• Accentia Biopharmaceuticals Inc., of Tampa, Fla., reported that the FDA granted orphan drug designation to Revimmune for the treatment of systemic sclerosis and autoimmune hemolytic anemia. Accentia licensed the Revimmune therapy, which is based on high-dose administration of Cytoxan (cyclophosphamide) to reboot the immune system, from Johns Hopkins University.

• Arch Biopartners Inc., of Toronto, and its subsidiary Arch Cancer Therapeutics said Arch scientists have been awarded $561,251 of peer-reviewed research funding to support ongoing work in the area of malignant glioma and the development of brain tumor cell-targeting technology. The funding award is from a recent Alberta Cancer Research Operating Grants Competition sponsored by Alberta Innovates – Health Solutions.

• Avila Therapeutics Inc., of Waltham, Mass., said preclinical data showed its lead candidate, AVL-292, rapidly reduced clinical arthritis scores, as well as inflammation, joint damage and bone erosion in animal models. A selective inhibitor of Bruton's tyrosine kinase, AVL-292 is in Phase I trials in hematological cancers. The arthritis data were presented at the Federation of Clinical Immunology Societies meeting in Washington.

• BioMarin Pharmaceutical Inc., of Novato, Calif., paid $48.5 million to purchase a bulk biologics manufacturing plant in Cork, Ireland from New York-based Pfizer Inc. BioMarin said the purchase cost was one-fifth of the cost estimated to build and validate a new facility. The plant will be used to produce enzyme replacement therapy GALNS (N-acetylgalactosamine 6-sulfatase), which is in Phase III for mucopolysaccharidosis Type IVA, as well as other products.

• Clovis Oncology Inc., of Boulder, Co., expanded an ongoing observational study of CP-4126, which it is developing in partnership with Clavis Pharma ASA, of Oslo, Norway. The lipid-conjugated form of gemcitabine is in a pivotal clinical trial (LEAP) for newly diagnosed metastatic pancreatic cancer. Its primary endpoint is overall survival. The expansion of the trial will help determine patient stratification parameters in connection with a new hENT1 biomarker assay.

• CMEA Capital, of San Francisco, launched Velocity Pharmaceutical Development (VPD), a virtual drug development company that will acquire early stage drug candidates, advance them through proof of concept and sell them to drug companies. VPD has evaluated more than 100 drug programs over the past few months and expects to acquire its first drug candidate later this summer. VPD CEO David Collier is a managing director at venture firm CMEA.

• CureFAKtor Pharmaceuticals LLC, of Buffalo, N.Y., presented preclinical results demonstrating that its focal adhesion kinase inhibitors, which target the binding site of vascular endothelial growth factor receptor 3, decreased pancreatic cancer tumor blood flow and reduced blood vessel density in vivo. The data were discussed at the European Society for Medical Oncology's World Congress on Gastrointestinal Cancer in Barcelona, Spain. CureFAKtor is planning a Phase I trial of its lead candidate, CFAK-C4, in combination with gemcitabine chemotherapy, the current standard of care for pancreatic cancer, next year. (See BioWorld Today, Feb. 9, 2011.)

• Epizyme Inc., of Cambridge, Mass., and the Leukemia & Lymphoma Society (LLS) are collaborating on preclinical and Phase I development of Epizyme's DOT1L-targeted histone methyltransferase inhibitor for mixed lineage leukemia. LLS will provide up to $7.5 million in milestone funding to Epizyme to support the early development of the personalized epigenetic therapy.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., presented IMO-3100 mechanism-of-action data in a preclinical model of arthritis. In the study, improvements in disease-related parameters resulting from IMO-3100 treatment were associated with suppression of interleukin 6 and complement C3 and with induction of interleukin 10, resulting in significant reduction in arthritis symptoms compared to placebo. The data were presented at the Annual Meeting of the Federation of Clinical Immunology Societies in Washington.

• Medivir AB, of Huddinge, Sweden, signed an agreement with Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, to distribute Xerclear, a cold sore treatment, in China and Hong Kong. Daewoong will carry out clinical studies and obtain regulatory approval for marketing and sales of the product in those territories. Medivir will be eligible for royalties on all product sales.

• Radient Pharmaceuticals Corp., of Tustin, Calif., began trading Thursday on the OTC QX after being delisted from the NYSE Amex. Radient had been notified that it was out of compliance, but was not able to regain compliance. Radient reported 125 million shares outstanding, 38.08 million warrants and options, and $1.7 million in cash on hand. It will trade under the symbol RXPC.

• The FDA granted fast-track designation to RG3039, a spinal muscular atrophy candidate by Repligen Corp., of Waltham, Mass. Repligen has received the go-ahead to begin a Phase I trial of RG3039 in 40 healthy volunteers, to evaluate the pharmacokinetic and safety profile of the drug.

• Scil Technology GmbH, of Martinsreid, Germany, received research funding of €0.9 million (US$1.28 million) from the German Federal Ministry of Education and Research under its KMU-innovativ scheme. The grant will support the company's research in repellant proteins for rheumatoid arthritis.

• Sirnaomic Inc., of Gaithersburg, Md., signed a partnership agreement with Guangdong Zhongsheng Pharmaceutical Co. Ltd., of Dongguan City, China, to develop small interfering RNA for diabetic retinopathy and age-related macular degeneration. The partnership will focus on clinical development and commercialization of STP601, a Sirnaomics compound, for ocular neovascularization conditions. Guangdong Zhongsheng will commit $9.75 million including up-front and milestone payments, and Sirnaomics will also be eligible for royalty sharing.

• Synageva BioPharma Corp., of Lexington, Mass., said that its compound SBC-102 received fast-track designation from the FDA for lysosomal acid lipase deficiency. The enzyme replacement therapy has already received orphan drug designation in the U.S. and EU.

• Syntarga BV, of Nijmegen, the Netherlands, was acquired by generics firm Synthon BV, also of Nijmegen. Financial terms were not disclosed. Syntarga's antibody-drug conjugate program will support Synthon's move into branded oncology markets.