• Actelion Ltd., of Allschwil, Switzerland, said that it will take a $80 million loss in 2009 profits as a result of an arbitration panel's decision calling for its subsidiary CoTherix to pay Asahi Kasei Pharma Corp., of Tokyo, about $91 million, plus interest. The arbitration proceeding in California stems from a dispute over a 2006 licensing agreement between CoTherix Inc. and Asahi Kasei regarding the development of the Japanese company's rho kinase inhibitor, fasudil. In 2007, Asahi Kasei was advised that CoTherix would not continue development of fasudil, and thereafter the Swiss firm returned fasudil to Asahi Kasei. Asahi Kasei disputed the basis for terminating the development and began the arbitration proceeding in October 2007. Asahi Kasei also filed a lawsuit against Actelion and certain subsidiaries in 2008 in California state court. The lawsuit is ongoing.

• Applied NeuroSolutions Inc., of Vernon Hills, Ill., agreed to increase the scope of its Alzheimer's disease drug discovery collaboration with Indianapolis-based Eli Lilly and Co. and will receive an up-front cash payment of $750,000 and be eligible for up to $25.5 million in milestones plus royalties. That's in addition to the original terms of the 2006 agreement, in which Lilly agreed to pay $2 million up front. (See BioWorld Today, Nov. 29, 2006.)

• Arena Pharmaceuticals Inc., of San Diego, has submitted a new drug application to the FDA for weight loss drug candidate, lorcaserin. In addition to the pivotal program, Arena is evaluating lorcaserin in obese and overweight patients with Type II diabetes in its BLOOM-DM trial. BLOOM-DM is planned as a supplement to the NDA. Rodman & Renshaw analyst Elemer Piros wrote that he expects competitors Vivus Inc., of Mountain View, Calif., and Orexigen Therapeutics Inc., of San Diego, to submit applications for their respective obesity drug candidates within the next few months. Cowen & Co. analyst Phil Nadeau stated that an FDA advisory panel meeting on lorcaserin is likely to occur in third quarter 2010 and said consultants to his firm generally expect the FDA to approve the drug.

• Bioheart Inc., of Sunrise, Fla., said it has made a breakthrough in critical limb ischemia therapy with stem cells obtained from adipose (fat) tissue. The stem cells aid in promoting angiogenesis or the formation of new blood vessels and providing support for the healing of damaged blood vessels. Bioheart, in collaboration with University Hospital Ostrava in the Czech Republic, has already begun treating patients with critical limb ischemia using adipose stem cells. The cells can be separated from the fat cells very quickly with BioHeart's TGI system, making treatment after an event like a heart attack more efficient, the company said. In contrast, the alternative procedure is to use bone marrow to obtain stem cells, which is extremely painful and often yields a low volume of stem cells, according to BioHeart.

• Cephalon Inc., of Frazer, Pa., said that the FDA has extended its action date to March 29, 2010, for its review of the supplemental new drug application for Nuvigil (armodafinil) tablets [C-IV]. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Cephalon said that it does not anticipate any further delays beyond the March action date.

• Clarient Inc., of Aliso Viejo, has acquired privately held Applied Genomics Inc., of Huntsville, Ala., in an all-stock merger valued at up to $17.6 million. AGI would become a wholly owned subsidiary of Clarient. Under the agreement, Clarient acquired all of the outstanding capital stock of AGI in exchange for up to an aggregate of 7.6 million shares of Clarient common stock. Clarient CEO Ron Andrews said that AGI will provide Clarient a pipeline of cancer tests, including the planned commercial launch of an important lung cancer test Pulmotype in the first quarter of 2010.

• CombinatoRx Inc., of Cambridge, Mass., and Neuromed Pharmaceuticals Inc., of Vancouver, British Columbia, completed their merger and will trade on Nasdaq under the symbol "CRXX." Under the merger agreement, CombinatoRx issued about 14.9 million shares, with another 67.8 million placed in escrow to be released based upon the outcome and timing of the FDA's review of pain drug Exalgo (hydromorphine). The drug's application suffered a setback in November, when FDA reviewers said it was not sufficient in its current form. The FDA extended the PDUFA date by three months, until Feb. 22, 2010. (See BioWorld Today, July 2, 2009, and Nov. 17, 2009.)

• Fibrocell Science Inc., of Exton, Pa., received a complete response letter for azficel-T, an autologous cell therapy to treat moderate to severe nasolabial fold wrinkles in adults. The FDA requested that the company provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T and also requested finalized chemistry, manufacturing and controls. Shares of Fibrocell (OTC BB:FCSC) lost 1 cent, to close Tuesday at $1.14.

• Organogenesis Inc., of Canton, Mass., filed a premarket approval application for its CelTx product, a living cellular construct for oral soft-tissue regeneration, specifically the regeneration of new gum tissue for patients with gingival recession. CelTx is composed of human fibroblasts, keratinocytes and extracellular matrix proteins.

• PDL BioPharma Inc., of Incline Village, Nev., entered a nonexclusive license agreement with Eli Lilly and Co., of Indianapolis, under PDL's Queen et al patents with respect to teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other next-generation anti-CD3 molecules. Teplizumab is in development by Lilly and partner, MacroGenics Inc., of Rockville, Md., for treating patients with newly diagnosed Type I diabetes mellitus. No financial terms were disclosed.

• PGxHealth, a division of Clinical Data Inc., of Newton, Mass., established a research collaboration with Deutsches Herzzentrum, of Munich, Germany, to evaluate the predictive value of genetic markers, including PGxHealth proprietary markers, for response to clopidogrel (Plavix). PGxHealth scientists will collaborate with researchers at DHZ to conduct a large retrospective case/control study to validate genetic variants associated with response to clopidogrel.

• QLT Inc., of Vancouver, British Columbia, established a U.S. subsidiary, QLT Ophthalmics Inc., to take on sales and marketing of Visudyne (verteporfin) photodynamic therapy in the U.S. from Basel, Switzerland-based Novartis Pharma AG, effective Jan. 1. Under the companies' amended deal, QLT will receive exclusive U.S. rights, while Novartis retains responsibility for sales and marketing of the product in all other countries.

• Santarus Inc., of San Diego, received a $20 million milestone payment from Kenilworth, N.J.-based Schering-Plough HealthCare Products Inc. (now part of Merck & Co. Inc.) relating to the approval of Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1,100 mg capsules) for frequent heartburn.

• Shire plc, of Basingstoke, UK, submitted a biologics license application for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. The product already is available to patients under an early access program set up by the FDA to address shortages after production of the only available ERT for Fabry disease, Cerezyme (imiglucerase) from Cambridge, Mass.-based Genzyme Corp. was temporarily halted after a virus was detected in bioreactors used to manufacture Cerezyme. Another ERT, Carmiel, Israel-based Protalix BioTherapeutics Inc.'s Uplyso (taliglucerase, now partnered with Pfizer Inc.) is expected to complete a rolling BLA shortly. Shire's Replagal received marketing approval in Fabry disease in Europe in 2001. (See BioWorld Today, July 7, 2009, Nov. 5, 2009, and Dec. 2, 2009.)

• To-BBB Technologies BV, of Leiden, the Netherlands, entered a research collaboration with H. Lundbeck A/S, of Copenhagen, Denmark, to evaluate the delivery of antibodies to the brain for central nervous system diseases. To-BBB's G-Technology is designed to deliver drugs across the blood-brain barrier, and the firm has shown proof of concept in several model systems, including brain microdialysis, pain inhibition, viral encephalitis and brain tumors. Terms of the deal were not disclosed.

• Vivalis, of Nantes, France, said an undisclosed veterinary client exercised its option for a commercial license after evaluating the company's EB66 technology in the frame of a research license. Terms of the deal were not disclosed.

• XOMA Ltd., of Berkeley, Calif., said its independent registered public accounting firm agreed to remove its going concern qualification. The company requested the removal following an improvement in its financial status and full repayment of an outstanding loan. The going concern qualification was based on XOMA's need to repay or restructure its then-outstanding loan as a result of the cessation of royalties from sales of psoriasis drug Raptiva (efalizumab), which was pulled from the market early this year following reports of progressive multifocal leukoencephalopathy. (See BioWorld Today, April 10, 2009.)

• ZymoGenetics Inc., of Seattle, is restructuring its U.S. co-promotion and ex-U.S. license and collaboration agreements with Bayer Schering Pharma AG and Bayer HealthCare, both part of Bayer AG, of Leverkusen, Germany, relating to Recothrom Thrombin, topical (recombinant), now that Bayer has handed back rights to the product. Effective Jan. 1, ZymoGenetics will regain full promotion rights in the U.S. and all ex-U.S. rights except in Canada, where Bayer will market and sell the product. ZymoGenetics plans to increase the size of its field force to compensate for Bayer's exit but expects to see a decrease in its selling costs. Beginning in 2010, Bayer will receive a reduced sunset period commission through Dec. 31, 2011, which was previously capped at $25 million per year and now will be subject to an aggregate maximum of $12 million. ZymoGenetics will no longer be required to pay Bayer U.S. sales bonus payments totaling $20 million, which were anticipated to have been payable in 2010 and 2011 or upon termination of the co-promotion agreement. Bayer will no longer be required to pay ZymoGenetics up to $16 million in milestone payments for ex-U.S. regulatory approvals.