Albany Molecular Research Inc., of Albany, N.Y., opened its 28,000-square-foot Syracuse Research Center in North Syracuse, N.Y., a facility where it will conduct small-scale custom chemical synthesis to support early stage drug discovery and larger, kilogram-scale chemical development to produce drug candidates and intermediates for use in preclinical or clinical studies. Albany Molecular said the center employs 43 individuals, a number expected to rise to approximately 65 in the next few years.
BattellePharma Inc., of Columbus, Ohio, entered a second agreement with Eiffel Technologies Ltd., of Victoria, Australia, under which Eiffel will create drug nanoparticles using its suite of supercritical fluid technologies for BattellePharma's development-stage asthma product. The reformulation will be tested with BattellePharma's Mystic inhalation delivery technology. Each company will retain intellectual property related to its technology. Financial terms were not disclosed.
BioMarin Pharmaceutical Inc., of Novato, Calif., said it will present later this month at the International Symposium on Mucopolysaccharide and Related Diseases and the Scientific Lysosomal Storage Disorders Congress in Paris, data from its Phase III trial of Aldurazyme (laronidase) and from a Phase I trial of Aryplase. Data on Aldurazyme, an enzyme replacement therapy for mucopolysaccharidosis I, will include results from the six-month placebo-controlled portion of the trial as well as preliminary results from the six-month open-label extension study. The Aryplase trial includes 48 weeks of data, with 24 weeks of data from an ongoing extension study.
Connetics Corp., of Palo Alto, Calif., initiated a Phase III trial of Extina, a formulation of 2 percent ketoconazole in the company's foam delivery system, for the treatment of seborrheic dermatitis. The four-week, double-blinded, placebo- and active-controlled trial is designed to include about 600 patients at 28 centers. Subject to a successful outcome of the trial, Connetics plans to submit a new drug application to the FDA in 2003.
Genomic Solutions Inc., of Ann Arbor, Mich., said it received a deficiency notice from the Nasdaq staff dated June 12 indicating that its common stock failed to maintain a minimum bid price of $1 over the previous 30 consecutive days as required by the Nasdaq National Market. The notice does not affect the availability of trading the company's stock and it remains listed on the Nasdaq National Market. The company has 90 calendar days to regain compliance.
Immunex Corp., of Seattle, presented at last week's European League Against Rheumatism meeting in Stockholm, Sweden, data on Enbrel (etanercept) that showed improvement in physical functioning measurements as assessed by a health assessment questionnaire (HAQ) for rheumatoid arthritis (RA). At three years, patients with early disease experienced a 56 percent reduction in HAQ scores compared to a 35 percent improvement in patients with longstanding disease. Also, 26 percent with early RA had no measurable disability, while only 14 percent with established RA achieved a zero HAQ score. In another study, Enbrel was generally well tolerated over its five years. Serious adverse events occurred at a rate of 0.14 per patient-year compared, compared to previous controlled study results of 0.13 in patients treated with Enbrel and 0.20 in placebo patients.
Large Scale Biology Corp., of Vacaville, Calif., entered a collaborative research agreement with the National University of Singapore regarding Large Scale's Plurigen CM stem and progenitor cell cultivation product. Initial studies will focus on enhancing proliferation of human peripheral blood stem cells, umbilical cord blood stem cells and mesenchymal stem cells in vitro with the aid of Plurigen. Financial terms were not disclosed.
Noxxon Pharma AG, of Berlin, named David Pearson as CEO. Previously, he worked with Sandoz Ltd. and Novartis AG, both of Basel, Switzerland. Noxxon aims to develop biopharmaceuticals based on its spiegelmer technology, or mirror-inverted nucleic acids that can be RNA or DNA and bind tightly and specifically to biological targets.
Neurocrine Biosciences Inc., of San Diego, reported at last week's American Diabetes Association meeting in San Francisco Phase I/II safety results of NBI-6024 for Type I diabetes. The multicenter, randomized, double-blind, placebo-controlled, multidose, dose-escalating study in 35 adolescent patients showed the overall safety profile and incidence of adverse events for all dosing cohorts was similar to that of placebo. There were no detectable anti-6024 antibodies following single- and multiple-dose administration. No significant increase in anti-insulin, anti-GAD, and anti-ICA 512 levels relative to placebo was observed. Cell-mediated immune response was not affected. Developed in collaboration with Taisho Pharmaceutical Co. Ltd., of Tokyo, NBI-6024 is a therapeutic vaccine created using Neurocrine's Altered Peptide Ligand technology.
North American Scientific Inc., of Chatsworth, Calif., said it requested a meeting with the FDA to resolve issues of protocol design and related matters for its planned U.S. studies of Tc-99m hynic-annexin for the early determination of response to cancer treatment. To incorporate expected changes in laboratory validation testing and clinical protocol into future studies, North American Scientific withdrew its recently filed investigational new drug application. The company said a revised IND would be filed shortly after the FDA meeting.
Oncolytics Biotech Inc., of Calgary, Alberta, agreed to acquire a 15 percent interest in Transition Therapeutics Inc., of Toronto. Oncolytics will issue about 1.9 million common shares from treasury, which will be subject to a four-month hold provision, worth approximately $3.2 million based on its Friday opening price of $1.65 on Nasdaq, in consideration for about 6.9 million Transition common shares. Transition has approximately 45.9 million common shares issued and outstanding, assuming the 4.5 million Class B common shares have been converted into common shares. Transition is a public company developing drugs for multiple sclerosis, diabetes and restenosis.
Orchid BioSciences Inc., of Princeton, N.J., launched its service for whole-genome single nucleotide polymorphism analyses, using an evenly spaced low-density SNP panel it assembled. Orchid said the service allows customers to conduct SNP-based whole-genome linkage scans, which are expected to facilitate the identification of loci associated with traits of interest. Orchid's stock (NASDAQ:ORCH) rose 35 cents Friday, or 29.2 percent, to close at $1.55.
Panacos Pharmaceuticals Inc., of Gaithersburg, Md., was awarded a $125,000 Phase I Small Business Innovative Research grant by the National Institutes of Health in Bethesda, Md. The award will help support preclinical development of its drug candidate PA-457, an inhibitor of HIV infection that was discovered in collaboration with researchers at the University of North Carolina at Chapel Hill. Currently in preclinical testing, Panacos said it would file an investigational new drug application for PA-457 to begin clinical trials within the next year.
Xenova Group plc, of Slough, UK, reported at the College on Problems of Drug Dependence meeting in Quebec Phase I trial safety and preliminary immunogenicity data analysis for its anti-nicotine vaccine, TA-NIC. The double-blind, randomized, placebo-controlled study showed TA-NIC to be safe and well tolerated both systemically and locally, and that the vaccine generated a specific anti-nicotine response in the 60 smokers and nonsmokers involved. The vaccine was administered by intramuscular injection and investigated at two dose levels in a variety of dosing regimens.