• Arena Pharmaceuticals Inc., of San Diego, said partner Eisai Inc., of Woodcliff Lake, N.J., plans to double the size of its Belviq (lorcaserin) sales force to approximately 400 by the end of the year. That expansion follows increases in coverage of the drug by health plans and pharmacy benefit managers since its launch. Eisai is responsible for the marketing and distribution of Belviq in the U.S., where it is approved for chronic weight management.

• Biotime Inc., of Alameda, Calif. said subsidiary Oncocyte Corp. entered into a sponsored research agreement and a material transfer agreement with the Wistar Institute to collaboratively develop lung cancer diagnostic products. Under the agreement, Wistar investigators are conducting a multicenter patient study in which they will assess gene expression patterns in blood cells of patients with malignant vs. non-malignant lung disease. For its part, Oncocyte scientists will analyze blood samples obtained from patients in the study to determine levels of tumor-associated proteins using its PanC-Dx non-invasive cancer diagnostics. Oncocyte will have an option to exclusively license any inventions, discoveries or technology developed by Wistar or by Oncocyte using Wistar technology, in the course of the collaborative research.

• Boston Therapeutics Inc., of Manchester, N.H., said it is sponsoring a research study with the University of Minnesota on PAZ320, a complex carbohydrate-based drug designed to reduce the elevation of postmeal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes. The study aims to provide molecular-level information on PAZ320 and its mechanism of action, specifically characterizing PAZ320 galactomannan and assessing interactions of the drug with various sugar-hydrolyzing enzymes.

• Brainstorm Cell Therapeutics Inc., of New York, said it will initiate a preclinical study for multiple sclerosis (MS) at the Hebrew University Hadassah Medical Center’s SPF-grade animal laboratory in Jerusalem. Using the experimental autoimmune encephalomyelitis animal model, the company will conduct further studies to evaluate MS as an additional indication for its NurOwn technology, an autologous, adult stem cell therapy technology that induces bone marrow-derived mesenchymal stem cells to secrete high levels of neurotrophic factors for protection of existing motor neurons, promotion of motor neuron growth and re-establishment of nerve-muscle interaction.

• Cell Therapeutics Inc., of Seattle, said the National Institute for Health and Care Excellence, a nondepartmental public body of the Department of Health in the UK, issued a second draft guidance on Pixuvri (pixantrone) as a monotherapy for the treatment of adults with multiply relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma. The result is a second appraisal consultation document in which the committee concluded that the scheme does not overcome the uncertainties in the evidence for pixantrone’s clinical effectiveness and requests that consultees, including the company, comment on the draft guidance. The European Commission granted conditional marketing authorization for Pixuvri in May 2012.

• Cel-Sci Corp., of Vienna, Va., signed a co-development and profit-sharing agreement with Ergomed Clinical Research Ltd., a clinical research organization, for the investigational immunotherapy drug Multikine (leucocyte interleukin injection) in women with cervical dysplasia who are co-infected with HIV and the human papillomavirus (HPV). Ergomed will assume 50 percent of the clinical and regulatory costs, up to $3 million, to develop Multikine as a potential treatment for HIV/HPV co-infected women with cervical dysplasia. The companies plan to structure the full co-development program jointly before implementation. Ergomed has a similar co-development agreement with Cel-Sci to fund up to $10 million in an ongoing Phase III trial of Multikine in head and neck cancer. Terms call for Ergomed to receive a single-digit percentage of net income for sales of Multikine in indications included in the co-development agreements.

• Evotec AG, of Hamburg, Germany, said it reached a milestone in its research alliance with Boehringer Ingelheim GmbH, of Ingelheim, Germany, that has triggered revenues of 4 million (US$5.4 million). The event was for the transition of an oncology molecule into preclinical development – the second oncology compound that has achieved that development.

• Genzyme Corp., of Cambridge, Mass., a unit of Sanofi SA, said it plans to invest $80 million to build a downstream processing facility for Fabry disease enzyme replacement therapy Fabrazyme (agalsidase beta). The plant will be located adjacent to the company’s Fabrazyme cell culture manufacturing site in Framingham, Mass.

Janseen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a once-daily, single-tablet, fixed-dose antiretroviral combination product containing Janssen’s darunavir and cobicistat from Foster City, Calif.-based Gilead Sciences Inc. Darunavir is a protease inhibitor and cobicistat is an enhancing agent. Once-daily darnavir is marketed as Prezista in the European Union. Janssen and Gilead are working together under a 2011 license agreement, under which Janssen is responsible for formulation, manufacturing, registration, distribution and commercialization of the combination product worldwide. Gilead retains rights to cobicistat as a standalone product.

• Immunogenes AG, of Zug, Switzerland, disclosed the publication of a paper that provides additional explanation for the antibody-generating attributes observed in the company’s FcRn-overexpressing mice. The article, titled “NFκB induces overexpression of bovine FcRn: A novel mechanism that further contributes to the enhanced immune response in genetically modified animals carrying extra copies of FcRn,” offers detail on the causes behind the increased amount and diversity of antigen-specific antibodies. The article was published in the November/December 2013 issue of Mabs.

• Inform Genomics Inc., of Boston, entered a collaboration agreement with Tesaro Inc., of Waltham, Mass., under which Tesaro will utilize Inform’s bioinformatics and genomic platforms to evaluate the risk of chemotherapy-induced nausea and vomiting in patients who receive certain moderately emetogenic chemotherapy regimens and standard antiemetic therapy (without an NK-1 receptor antagonist). Terms were not disclosed.

• Kinemed Inc., of Emeryville, Calif., said it entered an agreement with Amgen Inc., of Thousand Oaks, Calif., to apply its mass spectrometric dynamic proteomics platform to the study of brain protein homeostasis linked to neurodegenerative diseases. The company’s biomarker platform will allow Amgen to track synthesis and clearance rates of pathogenic proteins in the brain that drive neurodegeneration.

• Mersana Therapeutics Inc., of Cambridge, Mass., said it achieved the first preclinical milestone in its collaboration with Endo Pharmaceuticals Inc., of Malvern, Pa., and received an undisclosed milestone payment. The multitarget partnership is focused on developing next-generation Fleximer antibody-drug conjugates in various cancers. (See BioWorld Today, March 8, 2012.)

• Omeros Corp., of Seattle, said the FDA confirmed its agreement with the pediatric study plan proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a written request consistent with the plan, which means that successful completion of the plan would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros’ Pharmacosurgery product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction) and reduce postoperative pain resulting from cataract and other lens replacement surgery.

• Prolong Pharmaceuticals LLC, of South Plainfield, N.J., said it licensed a compound developed at the University of Toledo that can be used to prevent blood vessels from leaking fluid into surrounding tissue following a traumatic injury to the body. The invention uses polyethylene-glycol to modify albumin, a protein found in blood, to expand the blood’s volume and prevent it from escaping through holes in blood vessels. Prolong will have rights for continued development and commercialization. Financial terms were not disclosed.

• Qrxpharma Ltd., of Sydney, executed a licensing agreement with Aspen Pharmacare Holdings Ltd., of Durban, South Africa, for rights to commercialize immediate-release Moxduo in South Africa. The agreement was an extension of a licensing deal last month between Qrxpharma and Aspen’s Australian subsidiary for Moxduo commercialization rights in Australia, New Zealand and Oceania. Aspen assumed responsibility for the regulatory filing, product launch costs and ongoing marketing and sales efforts in South Africa. Qrxpharma is set to receive a milestone payment of A$250,000 (US$237,800) upon regulatory approval of immediate-release Moxduo in South Africa, plus double-digit royalties. Qrxpharma retained rights to the intravenous and controlled release formulations of Moxduo, a combination of oxycodone and morphine, in South Africa.

Rainbow Coral Corp., of Nakomis, Fla., said its joint venture partner, Therakine Ltd., of Hermosa Beach, Calif., achieved a milestone in development of a matrix release formulation of naltrexone, a drug for alcohol and opioid dependence. Results in preliminary testing of the matrix were better than expected.

Seek, of London, received a European Union Framework 7 (FP7) grant worth 5.3 million (US$7.16 million) to advance development of its universal flu immunotherapeutic, FLU-v. SEEK will use the award to run a Phase IIb trial of the product. FLU-v is designed to target regions of the virus present in all flu strains, including pandemic strains. It is designed to be given at the start of every flu season, even before the dominant strain for the season is known, and to reduce severity and duration of the flu.

Symphogen A/S, of Lyngby, Denmark, partnered with Open Monoclonal Technology Inc. (OMT), of Palo Alto, Calif., to develop human therapeutic antibodies. OMT will provide access to its Omnirat and Omnimouse platforms, and Symphogen will contribute its B cell-based antibody identification technology, Symplex, to the collaboration. Financial terms were not disclosed.

• Synthetic Biologics Inc., of Rockville, Md., disclosed the successful completion of the protein expression evaluation with regard to the company’s oral beta-lactamase enzyme (Syn-004) targeting the prevention of Clostridium difficile infections. Fujifilm Diosynth Biotechnologies UK Ltd., of Billingham, UK, analyzed and demonstrated a greater than 20-fold improvement in Syn-004 expression titers with consistent biological activity utilizing its Paveway platform (an E. coli system) compared to the Bacillus platform previously employed by Ipsat Therapeutics Oy, of Helsinki, Finland, for the expression of P1a, a first-generation candidate of Syn-004. Pursuant to an agreement inked with Fujifilm this month, manufacturing of Syn-004 material to support Synthetic Biologics’ planned preclinical and clinical studies is under way.

• Zalicus Inc., of Cambridge, Mass., received notice from the listing qualifications staff of Nasdaq that the company has regained compliance with Nasdaq’s listing rule relating to the maintenance of a minimum $1 bid price.