• Affinium Pharmaceuticals Inc., of Toronto, selected a drug candidate for development of a novel MRSA antibiotic to be used in hospital and community settings. The compound is from the company's Galapagos program. Affinium said its candidates selectively inhibit a bacterial pathway to kill bacteria without any detectable side effects to the analogous human pathway.

• Affymetrix Inc., of Santa Clara, Calif., agreed to provide the Harvard Medical School - Partners HealthCare Center for Genetics and Genomics early access to its next-generation GeneChip Human Mapping microarrays, which are capable of scanning up to 500,000 single nucleotide polymorphisms. The center's researchers will investigate the genetic origins of atherosclerosis, examining more than 1,200 patient samples from the National Institutes of Health's ongoing Women's Health Study. Research is set to begin when the arrays become available under a limited-release early access program in the first half of the year.

• Alimera Sciences Inc., of Atlanta, and Control Delivery Systems Inc., of Watertown, Mass., entered a worldwide agreement to co-develop and market a pharmacologic treatment for diabetic macular edema (DME). Alimera and CDS are in discussions with the FDA to initiate clinical trials to determine the effectiveness of the product, which would entail an injection an implantable form of CDS technology into the vitreous of the eye.

• AlphaRx Inc., of Markham, Ohio, received approval from the appropriate authorities to begin a Phase I trial of its lead product, Indaflex. Indaflex is its topical non-steroidal anti-inflammatory agent for which trials are expected to begin soon for treating symptoms of arthritis.

• Astralis Ltd., of Fairfield, N.J., appointed James Sharpe CEO. Sharpe, who previously served as founder and president of Ankyr Consulting LLC, and has executive management experience with several biotechnology companies, will work to bring Astralis' first product candidate, Psoraxine, to the market for the treatment of psoriasis, as well as continue research and product development in immune system disorders and skin diseases.

• Atugen AG, of Berlin, renewed its nonexclusive target-validation and license agreement with Altana Pharma AG, of Bad Homburg, Germany, for another year. The agreement gives Altana the right to have molecular targets validated by Atugen's discovery team, using knockdown tools and transfection technologies. Altana also receives a license to use Atugen's gene silencing and oligonucleotide delivery technologies. The original license was granted in August 2001, and Altana has paid Atugen several research milestones.

• Axonyx Inc., of New York, was the subject of a class-action lawsuit filed by Schatz & Nobel in the U.S. District Court in the Southern District of New York on behalf of anyone who bought stock June 26, 2003 and Feb. 4. The complaint alleges that Axonyx failed to disclose shortcomings for Phenserine, an acetylcholinesterase inhibitor designed to curb symptoms of Alzheimer's disease. On Feb. 7, Axonyx reported Phenserine did not achieve efficacy in a Phase III Alzheimer's trial. The news caused the company's stock to drop 62 percent. (See BioWorld Today, Feb. 8, 2005.)

• BAC BV, of Naarden, the Netherlands, completed a €3.5 million (US$4.6 million) private financing round. The financing is expected to enable the company to continue development of solutions for lab-scale separations and to advance its lead products toward launch for large-scale use in pharmaceutical processes. BAC's platform technology is based on the binding domain of a class of antibodies from the immune repertoire of the family Camelidae.

• Bioenvision Inc., of New York, enrolled the first patients in an international Phase II trial of Virostat in chronic hepatitis C to assess the ability of the drug to reduce viral load. The company said Virostat has shown viricidal activity in vitro and has demonstrated effectiveness in laboratory studies against HIV and West Nile virus. Bioenvision obtained global rights to develop and market the product from Oklahoma Medical Research Foundation in Oklahoma City.

• Biolex Inc., of Pittsboro, N.C., and OctoPlus Technologies BV, of Leiden, Netherlands, entered a collaboration for co-development of a controlled-release formulation of recombinant human alpha-interferon called Locteron. The product combines OctoPlus' PolyActive drug delivery technology with Biolex's BLX-883, a recombinant alpha-interferon. The companies said Locteron, which will be tested first in hepatitis C, is expected to be administered every two weeks.

• Biosite Inc., of San Diego, reported the U.S. launch of its quantitative Triage D-Dimer Test. The test aids in the assessment and evaluation of patients suspected of having thromboembolic events. The point-of-care tests provide results in about 15 minutes, Biosite said.

• Chelsea Therapeutics Inc., of Charlotte, N.C., completed its reverse merger with Ivory Capital Corp., of Littletown, Colo. The merged company will operate under the Chelsea Therapeutics name and be led by Chelsea President and CEO Simon Pedder. The company intends to soon launch Phase I trials of its lead product, CH-1504, in multiple indications, including rheumatoid arthritis. Chelsea recently raised $14.5 million in a Series A round. (See BioWorld Today, Jan. 13, 2005, and Jan. 24, 2005.)

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, and AppTec Laboratory Services Inc., reported an alliance for providing the biopharmaceutical industry cell line engineering and contract manufacturing services. Under the nonexclusive agreement, Chromos and AppTec will coordinate marketing efforts.

• Crucell NV, of Leiden, Netherlands, and DSM Biologics, of Groningen, Netherlands, signed a research license agreement to allow Basel, Switzerland-based F. Hoffmann-La Roche Ltd. to use the PER.C6 cell line for production of monoclonal antibody products, as well as a specific undisclosed protein. As part of the agreement, Crucell will work with Roche in creating a production clone for the specific protein. Roche will pay a research license payment, annual maintenance fees and research funding. Further financial terms were not disclosed.

• CytImmune Sciences Inc., of Rockville, Md., entered a licensing agreement with Boehringer Ingelheim Vetmedica GmbH, a subsidiary of Ingelheim, Germany-based Boehringer Ingelheim GmbH, for the right to use CytImmune's drug delivery technology to develop, produce and market tumor-targeted cancer drugs for veterinary use. CytImmune said it has seen promising results with its technology used on more than a dozen dogs and cats with cancer.

• Diatos NV, of Leuven, Belgium, said its oncology research program received support through a grant from the Flemish Institute for Science and Technology. Diatos focuses its research on anticancer prodrugs. The funding of €650,000 (US$846,605) over the next two years will be applied to extend its Selective Prodrug Technology to the development of cytokine prodrugs with antitumor activity.

• DOR BioPharma Inc., of Miami, initiated a rational drug design program to identify small-molecule drugs to counter the effects of botulinum toxin exposure. DOR entered an agreement with Blue Dolphin LLC to apply computer-aided design to the discovery, building on research by Lance Simpson, director of the Center for Research on Bioterrorism and Biodefense at Thomas Jefferson University in Philadelphia and inventor of DOR's oral toxin vaccine BT-VACC. Blue Dolphin will propose drug-like inhibitors of botulinum toxin by targeting a new site on the toxin's structure, and candidate molecules will be modeled for structural and chemical fit to the target site using the computer-aided discovery techniques.

• Draxis Health Inc., of Mississauga, Ontario, said its radiopharmaceuticals division, Draximage, received approval from the Dutch regulatory authority for its MAA Kit for lung imaging. Draximage intends to initiate the mutual recognition procedure to gain approvals in additional European Union countries. The MAA Kit is a lyophilized formulation of aggregated albumin that is labeled with the short-lived medical isotope Technetium Tc 99m by radiopharmacists just before injection.

• Durect Corp., of Cupertino, Calif., initiated a Phase II program for its Transdur-Sufentanil patch. The trial is designed to evaluate the pharmacokinetics, efficacy and safety of repetitive applications of the patch in chronic pain patients for up to four weeks. Durect previously reported results from its Phase I trial in which the drug demonstrated safety and tolerability and provided extended pain relief for up to seven days, compared to three days of relief provided by existing opioid patches.

• The EuroVacc Foundation is sponsoring a Phase I trial in Lausanne, Switzerland, and London of investigational vaccines comprising DNA-HIV-C and NYVAC-HIV-C for the prevention of HIV infection. The vaccines were developed by the European Vaccine Effort against HIV/AIDS and are based on HIV subtype C, which is prevalent in China, India and sub-Saharan Africa. The trial will evaluate the safety of DNA-HIV-C alone and as a prime-boost regimen with NYVAC-HIV-C, and also will compare the immunogenicity of the prime-boost regimen to NYVAC-HIV-C alone in healthy volunteers.

• Evotec OAI AG, of Hamburg, Germany, said that AnorMED Inc., of Vancouver, British Columbia, selected Evotec to support it with the chemical development of its candidate AMD 3100, currently under evaluation in the clinic in stem cell mobilization for stem cell transplantation in cancer patients. Using its chemical and development platform, EVOdevelop, Evotec will complete full validation of the process on AMD 3100.

• Galenea Corp., of Cambridge, Mass., signed a research and development collaboration and license agreement with Otsuka Pharmaceutical Co. Ltd., of Tokyo, to discover drugs to treat central nervous system diseases, including schizophrenia and bipolar disorder. The collaboration includes an equity investment in Galenea by Otsuka, which also will provide five years of research and development funding. Otsuka gains rights to a number of Galenea's targets and development candidates, and it will have an exclusive, worldwide license to further develop and commercialize products identified in the collaboration. Galenea also will receive milestone and royalty payments on products that are commercialized, and will have an option to share in profits.

• Gen-Probe Inc., of San Diego, signed an agreement to purchase from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and its affiliate, Roche Molecular Systems Inc., products for use in molecular diagnostic assays for human papillomavirus. Roche will manufacture DNA probes for HPV, which Gen-Probe will purchase at an agreed-upon transfer prices. Gen-Probe will pay initial manufacturing fees, and it plans to use the probes in APTIMA format HPV test kits to detect high-risk subtypes of HPV.

• Human Genome Sciences Inc., of Rockville, Md., completed enrollment, randomization and dosing in a 56-patient Phase II trial of Albuferon (albumin interferon-alpha) in chronic hepatitis C patients who are na ve to interferon-alpha treatments. The company said patients are being given two doses of the drug, administered subcutaneously 14 days apart, and Albuferon will be evaluated based on HCV RNA viral load reductions over a 28-day period. Preliminary data, to be presented in March at the annual meeting of the Canadian Association for Studies of the Liver, show the drug is well tolerated with antiviral activity in genotype 1 HCV. HGS said it will use the active dose range identified in the trial to design a larger 48-week study in combination with ribavirin.

• Jubilant Biosys, a subsidiary of Jubilant Organosys, of Bangalore, India, and Genomics Collaborative Inc., a division of Oceanside, Calif.-based SeraCare Life Sciences, entered a collaboration to allow users of Jubilant's website to link to information in GCI's Global Repository, a biorepository consisting of tissue, serum, DNA and RNA from 120,000 donors.

• Matritech Inc., of Newton, Mass., said its NMP22 BladderChek Test detects cancers missed by cystoscopy, according to a study published in the Journal of the American Medical Association. Matritech's test is the only FDA-approved in-office test for the diagnosis of bladder cancer. Authors of the study include investigators from the University of Texas M.D. Anderson Cancer Center, the University of Rochester Medical Center, the University of Miami School of Medicine and other clinicians.

• Mayo Medical Laboratories, of Rochester, Minn., said a new process that helps unmask genetic mutations by separating chromosomes so they can be studied individually might improve the diagnostic yield of some genetic tests, according to a study published in the Journal of the American Medical Association. Conventional gene sequencing analyzes chromosomes simultaneously, but normal copies of DNA sequences on one-half of the pair can mask or hide genetic mutations or deleted DNA sequences on the other allele. Evaluating the alleles separately led to a significant increase in mutations identified.

• MNBIO, the Minnesota biotechnology association and Medical Alley, the Minnesota health care trade association, are merging. The merger is expected to be complete by March 1. The groups said they have a shared interest in life sciences and biosciences and in supporting the growth of the industry. The merged group will be called Medical Alley until a revised mission is developed and a new name determined.

• Neosil Inc., of Emeryville, Calif., completed the in-licensing of several hair-growth products from San Antonio-based OsteoScreen Inc., a private company focused on drug discovery for bone diseases. The acquisition adds another topical product to Neosil's pipeline of antibacterial and antifungal programs. One of the acquired products has already been in an early stage clinical trial in Europe.

• Neurocrine Biosciences Inc., of San Diego, said its indiplon modified-release 15-mg tablets demonstrated statistically significant improvement for all primary and secondary endpoints in a randomized, double-blind, placebo-controlled Phase III trial of 248 patients with chronic insomnia. Indiplon MR showed a highly statistically significant improvement on the primary endpoint of patient-reported total sleep time, as compared to placebo (p=0.0002) over four weeks of treatment. Neurocrine expects to submit a new drug application for indiplon MR in the second quarter. The company filed an NDA for immediate-release indiplon in October. (See BioWorld Today, Oct. 20, 2004.)

• Nymox Pharmaceutical Corp., of Maywood, N.J., entered a distribution agreement with Italy-based Alifax SpA for the marketing and sales of Nymox's AlzheimAlert diagnostic product in Italy. The technology uses patient urine samples to measure levels of a biomarker for Alzheimer's disease.

• Perlegen Sciences Inc., of Mountain View, Calif., and the University of Cambridge in Cambridge, UK, and Cancer Research Technology and Cancer Research UK, of London, will collaborate to conduct a high-resolution, whole-genome association study on breast cancer. Scientists will determine more than 200 million individual genotypes in DNA samples collected from patients to further elucidate the genetic basis of the disease.

• Protein Design Labs Inc., of Fremont, Calif., closed its previously reported private placement of $250 million of 2 percent convertible senior notes due 2012. PDL also granted the purchasers of the notes an option to buy up to $50 million more in notes. The notes will be convertible into PDL common stock at a price equal to about $23.69 a share, subject to adjustment in certain circumstances, which represents a 30 percent premium to PDL's Feb. 8 closing price.

• Senomyx Inc., of La Jolla, Calif., adopted a stockholder rights plan, designed to enable all company stockholders to realize the value of their investment and to provide for fair and equal treatment to stockholders if an unsolicited attempt is made to acquire Senomyx. The company said the plan is a preventive measure and is not in response to a particular proposal. Senomyx also announced that stockholders as of Feb. 21 will receive rights to purchase shares of a new series of preferred stock.

• Sigma-Aldrich Corp., of St. Louis, signed a definitive agreement to acquire the Proligo Group, of Boulder, Colo., from Degussa AG, of Dusseldorf, Germany. Proligo is a global supplier of genomics research tools including custom DNA.

• Solvay Pharmaceuticals Inc., of Marietta, Ga., and CV Therapeutics Inc., of Palo Alto, Calif., said the FDA accepted the filing of Solvay's supplemental new drug application for Aceon (perindopril erbumine) tablets. The FDA granted a six-month priority review, setting the PDUFA date for June 10. Solvay and CV Therapeutics previously entered a co-promotion agreement for Aceon, an angiotensin-converting enzyme inhibitor with tissue activity, which is designed to treat hypertension, though Solvay is seeking an expansion of the drug's labeling based on its EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease) trial to assess Aceon's activity to reduce cardiovascular mortality, nonfatal myocardial infarction and cardiac arrest.

• SRI International, of Menlo Park, Calif., performed a computational analysis of the human genome to predict metabolic pathways and new gene functions within the human genome. Using SRI's PathoLogic software, the analysis assigned 622 human enzymes to roles in 135 predicted metabolic pathways.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, exercised the option to enter a joint venture with Gamida-Cell Ltd., also of Jerusalem, to develop and commercialize StemEx to treat leukemia and lymphoma. As part of an investment in Gamida-Cell in 2003, Teva held an option to jointly complete the development and globally commercialize StemEx. Teva will invest up to $25 million in the joint venture. StemEx is cord blood highly enriched with stem cells that could be used in patients requiring bone marrow transplantation. Teva and Gamida intend to start a pivotal study in the second half of 2005.

• Tissera Inc., of Herzlia, Israel, said an article on using embryonic pig liver, pancreas and lung as a source for transplantation will be published in the Proceedings of the National Academy of Sciences, available online. Using pig tissue to replace human organs could help address diseases such as diabetes, Parkinson's disease and liver failure, but the cells need to come from specific stages of an embryo's development.

• Vala Sciences, of La Jolla, Calif., established itself as a provider of cell image-based reagents and analysis software tools to academic, pharmaceutical and biotechnology scientists. The company obtained $3.5 million in grants and angel investments, including two National Institutes of Health Small Business Innovation Research grants, one for assay development and the other for cell image-based software analysis development. Vala's core scientific and engineering team hails from Q3DM Inc., of San Diego, a developer of high-throughput image analysis instrumentation and software that Beckman Coulter Inc., of Fullerton, Calif., acquired in December 2003.

• Voyager Pharmaceutical Corp., of Raleigh, N.C., completed its 48-week Phase II Alzheimer's disease study, which enrolled 109 female patients in 2003. The company expects results from the double-blind, placebo-controlled, multicenter trial within a few weeks. Interim data from 40 male subjects in a complementary Phase II study will follow. Voyager plans to present the findings to the FDA this year, and U.S. and international pivotal studies could start in September.

• Xcyte Therapies Inc., of Seattle, said a paper describing the mechanism of action of its Xcellerated T Cells in chronic lymphocytic leukemia was published in the Feb. 15, 2005, issue of the Journal of Immunology. The paper, "In Vitro Engagement of CD3 and CD28 Corrects T Cell Defects in Chronic Lymphocytic Leukemia," describes how Xcyte's Xcellerate Process appears to restore the ability of T cells to interact with malignant B cells and eliminate them by inducing apoptosis. The process activates T cells ex vivo using Dynabeads, which are superparamagnetic beads covalently linked to anti-CD3 and anti-CD28 monoclonal antibodies.

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