• Abcam plc, of Cambridge, UK, andOpen Biosystems Inc.,of Huntsville, Ala., entered an agreement for Open Biosystems to sell Abcam's primary antibodies alongside its libraries of cDNA, ORF and shRNA clones to expand its resource for gene function analysis. Tools allow researchers to conduct analyses expressing genes, knocking down genes and detecting genes. Financial terms were not disclosed.

• Active Biotech AB, of Lund, Sweden, said the FDA cleared its investigational new drug application for a Phase II trial of prostate cancer drug TASQ (ABR-215050). The company plans to initiate a randomized, double-blind, placebo-controlled, 200-patient Phase II trial before the end of the year comparing TASQ to placebo. Data regarding the primary endpoint of disease progression are expected in 2009. In a previous Phase I trial, five of six patients had a decrease in prostate-specific antigen velocity of more than 50 percent compared to prior treatment, and three of those five patients exhibited a decrease in absolute PSA levels.

• Ardana plc, of Edinburgh, Scotland, said the first patient has been enrolled in a U.S. registration Phase III study of its oral growth hormone secretagogue (GHS) ARD-07, in the diagnosis of growth hormone deficiency in adults. Results are expected in the second half of 2007, and the company expects to file for registration at the end of the year with a possible launch in 2008. The study will take place in 10 centers in the U.S. with 80 subjects. Half will be patients with proven GH deficiency, and the other half will be matched controls. GHS, a synthetic small-molecule peptidomimetic agent, is orally active and stimulates the secretion of GH from the patient's pituitary gland and/or indirectly via stimulation of GHRH from the hypothalamus.

• Arpida Ltd., of Basel, Switzerland, closed its acquisition of TLT Medical Ltd., of Reinach, Switzerland. The deal entails an up-front payment to TLT as well as potential milestone payments that together could total up to CHF57 million (US$47.3 million). The stock-and-cash deal was announced last month. Shares issued in connection with the closing represent less than 0.3 percent of those outstanding. TLT is developing a therapy to treat onychomycosis, or fungal infections of the nails of the fingers and toes.

• Biovitrum AB, of Stockholm, Sweden, entered a new agreement with Wyeth, of Madison, N.J., to co-promote BeneFIX, a coagulation factor IX for hemophilia B, in the Nordic countries of Denmark, Finland, Iceland, Norway and Sweden. Wyeth markets BeneFIX elsewhere around the world. Under the terms of the agreement, Biovitrum will receive a commission on BeneFIX sales, including an additional incentive if certain sales targets are exceeded, for up to five years, with possible one-year extensions thereafter. BeneFIX uses recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own.

• EiRx Therapeutics plc, of Cork, Ireland, obtained a grant of €362,000 (US$491,262) from the economic development agency Enterprise Ireland to fund the establishment of a medicinal chemistry team at University College Cork (UCC). The group, which will be directed by Anita Maguire, professor of pharmaceutical chemistry at UCC, will optimize tumor selective, pro-apoptotic compounds emerging from EiRx's cancer drug discovery efforts. EiRx will commit a further €139,000 to the initiative and will take on product development duties beyond the lead optimization stage. It will pay UCC milestones of up to €3 million per new therapeutic candidate, plus royalties, in return for exclusive rights to UCC's interest in the intellectual property generated via the collaboration.

• EvoGenix Ltd., of Sydney, Australia, said its shareholders approved the proposed merger with Peptech Ltd., also of Sydney. Peptech will pay 15 cents cash and 0.5055 Peptech shares for each share of EvoGenix. The deal is expected to be ratified by the Australian courts next week. The merged entity will assume a new name and focus on antibodies and protein-based therapeutics for inflammatory disease, bone disease and cancer.

• Flamel Technologies SA, of Lyon, France, posted a net loss of $22.7 million in the first half of 2007, up from $19.1 million the year before. The deterioration was due largely to a 37.2 percent increase in total costs, with research and development expenses in particular rising to $23.8 million in the second half of this year from $18.5 million in the corresponding period of 2006. While licensing and research income was halved from $9.4 million to $4.9 million from one period to the next, Flamel generated revenues of $10.2 million from sales of products and services in the first six months of 2007, up from virtually zero in the same period of last year. As a result, its total revenues almost doubled, from $9.8 million in January to June 2006 to $17.1 million in the first half of this year. The company had cash reserves of $47 million as of June 30.

• Galapagos NV, of Mechelen, Belgium, said its service division, BioFocus DPI, entered a drug discovery collaboration with AstraZeneca plc, of London, that builds on earlier deals. The new arrangement involves BioFocus performing medicinal chemistry, computational chemistry and supporting biology and ADMET services for AstraZeneca's infection discovery program based in Boston. The total contract value for Galapagos will be €680,000 (US$938,530). It is the companies' third deal, in a relationship that began in the summer of last year.

• GammaCan International Inc., of Kiryat Ono, Israel, said its lead cancer immunotherapy, VitiGam, received orphan drug designation from the FDA for Stage IIb to Stage IV metastatic melanoma. That would give the drug seven years of marketing exclusivity upon approval. The company anticipates filing an investigational new drug application for a Phase I/II trial by the end of the year, with testing to start in early 2008.

• Genmab A/S, of Copenhagen, Denmark, said partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, filed an investigational new drug application with the FDA for a Genmab antibody developed under the companies' 2001 collaboration. That filing triggers an undisclosed milestone payment from Roche. Under the agreement, Genmab creates human antibodies to a broad range of disease targets identified by Roche in return for milestone and royalty payments. In certain cases, Genmab might obtain product development rights. If all goals in the collaboration are reached, Genmab could receive as much as $100 million, plus royalties.

• GW Pharmaceuticals plc, of Porton Down, UK, and Bayer Inc., a Toronto-based subsidiary of Bayer AG, said Health Canada approved a new indication for Sativex, a cannabis-derived product delivered through an oral spray. The product was approved in Canada as adjunctive analgesic treatment for persistent background pain in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of opioid therapy. Sativex was approved in 2005 for treating neuropathic pain in adults with multiple sclerosis. Both approvals carry conditions.

• Phosphagenics Ltd., of Melbourne, Australia, said a Phase Ib trial demonstrated the ability of its TPM technology to deliver insulin into the bloodstream in a noninvasive manner. The trial in Australia showed the needle-free TPM/Insulin formulation safely penetrated through human skin and delivered insulin into the bloodstream over a sustained period, without causing adverse reactions, the company said. It is preparing for a Phase II trial, also to be conducted in Australia.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, licensed rights to develop a plant cell-based acetylcholinesterase and its molecular variants for use in several therapeutic and prophylactic indications, including a biodefense program. The license was granted by Yissum Research and Development Co., the technology transfer arm of the Hebrew University of Jerusalem, and the Boyce Thompson Institute for Plant Research at Cornell University. Protalix said in vitro experiments have shown that the AChE protein expressed in its plant-cell ProCellEx system demonstrated promising biological activity at both the biochemical and the cellular levels. Terms of the license deal were not disclosed.

• Regimmune Corp., of Tokyo, received a one-time grant from the Japanese Ministry of Economy, Trade and Industry to help fund development of cedar allergy drugs using the company's immune-regulating reVax (reverse vaccination) technology. Regimmune said the grant is similar to a Small Business Innovation Research grant.

• Sinobiomed Inc., of Shanghai, China, said its 82 percent-owned subsidiary, Shanghai Wanxing Bio-pharmaceuticals Co. Ltd., signed a formally equity transfer contract to acquire a 90 percent interest in pharmaceutical distribution firm Suzhou Boai. Under the contract, all the equity owners of Suzhou Boai will transfer their equity to Shanghai Wanxing, except for one owner who will retain a 10 percent interest, for a transfer price of about $2.4 million. The distribution company operates two wholly owned subsidiaries: one that sells vaccines and another that sells medical devices. Sinobiomed develops genetically engineered recombinant protein drugs and vaccines.

• Sloning BioTechnology GmbH, of Puchheim, Germany, said it will carry out a feasibility study with bioMerieux, of Paris, to generate gene variants of an essential enzyme to be used in diagnostic applications. Sloning will use its Slonomics industrial-scale gene synthesis technology to provide a gene library with a full set of ratio-controlled mutants. Successful completion would enable bioMerieux to identify an enzyme with enhanced characteristics. Terms of the deal were not disclosed.

• Sosei Group Corp., of Tokyo, and Vectura Group plc, of Chippenham, UK, announced the start of a U.S. Phase II clinical study by Novartis AG, of Basel, Switzerland, of NVA237, in the treatment of chronic obstructive pulmonary disease (COPD). The trial, a randomized, double-blind, placebo-controlled, parallel group, multicenter study will assess the safety of 28 days of treatment of NVA237 in patients with moderate to severe COPD. The product was licensed to Novartis by Sosei and Vectura in 2005 in a deal in which the two companies could receive up to $375 million in milestones, plus royalties.

• Summit Corp. plc, of Oxford, UK (formerly Vastox plc), said data generated by its zebrafish screening platform were used by an undisclosed biotechnology company to obtain regulatory clearance to begin Phase I clinical trials in the UK. The zebrafish platform provides whole-organism data regarding the safety and efficacy of drug-like molecules, and can be used for target validation or to predict clinical responses.

• TaiGen Biotechnology Inc., of Taipei, Taiwan, completed enrollment of a target 265 patents in its Phase II trial of Nemonoxacin (TG-873870) for adult community-acquired pneumonia. The double-blind study is designed to compare the drug's clinical and bacteriological success rates with those of levofloxacin. Data are expected in the fourth quarter. A Phase II trial also is planned in diabetic foot infections.

• Tercica Inc., of Brisbane, Calif., and Ipsen SA, of Paris, received approval from the European Commission to market Increlex (mecasermin, recombinant human insulin-like growth factor-1) for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency. The approval triggers a €15 million (US$20.5 million) milestone payment to Tercica from Ipsen, which will market the product in Europe. Increlex has orphan drug status in Europe, which includes 10 years of marketing exclusivity. Tercica markets Increlex in the U.S.

• Transgene SA, of Strasbourg, France, which raised €100 million (US$135.7 million) from a private share placement in June, has reported a net profit of €8.5 million for the first half of 2007, as against a net loss of €10.6 million in the corresponding period of last year. The turnaround essentially was due to a surge in revenues from research collaborations and licensing agreements, which totaled €24.7 million in the first six months of this year compared with just €2.8 million in the same period of 2006. Transgene's strategic partnership with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, (in the area of HPV-mediated diseases) alone netted it a net profit of €8.5 million. At the same time, its operating costs declined from €16.7 million in the first half of 2006 to €13.5 million in January to June this year. As of June 30, Transgene had cash and cash equivalents of €114.3 million.