• Abbott Laboratories, of Abbott Park, Ill., said the European Medicines Evaluation Agency granted a positive opinion on Humira (adalimumab), or D2E7, for the treatment of adult rheumatoid arthritis. Abbott said Humira will become the first human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha antagonist approved with an indication for use with methotrexate or as monotherapy. Humira works by blocking TNF-alpha.

• Advanced Life Sciences Inc., of Woodbridge, Ill., licensed proteomics-based technology from the Argonne National Laboratory in Argonne, Ill. Included is a compound called ALS-499, which has shown inhibitory activity against amyloid protein aggregation that is characteristic in the development of several diseases, including Alzheimer's and Type II diabetes. The company, which gained exclusive worldwide rights to commercialize ALS-499, as well as the platform technology as a method for preventing amyloid fibril formation, plans to immediately advance the compound into early stage lab studies.

• Agenix Ltd., of Brisbane, Australia, said it recovered all outstanding amounts from former U.S. distributor Synbiotics Corporation Inc., of San Diego, and that the company would soon be expanding distribution of key products into international markets. Agenix received $438,000 in three payments in the days leading up to court action reported on May 2. During the outstanding court action, Synbiotics' counsel paid Agenix's counsel the outstanding $350,000.

• Ardais Corp., of Lexington, Mass., launched a new business initiative focused on immunohistochemistry services, which allow for customized research study designs for specific client needs. Ardais said other benefits include research-quality tissue and access to its BIGR (Biomaterials and Information for Genomic Research) library.

• Atrix Laboratories Inc., of Fort Collins, Colo., said German regulatory authorities completed a successful inspection of its manufacturing facility as part of an ongoing marketing approval process for Eligard (leuprolide acetate for injectible suspension). Atrix's European marketing partner, MediGene AG, of Martinsreid, Germany, has applied for approval of two doses of the prostate cancer product, and both submissions are under review in Germany as a reference member state under a mutual recognition process.

• BattellePharma Inc., of Columbus, Ohio, elected new board members on the heels of its recent $22 million round of equity financing. Morton Collins was named chairman, while other newly elected members include Michael Cola, Devang Kantesaria, Mark Kontos, Dominique Semon and Timothy Tyson. Privately held BattellePharma is developing products based on two platforms, its Mystic inhalation technology and another in-house formulation technology. (See BioWorld Today, Feb. 20, 2003.)

• Biovitrum AB, of Stockholm, Sweden, and GlaxoSmithKline plc, of London, agreed to halt a Phase IIb study of BVT.933, a 5-HT2c receptor agonist compound, to focus instead on more highly selective compounds of the same class for obesity and other medical disorders. The companies said an obesity panel highlighted selectivity as the key component of an optimal profile for the class, and research efforts have led to the discovery of more selective compounds than BVT.933. To date, the three-month study has produced no unexpected findings or adverse events.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, completed the sale of three of its pharmaceutical products for more than £9 million (US$14.7 million) in cash. The planned use of funds includes the clinical development of pain treatments M6G (morphine-6-glucuronide), the company's lead candidate for the treatment of post-operative pain, and CNS 5161, for which a second Phase II trial is expected to start recruitment in 2003 in neuropathic pain.

• Connetics Corp., of Palo Alto, Calif., entered an agreement for the sale of $80 million of convertible senior notes. The amount would rise to $90 million if the over-allotment option is fully exercised. The notes will be convertible into Connetics stock at $21.41 per share, subject to adjustment in certain circumstances, which represents a 35 percent premium to Wednesday's closing price of $15.86. The notes, which will mature on May 30, 2008, will bear an interest rate of 2.25 percent per year. The offering is expected to close on May 28, subject to certain closing conditions. Connetics expects to use the proceeds for general corporate purposes, including potential future product or company acquisitions, capital expenditures and working capital. It said Tuesday it was seeking to raise $75 million through a sale of notes. (See BioWorld Today, May22, 2003.)

• Cyclacel Ltd., of Dundee, UK, reported progress in its genes-to-drugs CYC400 rational drug design program. The company said its CYC400 program succeeded in generating multiple specific cyclin-dependent kinase (CDK) inhibitors, with some achieving picomolar potency in enzymes and nanomolar potency against tumor cell lines. Specific details of several of the new agents will be presented by Cyclacel at the annual meeting of the American Association for Cancer Research later this year in Washington. A report on the complex crystal structures of the compounds was recently published in the journal Structure.

• CyDex Inc., of Overland Park, Kan., named John Siebert president and CEO. He also was appointed to the board. Siebert most recently served as president and CEO of CIMA Labs Inc., where he served as chief executive from 1995 through April. CyDex is involved in drug delivery solutions using its Captisol-Enabled drug formulations.

• Dainippon Pharmaceutical Co. Ltd., of Osaka, Japan, said data were reported on its zonisamide at the American Psychiatric Association meeting in San Francisco, suggesting that the anti-epileptic drug can promote weight loss among obese bipolar disorder patients. Researchers at Stanford University in Palo Alto, Calif., said bipolar disorder medications also cause unwanted weight gain. But preliminary data from an ongoing 26-week trial have shown that a mean zonisamide dose of 418 mg per day yielded a mean weight loss of 9.9 pounds. The results have been observed over an average nine-week period.

• Generex Biotechnology Corp., of Toronto, reported an agreement in principle for a collaboration to develop severe acute respiratory syndrome vaccines using the company's drug delivery and formulation technology. Generex will collaborate with Antigen Express Inc., of Worchester, Mass., which will use its li protein suppression and li-Key peptide vaccine-enhancing technologies in the development of SARS vaccines. Generex's stock (NASDAQ:GNBT) rose 9 cents Thursday, or 7 percent, to close at $1.46.

• Genetic Technologies Ltd., of Melbourne, Australia, granted a research license to its noncoding patents to the University of Utah in Salt Lake City. The university will expand its genetic research program into the noncoding regions of genomes with the support of Genetic Technologies. Financial terms were not disclosed. The company said additional licenses were being negotiated.

• Genetronics Biomedical Corp., of San Diego, entered an exclusive agreement with privately held Genteric Inc., of Alameda, Calif., covering joint evaluation of gene expression using electroporation-assisted delivery of DNA to the salivary gland. Both companies will own data generated by the research collaboration, which could lead to commercial development of multiple gene therapy products. Financial terms were not disclosed.

• Geron Corp., of Menlo Park, Calif., published data that demonstrate the potential of human embryonic stem cells (hESCs) for cell-based therapies. The research showed that hematopoietic cells could be derived from hESCs using defined combinations of growth factors. It will be published in the Aug. 1, 2003, issue of Blood, but is available online at www.bloodjournal.org.

• GlycoMimetics Inc., of Rockville, Md., raised $4.3 million after closing its Series A seed financing round. The company said it would use the proceeds to advance its lead small-molecule compound and others into preclinical testing to demonstrate their viability in mimicking the action of carbohydrates. With a $2 million investment, New Enterprise Associates led the round, which also included Alliance Technology Ventures, Anthem Capital and the Novartis Venture Fund.

• ILEX Oncology Inc., of San Antonio, re-elected seven members of its board, elected Victor Micati and Mark Watson to its board, and named Joy Amundson chair for the coming year. Also, it ratified the appointment of Ernst & Young LLP, of New York, as its public accountant for the fiscal year ending Dec. 31, 2003.

• ImClone Systems Inc., of New York, said it received written determination from Nasdaq allowing the company to continue listing its stock on the Nasdaq National Market, subject to satisfying certain requirements including deadlines for filing its 2002 annual report (by June 23) and first-quarter report (by July 7). ImClone will publicly update on or before June 6 the financial statement impact of certain option and warrant exercises by current and former officers, directors and employees.

• Kionix Inc., of Ithaca, N.Y., released LabMatrix, its modular, reconfigurable, microfluidic research system. LabMatrix is designed to allow a user to position fluid logic and functional microfluidic chips into its pockets to quickly build an application-specific microfluidic system.

• Lynx Therapeutics Inc., of Hayward, Calif., said the listing of its stock is being transferred to the Nasdaq SmallCap market effective March 22. Nasdaq decided to transfer the stock to the SmallCap market based on Lynx's reported shareholders equity of $8.1 million for the first quarter. That sum is below the minimum requirement for listing on the Nasdaq National Market. Lynx focuses on genomics analysis solutions, such as its Megaclone and MPSS technologies.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., presented results of a Phase II trial of MLN02 in ulcerative colitis that showed statistically significant improvements in the clinical remission rates of patients treated with MLN02, compared to placebo. The results were presented this week at Digestive Disease Week in Orlando, Fla. Results from a Phase II study of MLN02 in patients with mild to moderate Crohn's disease, which were initially announced last fall, were also presented. In the study of 185 patients, those treated with the higher dose of MLN02 showed a statistically significant improvement in remission rates compared to placebo, although the study did not achieve its primary endpoint. (See BioWorld Today, Sept. 17, 2002.)

• The National Institutes of Health in Bethesda, Md., said data published in the May 22, 2003, issue of Nature pointed to the ability of lithium to block an enzyme crucial to the formation of plaques and tangles characteristic of Alzheimer's disease. Studies in mice and cells have shown that using lithium to inhibit glycogen synthase kinase-3 alpha stems the accumulation of beta amyloid and the formation of neurofibrilary tangles by the tau protein.

• Neurocrine Biosciences Inc., of San Diego, presented data exploring the dose-related efficacy and tolerability of indiplon in healthy adults subjected to a well-accepted laboratory model of transient insomnia using objective polysomnography assessments. The Phase II study involved 228 adults with no history of insomnia and two doses of indiplon (15 mg and 30 mg). The primary endpoint was latency to persistent sleep and results showed it was met.

• OctoPlus Technologies BV, of Leiden, the Netherlands, and CytImmune Sciences Inc., of College Park, Md., entered an agreement to develop a treatment for solid cancers. The treatment's active agent is the tumor necrosis factor protein. The protein in the past was shown to be effective against solid tumors, but also toxic, limiting its use, the companies said. Using gold nanoparticles as a targeting drug delivery system, TNF will be specifically delivered to tumors. The parties will jointly develop a safer formulation to deliver more TNF to solid tumors and will evaluate the product in clinical studies, scheduled to start in early 2004.

• Omeris, Ohio's bioscience industry association, said it hosted a program in conjunction with the Japan External Trade Organization designed to attract biotechnology partnerships between U.S. and Japanese companies. The symposium was part of an initiative to foster such relationships between Midwest-based biotech firms with those in Japan's Kansai region, which the organization labeled that country's primary life science cluster.

• Point Therapeutics Inc., of Boston, said a study investigating its lead product, the small molecule PT-100, was published in Blood Online. The study also will be published in the Sept. 1, 2003, issue of Blood, a peer-reviewed publication of the American Society of Hematology. The study showed that PT-100 can stimulate the growth of hematopoietic progenitor cells in vivo, and accelerate neutrophil and erythrocyte regeneration in mouse models of neutropenia and acute hemolytic anemia. Hematopoietic stimulation by PT-100 appears to be due to its ability to rapidly increase cytokine production in vivo.

• Repligen Corp., of Waltham, Mass., said researchers from Duke University Medical Center reported results from a trial that demonstrated that SecreFlo, secretin for injection, reduced the incidence of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP), a procedure used to diagnose and treat diseases of the pancreas, liver and gall bladder. The trial involved 979 patients randomized to receive either SecreFlo or placebo at the time of the ERCP. The findings were presented yesterday at the Digestive Disease Week conference held in Orlando, Fla.

• Sequitur Inc., of Natick, Mass., reported its agreement to provide Procter & Gamble Pharmaceuticals, of Cincinnati, access to its functional genomics technology has been renewed and expanded. Sequitur will perform biological screening and supply its antisense/RNAi compounds and methods to P&G for use in its target validation studies as part of the multiyear agreement. The agreement was expanded to include additional therapeutic areas. Sequitur and P&G first entered an agreement in October 2001. (See BioWorld Today, Oct. 10, 2001.)

• Serono Inc., a unit of Serono SA, of Geneva, Switzerland, and Pfizer Inc., of New York, said the FDA approved additional efficacy and product stability information on the label for the multiple sclerosis treatment Rebif (interferon beta-1a). The expanded label reflects additional data demonstrating Rebif's clinical superiority over Avonex (interferon beta-1a, from Biogen Inc.) at reducing frequency of relapses in patients with relapsing remitting multiple sclerosis at 24 and 48 weeks. The new label also allows for room temperature storage of the product, marketed by both firms in the U.S.

• Sirna Therapeutics Inc., of Boulder, Colo., said its common stock would continue to be listed on the Nasdaq National Market. The market's listing qualifications panel said Sirna met all requirements for continued listing.

• Speedel Group, of Basel, Switzerland, exercised an option to license exclusive worldwide rights for the full development and commercialization to SPP301 from F. Hoffman-La Roche Ltd., also of Basel. Speedel, which said Roche also agreed to relinquish its call-back right, paid an undisclosed milestone for its part of the agreement. It said it expects to complete a Phase IIb dose-range study of the endothelin A antagonist for an unspecified cardiovascular indication by the end of next summer.

• Theratechnologies Inc., of Montreal, enrolled the first patient in a Phase II trial of ThGRF, its growth hormone-releasing factor analogue, in HIV-related lipodystrophy, a syndrome characterized by a number of metabolic and physical abnormalities that affects many patients on long-term HIV therapy. The purpose of the multicenter, double-blind, placebo-controlled study in Canada and the U.S. is to assess the safety and obtain preliminary efficacy data of ThGRF.

• TimeLogic Corp., of Crystal Bay, Nev., said its DeCypher bioinformatics system was used in the analysis pipeline for the Tobacco Genome Initiative of North Carolina State University in Raleigh. The school's college of agriculture and life sciences is working to sequence over 90 percent of tobacco's genes and provide an annotated resource and physical map of the plant's genome.

• Valentis Inc., of Burlingame, Calif., entered a non-exclusive licensing agreement to allow privately held Juvaris BioTherapeutics Inc., of Pleasanton, Calif., to use its plasmid backbone and cationic lipid delivery technologies for the development and commercialization of therapeutic vaccine products. Valentis will receive an up-front cash payment and is eligible for future product development milestones and royalties on sales. Juvaris will be responsible for the development, manufacturing and commercialization of products and will bear all related program expenses. More specific financial terms were not disclosed.

• Viragen Inc., of Plantation, Fla., and Viragen International Inc. said they entered an exclusive distribution agreement with Princeton, N.J.-based CJ Pharma, the U.S. pharmaceutical division of CJ Corp., of Seoul, South Korea, and the CJ Hong Kong Ltd. subsidiary, as exclusive distributors of natural interferon in Hong Kong. Viragen's human leukocyte-derived alpha interferon is approved in Hong Kong as a second-line therapy for the treatment of patients with hairy cell leukemia or chronic myelogenous leukemia who do not respond to recombinant interferon regimens. Viragen's stock (AMEX: VRA) rose 9 cents Thursday, or 30 percent, to close at 39 cents.

• Wilex AG, of Munich, Germany, said the FDA accepted its investigational new drug application to begin a Phase I trial of its noncytotoxic, antimetastatic serine protease inhibitor, WX-UK1. The study is deigned to assess the safety and preliminary antitumor activity of weekly WX-UK1 in combination with a chemotherapeutic agent in patients with advanced solid cancers. Wilex said it expects to begin the study in the second half of this year in collaboration with the Fox Chase Cancer Center in Philadelphia.

• Xenogen Corp., of Alameda, Calif., entered into an agreement with Biogen Inc., of Cambridge, Mass., which will evaluate Xenogen's real-time, in vivo imaging technology in its discovery research programs. Biogen gained a license to Xenogen's IVIS imaging system and Living Image software package, and will receive access to a limited number of Xenogen's Bioware cells and in vivo models. Financial terms were not disclosed.