• Accelrys Inc., a wholly owned subsidiary of Pharmacopeia Inc., of Princeton, N.J., agreed to a three-year global license of its Materials Studio software to Henkel KGaA, of Düsseldorf, Germany. The materials informatics tools will be used to rationalize the formulations process, formulate optimized products and help get those products to market faster, Accelrys said.

• Agencourt Bioscience Corp., of Beverly, Mass., launched RNAClean, a reagent system for the purification of nucleic acids from a number of enzymatic reactions, including antisense RNA amplification, cDNA synthesis, in vitro transcription, and cDNA and RNA labeling reactions. Based on Agencourt's patented Solid Phase Reversible Immobilization technology, RNAClean further expands Agencourt's suite of magnetic bead-based purification reagents.

• Agennix Inc., of Houston, said the European Patent Office decided in its favor in litigation concerning its European patent covering the cDNA sequence and expression of recombinant human lactoferrin (rhLF). The patent, which covers the cDNA sequence for human lactoferrin along with its recombinant expression in any eukaryotic cell, had been opposed by Pharming Group NV, of Leiden, the Netherlands.

• Applied Biosystems Group, of Foster City, Calif., released the latest version of its laboratory information-management system (LIMS) software, SQL*LIMS version 5.0, at the PittCon 2004 conference in Chicago. The new version includes an enhanced user interface delivered via a Web services application that provides a productivity solution for pharmaceutical manufacturing organizations, as well as instrument calibration, user qualification and reagent inventory tracking, Applied Biosystems said.

• Avigen Inc., of Alameda, Calif., named Ken Chahine president and CEO, promoting him from chief operating officer. He replaces John Monahan, who resigned after serving in a leadership role since the founding of the company, which is developing DNA-based drugs for serious chronic conditions.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said the FDA accepted for review its new drug application for oxypurinol, a treatment for allopurinol-intolerant hyperuricemia (gout). Cardiome submitted the NDA late last year.

• CIMA Labs Inc., of Eden Prairie, Minn., said the FDA approved Fazaclo (clozapine), a schizophrenia product from Alamo Pharmaceuticals LLC, of Beverly Hills, Calif. CIMA, which is manufacturing Fazaclo in an orally disintegrating tablet formulation based on its OraSolv technology, will receive revenue from the sale of the product to Alamo and royalty payments based on Alamo's commercial sales volume.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said it would receive about $1 million through biodefense-related contracts signed with unnamed federal agencies and private companies. One of the contracts continues and expands the company's programs in detection of bio-agents, including ricin and anthrax, in swab samples taken from mail-sorting facilities. The second pertains to analysis of other environmental samples for the presence of particular bio-agents.

• CyDex Inc., of Lenexa, Kan., entered an agreement to allow the use of its Captisol delivery technology by Array BioPharma Inc., of Boulder, Colo. The agreement provides Array the ability to use Captisol in formulation studies. The technology improves a compound's solubility, stability and bioavailability, CyDex said. Financial terms were not disclosed.

• Discovery Laboratories Inc., of Doylestown, Pa., completed a Phase Ib trial to evaluate the tolerability and lung deposition of DSC-104, its humanized lung surfactant delivered as an inhaled aerosol for asthma. The masked, placebo-controlled, randomized, dose-escalation study included six healthy subjects and eight mild-persistent asthmatic patients. Results demonstrated that DSC-104 was safe and well tolerated, did not induce bronchospasm and was deposited to both the central and peripheral regions of the lungs in the mild-persistent asthmatic group and the healthy volunteers.

• Elusys Therapeutics Inc., of Pine Brook, N.J., reported data at the American Society for Microbiology's Biodefense Research Meeting in Baltimore, showing that the company's anthrax antibody, ETI-204, provides complete protection from death due to anthrax exposure in two animal species, and might clear anthrax bacteria from the site of infection and the bloodstream. One trial showed that mice given ETI-204, an affinity-enhanced monoclonal antibody, fared significantly better than those given a non-affinity enhanced monoclonal antibody (14B7) or placebo. A second study found that ETI-204 completely protected rabbits exposed to aerosolized anthrax.

• Genetronics BioMedical Corp., of San Diego, contracted Quintiles Transnational Corp., of Research Triangle Park, N.C., as a clinical research organization to conduct the U.S. and European clinical trials for head and neck cancer. In the U.S., Genetronics has begun patient enrollment for two pivotal Phase III studies to evaluate the use of its MedPulser Electroporation Therapy System as a treatment for recurrent and second primary squamous-cell carcinomas of the head and neck.

• GenVec Inc., of Gaithersburg, Md., said Phase I data reported at the American College of Cardiology meeting in New Orleans showed that myoblast-cell transplantation resulted in no adverse events in six left ventricular assist device patients who had the transplants. The company said the findings detailed the survival of human myoblasts in the hearts of those patients receiving heart transplants, and preclinical data further validated the feasibility of cardiac repair.

• GTC Biotherapeutics Inc., of Framingham, Mass., entered a collaboration with Laureate Pharma LP, of Princeton, N.J., to coordinate their industry marketing efforts to provide clients with access to recombinant protein-production services required from small-scale through tonnage quantities, as well as for difficult-to-express products. The partners also will offer process design and development, in addition to downstream purification, for initial clinical material through commercial launch in accordance with good manufacturing practices. Financial terms of the collaboration, which do not include any initial payments, were not disclosed.

• Helsinn Healthcare SA, of Lugano, Switzerland, signed an agreement granting exclusive license and distribution rights to palonosetron in Spain to Italfarmaco SpA, of Milan, Italy. The highly selective 5-HT3 receptor antagonist for chemotherapy-induced nausea and vomiting received FDA approval last summer. It is marketed in the U.S. as Aloxi by MGI Pharma Inc., of Minneapolis, while the product remains under review in Europe, where it will be called Onicit. Financial terms were not disclosed.

• Human Genome Sciences Inc., of Rockville, Md., reported Phase I data at the American Society for Microbiology's Biodefense Research Meeting in Baltimore, showing that ABthrax (human monoclonal antibody to Bacillus anthracis protective antigen) was safe and well tolerated in healthy volunteers. Other findings showed that the product achieved the blood levels predicted by relevant animal models as necessary to afford significant protection from the lethal effects of the anthrax toxin, the company said. Separate preclinical data from rabbit models of inhalational anthrax demonstrated that a single dose of ABthrax administered following an anthrax-spore challenge significantly increased survival.

• Keryx Biopharmaceuticals Inc., of New York, said it entered four new collaborations related to its program called SOAR (Sulodexide Open Access Research), which is centered on KRX-101 (sulodexide), a compound in a Phase II/III program for diabetic nephropathy. New collaborators include researchers at Vanderbilt University in Nashville, Tenn.; the University of British Columbia in Vancouver; Baylor College of Medicine in Houston; and Thomas Jefferson University in Philadelphia. The program is designed to expand the compound's potential clinical applications.

• Light Biology Inc., of Dallas, was acquired by NimbleGen Systems Inc., of Madison, Wis. Founded on technology developed at the University of Texas Southwestern Medical Center at Dallas, Light Biology's Digital Optical Chemistry technology uses digital light processing, rather than traditional film processing, to manufacture DNA microarrays. With the acquisition, NimbleGen owns all of Light Biology's assets and patent rights to the technology. As part of the agreement, Light Biology's founder, Harold Garner, will join NimbleGen's scientific advisory board.

• MDS Sciex, a division of MDS Inc., of Toronto, released its ProteoSpin protein-purification product line. The products are based on a new technology applicable for protein clean-up and purification using processed silicon carbide as chromatographic matrix.

• Micromet AG, of Munich, Germany, began a Phase II trial to investigate the efficacy and safety of MT201 for the treatment of breast cancer patients who have experienced a metastatic relapse. The randomized, open-label, international study will evaluate the clinical response to two different dose levels of the compound in two parallel treatment groups. The multicenter European trial will enroll about 100 patients. Micromet's Phase II program for MT201 also includes prostate cancer.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., signed an agreement to supply Nabi-HB to Novation LLC, of Irving, Texas, through its Novaplus Private Label Program. Novaplus provides members of Novation's alliances with commonly used pharmaceutical products. Nabi-HB is a sterile solution of antibodies that was approved by the FDA for the prevention of hepatitis B virus infection following acute exposure.

• Nektar Therapeutics, of San Carlos, Calif., said it agreed to sell 9.5 million common shares in an underwritten public offering pursuant to an effective shelf registration statement. Lehman Brothers Inc., the offering's sole underwriter, has an option to purchase up to an additional about 1.4 million shares. Separately, Nektar said it plans to call for the full redemption of about $133.3 million worth of its outstanding 3 percent convertible subordinated notes due June 2010 issued last June and July, as well as its outstanding 3 percent convertible subordinated notes due June 2010 issued in October.

• NuGEN Technologies Inc., of San Carlos, Calif., launched its Ovation Biotin System for RNA amplification and labeling. The second product based on NuGEN's Ribo-SPIA technology, Ovation is optimized for use with Affymetrix Inc.'s GeneChip arrays and is designed to enable sensitive and rapid expression analysis with as little as five nanograms of RNA starting material, the company said.

• OriGene Technologies Inc., of Rockville, Md., sold its TrueClone collection of more than 20,000 non-redundant full-length human cDNA clones to the Genomics Institute of the Novartis Research Foundation, a unit of Novartis AG, of Basel, Switzerland. The foundation will supplement its high-throughput discovery efforts with TrueClone, which includes more than 75 percent of the NM sequences in the NCBI RefSeq database and covers 65 percent to 80 percent of the predicted human cDNA repertoire. Financial terms were not disclosed.

• Ortho Biotech Products LP, a unit of Johnson & Johnson, of New Brunswick, N.J., released Orthovisc (high-molecular-weight hyaluronan), a treatment for patients suffering from pain due to osteoarthritis of the knee, at the American Academy of Orthopaedic Surgeons meeting in San Francisco. The product, which was approved last month, was developed by Anika Therapeutics Inc., of Woburn, Mass. (See BioWorld Today, Feb. 6, 2004.)

• Point Therapeutics Inc., of Boston, began a Phase II trial of PT-100, its lead therapeutic compound for advanced non-small-cell lung cancer. The study is designed to evaluate the antitumor and hematopoietic activity of PT-100 in combination with Taxotere in up to 41 Stage IIIb/IV lung cancer patients. They will be studied in the single-arm study to evaluate overall tumor response rates in patients who have failed a platinum-containing regimen as first-line treatment. At its midpoint, tumor response rates will be compared to historical response rates to evaluate trial continuation. Secondary endpoints include duration of tumor response, time to disease progression and incidence of severe neutropenia and anemia.

• Promega Corp., of Madison, Wis., signed an agreement to gain exclusive rights to quantitative gene-expression assays using technology developed by EraGen Biosciences Inc., also of Madison. The technology, a nucleic acid-detection system combining chemistry with software, will enable Promega to offer researchers easier and more accurate methods to measure expressions of nucleic acids. Launch of the Promega-branded product is scheduled for this year. Financial terms were not disclosed.

• Proneuron Biotechnologies Inc., of Los Angeles, and the Shepherd Center in Atlanta received a $3.2 million commitment by The Marcus Foundation to help finance the establishment of a cell-processing center in Atlanta and to support the Shepherd Center's participation in Proneuron's Phase II study of ProCord, an experimental procedure for acute spinal cord injury. The international, randomized, controlled trial already is affiliated with four other sites to evaluate ProCord, which consists of autologous incubated macrophages that are activated and then injected directly into a patient's injured spinal cord.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Aventis SA, of Strasbourg, France, began a clinical development program for the VEGF Trap. An initial Phase I trial is being conducted in patients with the neovascular, or "wet," form of age-related macular degeneration (AMD). The randomized, placebo-controlled, dose-escalating study is designed to assess the safety and tolerability of VEGF Trap in wet AMD.

• Sinovac Biotech Ltd., of Beijing, said it is working with the Center for Disease Control of China to develop a human influenza vaccine. Sinovac has finished the research protocol and has started working toward a vaccine.

• Telik Inc., of Palo Alto, Calif., began a multicenter Phase I/IIa trial to evaluate Telcyta in combination with cisplatin in the front-line treatment of Stage IIIb or IV non-small-cell lung cancer. The trial is expected to enroll about 50 patients who have not previously received chemotherapy. Telcyta is a small-molecule, tumor-activated drug that is activated by an enzyme present in higher levels in many human cancers than in normal tissues. Upon activation, apoptosis is initiated.

• Vical Inc., of San Diego, received about $1 million in funding through two grants from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., for research and development related to its plasmid DNA vaccine against cytomegalovirus. A six-month, Phase I Small Business Innovation Research grant of about $300,000 will partially fund preclinical safety and toxicity evaluation of the CMV vaccine in support of the company's planned Phase I trial. An 18-month research grant of about $700,000 will partially fund assays to measure and characterize immune responses in volunteers participating in the trial.

• Zelos Therapeutics Inc., of Waltham, Mass., began clinical trials of Ostabolin-C (subcutaneous injection), a parathyroid hormone analogue for osteoporosis. The Phase Ia trial is being conducted by a clinical research organization at a site in Montreal. The company's lead compound, Ostabolin-C is a 31-amino-acid PTH analogue designed to have enhanced therapeutic properties in the treatment of osteoporosis, as compared to PTH and other PTH analogues.

• ZymoGenetics Inc., of Seattle, reported preclinical data at the American Academy of Orthopaedic Surgeons meeting in San Francisco showing that administration of FGF18 was found to reduce cartilage degeneration in a model of osteoarthritis. More specifically, results showed that local delivery of the growth factor product increased cartilage formation and reduced cartilage degeneration scores. FGF18, a member of the fibroblast growth factor family of proteins, was discovered by ZymoGenetics using its genomics-based therapeutic protein discovery platform.