• Active Biotech AB, of Lund, Sweden, said the European Medicines Agency completed the validation process for the marketing authorization application for laquinimod in relapsing-remitting multiple sclerosis (MS), triggering a $5 million milestone payment from partner Teva Pharmaceutical Industries Ltd., of Jerusalem. The acceptance of the filing now leads to a formal scientific review process by Europe's Committee for Medicinal Products for Human Use. In the U.S., Active Biotech and Teva said they continue to work with the FDA to determine a regulatory path for laquinimod, a once-daily, oral immunomodulator, in MS.

• Anavex Life Sciences Corp., of Vancouver, British Columbia, reported a synergic effect between its Alzheimer's disease candidate Anavex 2-73 and the Alzheimer's treatments Aricept (donepezil, Pfizer Inc.) and Namenda (memantine, Forest Laboratories Inc.). The preclinical study, conducted at the University of Montpellier and INSERM, in France, suggested Anavex 2-73 displayed anti-amnesic and neuroprotective effects and showed potential benefits when administered with donepezil, including efficacy in reversing learning impairments and toxicity. The data were presented at the Alzheimer's Association International Conference in Vancouver.

• Biogen Idec Inc., of Weston, Mass., entered a research collaboration with labs at Duke University and the HudsonAlpha Institute for Biotechnology to sequence the genomes of up to 1,000 patients with amyotrophic lateral sclerosis (ALS) to learn more about the fundamental genetic causes of the disease. Biogen is funding the project at the labs of David Goldstein, director of Duke's Center for Human Genome Variation, and Richard M. Myers, president and director of the HudsonAlpha Institute. The researchers will sequence the genomes of about 500 patients with ALS over the next two years, with an ultimate goal of sequencing 1,000 ALS genomes within five years. Others in the consortium include scientists at the University of Massachusetts Medical School, Stanford University, Columbia University and the University of Montreal.

• BioTime Inc., of Alameda, Calif., signed an exclusive sublicense agreement and a supply agreement with Jade Therapeutics LLC, of Park City, Utah, to provide clinical-grade HyStem hydrogels and other technology for use by Jade in developing pharmaceutical products for ophthalmologic use. Jade plans to use the hydrogels for time-release topical delivery of recombinant human growth hormone to help heal lesions on the ocular surface. Jade retained marketing rights to products developed from the partnership. Financial terms were not disclosed.

• Clovis Oncology Inc., of Boulder, Colo., and Array BioPharma Inc., also of Boulder, Colo., partnered to discover a new KIT inhibitor for gastrointestinal stromal tumors. Clovis will be responsible for preclinical and clinical development and commercialization, as well as development of a companion diagnostic. Financial terms were not disclosed.

• Emmaus Medical Inc., of Torrance, Calif., said the European Commission granted orphan designation for Levoglutamide in sickle cell disease. That designation would guarantee up to 10 years of marketing exclusivity in Europe upon approval. Levoglutamide is in Phase III testing.

• Isotechnika Pharma Inc., of Edmonton, Alberta, received funding from the National Research Council Industrial Research Assistance Program for research into the use of non-immunosuppressive cyclosporin analogue molecules for ischemia-reperfusion injury. The compounds also are being studied in a three-year collaboration with National Institutes of Health-funded contracters evaluating them for biodefense and infectious disease.

• NuPathe Inc., of Conshohocken, Pa., said it resubmitted its new drug application for migraine patch NP101, and expects confirmation from the FDA regarding acceptance, resubmission clarification and PDUFA date within the next few weeks. The firm continues to expect a six-month review by the agency. NuPathe originally filed for approval of the transdermal sumatriptan patch, known as Zelrix, in 2010, but the FDA issued a completed response letter last year, requesting additional information. (See BioWorld Today, Aug. 31, 2011.)

• OPKO Health Inc., of Miami, said Thomas Kodadek, a professor at the Scripps Research Institute and the company's director of chemistry and molecular biology, presented data on OPKO's blood serum test for Alzheimer's disease at the Alzheimer's Association International Conference in Vancouver, British Columbia. The presentation provided data from blinded studies of clinically characterized serum samples and autopsy-confirmed plasma samples, demonstrating the utility of OPKO's disease-specific small molecule-antibody complexes in the diagnosis of established Alzheimer's disease, including 100 percent diagnostic specificity in a blinded study of 36 autopsy-confirmed plasma samples. Kodadek also revealed the discovery of peptoids that capture diagnostic autoantibodies for the demyelinating disease neuromyelitis optica (NMO). OPKO plans to commercialize a serum test based on four of the markers that provided a diagnostic sensitivity of 90 percent and a diagnostic specificity of 100 percent to distinguish NMO patients from those with multiple sclerosis or other disorders that may require different treatment regimes.

• Soligenix Inc., of Princeton, N.J., received a $600,000 Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to support additional preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate) in gastrointestinal acute radiation syndrome. The award will fund about two years of study of the potentially life-threatening consequence of exposure to high-dose radiation following a serious nuclear event.

• StemCells Inc., of Newark, Calif., reported preclinical data showing that its human neural stem cells restored memory and enhanced synaptic function in two animal models. Results showed that transplanting the cells into a specific region of the brain, the hippocampus, statistically increased memory, without requiring the reduction in beta amyloid or tau that accumulate in the brains of Alzheimer's patients and account for the pathological hallmarks of the disease. Those data were presented at the Alzheimer's Association International Conference in Vancouver, British Columbia. Shares of StemCells (NASDAQ:STEM) jumped 93 cents, or 107 percent, on the news to close Tuesday at $1.80.

• Summit plc, of Oxford, UK, presented positive preclinical data for its O-linked N-acetylglucosaminidase (OGA) inhibitor program at the Alzheimer's Association International Conference in Vancouver, British Columbia. The data show that small-molecule OGA inhibitors reduce tau phosphorylation in vitro and in vivo. The OGA inhibitors were developed using Summit's Seglin platform.

• Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said the Supreme Court of British Columbia recently ruled that the litigation pending in Massachusetts Superior Court against Vancouver-based AlCana Technologies Inc. and Cambridge, Mass.-based Alnylam Pharmaceuticals Inc. should be resolved prior to proceeding to trial in the British Columbia litigation. Tekmira filed suit in Massachusetts last year, alleging misappropriation of information regarding Tekmira's siRNA delivery technology and seeking damages from RNAi partner Alnylam.