¿ Alza Corp., of Mountain View, Calif., and MedImmune Inc., of Gaithersburg, Md., said the American Society of Clinical Oncology published a pivotal Phase III study evaluating the use of Ethyol in head and neck cancer patients receiving radiation therapy. Data from the study showed a 35 percent reduction in the incidence of moderate to severe xerostomia (dry mouth) with the use of Ethyol in patients undergoing radiation therapy (p<0.0001).
¿ Care Capital LLC, of Princeton, N.J., an investment firm that will focus on life sciences, was formed. The principals for the company are Jan Leschly, John Parker and David Ramsay. Each has made significant financial commitments. The firm has a co-investment arrangement with Morgan Stanley Dean Witter Private Equity and Rho Management. The company has $100 million in available capital, but with the support of Dean Witter and Rho, can make larger transactions.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said Periostat, its drug for the adjunctive treatment of adult periodontitis, is now available for prescription in the UK. Periostat acts by suppressing enzymes that destroy the periodontal support tissues and will be marketed there by subsidiary CollaGenex International Ltd.
¿ Coulter Pharmaceutical Inc., of South San Francisco, and SmithKline Beecham plc, of London, said the radioimmunotherapy drug Bexxar has been assigned priority review status by the FDA. That means Bexxar will be reviewed and action taken by the agency within six months from the date of submission, Sept. 15. The companies are seeking marketing approval of Bexxar for the treatment of relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma.
¿ DeveloGen AG, of Gottingen, Germany, completed its merger with HepaVac AG, of Berlin. DeveloGen gained access to HepaVec's vector and cell-based technology through the merger to complement its functional genomics expertise. Carsten Dehning was appointed as finance director of the combined company.
¿ Escopia BioSciences Inc., of Saint Laurent, Canada, said it will list its shares on the Toronto Stock Exchange under the symbol "EIA." Trading is expected to begin Oct. 10.
¿ Genentech Inc., of South San Francisco, said its board approved a 2-for-1 split of its common stock to be effective in the form of a dividend. At the close of business Oct. 17, all shareholders of record will receive one additional share for each share held. As of Sept. 30, Genentech had 262.2 million shares outstanding.
¿ Genome Therapeutics Corp., of Waltham, Mass., said it is the first to sequence Proteus mirabilis, a Gram-negative bacteria that is a major cause of urinary tract infections, and it also sequenced Klebsiella pneumoniae, an organism implicated in urinary tract infections and other nosocomial bacterial infections. The sequencing of these organisms may help facilitate the development of novel antibiotics.
¿ Genzyme General, of Cambridge, Mass., and Pharming Group N.V., of Leiden, the Netherlands, said results from the first two clinical trials ever conducted on Pompe disease were presented this week at the American Society of Human Genetics meeting in Philadelphia. Three infants with Pompe disease received enzyme replacement therapy for over a year and results show the recombinant form of the enzyme human alpha-Glucosidase given intravenously is capable of improving cardiac and skeletal muscle functions. In a Phase II clinical trial, four infants with Pompe disease received weekly infusions of transgenic human alpha-Glucosidase and showed lowered lysosomal glycogen storage and improved tissue morphology.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, signed a four-year research agreement with Tularik Inc., of South San Francisco, under Lexicon's OmniBank Internet Universal program. Tularik will have access to conditional knockouts and gene-specific knockouts generated using Lexicon's gene-targeting program, with genetic alterations directed at specific drug targets selected by Tularik. Tularik also will have access to Lexicon's OmniBank library of 90,000 knockout mouse clones for use in determining the function of genes that represent potential drug targets. Financial terms were not disclosed.
¿ Ligand Pharmaceuticals Inc., of San Diego, said its product LY510929 and a backup compound have been declared clinical candidates for development as novel oral treatments for Type II diabetes and cardiovascular disease. Ligand expects an investigational new drug application to be filed with the FDA for one of the compounds in the second half of 2001. Ligand received undisclosed milestone payments from partner Eli Lilly and Co., of Indianapolis, and may receive additional milestone payments from Lilly should any compound progress through human development.
¿ Luminex Corp., of Austin, Texas, said it entered a strategic partnership aimed at developing reagents and assay kits based on LabMAP technology for drug discovery applications with Upstate Biotechnology Inc., of Lake Placid, N.Y. The assay detection system is planned to complement Upstate's cell-signaling reagents and assay kits.
¿ Maxygen Inc., of Redwood City, Calif., achieved a key milestone in its collaboration with Pioneer Hi-Bred International Inc., of Des Moines, Iowa. The milestone resulted in an extension of the collaboration for another two years, until December 2003. The companies are working on developing a portfolio of products for crop protection and quality grain traits in corn, soybeans and certain other crops using Maxygen's MolecularBreeding directed molecular evolution technologies.
¿ Myriad Genetics Inc., of Philadelphia, presented studies that led to the discovery of the HPC2 prostate cancer gene using Myriad's proprietary form of genomic analysis, at the annual meeting of the American Society of Human Genetics in Philadelphia. Myriad is working with Schering-Plough Corp., of Madison, N.J., to develop novel therapeutics for the treatment of prostate cancer based on the discovery of the HPC2 gene.
¿ Nanogen Inc., of San Diego, entered into a cooperative agreement with the U.S. Army Medical Research Acquisition Activity for approximately $1.1 million over the next two years. The agreement is to develop an arrayable electronic system for the identification of biological warfare or infectious disease agents.
¿ NeoTherapeutics Inc., of Irvine, Calif., sold 968,524 shares of common stock at $8.26 per share to two private investors, raising $8 million. The investors also received five-year primary warrants to purchase 193,706 shares of common stock at the exercise price of $10.13 per share. The funds will be used for ongoing U.S. and international clinical studies in the next year.
¿ Novavax Inc., of Columbia, Md., entered an agreement to acquire privately held Fielding Pharmaceutical Co., of St. Louis. Novavax will acquire 100 percent of the outstanding shares of Fielding for $31.5 million - $13 million in cash and the remainder in shares of common stock. An additional $5 million in either common stock or cash could be paid to former Fielding shareholders upon the successful and timely achievement of certain milestones over the next 12 to 18 months. Fielding will have the option to nominate one member to Novavax's board of directors and Novavax will operate Fielding as a wholly owned subsidiary. Novavax also said it completed enrollment of its multicenter Phase III trial of Estrabsorb, a topical estrogen replacement therapy for symptomatic post-menopausal women. Fielding markets women's health care products.
¿ Novazyme Pharmaceuticals Inc., of Oklahoma City, said its phosophorylated enzyme replacement therapy for the treatment of Pompe disease was granted orphan drug status by the FDA. Novazyme's application in July presented preclinical evidence that its therapeutic, NZ-1001, provided greatly enhanced enzyme uptake into affected cells.
¿ Oxford GlycoSciences plc, of Oxford, UK, said a paper published Oct. 5 in Biochemical and Biophysical Research Communications titled "Cloning and Expression Profiling of Hpa2, a novel Mammalian Heparanase Family Member," details the company's discovery of a novel heparanase gene and its protein, a member of a family of key oncological targets. Oxford also said it filed patent applications that cover genes, proteins, antibodies and small-molecule inhibitors related to the heparanase enzyme that block the growth of tumor cells and activated blood vessels.
¿ PPL Therapeutics Inc., of Blacksburg, Va., received a $1.9 million grant from the U.S. Department of Commerce to fund research. The grant, spread over three years, was awarded to fund further work on an approach to deriving mammalian pluripotent stem cells. Therapies and products from human pluripotent stem cells have broad potential applications in the treatment of Alzheimer's disease, Parkinson's disease, diabetes, spinal cord injury, cancer, burns and heart, lung and liver diseases.
¿ Procyon BioPharma Inc., of Montreal, said it plans to enter an agreement with Biovation Ltd., of Aberdeen, Scotland, for development of chimeric and de-immunized ANA therapeutic monoclonal antibodies. The ANA antibody platform has multiple applications, including therapeutic, diagnostic and vaccine uses. The agreement, expected to be in place in about 30 days, is likely to include milestones and contractual obligations.
¿ Pyrosequencing AB, of Uppsala, Sweden, said two departments of the Karolinska Institute in Stockholm, Sweden, purchased PSQ 96 Systems for single-nucleotide polymorphism analysis. A representative from the Karolinska Institute said it tested 2,000 genotypes using the Pyrosequencing technology without an error.
¿ Trinity Biotech plc, of Dublin, Ireland, acquired 33.3 percent of the share capital of Irish genomics company HiberGen Ltd. for $1.3 million. HiberGen has a proprietary platform, SNaPIT, a cost-effective single nucleotide polymorphism discovery and genotyping technology, for discovering disease genes for use in pharmacogenomic analysis. As part of the agreement, Trinity has rights to increase its stake to 49 percent for a further consideration of $950,000. Trinity also has the option to expand its stake up to 66 percent in the next 10 to 18 months, at a price dependent on the achievement of pre-determined milestones.
¿ Waratah Pharmaceuticals Inc., of Calgary, Alberta, said it received additional gross proceeds of C$1.2 million (US$801,442) in connection with its initial public offering, which closed Sept. 19 on the Canadian Venture Exchange. Agents Yorkton Securities and Canaccord Captial Corp. exercised their overallotment option in full, acquiring 1.5 million shares at C85 cents per share. The transaction brings the total gross proceeds raised from the IPO to C$9.7 million (US$6.48 million).