Actelion Ltd., of Allschwil, Switzerland, said results from the Breathe-1 study published in the March 21, 2002, issue of New England Journal of Medicine highlight the importance of Tracleer (bosentan) tablets for the treatment of pulmonary arterial hypertension. Tracleer is available to patients in the U.S., Canada and Switzerland. It is expected to be available by mid-2002 in the European Union, the company said. Tracleer is an endothelin receptor antagonist.
Atrix Laboratories Inc., of Fort Collins, Colo., commenced Phase II trials for a formulation of a low-dose, oral interferon-alpha product for the treatment of oral warts caused by human papillomavirus in HIV-infected patients. The product is administered as a lozenge.
Avanir Pharmaceuticals Inc., of San Diego, received a $1 million Small Business Innovation Research Phase II grant from the National Institutes of Health, of Bethesda, Md., to develop a docosanol-based product as a topical treatment for reducing the severity and healing time of recurrent genital herpes infections. Avanir will use the award to fund research for the development and testing of efficacy and safety in animal models of a new topical formulation of docosanol. Docosanol 10 percent cream is Avanir’s lead product, approved by the FDA for cold sores.
Biovail Corp., of Toronto, announced a public offering of $275 million of senior subordinated notes due 2010. The offering is being made in the United States and Canada under Biovail’s shelf prospectus filed in both countries in November. Biovail will use the net proceeds from the offering to repay existing debt and for general corporate purposes.
Bioxel Pharma Inc., of Quebec, said it entered an agreement with PolyGene Ltd., of Israel, to collaborate in the development of paclitaxel-based polymer implants for treating solid tumors. The development program has received approval for a 50 percent grant from the Canada-Israel Industrial Research & Development Foundation. Bioxel will supply the material for development and clinical trials. PolyGene will apply its proprietary biodegradable polymer technology to produce paclitaxel-loaded implant candidates. The trials will target tumors of the head and neck, brain, colon, prostate and sarcomas.
Boston Life Sciences Inc., of Boston, initiated regular production of its anti-angiogenic protein, Troponin I, at its facility in Baltimore. The company now is able to produce all anticipated clinical trial material. Also, the company said it submitted documentation and a request for a pre-investigational new drug application meeting with the FDA to discuss development plans and a proposed IND submission. Troponin I is a naturally occurring anti-angiogenesis factor designed to treat solid tumors.
Corus Pharma Inc., of Seattle, said Corus 1020 was granted orphan drug designation by the FDA for inhalation therapy to control Gram-negative bacteria in the respiratory tract of patients with cystic fibrosis. The antibiotic is being developed by Salus Pharma, a wholly owned subsidiary of Corus. Corus focuses on products for respiratory and infectious diseases.
Compugen Ltd., of Tel Aviv, Israel, entered an agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass., to co-develop software tools to assist in the prediction of protein pathways for use in drug discovery and development. The companies will share costs of the project and the rights to certain aspects of the technology developed. The collaboration combines Millennium’s knowledge of applying high-throughput genomics technologies, especially transcriptional profiling, for drug discovery and the development to personalized medicines with Compugen’s focus in predictive biology.
Dynavax Technologies Corp., of Emeryville, Calif., said an anti-allergy therapy it is developing proved effective in mice in reversing allergic response to ragweed pollen. A paper detailing the study was published in the March issue of the Journal of Allergy and Clinical Immunology. Mice were sensitized and challenged with ragweed pollen extract, then treated intradermally twice at one-week intervals with Dynavax’s immunostimulatory oligodeoxynucleotide chemically linked to Amb a 1. Results showed that after treatment, the mice had reduced asthma symptoms.
EmerGen Inc., of Salt Lake City, found strong evidence confirming endometriosis is an inherited disorder. EmerGen said endometriosis is one of the most common diseases in women, with estimates of up to 10 percent of women contracting it during reproductive years. At the World Conference on Endometriosis, Dale Hull presented the family histories of 719 women with a surgical diagnosis of endometriosis. In these families, the number of sisters and mothers with endometriosis was higher than expected. Hull said the findings confirm that there is an increased risk of developing the disease among first-degree relatives.
ID Biomedical Corp., of Vancouver, British Columbia, said data analysis from its Phase I trial of Strept-Avax showed that the desired immune response endpoints of the trial were achieved and no safety concerns were apparent. StreptAvax is a multivalent alum-adjuvanted vaccine containing recombinant proteins representing coverage for 26 significant serotypes of group A streptococci. ID Biomedical submitted an application seeking approval to proceed to Phase II trials.
Gene Logic Inc., of Gaithersburg, Md., said that Morphochem AG, of Munich, Germany, subscribed to components of Gene Logic’s GeneExpress Suite of products and services. Morphochem will subscribe to the GeneExpress Oncology DataSuite, which will provide Morphochem access to gene expression and other genomic information focused on oncology. Mophochem also will purchase a series of GeneExpress Reports. Financial terms of the multiyear agreement were not disclosed. Separately, Gene Logic said its ToxExpress Program identified gene markers associated with toxicity and pathology using gene expression for animal models, the basis for the predictive modeling capabilities. The predictive models should enable screening of potential toxicity and prioritization of lead compounds earlier in the drug development process, the company said.
Genome Therapeutics Corp., of Waltham, Mass., said it advanced a small-molecule compound series for optimization in its alliance with AstraZeneca plc, of London, to use genomic information to develop anti-ulcer products. The alliance is structured around the sequence of Helicobacter pylori, which Genome Therapeutics mapped. The alliance was formed in 1995.
Illumina Inc., of San Diego, and Oxagen Ltd., of Abingdon, UK, signed a collaborative commercial agreement to generate maps of single nucleotide polymorphism clusters in defined chromosomal regions. Oxagen will provide a collection of SNP loci within linkage regions together with samples from its library of family collection material and information. Illumina will use its BeadArray technology to design functional assays for the SNPs provided and generate several million overall genotype calls from the sample set. Oxagen will retain rights to all genes and novel associations discovered as a result of the study. Further details were not disclosed.
Inhale Therapeutics Systems Inc., of San Carlos, Calif., and Alliance Pharmaceutical Corp., of San Diego, expanded their agreement regarding the PulmoSphere particle and particle-processing technology, aspects of which Inhale initially acquired from Alliance in November 1999. As a result of the supplemental agreement, Inhale paid Alliance $5.25 million in exchange for rights beyond inhaleable applications and other considerations.
Nanogen Inc., of San Diego, introduced its first analyte-specific reagent, designed for the detection of Factor V Leiden, a gene mutation associated with cardiovascular disease and the pathology of thrombosis. The Factor V Leiden ASR determines if the Factor V Leiden gene is present in a blood sample by detecting the presence of a certain characteristic gene polymorphism.
Oxis International Inc., of Portland, Ore., closed the first phase of a private convertible preferred equity financing, in which $1.5 million was invested by Meridian Financial Group LLP. The company plans to increase this financing in a second phase offering in the near future for an additional $500,000. The financing includes Oxis issuing warrants that may be exercised to purchase 1.5 million shares of common stock at $1 per share.
Pharmexa A/S, of Horsholm, Denmark, said it presented its HER-2 DNA AutoVac therapeutic for the treatment of breast cancer at the third European Breast Cancer Conference, held in Barcelona, Spain. The company said it expects to announce Phase I/II trial results by year’s end. Pharmexa focuses its resources on a number of cancer forms and chronic inflammatory diseases.
Sangamo Biosciences Inc., of Richmond, Calif., said its articles and reviews were published in four scientific journals: “Validated Zinc Finger Protein Designs for All 16 GNN DNA Triplet Targets,” in The Journal of Biological Chemistry; “Biotechnologies and Therapeutics: Chromatin as a Target,” in Current Opinion in Genetics and Development; “Methods for the Analysis of Protein-Chromatin Interactions,” in Molecular Biotechnology; and “Plant Chromatin: Development and Gene Control,” in Bioessays. Sangamo is focused on the research and development of transcription factors for the regulation of gene expression.
SciQuest Inc., of Research Triangle Park, N.C., acquired the enterprise software assets of Groton NeoChem LLC, of Acton, Mass., in an all-cash transaction. All customer contracts, software and key people are being transitioned to SciQuest. The acquired software complements SciQuest’s solutions for substance and reagent management by capturing, storing and analyzing chemistry data about those reagents and substances directly from scientific instrumentation, the company said. Financial details were not disclosed.
Xoma Ltd., of Berkeley, Calif., said a federal court dismissed each of the three federal securities class action lawsuits filed last year against Xoma, Genentech Inc., of South San Francisco, and certain officers. In November and December of 2001, the lawsuits were filed alleging material misrepresentations and saying omissions were made concerning the anticipated timetable for the filing of a biologics license application with the FDA for the development of Xanelim.