• Acambis plc, of Cambridge, UK, said it completed delivery of the entire 2.7 million doses of its ACAM2000 smallpox vaccine to the Centers for Disease Control and Prevention ahead of schedule. As a result, the company expects to record total revenues of about £9.5 million (US$18.8 million) in 2007.

• Argenta Discovery Ltd., of Harlow, UK, has entered into an alliance with NeuroSolutions Ltd., of Cambridge, UK, to gain preferential access to its specialist electrophysiology and hERG testing services and expertise. The collaboration will enable Argenta to provide its contract research clients with an expanded assay development and screening resource. Financial terms were not disclosed.

• Ark Therapeutics Group plc, of London, will acquire Lymphatix Oy, of Helsinki, Finland, in an all-share deal valued at €2.25 million (US$3.3 million). That gives Ark royalty-free rights to the vascular endothelial growth factor genes VEGF-D and VEGF-C for use in developing gene therapies in angiogenesis and lymphangiogenesis. The company has VEGF-based programs in preclinical development in those areas in refractory angina, wound healing, prevention of restenosis and fetal growth restriction. Results to date have shown that VEGF plays a key role in these diseases. Ark said that it will incorporate the Lymphatix VEGF portfolio, alongside other genes including its own VEGF mutants, to optimize therapies prior to commencing clinical trials. Lymphatix was founded in 2003 by the Ludwig Institute for Cancer Research, Licentia Ltd/Helsinki University and a number of Finnish and Australian academics. Nigel Parker, chief executive officer of Ark, said buying Lymphatix was a highly targeted acquisition of a specific technology, which is well known to the company.

• Bioceros BV, of Utrecht, the Netherlands, and MaimoniDex RA Ltd., of Tel Aviv, Israel, are collaborating to develop a monoclonal antibody specific for CD44vRA, a splice variant of the adhesion molecule CD44 that is involved in the inflammatory process underlying rheumatoid arthritis. Under the terms, Bioceros will receive an option to a worldwide exclusive license on the intellectual property and technology owned by MaimoniDex. Specific financial terms were not disclosed.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, signed two worldwide research laboratories to promote its second drug, CF102, and facilitate joint research to investigate the drug's effect on hepatitis C virus replication in hepatocytes, as well as to elucidate the molecular mechanisms underlying the antiviral activity of CF102. One agreement was signed with a researcher from the Rabin Medical Center in Israel, while the second was signed with a researcher from the Center of Neurovirology and Cancer Biology at Philadelphia Temple University. Financial terms were not disclosed.

• Fovea Pharmaceuticals SA, of Paris, received orphan drug designation from the European Commission for its recombinant human rod-derived cone viability factor (rh-RdCVF) for the treatment of retinitis pigmentosa following a positive opinion from the European Medicines Evaluation Agency's Committee for Orphan Medicinal Products. Preclinical studies of RdCVF have demonstrated its efficacy in animal models of the disease. Orphan drug designation gives Fovea exclusive marketing rights for 10 years in European countries if it is the first company to receive marketing approval for the product and would allow it to apply for research funding, tax credits for certain research outlays and protocol assistance. Fovea also has applied to the FDA for orphan drug designation for RdCVF in the U.S. The company plans to start clinical trials of RdCVF in retinitis pigmentosa in 2009.

• Galapagos NV, of Mechelen, Belgium, said its BioFocus DPI service division has entered a two-year target discovery collaboration with Janssen Pharmaceutica, a division of New Brunswick, N.J.-based Johnson & Johnson, in the field of oncology. BioFocus DPI will apply Galapagos' adenoviral platform to identify novel drug targets for development. BioFocusDPI will receive an up-front payment of €2.9 million (US$4.3 million). In total, BioFocus DPI may receive additional research, acceptance, license and development fees of up to €7.6 million if predetermined criteria are achieved.

• Genmab A/S, of Copenhagen, Denmark, started a new preclinical antibody program, HuMax-CD32b, a fully human IgG1, k antibody aimed at targeting the CD32b receptor found on immune cells and hematological tumors. The company said HuMax-CD32b might have therapeutic potential in B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, Burkitt's lymphoma, follicular lymphoma and diffuse large B-cell lymphoma.

• Helsinn Healthcare SA, of Lugano, Switzerland, and and its partner MGI Pharma Inc., of Minneapolis, said the FDA has accepted the firms' supplemental new drug application for Aloxi (palonosetron hydrochloride) oral capsules. Aloxi injection is approved in the U.S. for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The supplemental application for the oral capsule formulation was submitted Oct. 24, 2007, the companies said. The Prescription Drug User Fee Act action date for the supplemental application is Aug. 22.

• PSivida Ltd., of Perth, Australia, received a non-compliance letter from Nasdaq, stating that the company's common stock has traded below the $1 minimum bid price for the last 30 consecutive business days. The company has 180 days, or until June 24, to regain compliance.

• ReNeuron Group plc, of Guildford, UK, did not get the answer it was hoping for from the FDA, which continued its clinical hold on the company's IND application to start clinical trials of its ReN001 stem cell therapy for stroke. The announcement sent the company's shares down from 20.5 pence to 16 pence when it was announced Jan. 3. On Dec. 3, the company said it had submitted its responses to all the requests for further information made by the FDA. But while most of the substantive issues raised in the original IND hold letter have been addressed, other issues remain to be resolved. ReNeuron said it is meeting the FDA soon in an attempt to resolve those issues. In the meantime, the company said, it will continue preparations for the trial. That includes talking to regulators in the UK and other countries.

• Rosetta Genomics, of Rohovot, Israel, said its subsidiary Rosetta Genomics Inc. has received a license from Roche Molecular Systems, of Pleasanton, Calif., to use its PCR technology in Rosetta Genomics' microRNA-based diagnostic tests. Rosetta Genomics has developed a microRNA detection platform based on Roche PCR technology. The platform allows Rosetta Genomics to identify microRNA biomarkers in several sample types and body fluids, with very high sensitivity and specificity.

• SkyePharma plc, of London, and Sciele Pharma Inc., of Atlanta, said the FDA has approved all four new dosage strengths of Sular, a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation uses SkyePharma's patented Geomatrix technology, which provides a lower dose of the drug for each of its current doses, the companies said. The firms expect to launch the new formulation during the first quarter. SkyePharma said it will receive $2 million on the approval and also mid-single-digit royalties on net sales of new Sular.

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