Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group launched Design-on-Demand Arrays, a catalog of microarray-expression products for microbial, eurkaryotic and viral genomes. The arrays offer scientists a tool to conduct whole-genome expression studies on a range of organisms, including influenza, HIV, anthrax and severe acute respiratory coronavirus.
Adenosine Therapeutics LLC in Charlottesville, Va., was awarded a Phase II SBIR grant from the National Institutes of Health in Bethesda, Md. The grant will fund research in collaboration with the University of Virginia to test the effectiveness of combining two anti-inflammatory drugs, ATL146e and a Type-IV phosphodiesterase inhibitor, in a drug-eluting stent. The amount of the award is about $1.2 million over a two-year period.
Adherex Technologies Inc., of Research Triangle Park, N.C., completed its acquisition of Cadherin Biomedical Inc., of Toronto. Terms of the $1.2 million deal call for Adherex to issue about 3.2 million shares in exchange for all of the issued and outstanding shares of Cadherin, or about 0.069 shares of Adherex common stock for each share of Cadherin preferred stock held (subject to any claims made against the 500,000 Adherex shares to be held in escrow). The acquisition settles outstanding litigation between the companies, Adherex said.
AEterna Zentaris Inc., of Quebec, received German approval for Impavido (miltefosine), an orally administered therapy for visceral and cutaneous leishmaniasis. The approval allows the company to market it in Germany, as well as to distribute it to military personnel who have become infected with leishmaniasis while serving in Afghanistan and Iraq. In addition, the approval enables AEterna Zentaris to receive a free sales certificate, which could provide the basis for registration in countries where leishmaniasis is endemic, such as Colombia and Pakistan.
Amnis Corp., of Seattle, launched its flagship product, the ImageStream 100 cell-analysis system. The ImageStream system combines the image quality of a microscope and the statistical power of a flow cytometer.
Applied Biosystems Group, of Foster City, Calif., introduced a new forensic identification kit for the detection of male DNA. The AmpFistr Yfiler PCR Application Kit enables forensic scientists to detect low levels of male DNA in the presence of large amounts of female DNA, a situation routinely encountered in cases of sexual assault, the company said.
BioMarin Pharmaceutical Inc., of Novato, Calif., filed for European approval of Aryplase (galsulfase), an investigational enzyme-replacement therapy for mucopolysaccharidosis-VI. The company, which last week filed for FDA approval, said the product has received orphan designation in Europe. (See BioWorld Today, Nov. 30, 2004.)
BioVision AG, of Hannover, Germany, said CEO Sven Rohmann founded a new company, ImVision GmbH, to develop therapies to cure allergic diseases. ImVision will be an independent company. The lead compound will target cat allergy. Trials are anticipated to start next year.
Cyclacel Group plc, of Dundee, UK, presented a series of small-molecule, cell-cycle drugs inhibiting Aurora kinase in a poster presentation at the American Association for Cancer Research Cell Cycle and Cancer: Pathways and Therapies conference in Fort Lauderdale, Fla. Cyclacel has advanced a lead compound from the series into preclinical development.
CytRx Corp., of Los Angeles, said arimoclomol accelerated the regeneration of damaged nerves in animals. The company plans to begin a Phase II trial for ALS, or Lou Gehrig's disease, in the second quarter. On Monday, CytRx's stock (NASDAQ:CYTR) gained 17 cents, or 13.4 percent, to close at $1.44.
Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., began commercial sales of DepoDur (morphine sulfate extended-release liposome injection), a pain product delivered as a single epidural shot using DepoFoam technology. SkyePharma plc, of London, developed the product and licensed North American rights to Endo. It received FDA approval in May.
Endovasc Inc., of Montgomery, Texas, completed a study of a drug delivery system at the University of Texas at Arlington. Stemming from an earlier deal between Endovasc and Dallas-based TissueGen Inc., which holds the license to the system, the study evaluated the Angiogenix delivery system's ability to promote blood vessel formation in an animal implantation model developed at the university. It found that low levels of nicotine affect the proliferation of new capillaries that seemed to convene to form small vessels over a 14-day period. The findings confirm earlier data suggesting nicotine boosts the body's angiogenic powers in patients with chronic ischemic conditions, Endovasc said.
Gene-IT Inc., of Worcester, Mass., released the GenomeQuest GeneRef MAX, which contains more than 266,000 transcripts from six public data sources and is cross-referenced with microarray probe sets and genetic sequences found in patent literature. The company also released a network broadcast service to sequence content from worldwide sequence repositories.
ID Biomedical Corp. of Vancouver, British Columbia, entered several agreements for U.S. marketing and distribution of its Fluviral vaccine that together could mean sales upward of $2 billion. The proposed deals are with Henry Schein Inc., AmerisourceBergen Corp.'s specialty group and McKesson Corp. Fluviral is expected to be licensed in the U.S. no later than the 2007-08 flu season, and ID anticipates recognizing $2.3 billion in revenue, which could rise to $2.5 billion if the vaccine receives accelerated approval for the 2005-06 and 2006-07 seasons. The company's stock (NASDAQ:IDBE) rose $1.55 Monday to close at $18.36. The U.S. lost nearly half of its targeted supply of flu shots earlier this year, when Emeryville, Calif.-based Chiron Corp. announced contamination issues at its UK manufacturing facility.
Ingenuity Systems, of Mountain View, Calif., licensed the Ingenuity Pathways Analysis application to Merck & Co. Inc., of Whitehouse Stations, N.J. Under the multiyear agreement, Merck scientists will use Ingenuity's software and knowledge of biological networks and pathways curated from public literature. The Ingenuity Pathways Analysis application will be used in synergy with Merck's Molecular Profiling tools, technologies and databases.
LAB International Inc., of Laval, Quebec, plans to begin in the first quarter a Phase II trial of its growth hormone-releasing hormone analogue in malnutrition in patients with late pre-end-stage chronic renal failure. That is the first clinical indication for which the company intends to evaluate the efficacy of the 29-amino-acid peptide analogue of GHRH.
Maxygen Inc., of Redwood City, Calif., said it would advance a Factor VII program into preclinical development, but as part of its ongoing internal portfolio prioritization, will terminate development of its interferon beta program. In animal models, MAXY-VII has demonstrated efficacy and an improved in vivo circulating half-life compared to alternative products. It appears to stimulate more rapid and increased thrombin generation in blood, resulting in a significant reduction in blood loss in relevant preclinical models, Maxygen said.
Medarex Inc., of Princeton, N.J., and privately held PharmAthene Inc., of Annapolis, Md., entered a collaboration to develop and commercialize MDX-1303, a fully human monoclonal antibody targeting the Bacillus anthracis protective antigen. They agreed to jointly investigate the product's use as a therapeutic for individuals with active disease, as well as for prophylactic treatment of individuals exposed to anthrax. Medarex will receive an initial payment, which will be used to fund development activities already under way. PharmAthene will be responsible for funding future research and development activities that are not supported by government funds. The companies will share profits according to a pre-agreed allocation percentage. Specific financial terms were not disclosed.
MiraiBio Inc., of Alameda, Calif., previewed MasterPlex CT control and data collection software for the Luminex 100 multiplex assay-detection system at the American Society of Cell Biology conference Monday in Washington. MiraiBio is an authorized software partner of Luminex Corp., of Austin, Texas. MasterPlex CT software will be commercially available on Dec. 29.
NanoBio Corp., of Ann Arbor, Mich., named Michael Nestor CEO. Before joining the antimicrobial company, he served as president of Alpharma Branded Products, a specialty pharmaceutical unit of Alpharma Inc.
Nautilus Biotech, of Paris, and Angel Biotechnology, of Northumberland, UK, signed an agreement on the GMP manufacture of Nautilus' interferon-alpha product, Belerofon, for Phase I development. The non-pegylated, single-amino-acid variant of natural interferon-alpha offers lower frequency of administration and dosing than marketed pegylated interferon-alpha, Nautilus said. Belerofon is indicated for conditions including chronic hepatitis C and cancer.
Novasite Pharmaceuticals Inc., of San Diego, entered an alliance with the Stanley Medical Research Institute to discover drugs for schizophrenia. The institute will provide clinical guidance and fund research at Novasite, which will work to discover allosteric modulator drugs for schizophrenia acting on a validated G protein-coupled receptor target. Michael Knable and John Davis of the institute joined Novasite's scientific advisory board in the process.
Novavax Inc., of Malvern, Pa., reconfirmed its development strategy for Androsorb in light of a recent FDA advisory panel vote on Cincinnati-based Procter & Gamble Co.'s Intrinsa testosterone patch. The panel asked for additional tests to determine the product's long-term effects. Following establishment of its safety and efficacy in treating female sexual dysfunction, Novavax will focus on Androsorb's clinical development. The topical testosterone therapy is based on the company's micellar nanoparticle technology, which also was used in Estrasorb, its FDA-approved topical estrogen therapy launched in June.
Pain Therapeutics Inc., of South San Francisco, said clinical results demonstrate that Remoxy is significantly less abusable than Oxycontin. In a clinical study, 10 volunteers received either a crushed dose of Remoxy or Oxycontin with a glass of water. The study was repeated in the same subjects two days later with high-proof alcohol. In each study, levels of oxycodone (the active ingredient in both drugs) were measured from volunteers' blood samples, and, in both cases, oxycodone levels were significantly lower in the Remoxy group than the Oxycontin group within 120 minutes of ingestion (p<0.05), when drug abusers presumably expect to get high.
Pharsight Corp., of Mountain View, Calif., released the Drug Model Explorer Web Server, called DMX. DMX is a web-based commercialized software tool that allows users to access and use data contained within drug and disease models.
Praecis Pharmaceuticals Inc., of Waltham, Mass., said its commercialization of Plenaxis (abarelix for injectable suspension) in the U.S. has faced challenges, leading the company to forecast lower sales this quarter than it had in the preceding three-month period. Despite the shortfall, Praecis still expects to end the year with cash, cash equivalents and marketable securities of at least $75 million. On Monday, its stock (NASDAQ:PRCS) dropped 56 cents, or 25.8 percent, to close at $1.61.
Proteo Inc., a unit of Kiel, Germany-based Proteo Biotech AG, signed an exclusive license collaboration with Artes Biotechnology GmbH, of Dusseldorf, Germany, to produce Elafin on a recombinant basis with the yeast strain, Hansenula polymorpha. Using Artes' Hansenula technology as an expression system enables large-scale development of the compound, an inhibitor of human elastase and proteinase 3 that has shown promise in treating tissue and muscle damage, Proteo said.
Renovis Inc., of South San Francisco, said AstraZeneca plc, of London, exclusive licensee of Cerovive, has completed the enrollment of patients in SAINT I, one of two Phase III trials being conducted to determine the effect of Cerovive on disability and neurological recovery in acute ischemic stroke patients. Enrollment is continuing in the parallel Phase III trial and in a Phase IIb trial that is being conducted to assess the safety and tolerability of 72-hour intravenous infusion of Cerovive in adult patients with acute intracerebral hemorrhage.
Sinovac Biotech Ltd., of Beijing, said Phase I results showed that its inactivated vaccine for severe acute respiratory syndrome showed no obvious side effects and induced the production of SARS-neutralizing antibodies. The findings were produced after completion of a 56-day observation period of all 36 subjects participating in the trial.