of blood clots.

• CytRx Corp., of Los Angeles, said a paper regarding the RNA interference technology exclusively licensed to its majority-owned subsidiary, RXi Pharmaceuticals Corp., was published in the April 2007 issue of ACS Chemical Biology. The paper describes a nanoparticle-based delivery agent that enables the systemic delivery of RNAi in low clinically relevant doses in an animal model. (See BioWorld Today, Jan. 11, 2007.)

• Genentech Inc., of South San Francisco, and the FDA notified health care professionals of new safety information regarding tracheoesophageal fistula formation in a recent study of Avastin (bevacizumab) in patients with limited-stage, small-cell lung cancer. There have been two confirmed serious adverse events of those fistulas, one of which was fatal, reported in the first 29 patients enrolled in the study of Avastin plus chemotherapy and radiation. A third fatal event also was reported, in which tracheoesophageal fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases have been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment. Avastin is not approved for small-cell lung cancer.

• Geron Corp., of Menlo Park, Calif., and CXR Biosciences Ltd., of Dundee, Scotland, wrapped up a research collaboration begun in May 2004 with the Roslin Institute, of Midlothian, Scotland. The collaboration developed enhanced protocols for creating human embryonic stem cell-derived liver cells for use in drug metabolism and toxicity studies, potentially offering an alternative to liver cells sourced from cadavers or liver resections. Geron and CXR will share the intellectual property resulting from the collaboration.

• KaloBios Pharmaceuticals Inc., of Palo Alto, Calif., non-exclusively licensed its Humaneering method for humanizing antibodies to Novartis AG, of Basel, Switzerland. KaloBios already Humaneered three antibodies for Novartis under a pilot R&D relationship and will Humaneer three more as part of the deal. The Humaneered antibodies are as close or closer to human germline sequences than the products of fully human antibody generation techniques. Terms were not disclosed.

• Luminex Corp., of Austin, Texas, acquired a non-exclusive license to use The Johns Hopkins University's patented cystic fibrosis genetic markers in the company's molecular diagnostic products sold in the U.S. They will be included with Tag-It cystic fibrosis products, and extend to the company's distributors and end-user customers. Terms were not disclosed.

• Mirus Bio Corp., of Madison, Wis., received a two-year, $900,000 Phase II Small Business Innovation Research grant from the National Institute of General Medical Sciences. Funds will be used to optimize and extend its microRNA labeling technology for research and diagnostic applications. The basis for the grant work was the discovery at Mirus that certain common miRNA labeling methods do not detect all the miRNA species present in a sample. Mirus will work on the project with the Dartmouth Hitchcock Medical Center in Lebanon, N.H.

• MultiCell Technologies Inc., of San Diego, agreed to a five-year, non-exclusive license to allow its Fa2N-4 immortalized human hepatocyte cells and MFE culture media for drug discovery/ADMETOX applications to be used by Eisai Co. Ltd., of Tokyo. Terms were not disclosed.

• PDL BioPharma Inc., of Fremont, Calif., said the Opposition Division of the European Patent Office, in oral proceedings, upheld claims in PDL's European Patent No. 0 451 216 ('216 patent) that virtually are identical to the claims remitted to the Opposition Division by the Board of Appeal. The patent covers the production of humanized antibody light chains that contain amino acid substitutions made under PDL's antibody humanization technology, and provides specific coverage of its daclizumab (Zenapax) antibody. The opponents in the proceeding have the right to appeal the decision.

• Sciele Pharma Inc., of Atlanta, said it reached an agreement to acquire privately held Alliant Pharmaceuticals Inc., an Alpharetta, Ga.-based pediatric specialty pharmaceutical company. Sciele will pay $122 million in cash for Alliant. The agreement also includes potential payments of up to $55 million based on Alliant products meeting certain profit and product-development targets. The agreement was unanimously approved by each company's board, and is expected to be completed this quarter. Alliant, which has a portfolio of products for the pediatric market, is expected to generate revenues of $50 million to $60 million for the full-year 2007. Alliant has a field force of about 85 people, who will be retained by Sciele and form Sciele's new pediatric sales division.

• Vaxin Inc., of Birmingham, Ala., said data published in the journal Vaccine demonstrated that its vaccine technology elicits protective immunity against highly pathogenic avian influenza in chickens. The in ovo vaccination is a single-dose regimen with a non-replicating human adenovirus vector encoding an H5N9 bird flu virus hemagglutinin. Vaccinated chickens were protected against both H5N1 (89 percent hemagglutinin homology; 68 percent protection) and H5N2 (94 percent hemagglutinin homology; 100 percent protection) strains.

• Vernalis plc, of Winnersh, UK, said its board approved the delisting of its American Depositary Shares from the Nasdaq Stock Market after determining that continued compliance with the rules of the SEC and the exchange, in particular Section 404 of the Sarbanes-Oxley Act of 2002, would be excessively burdensome. The company will continue to list its shares on the London Stock Exchange.

• VGX Pharmaceuticals Inc., of Blue Bell, Pa., signed a license agreement with the University of Pennsylvania covering novel DNA vaccines and therapeutics. VGX gets exclusive worldwide rights to develop a number of DNA plasmids and constructs with potential for the treatment and/or prevention of HIV, hepatitis C, human papillomavirus and influenza. This deal broadens an existing relationship between the organizations, since VGX was founded up in 2000 based on technology licensed from the university. It has licensed a number of product candidates and technologies from the university, and sponsors research there. The work is focused on development of consensus DNA constructs for each virus.

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