¿ Avanir Pharmaceuticals Inc., of San Diego, acquired macrophage migration inhibitory factor (MIF) technology from the Ciblex Corp., also of San Diego. The asset acquisition provides various drug development opportunities including the exclusive worldwide rights to develop and commercialize a series of small-molecule compounds that target MIF. Avanir said the MIF program is a key addition to its development pipeline. Modulation of MIF activity may have potential in rheumatoid arthritis, asthma, ulcerative colitis, Crohn¿s disease, inflammatory neurological diseases, glomerulonephritis and sepsis. Financial details were not disclosed.
¿ AVI BioPharma Inc., of Portland, Ore., said it began work on a Department of Defense-funded study of its Neugene antisense drug platform in prostate cancer. AVI scientists will use their third-generation technology to regulate programmed cell death by interfering with the insulin-like growth factor system and the hormones that control cell growth. The study is funded by a $225,000 three-year grant from the Department of Defense Prostate Cancer Research Program.
¿ Biolog Inc., of Hayward, Calif., launched its OmniLog ID Microbial Identification System. The platform is designed to automate and simplify the process of characterizing and identifying a range of aerobic bacteria, the company said. Biolog develops cellular analysis tools for solving critical problems in pharmaceutical and biotechnology research and development.
¿ Cell Pathways Inc., of Horsham, Pa., said results of a double-blind, placebo-controlled study of exisulind in the treatment of recurrent prostate cancer following radical prostatectomy were reported in the September issue of The Journal of Urology. The results of the Phase II/III study involving 96 patients at centers across the United States demonstrated that exisulind inhibited the rise of prostate-specific antigen (PSA) levels in treated men overall and prolonged PSA doubling time in high-risk patients compared to placebo.
¿ ComGenex Inc., of Budapest, Hungary, said it launched a target-focused library series, Activerse. The first library in the series, MDR, targets MDR1/MRP1 efflux pumps to reverse multidrug resistance and enhance blood-brain barrier permeability. ComGenex is a drug discovery chemistry provider.
¿ Corixa Corp., of Seattle, and GlaxoSmithKline, of Philadelphia, said they submitted documentation, data and analyses to the FDA in support of the response to the FDA¿s complete review letter received March 16 regarding the biologics license application for Bexxar, a radioimmunotherapy. They are seeking approval of Bexxar for the treatment of relapsed or refractory, low-grade or transformed low-grade non-Hodgkin¿s lymphoma. The remainder of the response will be submitted following final compilation of an independent review of clinical response data from two recently completed Bexxar trials, as well as technical database information. Corixa expects to submit the remainder of the response shortly, it said.
¿ diaDexus Inc., of Santa Clara, Calif., entered a research and license collaboration with Fujirebio Inc., of Tokyo, to develop and sell cancer diagnostic tests in Japan. diaDexus will receive licensing fees and funding from Fujirebio to support further research and development efforts for three years. Also, diaDexus will receive royalty payments on future sales. Fujirebio was granted exclusive commercialization rights in Japan for any resulting cancer diagnostic products and it also purchased diaDexus Series D stock. Further financial details were not disclosed.
¿ Discovery Laboratories Inc., of Doylestown, Pa., was awarded orphan product designation from the European Agency for the Evaluation of Medicinal Products for its humanized lung surfactant Surfaxin (lucinactant) for the treatment of meconium aspiration syndrome (MAS) in full-term newborns. The designation grants 10 years of marketing exclusivity. Surfaxin is in a pivotal Phase III trial for MAS in the United States.
¿ Genetica Inc., of Cambridge, Mass., and Cold Spring Harbor Laboratory, of Cold Spring Harbor, N.Y., said they identified a protein that plays a key role in a natural pathway for silencing genes. The study, published in the current issue of Science, has the potential to advance the understanding of RNA interference and enable new methods for determining the function of genes for drug discovery.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., said its GeneMAP Rat P450 Array is now available. The pre-printed microarray is designed to help researchers more efficiently investigate metabolically relevant enzyme activity. Genomic Solutions designs, manufactures, markets and sells instruments, software, consumables and services for determining the activity levels of genes and isolating, identifying and characterizing proteins.
¿ Inflazyme Pharmaceuticals Ltd., of Richmond, British Columbia, said underwriters exercised their option to purchase 375,000 shares at a price of C$2.70 per share. Gross proceeds related to the exercise are about C$1 million (US$659,071). Closing is scheduled for Aug. 15. Inflazyme completed the public financing July 9.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its GeneTrove division introduced the antisense technology-based Human Gene Function Database, the first database containing information on the selective inhibition of 10,000 human genes. The Human Genome Function Database will allow partners to ask the questions concerning the role of genes in a particular disease process and the effect inhibiting a specific gene has on that process. Gene-Trove will preview the database at the IBC Drug Discovery Technology 2001 conference in Boston next week.
¿ Lynx Therapeutics Inc., of Hayward, Calif., and Phytera Inc., of Worcester, Mass., achieved the first milestone in their collaboration to discover genes responsible for the biosynthesis of antioxidant polyphenols in plants. Phytera applied its ExPAND manipulation technology to its collection of plant cell cultures and identified plant species and culture manipulation conditions where the synthesis of specific antioxidant polyphenols can be switched on or off. The companies will now analyze RNA derived from plant cultures using Lynx¿s Megasort technology.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, said that Patrick Lee and his researchers at the University of Calgary concluded studies in animal models, successfully demonstrating the systemic administration of Reolysin for the treatment of cancer. The effort complements initial work presented at the American Association of Cancer Research meeting in 2001. Reolysin is designed to infect and kill cancer cells with an activated Ras pathway.
¿ Praecis Pharmaceuticals Inc., of Waltham, Mass., said its meeting with the FDA regarding Praecis¿ new drug application for Plenaxis (formerly abarelix depot) to treat prostate cancer has been scheduled for Sept. 10. In June, the FDA said Praecis¿ submitted data was inadequate for approval, the news dropping Praecis¿ stock (NASDAQ:PRCS) by more than 25 percent. The drug is partnered with Amgen Inc., of Thousand Oaks, Calif. (See BioWorld Today, June 13, 2001.)
¿ Pyrosequencing AB, of Uppsala, Sweden, sold its high-throughput PTP system to Oxagen Ltd., of Abingdon, UK. Oxagen will use the PTP system to study the genetics of diseases. PTP ¿ Preferred Technology Program ¿ is a fully automated high-throughput process that incorporates robotics for sample preparation. Financial details were not disclosed.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., and Genzyme Corp., also of Cambridge, were the subjects of analyst reports after Genzyme¿s European label for its product, Fabrazyme, for Fabry¿s disease, was made public. Transkaryotic¿s product, Replagal, for the same indication, is in direct competition with Fabrazyme for the European market. Both products received approval last week. Research notes from Deutsche Banc Alex. Brown Inc and SG Cowen Securities Corp. said Replagal has a superior efficacy profile, thus making the product superior to Fabrazyme. Other investment firms, including Goldman Sachs, of New York, favor Genzyme¿s product because of its established marketing infrastructure in Europe.
¿ Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said both pivotal Phase III trials for T-20 are fully enrolled. Approximately 1,000 HIV patients in Europe, Australia, North America and Brazil are participating in the studies to evaluate T-20, a fusion inhibitor. Roche and Trimeris said they expect to submit for European and U.S. regulatory approval in the early second half of 2002. (See BioWorld Today, Oct. 4, 2000.)