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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of San Diego, said it plans to start a 13-week preclinical safety program for AKP-020, a vanadium compound that has shown potential in Type II diabetes. The studies will be conducted by Charles River Laboratories Inc., of Wilmington, Mass.
? Amgen (Europe) GmbH, of Zug, Switzerland, said the European Commission approved the extension of its marketing authorization for Mimpara (cinacalcet) for the reduction of hypercalcemia in patients with primary hyperparathyroidism (PHPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but in whom parathyroidectomy is not clinically appropriate or is contraindicated. That approval was based on a review of Amgen's clinical efficacy and safety Mimpara data, along with a risk/benefit assessment in patients with hypercalcemia due to PHPT for whom surgery is not an option.
? CV Therapeutics Inc., of Palo Alto, Calif., said it has earned a milestone payment of $10 million from TPG-Axon Capital in connection with the commercial launch of Lexiscan by Astellas Pharma US Inc., of Deerfield, Ill. CV Therapeutics will recognize the milestone as revenue earned in the second quarter. CV Therapeutics received $175 million at the closing of a nondilutive financing transaction with TPG-Axon, in which TPG-Axon agreed to pay up to $185 million in exchange for rights to 50 percent of its royalty on North American sales of Lexiscan.
? Encore Therapeutics Inc., of Carlsbad, Calif., said it created a nano-emulsion intravenous formulation of progesterone that is suitable to treat stroke and traumatic brain injury. That product, ETI-411, is a lyophilized and easy to reconstitute and administer I.V. formulation. Encore anticipates finding a partner to help bring ETI-411 to market.
? Geneart AG, of Regensburg, Germany, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, signed a technology and sales collaboration, under which BI technology will transfer to Geneart for the production and purification of plasmid DNA. The partners plan to collaborate in the distribution and marketing of their complementary services. Financial terms were not disclosed.
? GeneGo Inc., of St. Joseph, Mich., said VTT Research Center of Finland licensed MetaCore and MetaDrug for use in high-throughput compound screening, RNA interference experiments, cell biology and bioinformatics products to identify pathways and networks important in translational cancer research. Terms were not disclosed.
? GeNOsys Inc., of Provo, Utah, signed a one-year service contract with the University of British Columbia for research in support of international programs targeting infectious disease control and prevention. Work will focus on the molecular pathogenesis of Mycobacterium tuberculosis and the identification of new targets for drug therapy, and it will involve the use of the nitric oxide generator and nitric oxide-generating tablets manufactured by GeNOsys.
? Genzyme Corp., of Cambridge, Mass., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., have completed a licensing and collaboration agreement for mipomersen, in which Isis will receive a $175 million licensing fee. Isis previously received a $150 million payment when the two firms began the collaboration. (See BioWorld Today, Jan. 9, 2008.) The companies have updated the deal terms so that Isis will contribute up to $50 million in additional development funding for mipomersen, bringing Isis' development funding commitment up to $125 million. Thereafter, Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for the additional contribution, Isis has the opportunity to receive $75 million in milestone payments early.
? Health Discovery Corp., of Savannah, Ga., reported Phase II results for its gene-based molecular diagnostic test for prostate cancer, which demonstrated a high success rate for identifying the presence of Grade 3 or higher prostate cancer cells, as well as normal and benign prostatic hyperplasia cells. Combining all the patients from both Phase I and Phase II studies, the test achieved a sensitivity of 91.3 percent for identifying the presence of prostate cancer cells, a specificity of 100 percent for correctly identifying normal prostate cells and a 90 percent specificity for identifying BPH cells. Overall test accuracy was 93.2 percent. The test is licensed exclusively to Clarient Inc., of Aliso Viejo, Calif.
? Helicos BioSciences Corp., of Cambridge, Mass., said it entered a scientific collaboration with the Children's Oncology Group to investigate a wide spectrum of genomic variation within various sarcomas in children and young adults. The collaboration will involve the use of Helicos' True Single Molecule Sequencing technology, which aims to measure the DNA sequence, methylation state and mRNA expression levels of normal, primary and metastatic cell states. It is hoped that an in-depth comparison of genomic DNA sequence and RNA expression between the normal tissue, primary tumor and treatment-resistant metastasis will reveal structural and functional genomic changes associated with clinical aggressiveness and treatment resistance.
? Intellect Neurosciences Inc., of New York, and MRC Technology, of London, said they achieved a milestone through their collaborative efforts to humanize Intellect's lead antibody, IN-N01, in Alzheimer's disease. IN-N01 is designed to promote clearance from the brain of beta amyloid, the toxin that leads to Alzheimer's disease.
? Micromet Inc., of Bethesda, Md., started formal preclinical safety studies of anti-GM-CSF human antibody MT203, which triggered a $775,000 milestone payment from partner Nycomed A/S, of Zurich, Switzerland. Under a 2007 deal, the companies agreed to develop MT203 for inflammatory and autoimmune indications. To date, preclinical studies support the compound's development in rheumatoid arthritis and several other indications, including multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease.
? Novartis AG, of Basel, Switzerland, said the Novartis Institute for Tropical Diseases signed a five-year collaboration with the Global Alliance for TB Drug Development aimed at creating new medicines for tuberculosis, including drug-resistant TB. Under the terms, the partners will share information on new and ongoing TB drug discovery projects. Financial details were not disclosed.
? Pressure BioSciences Inc., of South Easton, Mass., said it was awarded a Phase II Small Business Innovation Research grant from the National Institutes of Health to help fund continuing experiments directed toward the development and commercialization of automated and reproducible methods for extracting clinically important protein biomarkers, subcellular molecular complexes and organelles from cells and tissues using the company's pressure cycling technology. The grant is expected to total $850,000 over two years.
? Replidyne Inc., of Louisville, Colo., said it has decided to terminate its license agreement with Tokyo-based Asubio Pharma Co. Ltd., a subsidiary of Tokyo-based Daiichi Sankyo Co. Ltd., for faropenem medoxomil (faropenem). The company also said it terminated its supply agreement with Asubio and Nippon Soda Co. Ltd., of Tokyo, for production of faropenem. As a result, Replidyne will take charges of about $9 million. Replidyne said the decisions were based on its not being able to secure a partner for the faropenem program. Replidyne had discontinued clinical development of faropenem pending the outcome of discussions with potential partners for the program.
? Scil Proteins Production GmbH, of Halle, Germany, closed a protein production deal with Basel, Switzerland-based F. Hoffmann-La Roche Ltd., under which Roche will transfer technology and know-how for the production of recombinant plasminogen activator, the active ingredient of Rapilysin for acute myocardial infarction, to Scil. Rapilysin is marketed by generic firm Actavis Ltd., of Reykjavik, Iceland. Terms of the deal were not disclosed.
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