• Anavex Life Sciences Corp., of Geneva, said that preclinical data showed that its colorectal drug candidate ANAVEX 7-1037, a novel small synthetic sigma ligand, kills human HCT116 colon cancer cells and demonstrated its ability to significantly suppress tumor growth in immune-deficient mice.
• Anesiva Inc., of South San Francisco, and Medical Futures Inc., of Richmond Hill, Ontario, announced an agreement granting an exclusive license to Medical Futures for the marketing and distribution of Anesiva's Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system in Canada. Medical Futures will be responsible for all regulatory filings, marketing, distribution and selling in Canada. No financial terms were disclosed.
• Aureus Pharma, of Paris, said it has licensed its AurSCOPE Ion Channel Knowledge database to Neuromed Pharmaceuticals Ltd., of Vancouver, British Columbia. The database contains biological activity mined from the scientific literature for all known ion channels and can be used by pharmaceutical researchers to rapidly access prior knowledge related to ion channels for all stages of the drug discovery process.
• Biovail Corp., of Toronto, has agreed to a $138 million settlement for a shareholder lawsuit alleging the company fraudulently inflated its stock value. The settlement class includes those who bought common stock between Feb. 7, 2003, and March 2, 2004. Biovail said it will pay about $85 million after insurance claims. The lawsuit, filed in June 2004, claimed the company made false and misleading statements to inflate the value of the stock price.
• Celsion Corp., of Columbia, Md., has re-filed for a special protocol assessment with the FDA for the design of its Phase III trial of ThermoDox (thermally sensitive liposomal doxorubicin) in combination with radiofrequency ablation to treat patients with nonresectable hepatocellular carcinoma. The submission retains the previously proposed global trial design, with clarifications requested by the FDA. The Phase III trial will continue to be a randomized, double-blinded trial and examine the efficacy and safety of ThermoDox plus RFA vs. RFA alone. As proposed, the global trial is expected to enroll and randomize approximately 600 patients.
• Curidium Medica plc, of London, has entered into a strategic partnership with Takeda Research Investment Inc., the corporate investment arm of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. TRI will purchase 10,491,803 ordinary shares and warrants for 20 million additional ordinary shares in Curidium, which will use the proceeds for research, using its platform Homomatrix, to identify potential patient subgroups within major depressive disorder characterized by unique gene expression profiles and specific drug targets. The warrant exercise is dependent on completion of the research program and future licensing. In addition, TRI and Curidium have entered into a license option agreement in which Takeda Pharmaceutical, through TRI, receives an option right to select major depressive disorder biomarker and drug target discoveries made by Curidium and to negotiate a license to the intellectual property rights in those assets. Financial terms were not revealed, but are expected to include up-front payments, milestones and royalties on product sales.
• Gene Logic Inc., of Gaithersburg, Md., said that its shareholders have approved the sale of its genomics assets to Ocimum Biosolutions, of Indianapolis. Gene Logic is changing its name to Ore Pharmaceuticals Inc. The company's stock will continue to trade on the NASDAQ exchange, but its stock ticker will change to ORXE. The firm said that, as a new company, Ore Pharmaceuticals will be focused on drug repositioning and development. Ownership of the name Gene Logic will transfer to Ocimum on the date of closing of the sale agreement.
• Generex Biotechnology Corp., of Worcester, Mass., said the Ministry of Health of the United Arab Emirates, Drugs Control Department, has issued a nonobjection letter to the Imperial College London Diabetes Centre to import Generex Oral-lyn, Generex's oral insulin spray product, into Abu Dhabi. The importation can be done via the issuance of a purchase order from the Imperial College London Diabetes Centre to a drug store or pharmacy licensed by the Ministry of Health of the United Arab Emirates.
• Gilead Sciences Inc., of Foster City, Calif., and Bristol-Myers Squibb Co., of Princeton, N.J., have entered into an agreement to commercialize Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe for the treatment of virologically suppressed adults with HIV-1 infection, subject to the product's approval by the European Commission. If approved, Atripla would represent the first once-daily single tablet regimen for HIV-1 infection in the European Union. The companies expect a decision by the end of the year. Under the agreement, Bristol-Myers Squibb and Gilead share responsibility for commercializing the drug throughout the EU and certain other European countries. Gilead will record revenues from future net sales of Atripla in most of the European countries, while Bristol-Myers Squibb will record revenues in most of the European countries at percentages relative to the contribution represented by its individual product.
• Martek Biosciences Corp., of Columbia, Md., has entered into a tentative settlement of all claims in the securities class action litigation filed in the U.S. District Court in Maryland alleging violations of the Securities Exchange Act. Market will pay $6 million which will result in the dismissal of the claims against Martek and all other defendants, subject to final court approval.
• Millipore Corp., of Billerica, Mass., and Novozymes AS, of Bagsvaerd, Denmark, said they have entered into an agreement to develop, market and sell animal-free cell culture supplements, which help mammalian cells produce the proteins that form the basis of biologic drugs. The supplements, which will be sold under the brand name CellPrime, will be made by Novozymes and sold by Millipore. The alliance expands the existing relationship between Millipore and Novozymes and will initially focus on developing recombinant human albumin and recombinant human transferring, the firms said.
• MorphoSys AG, of Martinsried, Germany, has entered into a therapeutic target sourcing collaboration in Japan with its Tokyo-based partner GeneFrontier Corp. The expansion of the existing alliance with GeneFrontier aims to increase MorphoSys's access to druggable therapeutic targets from leading Japanese research institutes and universities. Financial details of the agreement were not disclosed. Research institutes in Japan will be offered access to HuCAL-based research antibodies against disease-related target molecules in exchange for commercialization rights. Antibodies for selected projects will be generated by GeneFrontier using MorphoSys's HuCAL antibody technology. MorphoSys will have access to all research results and data around the selected research programs and the option to secure worldwide rights on such antibody programs.
• Oncothyreon Inc., of Bellevue, Wash., said that its common stock began trading Tuesday on the Nasdaq Global Market under the symbol ONTY and on the Toronto Stock Exchange under the symbol ONY. Oncothyreon Inc. changed its name from Biomira Inc. as part of its move of jurisdiction of incorporation from Canada to Delaware. Shareholders of the former Biomira received one share of Oncothyreon common stock for each six shares of Biomira that they held.
• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., said it has started manufacturing its PC Detect kits, a diagnostic test for prostate cancer. PC Detect has demonstrated sensitivity and specificity of greater than 90 percent in identifying men with prostate cancer, the firm reported. The kit was initially launched in May 2007 as a laboratory service by Panacea's laboratories division, which is regulated under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity testing. The company said it is seeking FDA approval of the kit, which could lead to the wider distribution and availability of the test through clinical laboratories and hospitals across the U.S. Panacea said it is seeking to identify one or more partner companies to facilitate the distribution and commercialization of PC Detect in the U.S. and other countries.
• Replidyne Inc., of Louisville, Colo., is undertaking a restructuring that includes laying off 35 percent of its staff, refining its pipeline priorities and searching for a partner for its late-stage antibiotic, faropenem medoxomil (faropenem). It will retain key research and development people to progress promising preclinical programs, including REP3123, its investigational antibacterial for C. difficile-associated disease and its DNA replication inhibition program. But it will suspend development of topical antibiotic REP8839 due to the cost of moving it forward. As of Nov. 30, Replidyne had cash assets of approximately $93 million. Based on planned clinical trials and development activities, plus the restructuring, the company has funds for at least the next two fiscal years, it said. It expects to include a restructuring expense of approximately $1.5 million primarily related to employee severance payments. Faropenem is an antibiotic intended to treat adult respiratory tract infections including acute bacterial sinusitis, community-acquired pneumonia and acute exacerbation of chronic bronchitis. Phase III trials are planned in each indication.