• Ambrx Inc., of San Diego, entered a deal with Indianapolis-basedEli Lilly and Co. to discover and develop drugs in several therapeutic areas, including metabolic diseases, central nervous system disorders and other diseases. The collaboration will apply Ambrx's protein optimization technology, ReCODE, with Lilly's expertise in biologics discovery, development and commercialization to develop drug candidates, which could include therapeutic antibodies and improved variants of native proteins. Specific financial terms were not disclosed, but Ambrx expects to receive an up-front payment and ongoing research support payments, and might also receive milestones if assets resulting from the collaboration are successfully commercialized.

• Biota Holdings Ltd., of Melbourne, Australia, said the Australian Supreme Court referred the company's ongoing litigation against London-based GlaxoSmithKline plc to mediation and directed that the mediation be completed by May 16, 2008. Biota has alleged that GSK failed to property develop and promote the licensed influenza drug Relenza.

• Crucell NV, of Leiden, the Netherlands, entered a nonexclusive STAR research license agreement with ProFibrix BV, also of Leiden, covering the production of specific forms of human fibrinogen, a protein involved in haemostasis and tissue repair. The STAR technology is used for producing recombinant human antibodies and proteins. Financial terms were not disclosed.

• Gene Logic Inc., of Gaithersburg, Md., completed the sale of its genomics assets to Ocimum Biosolutions Ltd., of Indianapolis. Gene Logic received $7 million, with an additional $3 million to be payable pursuant to a promissory note due 18 months from the closing date. The company's name changed to Ore Pharmaceuticals Inc.

• Genzyme Corp., of Cambridge, Mass., said the FDA approved a supplemental indication for Thyrogen (thyrotropin alfa) for use in combination with radioiodine to ablate the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Thyrogen initially was approved in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer.

• Gilead Sciences Inc., of Foster City, Calif., and Bristol-Myers Squibb Co., of Princeton, N.J., said the European Commission granted marketing approval of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for commercialization in the 27 countries of the European Union, as well as in Norway and Iceland. Atripla, which combines the active ingredients of Gilead's Emtriva and Viread with BMS's Sustiva, is approved for HIV-1 infection in adults with virologic suppression to HIV-1 RNA levels < 50 copies/ml on their current combination antiretroviral therapy for more than three months.

• GlaxoSmithKline plc, of Philadelphia, said it received a complete response letter from the FDA related to its application for cervical cancer vaccine, Cervarix, and said it will work closely with the agency to prepare its response. Cervarix previously gained approved in 45 other countries, including countries in the European Union, Mexico, Australia, Singapore and the Philippines.

• Immusol Inc., of San Diego, changed its name to ItherX Pharmaceuticals Inc. and appointed Jeffrey McKelvy president, CEO and director. The company is developing drugs for oncology and virology, with a focus on solid tumors and hepatitis C.

• MGI Pharma Inc., of Minneapolis, said the FDA accepted for filing its new drug application for Aquavan (fospropofol disodium) injection. The company submitted the application in September, seeking approval of Aquavan as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures. The PDUFA data is July 26, 2008. (See BioWorld Today, Sept. 28, 2007.)

• Neuralstem Inc., of Rockville, Md., entered a clinical trial research agreement aimed at treating patients suffering from ischemic spastic paraplegia, a form of spinal cord paralysis, with the trustees of the University of Pennsylvania through its Department of Anesthesiology and Critical Care. Terms were not disclosed.

• Novavax Inc., of Rockville, Md., said results from preclinical studies of its recombinant trivalent seasonal influenza virus-like particle (VLP) vaccine showed that when three seasonal flu VLPs were given as a single trivalent vaccine, the immune response to each subtype (H3N2, H1N1 and B) was comparable to that observed when the VLPs were given in a monovalent formulation. The study tested two injections of Novavax's vaccine, without an adjuvant, in mice. The company plans to file an investigational new drug application for clinical testing in the second quarter of 2008.

• OncoMethylome Sciences, of Liege, Belgium, entered a pharmacogenomic service collaboration to assist Abbott Park, Ill.-based Abbott Laboratories in profiling tumors. Specifically, OncoMethylome will be testing its DNA methylation biomarkers on Abbott's biological samples. Financial terms were not disclosed.

• Oncothyreon Inc., of Bellevue, Wash., completed the transfer of certain assays and methodology related to Stimuvax (BLP25 liposome vaccine) to Darmstadt, Germany-based Merck KGaA, triggering $5 million payment under the companies' August supply agreement. Stimuvax, a vaccine designed to induce an immune response to cancer cells expressing MUC1, is in Phase III development in patients with unresectable Stage III non-small-cell lung cancer.

• OncoVista Inc., of San Antonio, completed its acquisition of additional shares of Hanover, Germany-based AdnaGen AG, increasing its ownership from 51 percent to 85 percent of the company's issued and outstanding shares. AdnaGen's technology includes a method for detecting circulating tumor cells from blood, which involves immunomagnetic separation of CTCs, followed by detection of tumor-associated markers using RT-PCR-based molecular diagnostic techniques. The firm plans to start pivotal testing of its CTC test in breast cancer in 2008.

• Oxford Genome Sciences Ltd., of Oxford, UK, is collaborating with Thousand Oaks, Calif.-based Amgen Inc. to discover, develop and commercialize therapeutic antibodies in cancer. The deal is designed to enable Oxford Genome Sciences to further strengthen its antibody pipeline based on the target discovery capabilities of its OGAP (Oxford Genome Anatomy Project) database. Under the terms, the companies will jointly discover antibodies, which they will fully generate using Amgen's XenoMouse technology and then raise against druggable targets identified by Oxford Genome Sciences' database. The agreement covers up to six oncology programs, of which Amgen will have the right to select three. Specific financial terms were not disclosed.

• Point Therapeutics Inc., of Wellesley Hills, Mass., said Nasdaq granted the company's request for continued listing, subject to satisfaction of certain conditions by Jan. 30, 2008, including completion of its previously announced merger with Raleigh, N.C.-based DARA BioSciences Inc. (See BioWorld Today, Oct. 11, 2007.)

• Quest PharmaTech Inc., of Edmonton, Alberta, signed an agreement with an undisclosed multinational technology development company to receive $3 million to develop oncology products based on its SonoLight technology. Under the terms, Quest already received $1 million, and the balance of $2 million will be paid within the next 12 months. In return for that non-equity funding, the investor will receive 35 percent of all future net revenue from the commercialization of Quest oncology products. The agreement does not preclude Quest from out-licensing the oncology applications of SonoLight to a third party.

• Raptor Pharmaceuticals Corp., of Novato, Calif., said its clinical development division, Bennu Pharmaceuticals Inc., acquired a worldwide license to EC Cysteamine, an enterically coated formulation of cysteamine bitartrate for the orphan indication nephropathic cystinosis, by way of its merger with Encode Pharmaceuticals Inc. Raptor also intends to evaluate EC Cysteamine in other indications. Terms of the deal were not disclosed.

• Upstream Biosciences Inc., of Vancouver, British Columbia, entered a collaboration with Makerere University in Kampala, Uganda, to start in vivo efficacy and toxicity testing of compounds for trypanosomiasis (African sleeping sickness.) Upstream's candidates have demonstrated encouraging preclinical data to date. In the collaboration, researchers will determine the tolerability of various doses of the compounds in infected and uninfected mice and then will test the most promising compounds in infected animals to assess efficacy. Those studies are expected to be completed in early 2008.