¿ Actelion Ltd., of Allschwil, Switzerland, and Genentech Inc., of South San Francisco, said results from their Phase III BREATHE-1 (bosentan: randomized trial of endothelin receptor antagonist therapy) trial of Tracleer (bosentan) in pulmonary arterial hypertension were positive. The double-blind, placebo-controlled, multicenter trial indicated Tracleer treatment produced a statistically significantly greater walking distance in treated patients (p=0.0002). Tracleer is similar to Actelion¿s other endothelin receptor antagonist, Velerti, which produced positive results in a Phase III trial in acute heart failure in March. (See BioWorld Today March 21, 2001.)
¿ Alkermes Inc., of Cambridge, Mass., and Janssen Pharmaceutical Products LP, of Titusville, N.J., had results of a study on the long-lasting injectable form of Risperdal, using Alkermes¿ Medisorb technology, presented at a psychiatric research meeting Wednesday. The results suggest that the formulation of Risperdal providesrelief for schizophrenia without the need to take daily medication. The trial was a three-month, randomized, double-blind, placebo-controlled study involving 400 patients at 41 U.S. centers.
¿ Alliance Pharmaceutical Corp., of San Diego, said it modified the payment schedule of its Oxygent development agreement with Baxter Healthcare Corp., of Deerfield, Ill. The modification calls for Baxter to make a $4 million investment in Series F preferred stock in Alliance and an additional $3 million investment later this month. To maintain rights to Oxygent, Baxter must make an additional investment of $23 million by the end of September. The original alliance, established in May 2000, called for an exclusive license for Oxygent sales and distribution of Baxter in the U.S., Canada and Europe, and an option to manufacture the product in return for a $20 million investment in Alliance preferred stock and an additional investment of $30 million in 2001.
¿ Applied Biosystems Group, of Foster City, Calif., will provide ViroSeq HIV-1 genotyping kits to the Brazilian National Ministry of Health for a large-scale study to evaluate the clinical utility of routine genotyping. The year-long study will include 6,000 tests.
¿ British Biotech plc, of Oxford, England, said it will halt Study 173, an investigation of Marimastat, its oral matrix metalloproteinase inhibitor, in non-small-cell lung cancer. The drug has already failed to meet its primary endpoint in a gastric cancer trial. Study 183 in patients with pancreatic cancer continues.
¿ Cytran Inc., of Kirkland, Wash., said the University of Washington and the Fred Hutchinson Cancer Research Center¿s Puget Sound Oncology Consortium will lead a nationwide Phase II trial evaluating the safety and efficacy of IM862, Cytran¿s anticancer peptide, in combination with initial chemotherapy using paclitaxel and carboplatin. Preclinical research indicates that IM862 inhibits tumor angiogenesis.
¿ Digene Corp., of Gaithersburg, Md., terminated its marketing and distribution agreement with Abbott Laboratories, of Abbott Park, Ill., for Digene¿s human papillomavirus DNA tests and accessories. The agreement provided for a 12-month nonexclusive, wind-down distribution period for the tests. Digene also converted the rights for distribution of its hepatitis B DNA tests to a nonexclusive basis for the remainder of the term of the agreement.
¿ FibroGen Inc., of South San Francisco, received a grant from the Small Business Innovation Research program of the National Institutes of Health for research and development of FibroGen¿s Prolyl Hydroxylase Inhibitor Program. The grant will be used to fund final formulation of FibroGen¿s topically available compound for use as an anti-scarring agent. The amount of the SBIR grant was not disclosed.
¿ Transgenomic Inc., of Omaha, Neb., will acquire Annovis Inc., of Aston, Pa. for 1.9 million Transgenomic shares and $500,000 in cash. The transaction is expected to close within 30 days. Annovis is a specialty chemical company that develops and markets nucleic acid-based products and services for the life sciences industry. Transgenomic provides the life sciences industry with consumables and research tools, including its WAVE nucleic acid fragment analysis system.
¿ GenVec Inc., of Gaithersburg, Md., said data from studies of the company¿s PEDF products indicated that administration in the eye of the pigment epithelium-derived factor (PEDF) gene using GeneVec¿s delivery technology resulted in a substantial reduction in new blood vessel formation in animal models of macular degeneration and diabetic retinopathy. The PEDF product candidates use an adenovector to produce PEDF.
¿ Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application as planned for tenofovir disoproxil fumarate, a reverse transcriptase inhibitor in development for treatment of HIV. Gilead announced its intent to file for marketing approval in February after positive results from a pivotal Phase III trial. (See BioWorld Today, Feb. 21, 2001.)
¿ Harvard Bioscience Inc., of Holliston, Mass., acquired Warner Instruments Corp., of Hamden, Conn. Warner designs, manufactures and markets products for cell and tissue electro-physiology research. Financial details were undisclosed.
¿ Immunomedics Inc., of Morris Plains, N.J., presented clinical results on a new method for targeting drugs and isotopes to cancers that is being developed by Immunomedics and its affiliated company, IBC Pharmaceuticals LLC, at the CIBC World Markets Bio-Technology Conference in New York. The pretargeting methodology, called Affinity Enhancement System, involves bispecific, or two-armed antibodies.
¿ International Wex Technologies Inc., of Vancouver, British Columbia, commenced a Phase I multidose safety study of Tetrodin, its drug abuse treatment. The trial is scheduled for completion by the end of June.
¿ Iomed Inc., of Salt Lake City, announced after market¿s close Monday that the Phase III study of its G-II product, formerly called ProDex, failed to produce results that met the trial¿s primary endpoint in treatment of epicondylitis. The trial did not confirm previous Phase III trial results. Though the company said the confirmatory study produced results indicating that patients treated with the drug experienced a positive response, results did not support the reduction of local inflammation and tenderness associated with both epicondylitis and plantar fasciitis. The company will now analyze the complete G-II database from all its clinical trials to assess its next step in product development. Iomed¿s stock (AMEX:IOX) dropped three cents Wednesday to close at $3.10.
¿ Novartis AG, of Basel, Switzerland, subsidiary Novartis Ophthalmics and QLT Inc., of Vancouver, British Columbia, reported that average visual activity remained stable during the third year of Visudyne (verteporfin for injection) treatment in patients with age-related macular degeneration. Results were based on an extension of the pivotal Phase III trial which offered ongoing open-label Visudyne treatment to 79 percent of the trial¿s 609 patients.