• Ablynx NV, of Ghent, Belgium, said the European Patent Office upheld key claims for its Nanobodies platform in response to proceedings initiated by Domantis Ltd., of Cambridge, UK. Nanobodies, a class of antibody-derived therapeutic proteins, are functional antigen-binding domains derived from an antibody-heavy chain. Ablynx retains access to Nanobody property through its Hamer patent portfolio. Domantis said its Domain Antibodies are based on the heavy or light chains of fully human antibodies and contain no components derived from animals.

• Allergy Therapeutics plc, of Worthing, UK, started in Canada a Phase II trial of an advanced formulation of its ragweed allergy vaccine. The new formulation incorporates MPL, an adjuvant that drives the balance of the immune response from TH2 to TH1, thus preventing the release of histamine. The vaccine is available on a named-patient basis in Germany, and the regulator Health Canada has said positive results from the trial would support an application for marketing authorization.

• Antisoma plc, of London, reopened the Phase I trial of its aptamer drug AS1411 and began enrolling patients with renal and non-small-cell lung cancer. The compound has orphan drug status in both indications.

• Apollo Life Sciences Ltd., of Adelaide, Australia, said its human-expressed interleukin-2, a protein involved in stimulating T-cell growth, performed six times better in a recognized test of bioactivity than a leading competitor's protein, and was more than twice as effective as the World Health Organization's protein standard. The company's recent research has focused on the use of interleukin-2 to boost antiviral immunity in AIDS patients. The protein has been used primarily to treat metastatic melanoma and renal-cell carcinoma.

• Arakis Ltd., of Little Chesterford, UK, began a Phase IIb trial of AD452 in the treatment of rheumatoid arthritis. The 12-week study is designed to evaluate safety and efficacy of AD452 in patients with active RA who are receiving standard methotrexate therapy. A total of 292 patients in four groups will be enrolled in the U.S. and Europe.

• Astex Therapeutics Ltd., of Cambridge, UK, signed a new alliance with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to discover, develop and commercialize drug candidates against undisclosed targets in different therapeutic areas. Under the agreement, Astex will provide drug candidates to Boehringer, which will move the candidates through development and into the market. Astex will receive an up-front payment in return for access to its fragment-based discovery technology, and could get research funding, milestone payments and royalties.

• Biacore International AB, of Uppsala, Sweden, launched its Biacore A100 and Flexchip systems. Both systems offer array-based protein interaction analysis.

• BTG plc, of London, agreed to a collaboration with Collegium Pharmaceuticals Inc., of Cumberland, R.I., to develop CP-141, a modified oral formulation of an existing asthma drug. The aim is to develop an extended-release product that can be used by patients who find current formulations unsuitable. The work will be co-funded by the partners, which have an existing collaboration in sleep apnea.

• DxS Ltd., of Manchester, UK, completed a pilot study for UK Biobank, showing the company's method of extracting, transporting and storing DNA from blood samples of volunteers taking part in the population genomics study produced material suitable for a variety of tests, including clinical chemistry, proteomic and metabolomic analyses. UK Biobank will recruit up to half a million subjects over the next five years in the world's largest study of the role of genes, environment and lifestyle in health and disease.

• Evolutec Group plc, of Reading, UK, said the veterinary products company Merial Ltd., completed initial testing of Evolutec's anti-tick vaccine in cattle. In the trial, levels of infestation with Boophilus ticks were significantly reduced. Merial is to continue proof-of-concept work, evaluating vaccine candidates against tick-borne diseases. A new agreement will be drawn up between the two companies.

• Evolva SA, of Allschwil, Switzerland, acquired the pharmaceutical assets of Poalis A/S of Copenhagen, Denmark. Financial terms were not disclosed. The transaction does not include Poalis' flavor chemicals, food or agriculture activities.

• ExonHit Therapeutics SA, of Paris, and Agilent Technologies Inc., of Palo Alto, Calif., signed an agreement for Agilent to distribute ExonHit's SpliceArrays. ExonHit launched its SpliceArrays last February. Customers now can obtain the microarrays from Agilent for use in their own laboratories, after signing a license agreement with ExonHit authorizing them to utilize the arrays' proprietary contents. Alternatively, they can still opt for ExonHit's SpliceArray Service. ExonHit has so far developed SpliceArrays for five different gene families - G-protein coupled receptors, ionic channels, nuclear receptors, apoptosis and cytokines.

• InforSense Ltd., of London, said the National Cancer Institute selected the company's InforSense technology for high-throughput genetic data analysis in its oncology research.

• Innate Pharma SAS, of Marseille, France, received ISO9001:2000 certification for its research and development activity in immunotherapy. Innate Pharma specializes in cancer immuno-therapeutics and had developed immuno-modulating agents targeting non-conventional lymphocytes. It has two products in Phase I development in cancer.

• Inyx Inc., of New York, completed the acquisition of all of the outstanding shares of Ashton, UK-based Celltech Manufacturing Services Ltd., from UCB Group SA, of Brussels, Belgium. The companies agreed on a purchase price of €27.5 million (US$33.8 million) to be financed through a non-dilutive, asset-based facility provided by Westernbank Business Credit Division, of Westernbank, Puerto Rico. Inyx said the acquisition is expected to contribute annual revenues in excess of $50 million over the first 12 months. As part of the agreement, Inyx received a five-year manufacturing contract from UCB, as well as a long-term product support and services contract.

• Neuren Pharmaceuticals Ltd., of North Sydney, Australia, initiated a Phase II trial of its lead drug Glypromate. Recruitment has begun for the 30 patients involved in the trial, which is scheduled for completion at the end of 2005. The trial is aimed at confirming the pharmacokinetic profile and safety of Glypromate ahead of a Phase III trial that will assess the effectiveness of the compound as a protection from neurocognitive disturbance following coronary artery bypass graft surgery.

• Novagen Ltd., of Sydney, Australia, expanded its U.S. subsidiary, Glycotex Inc., a business based on the development of wound-healing glucan compounds. The intellectual property used by Glycotex was developed by Graham Kelly, who agreed to step down from Novagen's board to focus on the development and expansion of the subsidiary.

• Peplin Ltd., of Brisbane, Australia, initiated its U.S.-based Phase IIa trial to study increasing doses of its PEP005 topical product on actinic keratosis (AK), lesions that can lead to skin cancer. The trial is expected to assist in the planning of more advanced clinical trials expected to start in the first half of 2006. A Phase I trial in 16 patients with AK demonstrated the drug's safety profile and indicated an ability to impact lesions within 21 days of a single treatment.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., extended its 2002 collaboration with NV Organon, of Oss, the Netherlands, through 2007. The partnership has delivered multiple lead drugs that are moving into or have completed preclinical toxicological studies. Organon elected to continue the collaboration by accepting the latest preclinical lead candidate generated by Pharmacopeia.

• Pharmaxis Ltd., of Sydney, Australia, said results of its Phase II trial in cystic fibrosis patients showed that those receiving the company's Bronchitol had statistically significant improved lung function compared to placebo at the end of a two-week treatment period. The drug also demonstrated significantly better respiratory symptoms. Bronchitol, which received orphan drug designation by the FDA, is a formulation of mannitol administered in a hand-held inhaler.

• Sareum Holdings, of Cambridge, UK, launched Crystal Bank, a database of protein structure information for use in drug discovery. The bank contains therapeutically relevant protein targets, allowing Sareum to generate structural data showing how drug candidates bind to a target site.

• Solbec Pharmaceuticals, of Perth, Australia, said it was successful in securing an industry collaboration scheme grant from Edith Cowan University in Perth to identify a specific melanoma gene and allow for the potential development of a melanoma diagnostic test. The hoped-for outcome is a diagnostic test that can be used to determine the stage and progression of the melanoma.

• Tel Aviv Stock Exchange changed rules for registration to better facilitate R&D companies to listing for trading. The change is part of an effort to encourage new high-tech and biotech companies to raise money in Israel, it said. The definition of an R&D firm now will include companies supported by investments of at least NIS3 million (US$700,000) in R&D during the three years preceding an IPO, including support by the Office of the Chief Scientist and from private sources, among other changes.

• University College Dublin will be the location of a €72 million National Institute for Bioprocessing, Research and Training (NIBRT), following a competitive bid process organized by IDA Ireland, the state agency responsible for foreign investment in Ireland. UCD is establishing the institute along with three other partners: Trinity College Dublin, Dublin City University and the Sligo Institute of Technology. The NIBRT will act as a center of excellence in all aspects of biomanufacturing, an area identified by IDA Ireland as a priority.

• Vernalis plc, of Reading, UK, completed enrollment of 550 patients in a Phase III study of frovatriptan in the treatment of menstrually related migraine. First data from the trial are expected in the first half of 2006.

• Xechem International Inc., of New Brunswick, N.J., has formed Xechem UK Ltd., a wholly owned subsidiary based in the UK, to expedite the distribution of Nicosan/Hemoxin for the treatment of sickle cell disease. The drug has been designated an orphan drug in the U.S. and an application has been filed for designation in the European Union. Xechem is preparing the drug for application for investigational new drug status in the U.S.

• Xenova Group plc, of Slough, UK, expects its listing on the London Stock Exchange to be cancelled as of Sept. 1. Xenova board members agreed to a buyout in June for up to £26.1 million (US$47.5 million) by Celtic Pharma Group, a private equity business. Shareholders holding about 61 percent of Xenova - or 263 million shares - opted for the cash alternative. Shareholders with 2.7 percent, or 11.6 million shares, chose the cash and secured loan note alternative. Shareholders with 36 percent of the company, or 156.5 million shares, will receive secured loan notes.

• York Pharma plc, of Hitchin, UK, said it validated novel protease inhibitors discovered through its skin-barrier repair technology platform. The company is developing the inhibitors, which are non-steroidal and non-immunomodulatory, in the treatment of atopic eczema and dermatitis. Patients with atopic eczema have high levels of protease activity in their skin, leading to the breakdown of the skin barrier and allowing the ingress of irritants and allergens. In volunteers, York Pharma's inhibitors blocked the action of protease, interrupting the cascade that leads to an eczema flare.

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