• Acusphere Inc., of Watertown, Mass., said Phase II data reported at the American Society of Echocardiography meeting in San Diego indicated that stress myocardial perfusion echo with AI-700 performed well in a comparison with nuclear stress perfusion in patients being evaluated for coronary heart disease. The product, which is being developed to enhance ultrasound imaging for the detection of coronary heart disease, is in Phase III trials designed to demonstrate similar specificity and sensitivity to nuclear stress tests.

• Advancis Pharmaceutical Corp., of Germantown, Md., paid $11 million to acquire exclusive U.S. rights to the Keflex brand of cephalexin from Eli Lilly and Co., of Indianapolis. With the purchase, Advancis acquired Keflex's trademarks, technology and new drug applications. Following a transition period, Advancis will assume product inventory and begin marketing and distributing the Keflex brand.

• Aradigm Corp., of Hayward, Calif., promoted Bryan Lawlis to president and CEO from his previous post of president and chief operating officer, effective Aug. 1. Aradigm's chairman and current CEO, Richard Thompson, will remain as chairman. Aradigm is working to develop new therapies using its liquid delivery technologies.

• Australian Cancer Technology, of Sydney, Australia, signed a second material transfer agreement with New York's Memorial Sloan-Kettering Cancer Center. The agreement relates to the use of GPI-0100, the lead product of its Galenica Pharmaceuticals business, in a study for vaccination of leukemias and lymphomas. The product is being evaluated in two clinical trials, a Phase I and Phase I/II.

• Becton, Dickinson & Co., of San Jose, Calif., acquired privately held Atto Bioscience Inc., of Rockville, Md., in a cash transaction worth about $25 million. Atto, which specializes in optical instrumentation, software and reagents for real-time analysis of interactions taking place in living cells, reported 2003 sales of $3 million and is expected to double its sales this year, Becton said.

• BioAlliance Pharma SA, of Paris, said preclinical data published in the Journal of Virology detailed a new means of anti-integrase therapy involving styrylquinolines (SQLs). Investigators confirmed the target of SQLs by mutations evidenced in the integrase gene when viruses were grown in the presence of increasing concentrations of SQLs. Treatment of HIV-1-infected cells with SQLs reduced the amount of the late cDNA, suggesting that integrase-targeting molecules might affect the accumulation of DNA during reverse transcription. The data also were reported at last month's International HIV Drug Resistance Workshop in the Canary Islands.

• Celgene Corp., of Warren, N.J., said Phase II results published in the July 1, 2004, issue of the Journal of Clinical Oncology showed that the proportion of patients with a greater than 50 percent decline in prostate-specific antigen was 53 percent in those treated with a combination of thalidomide and docetaxel (taxotere) vs. 37 percent in those treated with docetaxel alone. The randomized trial in patients with metastatic androgen-independent prostate cancer was conducted by the Bethesda, Md.-based National Cancer Institute.

• Charles River Laboratories International Inc., of Wilmington, Mass., agreed to pay about $1.5 billion to acquire Inveresk Research Group Inc., of Cary, N.C. The merger of the contract research organizations combines their preclinical and clinical drug development services and products into a single entity with $920 million in revenues based on the 12 months ended in March.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said it received biodefense-related contract work worth nearly $1.2 million from government and private-sector clients. The company said the contracts would involve virtually all of its core technology platforms.

• Compugen Ltd., of Tel Aviv, Israel, established a new subsidiary called Keddem Bioscience Ltd. to focus on small-molecule drug discovery. The program underlying the new company began in 2000 as the chemistry division of Compugen. Keddem's discovery approach is based on a proposed creation of a set of molecules and a suite of algorithms. The set will consist of less than 100,000 molecules, mostly new compounds that differ from molecules in existing screening libraries. The subsidiary's offices and laboratories are located in Ashkelon, Israel.

• Discovery Laboratories Inc., of Doylestown, Pa., said a European regulatory committee recommended granting orphan medicinal product designation for Surfaxin for the prevention and treatment of respiratory distress syndrome in premature infants. The committee concluded that although satisfactory methods of prevention and treatment have been authorized in Europe, justifications have been provided that Surfaxin might be of significant benefit to those at risk of developing, or affected by, the condition. In the U.S., the FDA has accepted the company's new drug application for Surfaxin.

• Europroteome AG, of Berlin, entered a collaboration to evaluate approaches for molecular profiling of tissue specimens from cancer patients with Altana Pharma AG, of Konstanz, Germany. Europroteome will use its collection of purified human cancer cells to analyze molecular expression of a panel of cancer targets. The molecular data then will be aligned with a selected set of clinical data, such as cancer stage and disease progression, in order to assess disease-associated expression signatures and prioritize molecular target candidates for therapeutic intervention with new drugs and accompanying diagnostics. Financial terms were not disclosed.

• Flamel Technologies SA, of Lyon, France, said GlaxoSmithKline plc, of London, selected a Flamel Micropump formulation for use in an ongoing development project for a commercial product that will progress to Phase III testing. The company's Micropump technology, which is a controlled-release technology for the oral administration of small-molecule drugs, was licensed to GSK in March 2003.

• Geron Corp., of Menlo Park, Calif., said preclinical data published in this month's issue of Neuro-Oncology indicate that GRN163 can prevent or suppress the growth of human glioblastoma tumor cells in mice and rats. Also, the data suggest that intracranial injection of the first-generation telomerase inhibitor achieves robust distribution of the compound in the brain.

• Helsinn Healthcare SA, of Lugano, Switzerland, and MGI Pharma Inc., of Minneapolis, said data related to palonosetron HCl (Onicit, Aloxi) were presented at the Multinational Association of Supportive Care in Cancer meeting in Miami. Three poster presentations described the impact of treatment with Onicit/Aloxi injection on various quality-of-life parameters, the maintenance of efficacy in patients weighing more than 90 kilograms and the pharmacokinetics and safety of repeat doses.

• ILEX Oncology Inc., of San Antonio, and Genzyme Corp., of Cambridge, Mass., reported that the holders of a majority of the outstanding shares of ILEX common stock voted to approve the proposed merger of the companies at a special meeting held Thursday in Boston. ILEX and Genzyme expect the transaction to close sometime this summer. Genzyme reported in March that it intended to buy ILEX for $1 billion. (See BioWorld Today, March 1, 2004.)

• Illumina Inc., of San Diego, entered an agreement with the Southern California Genotyping Consortium for an Illumina BeadLab. The BeadLab, a production-scale SNP (single nucleotide polymorphism) genotyping laboratory, was purchased and will be installed at the University of California at Los Angeles.

• Imcor Pharmaceutical Co., of San Diego, said it closed the second and final tranche of its $10.2 million financing. The specialty pharmaceutical company, which develops and markets imaging products, issued about 25.4 million common shares and warrants exercisable for about 12.7 million shares. In addition, Imcor converted about $13.5 million of debt into about 33.7 million shares.

• Immunicon Corp., of Huntingdon Valley, Pa., was added to the Russell 3000 Index, following the reconstitution of the index on June 25 and to the Merrill Lynch Nanotech Index, which was created in March. Immunicon develops and commercializes cell-based research and human diagnostic products with an initial focus on cancer disease management.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said its board authorized the occasional repurchase of up to 2.5 million of its common shares in open-market transactions. The company said that given its strong cash position, it sees the repurchase as an attractive option to invest a portion of its capital in its own stock, though the use of funds is not expected to affect plans to invest in its internal pipeline and to seek in-licensing and product-acquisition opportunities.

• Interleukin Genetics Inc., of Waltham, Mass., signed a research agreement with Access Business Group LLC, a subsidiary of Alticor Inc., to conduct research into the development of a test to identify individuals with specific genetic variations that affect how people gain and maintain weight. The agreement also includes provisions to help ABG in the development of nutritional products to help manage weight in those individuals who are overweight but not obese. The agreement made Interleukin eligible to receive up to $1.9 million in additional research funding over a period of 12 months.

• Norwood Abbey Ltd., of Melbourne, Australia, said all the options in the money expiring June 30 have been exercised, and the total amount received from the options' exercise is $10.1 million. As a result, cash holdings for the Norwood Abbey Ltd. Group, including its 83 percent-owned subsidiary, Norwood Immunology Ltd., have increased to more than $20 million. At the same time, Norwood Abbey said the securities of its subsidiary began trading on London's Alternative Investment Market under the symbol "NIM."

• NV Organon, of Oss, the Netherlands, and Grupo Uriach, of Barcelona, Spain, entered a global license agreement for the discovery and development of kinase inhibitors for anti-inflammatory diseases such as rheumatoid arthritis. The alliance involves the optimization and selection of p38 MAP kinase inhibitors from Uriach's preclinical portfolio. Organon will perform preclinical and clinical development, and will hold worldwide commercialization rights for any resulting products. Uriach will receive an up-front payment and also would receive milestone payments and royalties. Uriach also receives an option to commercialize in the Spanish market one of Organon's late-stage products. Further terms were not disclosed.

• Ondine Biopharma Corp., of Vancouver, British Columbia, completed its private placement to Canadian, European and U.S. institutions of about 7.5 million shares at C$2.25 (US$1.70) a share, yielding gross proceeds of about C$17 million. Of the total number of shares, 350,000 are being held in escrow pending receipt of funds. Net proceeds will be used for product development, clinical trials, working capital and preparation of the company's commercialization of its topical non-antibiotic treatment for periodontal infections. Ondine is developing a laser-activated approach to broad-spectrum disinfection.

• Orphan Medical Inc., of Minneapolis, initiated patient enrollment in a trial designed to evaluate Xyrem (sodium oxybate) oral solution in the treatment of fibromyalgia. The protocol calls for 150 patients to complete a three-month trial with an eight-week active-treatment period that will assess the impact of Xyrem on fibromyalgia, including the sleep disturbance that usually accompanies it. The company expects that the initial data will be available in mid-2005.

• Protein Design Labs Inc., of Fremont, Calif., said that Max Link, a director of PDL since 1993, was elected chairman. PDL develops humanized antibodies to prevent or treat diseases.

• Provalis plc, of Deeside, UK, entered an option agreement with Chiron Vaccines, a unit of Chiron Corp., of Emeryville, Calif. Chiron was granted an initial 12-month exclusive option (extendable by another 12 months on payment of a fee) to evaluate Provalis' protein-based vaccine candidates to prevent Group B Streptococcus infection. Chiron paid an initial option fee to Provalis and will pay all costs connected with the patents underpinning the vaccine candidates, and has the right to an exclusive license for, or to acquire, the vaccine candidates. Both cases include pre-determined terms that include staged milestone payments and royalty rates for the license.

• Qiagen NV, of Venlo, the Netherlands, sold its synthetic DNA business to a management team previously employed at the company for $24.3 million in cash and in the form of a promissory note. Qiagen will retain a 16 percent stake in the new company, called Operon Biotechnologies Inc. It retains all rights and activities in its siRNA business, including ownership of its TOM-amidite chemistry, and will receive preferred access to Operon's synthetic nucleic acid-manufacturing capacities and preferred purchasing rights. The synthetic DNA business came out of Qiagen's acquisitions of Operon Technologies Inc., of Alameda, Calif., in 2000, and the Sawady Group, of Tokyo, in 2001. In other news, Qiagen entered a supply agreement for siRNA molecules with AstraZeneca plc, of London. Qiagen will be the preferred supplier to AstraZeneca for siRNA products used in gene-silencing applications. Financial terms were not disclosed.

• Solvay Pharmaceuticals Inc., of Marietta, Ga., submitted a new drug application for cilansetron, a product being studied for irritable bowel syndrome with diarrhea predominance (IBS-D), to the FDA on June 30. Cilansetron is a 5-HT3 receptor antagonist, which has been shown to inhibit 5-HT3 receptors, resulting in gastrointestinal motility, secretion and sensation, thus improving symptoms of IBS-D in both women and men. Current 5-HT3 therapies indicated for IBS are approved for women only.

• Stressgen Biotechnologies Corp., of San Diego, achieved another drug development milestone and held an end-of-Phase II meeting with the FDA for its lead compound, HspE7. As a result, a path forward for clinical development of the compound was identified for recurrent respiratory papillomatosis. Following the FDA's recommendation, Stressgen will submit a final pivotal trial protocol for a special protocol assessment.

• SuperGen Inc., of Dublin, Calif., submitted a marketing authorization application seeking approval of Orathecin (rubitecan) capsules to the European Agency for the Evaluation of Medicinal Products, as a treatment for pancreatic cancer in patients who have failed at least one prior chemotherapy regimen. The application was submitted by SuperGen's European subsidiary, EuroGen Pharmaceuticals Ltd., of Cheltenham, UK. SuperGen filed a new drug application for Orathecin in January. (See BioWorld Today, Jan. 28, 2004.)

• The Immune Response Corp., of Carlsbad, Calif., said Phase II data from an open-label trial of its multiple sclerosis treatment, NeuroVax, were presented at the 4th meeting of the European Neurological Society in Barcelona, Spain, showing overall immunological activity and that the drug might directly induce regulatory T cells. The trial will enroll 40 MS patients total. Of the 21 enrolled, 11 were tested for overall immunogenicity and all showed a strong immune response to NeuroVax. The company plans to soon initiate another NeuroVax trial.

• Transgene SA, of Strasbourg, France, manufactured clinical lots of HIV vaccine candidates in the frame of Eurovac (European Vaccine Effort Against HIV/AIDS), a European cluster of 21 laboratories, funded since 2000 by the European Union under the 5th Framework Program. Partners of Eurovac; the Karolinska Institute in Stockholm, Sweden; and Aventis Pasteur, of Lyon, France, selected the company to produce the lots of NYVAC-based vaccines carrying genes of HIV-1.

• Zonagen Inc., of The Woodlands, Texas, said results of its placebo-controlled challenge study of Androxal in hypogonadal men showed no side effects and demonstrated statistically significant changes in testosterone levels from baseline. Androxal is an orally administered antagonist that induces increased production of endogenous testosterone. The trial enrolled 70 men that were randomized into six different arms, including three doses of Androxal, placebo, and high and low doses of Androgel.

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