¿ Bio-Technology General Corp., of Iselin, N.J., signed an agreement with Abbott Laboratories, of Abbott Park, Ill., to co-market Oxandrin in the U.S. Oxandrin is Bio-Technology General's leading oral anabolic agent indicated to promote weight gain after involuntary weight loss following extensive surgery, chronic infections or severe trauma. Terms of the deal were not disclosed.
¿ Biogen Inc., of Cambridge, Mass., said data from the Phase III CHAMPS trial (Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study) showed Avonex had highly statistically significant beneficial effect (interferon beta-1a) on delaying the development of clinically definite MS in individuals at high risk for the disease. Biogen is proceeding with plans to file an application for a broadened prescribing label for Avonex, which was launched in 1996 as a treatment of relapsing forms of MS. Biogen also announced that James Mullen has been named president and CEO, succeeding James Vincent, who will continue as chairman. The change will be effective June 16, the date of the annual shareholder meeting. Mullen has served as president and chief operating officer of Biogen since 1999. He joined the company in 1989 as director of facilities and engineering.
¿ Cel-Sci Corp., of Vienna, Va., said Dr. H. Mao from the Northeastern Ohio Universities College of Medicine presented data showing that immunization of animals with an experimental herpes simplex vaccine based on Cel-Sci's LEAPS technology conferred protection against death from herpes simplex virus infection. The study was presented at at the 3rd Annual Conference on Vaccine Research in Washington
¿ Chiron Corp., of Emeryville, Calif., and Berlex Laboratories Inc., of San Diego, said findings from the North American trial of Betaseron in secondary progressive multiple sclerosis (SPMS) suggest that patients with more advanced disease are less likely to show a measurable response to treatment with interferon-beta therapy. However, evidence suggests there may be a subset of the patient population in which clinical treatment with Betaseron slows the progression of disability. This phenomenon may explain why responses in the delay of progression of disability was statistically significant in the European trial, but not in the North American trial, the companies said. Betaseron was the first therapy approved in the U.S. to treat relapsing-remitting MS.
¿ DoubleTwist Inc., of Oakland Calif., and BioTools Inc., of Edmonton, Alberta, partnered to provide DoubleTwist.com users with BioTools' PepTool and GeneTool software products for protein and genomic sequence analysis. The products offer scientists an environment in which to rapidly search public and proprietary databases, probe sequence homologies, access functional information, align multiple sequences and predict the secondary structure of proteins.
¿ Dynavax Technologies Corp., of Berkeley, Calif., said its researchers, working in collaboration with the University of California, San Diego, have shown that a novel tumor conjugate DNA vaccine induces a significant immune response against tumor cells in mice. The findings are published in the May issue of Nature Biotechnology. They show that immunostimulatory DNA sequences conjugated with a tumor antigen induce high antigen-specific cytotoxic T-lymphocyte activity.
¿ Elan Pharmaceuticals, of San Francisco, said it awarded a $100,000 unrestricted grant to the American Academy of Neurology Education and Research Foundation to support outcomes research and quality improvement initiatives in the field of neurology. Parent company Elan Corp., of Dublin, Ireland, also said its licensor Vanguard Medica Group plc, of Guilford, UK, received a letter from the FDA stating the new drug application (NDA) for the migraine drug frovatriptan is approvable.
¿ Genome Therapeutics Corp., of Waltham, Mass., and Schering-Plough Corp., of Madison, N.J., extended their human genomics alliance to discover new therapeutics for treating asthma. The original agreement announced in December 1996 was worth $67 million. With the extension, which carries the research portion of the alliance at least through December 2001, potential proceeds could be $76 million, excluding royalties. To date, Genome Therapeutics has received about one-third of those proceeds through milestone payments and funded research. (See BioWorld Today, Dec. 26, 1996, Special News Bulletin.)
¿ ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said the FDA approved its Czech-manufactured formulation of the antifungal drug nystatin. With the approval, bulk nystatin will be exported to the U.S.
¿ Immtech International Inc., of Vernon Hills, Ill., said its first pharmaceutical product, DB-289, for the treatment of Pneumocystis carinii pneumonia (PCP) and Trypanosomiasis, is on schedule to begin human trials in the third quarter. PCP is common among immune-suppressed patients, and Trypanosomiasis is a fungal disease also known as "sleeping sickness." In July, the company plans an investigational new drug filing for a Phase I study in Germany.
¿ Immunex Corp., of Seattle, and Genentech Inc., of South San Francisco, reiterated the intention of the two companies to move forward in their collaborative preclinical study of TRAIL/Apo2L in cancer research. The future development of TRAIL/Apo2L will be based on the results of numerous toxicology and other preclinical testing. Experiments thus far have demonstrated that the TRAIL/Apo2L molecule has the ability to kill a broad cross-section of human tumor cell types without significantly affecting the survival of normal human cells.
¿ King Pharmaceuticals Inc., of Bristol, Tenn., said the FDA's Cardio-Renal Drugs Advisory Committee recommended the approval of Altace (ramipril) for the significant reduction of cardiovascular death, myocardial infarction, stroke and "all-cause mortality" in patients at risk for such cardiovascular events. King filed a supplemental new drug application with the FDA in January. Altace is indicated for the treatment of hypertension and congestive heart failure after myocardial infarction.
¿ La Jolla Pharmaceutical Co., of San Diego, said that after a positive meeting with the FDA, it plans to conduct a Phase III trial of its lupus drug candidate, LJP 394, beginning in the second half of this year. The product generated positive results in a Phase II/III trial when more than 80 percent of the patients evaluated showed high-affinity antibodies to the drug. In those patients, the time to renal flare, which was the trial's primary endpoint, increased to a statistically significant degree in the drug-treated group compared to the placebo group. The company said at the time the results were released that it expected to start a Phase III this year. (See BioWorld Today, Feb. 17, 2000, p. 4.)
¿ Lorus Therapeutics Inc., of Toronto, said its underwriters exercised in full their overallotment option to buy up to 2 million additional common shares at C$3 each in the company's recent bought-deal financing. Lorus sold 15.3 million shares, including the overallotment option, raising gross proceeds of C$46 million (US$31 million). HSBC Securities Inc. led the syndicate of underwriters, which included Yorkton Securities Inc., TD Securities Inc. and Dominick & Dominick Securities Inc. (See BioWorld Today, April 13, 2000, p. 1.)
¿ NeoTherapeutics Inc., of Irvine, Calif., completed a sale to a major Canadian financial institution of 500,000 shares of common stock at $14 per share for total proceeds of US$7 million. The investor received a five-year warrant to buy up to 125,000 shares of common stock at an exercise price of $17.50 per share. Dlouhy Investments Inc., of Montreal, acted as the placement agent. Proceeds will help fund the clinical development of the company's lead product candidate, Neotrofin, which is being developed for nerve repair and regeneration.
¿ Neurobiological Technologies Inc., of San Diego, reported clinical trial results showing diabetic patients experienced significant reduction in nighttime neuropathic pain after treatment with Memantine. The trial compared two dose levels of Memantine, 20 mg and 40 mg, with placebo. In the 40-mg group, 44 percent of the patients enjoyed a 50 percent pain reduction, compared to 29 percent in the placebo group. There was no significant difference between the 20-mg dose and placebo. The company expects to design a Phase III study comparing the 40-mg dose with a placebo in 400 to 500 patients. Memantine is used in Europe to treat dementia and other neurodegenerative disorders.
¿ NexMed Inc., of Robbinsville, N.J., said its Femprox cream, incorporating the active drug ingredient alprostadil (prostaglandin E1) for treating women with female sexual arousal disorder, demonstrated a positive effect on increasing blood flow to the clitoris and labia in 18 female subjects. In addition to observations of labial and clitoral engorgement, 13 subjects reported a "pleasant" warm sensation.
¿ Oxford Molecular Group plc, of Oxford, UK, said it has made significant enhancements to Tsar, its tool for quantitative structure activity relationship and for designing libraries of compounds. Tsar has been enhanced to process libraries of unlimited size and improve data retrieval.
¿ Pharmacia Corp., of Bridgewater, N.J., and Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., said clinical results show that treatment in early Parkinson's disease with the dopamine agonist Mirapex significantly delays the onset of major motor complications compared to levodopa. The study showed that 51 percent of patients who received levodopa were affected by motor complications vs. 28 percent of patients treated with Mirapex. After two years in the study, 72 percent of patients who received initial treatment with Mirapex were free from motor complications, compared to 49 percent of patients initiated on levodopa. The results were presented at the American Academy of Neurology meeting in San Diego. Mirapex received FDA approval in 1997 as a treatment for Parkinson's disease. Pharmacia also said clinical results show an 81 percent response rate with Caverject Sterile Powder in men with erectile dysfunction who had previously failed to achieve desired results on Viagra. The results were presented at the American Urological Association meeting in Atlanta.
¿ PowderJect Pharmaceuticals plc, of Oxford, UK, and its subsidiary, PowderJect Vaccines Inc., of Madison, Wis., said results from two studies demonstrate that DNA vaccination via the PowderJect System results in an unprecedentedly high cellular immune response. The first study demonstrated that a dual modality DNA vaccine immunization strategy against simian immunodeficiency virus (SIV) elicited the highest killer T cell immune response reported to date with a DNA vaccine. A second study showed that powder injection of a DNA vaccine encoding specific genes from SIV offered good protection against SIV infection transmitted by two different routes.
¿ Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., received a $3 million milestone payment from Sumitomo Pharmaceuticals Co. Ltd., of Point Richmond, Calif., related to the development of Regeneron's brain-derived neurotrophic factor in Japan. The companies have collaborated since 1994.
¿ Steroidogenesis Inhibitors International Inc., of Las Vegas, has begun a formal search for an investment banking firm for the purpose of synergistic acquisitions that can improve the efficacy and impact of Anticort on the marketplace. Anticort is in clinical and non-clinical trials as an anticortisol.
¿ SuperGen Inc., of San Ramon, Calif., received a grant of $750,000 from the National Cancer Institute to initiate clinical trials of IpdR. The company will evaluate the compound in single- and multi-dose studies to determine maximum tolerable doses and safety in humans.
¿ Transgene SA, of Strasbourg, France, presented Phase I results for VV-MUC1-IL2, the company's cancer vaccine directed against the Muc1 tumor-associated antigen, at the American Urological Association's Annual Meeting in Atlanta. Results showed intramuscular administration of the vaccine was safe and well-tolerated in all patients, and objective evidence of tumor response was observed in one patient. Two other patients had stabilization of cancer.
¿ Univera Pharmaceuticals Inc., of Broomfield, Colo., entered into a strategic collaboration with Unigen Ltd., of Seoul, Korea, providing for the transfer of Univera's PhytoLogix and PhytoGenEx technologies to Unigen and the sharing of future technical improvements. Univera received a $1 million licensing fee and will receive royalties on future developments. As part of the agreement, both companies will collaborate on the screening of plants from around the world.