• 454 Life Sciences Inc., of Branford, Conn., received $11.5 million after achieving all initial milestones under an exclusive worldwide agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. 454 said its accomplishments laid the foundation for the commercial launch of its Genome Sequencing Systems and reagents by Roche. The five-year, worldwide agreement calls for Roche to promote, sell and distribute 454's Genome Sequencing Systems, including kits and reagents. 454 is a majority-owned subsidiary of CuraGen Corp., of New Haven, Conn.

• aaiPharma Inc., of Wilmington, N.C., completed the sale of substantially all of the assets of its pharmaceuticals division to Florence, Ky.-based Xanodyne Pharmaceuticals Inc. Xanodyne paid $209.25 million upon closing, with $8 million of that paid into an escrow account to satisfy aaiPharma's post-closing obligations. AaiPharma used a portion of the proceeds to repay in full the $180 million term loan portion of its debtor-in-possession financing facility.

• Acambis plc, of Cambridge, UK, started a Phase I trial of its vaccine against Clostridium difficile. The trial is designed to test the safety, tolerability and immunogenicity of Acambis' vaccine when administered at different dose levels. It is being conducted at two study centers in the U.S., and Acambis plans to start a second Phase I trial in elderly subjects.

• Adventrx Pharmaceuticals Inc., of San Diego, said in vitro data reported at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro, Brazil, indicated that Thiovir, the company's non-nucleoside reverse transcriptase inhibitor, demonstrated effectiveness against HIV-1. The company added that Thiovir exhibited a slightly higher level of antiviral activity against HIV-1 than foscarnet, a currently marketed antiviral indicated for treatment of opportunistic infections in HIV patients.

• Ambit Biosciences Corp., of San Diego, said a study using its kinase-profiling technology revealed several existing drug candidates that bind to and inhibit various mutations responsible for the development of resistance to targeted drugs Gleevec, Iressa and Tarceva. The study was published in the Proceedings of the National Academy of Sciences.

• Arena Pharmaceuticals Inc., of San Diego, said its partner Merck & Co. Inc., of Whitehouse Station, N.J., initiated a Phase I trial of an orally administered drug candidate to treat atherosclerosis and related disorders. The start of the trial triggers a $2 million milestone payment to Arena under its agreement with Merck to develop compounds targeted to a G protein-coupled receptor that has the potential to regulate plasma lipid profiles, including HDL, similar to the therapeutic action of niacin.

• Arginox Pharmaceuticals Inc., of Menlo Park, Calif., began patient enrollment in Europe in its pivotal Phase III trial of its lead drug, tilarginine acetate injection, to treat cardiogenic shock. The trial, called Triumph, already has begun enrollment in the U.S. The trial will enroll about 650 patients at more than 130 sites in Europe and North America.

• AVI BioPharma Inc., of Portland, Ore., said positive results from five collaborative projects using Neugene antisense drugs demonstrate the potential for the company's antisense drug technology against several viral pathogens. The results were presented at the International Congress of Virology in San Francisco.

• Axonyx Inc., of New York, said a second interim analysis of 59 patients in an ongoing Phase IIb trial of Phenserine tartrate appears to confirm that the drug might have an impact on the levels of beta amyloid in mild to moderate Alzheimer's disease patients, though the company reported insufficient evidence due to the variability of the data. Further analysis will be conducted, and enrollment in the trial will continue at the 15-mg dose level and placebo. Axonyx halted a Phase III study of Phenserine, a selective acetylcholinesterase inhibitor, in March after the drug failed to show statistical significance compared to placebo. (See BioWorld Today, March 15, 2005.)

• Biolog Inc., of Hayward, Calif., is extending its collaboration with Axiohelix, of Tokyo, and the NARA Institute in Nara, Japan, to phenotype and determine the function of each gene in the E. coli genome. Biolog began using its Phenotype MicroArray technology in November on the E. coli K-12 strain library developed at the institute, a collection that contains strains for which each gene in the genome has been mutated or knocked out. It is expected that the analysis will be expanded to the entire E. coli genome next year.

• Bionovo Inc., of Emeryville, Calif., finalized a lease agreement and employment contracts to open its first laboratory facility at the Fitzsimmons Biotechnology Park in Aurora, Colo., on Aug. 1. The lab will be supervised by Uwe Christians. Bionovo develops drugs for cancer and women's health.

• Cellumen Inc., of Pittsburgh, entered a nonexclusive commercial licensing agreement to use technology of RheoGene Inc., also of Pittsburgh. Specifically, Cellumen gained access to the RheoSwitch inducible gene regulation technology and the RheoPlex multigene regulation technology to develop systems cell biology screening products. The companies also agreed to collaborate on the development and validation of mammalian cell lines to be used in Cellumen's systems cell biology profiling assays. Cellumen will provide its capabilities in molecular cell biology, high-content screening and development of advanced reagents for cell analysis, while RheoGene will contribute in RheoSwitch and RheoPlex system optimization, gene expression and development of stable cell lines. Financial terms were not disclosed.

• Cellzome Inc., of Boston, expanded its research collaboration with Basel, Switzerland-based Novartis AG. Since September, Cellzome has mapped the protein networks of several different signaling pathways implicated in various therapeutic areas, and it has characterized several Novartis compounds using its chemical proteomics methodology. The new effort will focus on providing more in depth functional analyses of target candidates and signaling aspects of the disease pathways.

• DOR BioPharma Inc., of Miami, entered a joint development agreement with Dowpharma, a unit of The Dow Chemical Co., of Midland, Mich., to advance DOR's oral botulinum vaccine, BT-VACC. Under the agreement, Dowpharma will provide process development leading to cGMP production services for BT-VACC using its Pfenex Expression Technology, a Pseudomonas-based technology that accelerates speed to market for vaccines and biotherapeutics by surpassing the quality and yield capabilities of existing microbial systems. DOR said the arrangement would allow it to expedite the production of multiple botulinum toxin serotype antigens from the laboratory to cGMP production to rapidly advance BT-VACC into the clinic. Financial terms were not disclosed.

• Epimmune Inc., of San Diego, said the National Institute of Allergy and Infectious Diseases holds an active investigational new drug application from the FDA to test the company's multiepitope recombinant protein vaccine, EP-1043, as a component in vaccines designed to prevent HIV infection. The candidate will be evaluated in a Phase I trial in healthy volunteers.

• GammaCan International Inc., of Givat Shmuel, Israel, said it initiated a Phase II trial of GCAN 101 for the treatment of metastatic melanoma, prostate and/or colon cancers. The company's drug is based on IVIg, described as a relatively non-toxic human plasma-based product used to treat immune deficiencies and autoimmune diseases.

• Gene Network Sciences, of Ithaca, N.Y., received a Phase I Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health. The six-month, $137,800 grant will be used to further the company's cardiac modeling efforts.

• GlobeImmune Inc., of Denver, initiated a Phase Ib study of its hepatitis C drug GI-5005. The trial is designed to evaluate the safety, immunogenicity and efficacy of GI-5005, a Tarmogen expressing an Ns3-Core fusion protein, an antigen found in infected cells and essential for virus replication.

• ImClone Systems Inc., of New York, reported Erbitux sales of $97.8 million for the quarter ending June 30, up 12 percent from the first quarter of 2005 and up 37 percent over the second quarter of 2004. The company reported net income for the quarter at $26 million, or 30 cents per share, compared to $24.3 million, or 29 cents per share, a year ago. As of June 30, ImClone had cash, cash equivalents and available securities totaling about $811.8 million. Its shares (NASDAQ:IMCL) lost 85 cents Tuesday to close at $34.23.

• Immune Response Corp., of Carlsbad, Calif., said preliminary results of its first trial of IR103 indicated that the drug induces HIV-specific immune responses and enhances IFN-gamma and RANTES mRNA, both of which are considered immune system markers for estimating immune response. The data were presented at the International AIDS Society meeting in Rio de Janeiro, Brazil.

• ImmunoGen Inc., of Cambridge, Mass., said South San Francisco-based Genentech Inc. licensed exclusive rights to use its Tumor-Activated Prodrug technology with therapeutic antibodies to an undisclosed target. Genentech previously licensed rights to use the technology with antibodies to one undisclosed target and one aimed at HER2. ImmunoGen will receive a $1 million license payment and is entitled to milestones, as well as royalties on any product sales.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said the FDA accepted the filing of its new drug application for INKP-102, the company's next-generation purgative product. The agency also indicated that clinical audits of its Phase III trial sites soon will begin.

• MerLion Pharmaceuticals Pte. Ltd., of Singapore, extended its existing collaboration with Whitehouse Station, N.J.-based Merck & Co. Inc. to discover and develop new drug candidates derived from natural products chemistry. The agreement extends the term for an additional two years, increases the number of validated drug targets under collaborative research, and includes the discovery and development of new animal health care products. MerLion will provide access to its sample collection for selected targets, and work to isolate new chemical leads, in return for up-front payments, milestones and royalties.

• Nanogen Inc., of San Diego, made an equity investment in Jurilab Ltd., a Kuopio, Finland-based company focused on the discovery and identification of new genes and gene markers associated with common diseases and drug responses. Nanogen will acquire certain rights to develop diagnostic products based on genes and gene markers discovered by Jurilab. Nanogen initially invested €1.25 million (US$1.5 million) for a less than 20 percent equity interest, and it will invest an equal amount within six months.

• Neurocrine Biosciences Inc., of San Diego, said the FDA has accepted the company's new drug application for review of indiplon tablets to treat insomnia in both adult and elderly patients. Indiplon is a non-narcotic, non-benzodiazepine agent that acts on a specific site of the GABA-A receptor. Upon approval, it will be co-promoted in the U.S. with New York-based Pfizer Inc.

• Oncolytics Biotech Inc., of Calgary, Alberta, began patient enrollment in its UK trial investigating Reolysin in combination with radiation therapy as a treatment for patients with advanced cancers. The Phase I study of Reolysin combined with two different radiation dosages will enroll about 30 evaluable patients.

• Pharmasset Inc., of Princeton, N.J., relocated after seven years of being based in Atlanta, where the antiviral company was founded. In explaining the move, it attributed the decision to access to experienced pharmaceutical talent, as well as easier geographic access to two corporate partners, Incyte Corp., of Wilmington, Del., and the U.S. operations of F. Hoffmann-La Roche Ltd., of Basel, Switzerland.

• Procyon Biopharma Inc., of Montreal, said preclinical data reported at the Royal Society of Canada/Korean Academy of Science and Technology Bilateral Symposium on drug delivery systems in Vancouver, British Columbia, showed that its recently acquired TVT-Dox cancer technology reduced tumor volumes by 75 percent to 88 percent in treated vs. control subcutaneous solid-tumor models for colorectal and two renal carcinomas. Also, a 52 percent to 58 percent lifespan increase was observed in a lung tumor model.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., completed enrollment in a Phase I trial of PRO 140, an HIV entry inhibitor. The drug was evaluated in 20 normal volunteers, and the company expects to present results at a scientific conference in the fall. PRO 140 is a humanized monoclonal antibody against CCR5, one of the principal portals used by HIV to enter cells, it said.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said the journal of Pharmacology published a Samaritan Laboratories study suggesting that procaine exerts neuroprotective properties against Alzheimer's disease.

• Santarus Inc., of San Diego, said the FDA accepted for filing the company's new drug application for Zegerid (omeprazple) chewable tablets 40 mg and 20 mg. Santarus expects the agency to respond to the NDA by March 26, 2006. Zegerid, an immediate-release proton pump inhibitor, is designed to treat heartburn and other symptoms associated with gastroesophogeal reflux disease, erosive esophagitis, duodenal ulcers and gastric ulcers.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Chemicon International Inc., of Temecula, Calif., acquired nonexclusive rights to the Wisconsin Alumni Research Foundation's portfolio of stem cell technologies. Chemicon and WARF will commercialize research products derived from the human embryonic cell technology.

• Targeted Genetics Corp., of Seattle, said preliminary Phase I results demonstrated that tgAAC94 is well tolerated and can be safely administered directly into joints of patients with inflammatory arthritis. The findings also suggested improvements in signs and symptoms of arthritis in the treated joints. Enrollment is closed and patients will continue to be followed for 24 weeks post-injection, and additional results will be reported at a coming scientific venue.

• V.I. Technologies Inc., of Watertown, Mass., and collaborators at the University at Buffalo's School of Pharmacy and Pharmaceutical Sciences reported data from a detailed analysis of a Phase I/II trial of the company's HIV drug candidate, PA-457, confirming and extending previously presented findings that a single dose of PA-457 was associated with a dose-related reduction in viral load in HIV-infected patients. The latest findings were announced at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro, Brazil.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and GlaxoSmithKline plc, of London, reported that HIV patients with hepatitis C or B had no negative effect to liver enzymes through 120 weeks of treatment with once-daily Lexiva (fosamprenavir calcium) boosted with ritonavir as part of an antiretroviral regimen. The data were presented at the 3rd annual International AIDS Society Conference in Rio de Janeiro, Brazil. Lexiva is an HIV protease inhibitor designed to be administered with flexible dosing and no food or water restrictions. Results of another study presented at the conference showed that in 15 HIV-positive patients given a once-daily combination of Lexiva, ritonavir and Truvada (tenofovir and emtricitabine, Gilead Sciences Inc.) plasma levels of all four drugs remained within previously described pharmacokinetic parameters. Those results support the potential for that combination as a once-daily treatment regimen, though the companies said further study is needed to evaluate the safety and efficacy of Lexiva/ritonavir in combination with Truvada.

• Vion Pharmaceuticals Inc., of New Haven, Conn., initiated a Phase I/II trial of Cloretazine (VNP40101M) as a single agent in refractory or relapsed chronic lymphocytic leukemia and Richter's syndrome. The trial's objectives include determining toxicities and the maximum tolerated dose of Cloretazine, and assessing the drug's efficacy at the maximum dosage.

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