• Astex Ltd., of Cambridge, UK, received FDA clearance for its investigational new drug application for AT7519, a cell-cycle inhibitor for cancer. The compound was discovered internally and progressed from first synthesis to Phase I in 14 months. The multicenter trial in patients with refractory solid tumors will take place in the U.S. and the UK.

• Avantogen Ltd., of Sydney, Australia, signed a manufacturing agreement with Dr. Reddy's Laboratories, of Hyderabad, India, for the production of its adjuvant GPI-100, a component of vaccines for boosting immune response. GPI-100 is under license to New York-based Pfizer Animal Health Inc. and West Lafayette, Ind.-based Endocyte Inc. as an adjuvant to boost immunity to their vaccine-based products.

• Bionomics Ltd., of Adelaide, Australia, said shareholders gave their formal support to the company's acquisition of Iliad Chemicals Pty. Ltd., of Melbourne, Australia, for $9 million. Shareholders also approved a $6 million placement to fund development programs in cancer and central nervous system disorders.

• BioTie Therapies Oyj, of Turku, Finland, raised €6.6 million (US$8 million) through the issue of almost 8.8 million shares, corresponding to 73% of the total number of shares it originally offered. The company now has about 52.7 million shares outstanding.

• Bone Medical Ltd., of Bentley, Western Australia, appointed Paul Hopper chairman, effective July 1. The appointment follows the board's intention to separate the role of CEO and chairman. Hopper co-founded Alpha Healthcare Ltd. and previously served as CEO of Australian Cancer Technology Ltd. in Sydney, Australia.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said preliminary results of a Phase I trial of CAT-354 showed the drug to be well tolerated with no reported safety concerns. CAT-354 is a human anti-IL13 monoclonal antibody in development as a treatment for severe asthma. A pharmacology study is set to begin in the fourth quarter.

• Debiopharm SA, of Lausanne, Switzerland, signed a license and equity agreement with Neovacs SA, of Paris, for the development of a TNF alpha kinoid and its related technology programs. Terms of the deal call for Debiopharm and its wholly owned investment affiliate, Debioinnovation, to make up-front and milestone payments, in both cash and equity, at various stages of development. In addition, Debiopharm will fund the product's entire development. Upon commercialization, Neovacs will receive staggered royalties based on Debiopharm's revenues from worldwide sales. Potential indications include wasting syndromes such as cancer cachexia and autoimmune diseases. Debiopharm will fund and develop at least one indication until completion of Phase IIb before out-licensing to sales and marketing partners.

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., said the European Committee for Medicinal Products for Human Use has adopted a positive opinion on Berlin-based Schering AG's marketing authorization application for Vasovist (gadofosveset trisodium) for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease. The EU marketing application for MS-325, trade named Vasovist, was submitted in June 2004 by Schering, EPIX's worldwide development and marketing partner.

• Evotec AG, of Hamburg, Germany, is raising €28.4 million (US$34.3 million) through a capital increase of about 10.5 million shares issued at €2.72 per share. The company said it intends to use the funds to advance and expand its pipeline of drug candidates. The number of Evotec shares increased to 62.7 million.

• Generex Biotechnology Corp., of Toronto, said its subsidiary, Antigen Express Inc., agreed to collaborate with Stallergenes SA, of Antony, France, on studies to design and test Ii-Key/allergen epitope hybrid peptides to control of asthma and allergic reactions. Financial terms were not disclosed.

• Geneva Bioinformatics SA, of Geneva, signed an agreement under which Singapore-based KOOPrime Pte. Ltd. will distribute its Phenyx software platform in Singapore, Malaysia, China and Taiwan. Phenyx is used for the identification and characterization of proteins and peptides from mass spectrometry data.

• GenPat77, of Berlin, said it discovered a protein, TZAP7, that regulates immune cell activation via the Notch signaling system, a family of receptors implicated in controlling immune cell regulation. Initial research presented at the 9th Basic Science Symposium of the Transplantation Society in La Baulle, France, suggests that therapeutic blockage of TZAP7 might lead to new treatments for preventing transplant rejection and other disorders caused by overactivation of the immune response. Data indicate that TZAP7 might also act as a biomarker for diagnostic applications.

• GlaxoSmithKline Biologicals, of London, and the International AIDS Vaccine Initiative (IAVI) formed a public-private partnership to develop an AIDS vaccine. Under the agreement, the collaborators will advance the development of GSK's technology, which uses non-infectious vaccine vectors to stimulate specific immune responses directed against HIV. The vectors are derived from adenoviruses, originally isolated from non-human primates. IAVI will contribute technical expertise and funding.

• Helsinn Healthcare SA, of Lugano, Switzerland, agreed to grant Lisbon, Portugal-based Angelini Farmaceutica exclusive license and distribution rights for Aloxi (palonosetron hydrochloride) in Portugal. Aloxi is a long-acting anti-emetic, belonging to the class of second-generation serotonin (5-HT3) antagonists. It has been granted European registration in the prevention of nausea and vomiting associated with chemotherapy. Financial terms were not disclosed.

• Immuno-Designed Molecules SA, of Paris, said it licensed marketing rights for Junovan (formerly Mepact) in the UK and Ireland to UK-based Cambridge Laboratories Ltd. In exchange, IDM will receive an up-front license fee and milestone payments throughout product development, as well as royalties on product sales. Junovan, an immune system stimulator designed to destroy cancer cells by activating macrophages present in the patient, recently demonstrated significant survival data in a Phase III trial in non-metastatic osteosarcoma.

• Innate Pharma SAS, of Marseille, France, attained the first milestone in its collaboration with Novo Nordisk A/S, of Bagsvaerd, Denmark. The companies signed a research, development and licensing deal in November 2003 aimed at developing new therapeutics for cancer and possibly other diseases. It was aimed at generating a new class of immunomodulatory antibodies targeting natural-killer (NK) cells, a subset of non-conventional lymphocytes involved in immune system regulation that have a direct cytotoxic effect on a wide range of tumor targets. The deal grants Novo Nordisk exclusive rights to one family of receptor targets expressed by NK cells. Novo will develop and commercialize products arising from the collaboration, and has rights for all indications.

• Kreatech Biotechnology BV, of Amsterdam, the Netherlands, signed a technology agreement with Ambion Inc., of Austin, Texas, to use Ambion's MessageAmp II aRNA amplification system in conjunction with its own Universal Linkage system labeling technology. The collaboration aims at providing a series of complete RNA amplification and labeling kits for gene-expression analysis. Financial terms were not disclosed.

• Miraculins, of Winnipeg, Manitoba, acquired intellectual property assets of Europroteome AG, of Berlin, a former developer of products for the diagnostic, prognostic and patient-specific therapy of human cancers. The intellectual property portfolio includes 14 patents and numerous discoveries related to the diagnosis and treatment of several cancers, the company said, that uses the human sample collection of Europroteome, which contained samples from more than 4,000 patients. Miraculins purchased all rights to the patents and has no further milestone or royalty commitments related to them.

• ML Laboratories plc, of St. Albans, UK, said Maxygen Inc., of Redwood City, Calif., upgraded its agreement for ML's Ubiquitous Chromatin Opening Element (UCOE) from a research to a commercial license. At the same time, ML said it received a second U.S. patent on the technology, which is applied to improve yield, consistency and stability of protein production in mammalian cell cultures. As part of its current restructuring ML is seeking to sell the rights to UCOE.

• Neurobiological Technologies Inc., of Richmond, California, signed agreements with Nordmark Arzneimittel GmbH & Co. KG, of Uetersen, Germany, and Baxter Pharmaceutical Solutions, part of Baxter Healthcare Corp., of Deerfield, Ill., to manufacture, fill and package Viprinex (ancrod) for NTI's Phase III trials in acute ischemic stroke. Nordmark will manufacture the biological active ingredient, ancrod, which is derived from the venom of the Malayan pit viper.

• Nuevolution A/S, of Copenhagen, Denmark, signed an agreement to use its Chemetics drug discovery technology to find drug leads against targets provided by Schering AG, of Berlin. Nuevolution will generate and screen several different Chemetics libraries against the collaboration targets to identify ligands. Financial terms were not disclosed.

• Peptech Ltd., of Sydney, Australia, said its joint venture partner, Biosceptre International Ltd., also of Sydney, reported significant results from a study of the development of a diagnostic test for cancer. The study tested 55 ovarian tissue samples, and Biosceptre's antibody detection method identified all of the invasive ovarian carcinomas included in the tissue analysis.

• Pharmasset Inc., of Atlanta, entered an exclusive license agreement with Bukwang Pharm. Co. Ltd., of Seoul, South Korea, under which Pharmasset will develop and commercialize the antiviral Clevudine for chronic hepatitis B virus infections in the Americas, Europe and other select territories. Also known as L-FMAU, Clevudine is an oral, once-daily nucleoside analogue currently in Phase III trials in Korea and has been the subject of earlier-stage clinical trials under an investigational new drug application filed with the FDA. At the same time, Bukwang received an option on Racivir for the treatment of chronic hepatitis B in Korea. Financial terms were not disclosed.

• Physiomics plc, of Oxford, UK, and Bayer Technology Services GmbH, of Leverkusen, Germany, signed an agreement for Physiomics to distribute Bayer's PK-Sim pharmacokinetic modeling products and services for a renewable five year period. The agreement covers all therapeutic areas.

• Proteome Systems, of Sydney, Australia, signed a letter of intent with the Geneva-based Foundation for Innovative New Diagnostics, a firm funded by the Bill & Melinda Gates Foundation, to fast track the development of an antigen-based diagnostic test to detect active tuberculosis. Proteome Systems' test is designed to detect TB antigens, as well as monitor disease progression and treatment response.

• pSivida Ltd., of Perth, Australia, and the Singapore General Hospital said a Phase IIa trial with BrachySil in inoperable primary liver cancer found the brachytherapy treatment to be safe and well tolerated. BrachySil also significantly reduced the size of tumors, as determined by CT scanning. A Phase IIb study is set to begin later this year.

• Qiagen NV, of Venlo, the Netherlands, said it extended a distribution agreement with Abbott Park, Ill.-based Abbott Laboratories. Under the terms of the agreement, Abbott received distribution rights to a number of real-time PCR diagnostic tests for use on Applied Biosystems Group's detection instruments. The PCR assays were developed by Hamburg, Germany-based Artus GmbH, which Qiagen recently acquired.

• Revivicor Inc., of Blacksburg, Va., said it purchased all of the intellectual property and tangible assets of Melbourne, Australia-based XenoTrans Ltd., a firm focused on xenotransplantation technology. As part of the agreement, Revivicor obtained all IP relating to pig alpha-1,3 galactosyl transferase. The IP adds to property owned by Revivicor, the first company to clone pigs, and to generate GT-negative pigs. As part of the transaction, XTL shareholders will receive a minority equity stake in Revivicor, and former XTL CEO Ian Mckenzie will join Revivicor's board. No further terms were disclosed.

• Rosetta Genomics Ltd., of Rehovot, Israel, said a study to be published in the July issue of Nature Genetics reports that company scientists have identified hundreds of human microRNA genes, including the first report of primate-specific microRNAs. Rosetta said researchers successfully cloned and sequenced 89 human microRNAs, nearly doubling the number sequenced in humans to date.

• Sanofi-Aventis Group, of Paris, said the FDA accepted for filing its new drug application for rimonabant, the first agent in a therapeutic class known as selective cannabinoid Type 1 blockers. The company seeks approval for the drug in the management of cardiovascular risk factors, such as obesity.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it expects to close the sale of its global biologics manufacturing business to subsidiaries of Ferring Holding SA, of Lausanne, Switzerland, within 30 days. Savient expects to receive about $80 million in three installments, with $55 million at closing, $15 million at the first anniversary of closing and $10 million at the second anniversary. The company announced the sale in March to Ferring BV and Ferring International Centre SA

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Upstate Group, agreed to collaborate with CXR Biosciences Ltd., of Dundee, UK, to establish a battery of in vitro screens to select early stage candidate molecules for further development. The screening platform will use predictive toxicity and drug metabolism screens to profile compounds in various cell-based and in vitro assays.

• TopoTarget AB, of Copenhagen, Denmark, said Savene (dexrazoxane) demonstrated a 97 percent success rate in a multicenter Phase II/III trial of 35 patients in treating accidental extravasation of anthracycline chemotherapeutics. A previous trial in 18 patients had a 100 percent success rate. Savene, a topoisomerase II inhibitor, is administered as an antidote when anthracyclines are accidentally infused outside the vein. The only treatment for the subsequent tissue damage is surgery. The product has orphan drug status in the U.S. and Europe.

• Vernalis plc, of London, said six-month interim data showed that frovatriptan, its menstrually related migraine (MRM) drug, is well tolerated when used as a six-day dosing regimen to for up to six menstrual periods as preventative therapy. No serious adverse events were recorded. The data, presented at the 47th annual meeting of the American Headache Society in Philadelphia, will be included in a supplemental new drug application expected to be submitted during the first half of 2006 to market the drug as a short-term prophylaxis for MRM.

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