• Ablynx NV, of Ghent, Belgium, entered a drug discovery and development partnership with Procter & Gamble Pharmaceuticals Inc., a subsidiary of the Procter & Gamble Co., of Cincinnati. Ablynx will use its Nanobody platform to discover and develop drug candidates against a G protein-coupled receptor target specified by P&G, which will provide Ablynx with research and development funding, pre-determined milestone payments and royalties upon commercialization. Ablynx will be responsible for discovering Nanobodies that meet a pre-defined product profile. P&G will assume responsibility for preclinical and clinical development of lead Nanobodies, as well as the commercialization of any resulting products.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said that Boston Scientific Corp., of Natick, Mass., is expanding its voluntary worldwide recall to include certain additional units of its Taxus Express2 Paclitaxel-Eluting Coronary Stent System. Boston Scientific also is beginning a voluntary recall of certain units of its Express2 Coronary Stent Systems (bare metal stents). The recall will involve about 85,000 Taxus stent systems and about 11,000 Express2 stent systems. Angiotech provides the products' coating. On Monday, its stock (NASDAQ:ANPI) dropped $1.29 to close at $16.76.

• AOP Orphan Pharmaceuticals, of Vienna, Austria, achieved its goal to make Thromboreductin available in the EU by means of a confirmatory clinical trial program. Thromboreductin is the first anagrelide-containing medicinal product approved within the EU. It is available to treat patients with essential thrombocythaemia (ET). Hydroxurea was the only drug approved to treat ET in some European countries, but the therapeutic showed it might lead to leukemia in long-term treatment. The ongoing Phase III study will include 220 treatment-na ve, high-risk ET patients at 30 centers.

• Applied NeuroSolutions Inc., of Vernon Hills, Ill., said data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed a biological marker called p-tau231 (phosphorylation of the tau protein at amino acid 231) appears to be a good biomarker for the early detection of the disease. The company is developing an assay based on p-tau231 levels in cerebrospinal fluid.

• Atrix Laboratories Inc., of Fort Collins, Colo., said Sanofi-Synthelabo Canada, a unit of Sanofi-Synthelabo SA, of Paris, filed for marketing authorization in Canada for the six-month Eligard 45-mg product (leuprolide acetate for injectable suspension). Sanofi-Synthelabo Canada, Atrix's licensee, will be responsible for marketing the products in Canada.

• Biogen Idec Inc., of Cambridge, Mass., selected Evotec OAI AG, of Hamburg, Germany, as one of its service providers for chemical process research and development and cGMP manufacturing. The companies have expanded their relationship under a master services agreement to progress one of Biogen Idec's development candidates through preclinical testing into clinical trials through provision of Evotec's chemical and pharmaceutical development platform, EVOdevelop.

• Cambria Biosciences LLC, of Woburn, Mass., formed a three-year collaboration with Syngenta Ltd., of Basel, Switzerland, to elucidate the mechanism of action of small-molecule compounds supplied by Syngenta, to guide the discovery and development of new classes of safe, effective insecticides. Syngenta will provide full research funding and certain in-kind resources to Cambria. Specific financial terms were not disclosed.

• Ciphergen Biosystems Inc., of Fremont, Calif., said three studies involving a SELDI ProteinChip Amyloid Beta Multi-Peptide Immunoassay were presented at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia. The first study used a SELDI immunoassay to evaluate the presence of N-terminally truncated A-beta42 peptides in cerebrospinal fluid (CSF). The second study looked at the use of the assay to discover three A-beta peptides in clinical CSF samples. And the third study showed reproducible, quantitative changes in the concentration of clinical CSF A-beta peptide variants in response to treatment with non-steroidal, anti-inflammatory drug compounds.

• Compugen Ltd., of Tel Aviv, Israel, said an article in Nature Biotechnology highlighted the systematic identification of adenosine to inosine RNA-editing sites in the human transcriptome. The discovery increases the known A to I editing sites from about 100 to more than 10,000. The company said it used its LEADS computational biology platform, which uses algorithms to create a predictive view of the complete transcriptome of complex organisms. RNA editing involves changes to small nucleotides after DNA has been transcribed into RNA. The deficiency or misregulation in that type of editing has been associated with amyotrophic lateral sclerosis, malignant gliomas, epilepsy and depression. On Monday, Compugen's stock (NASDAQ:CGEN) gained 93 cents, or 22.7 percent, to close at $5.03.

• Curis Inc., of Cambridge, Mass., said the current online issue of the Proceedings of the National Academy of Sciences contains a study report demonstrating that human medulloblastoma is correlated with deletion of a gene that encodes a suppressor of the Hedgehog signaling pathway. The study shows that certain cancers promote tumor growth by exploiting some means of up-regulating the Hedgehog signaling pathway. Curis has developed several candidates designed to block or antagonize abnormal activation of the Hedgehog pathway.

• CytRx Corp., of Los Angeles, and the University of Massachusetts Medical School broadened their existing alliance through a new agreement giving CytRx option rights to license new technologies over the next three years in the fields of RNAi, Type I and Type II diabetes, obesity, neurodegenerative diseases and cytomegalovirus. CytRx would make certain cash payments to the university over the next two years.

• Endovasc Inc., of Montgomery, Texas, concluded its Phase II Liprostin trial for peripheral vascular disease. The purpose of the study was to determine if Liprostin could postpone or eliminate the need for surgical intervention. Its efficacy endpoints include maximum walking distance and pain-free maximum walking distance compared to baseline, and the company said it has noticed a marked improvement in patients on both endpoints. Endovasc is reviewing a number of financial strategies to move Liprostin into a Phase III trial.

• GenoMed Inc., of St. Louis, said data from its initial case series of eight West Nile virus encephalitis patients were published in Current Topics in Medicinal Chemistry. Since publication, the company said it has treated four more patients, and it has recorded 11 successful treatments in patients with an intact immune system. The single failure came in an immunosuppressed patient with chronic leukemia.

• GenProbe, of San Diego, and Chiron Corp., of Emeryville, Calif., began pivotal trials of their Procleix West Nile virus (WNV) blood-screening assay. Since the start of this year's mosquito season in May, the Procleix WNV Assay has detected 20 WNV-infected donations to date. The trial will be conducted at five U.S. blood centers and should last about four months.

• Insmed Inc., of Richmond, Va., said two independent studies were presented at the Specialized Programs of Research Excellence meeting in Baltimore. Data from one study in models of human head and neck cancer demonstrated that a new class of compounds, called farnesyl transferase inhibitors, exert their antitumor activity largely through up-regulation of IGFBP-3. In the other experiments, treatment of cells with recombinant human IGFBP-3 and an RXR-specific ligand resulted in rapid nuclear localization of IGFBP-3. The company is developing a rhIGFBP-3 product. The meeting was sponsored by the National Cancer Institute in Bethesda, Md.

• Inspire Pharmaceuticals Inc., of Durham, N.C., plans to publicly offer 6 million shares of its common stock. Morgan Stanley is acting as sole book-running manager, with Deutsche Bank Securities as co-lead manager. Other underwriters include SG Cowen & Co. LLC and Piper Jaffray & Co. They will have the option to purchase up to an additional 900,000 shares to cover overallotments. Inspire focuses on therapeutics in the ophthalmology and respiratory fields.

• Kosan Biosciences Inc., of Hayward, Calif., began the first Phase II monotherapy trial of 17-allylamino-17-demethoxy-geldanamycin. The study will evaluate antitumor efficacy in cancer patients with metastatic melanoma. The National Cancer Institute in Bethesda, Md., is sponsoring the trial under a Cooperative Research and Development Agreement between Kosan and the NCI's Cancer Therapy Evaluation Program. Preclinical research has shown that the MAPK pathway is critical for melanoma growth, and scientists believe that 17-AAG effectively can interrupt the pathway.

• Martek Biosciences Corp., of Columbia, Md., said a study published in the July/August 2004 edition of Child Development found that infants whose mothers had higher blood levels of docosahexaenoic acid (DHA) at birth showed more mature forms of attention during their first two years of development. DHA supports an infant's brain and eye development. Martek's DHA, along with arachidonic acid (ARA), is the only source cleared by the FDA for use in U.S. infant formula. Martek develops, manufacturers and sells products from microalgae.

• Monsanto Co., of St. Louis, said the European Commission approved the import, processing and use in animal feed of the company's NK603 Roundup Ready Corn grain in the European Union, conditional on its pending approval under the EU Novel Foods Regulation. Monsanto's NK603 corn, which is designed to be tolerant to the active ingredient in Roundup agricultural herbicides, is marketed as Roundup Ready Corn 2.

• Neurochem Inc., of Montreal, said interim Phase II data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed that about 70 percent of mild Alzheimer's disease patients had stabilized or had improved cognitive function tests, even after 20 months of enrollment in the open-label extension study of Alzhemed. The investigational oral product candidate for the mild to moderate form of the disease is designed to modify the course of Alzheimer's through its anti-amyloid activity. Phase III trials began in 70 North American sites last month. On Monday, Neurochem's stock (NASDAQ:NRMX) dropped $3.50, or 15.8 percent, to close at $18.72.

• New River Pharmaceuticals Inc., of Radford, Va., said it would sell 4.2 million common shares at a range of $10 to $14 apiece as part of its proposed initial public offering. The specialty pharmaceutical company, which aims to develop improved versions of widely prescribed drugs, registered for its IPO in May.

• Osel Inc., of Santa Clara, Calif., began Phase I trials of its first product candidate, Lactin-V, as a treatment for bacterial vaginosis. The company also submitted a second investigational new drug application for the product as a treatment for recurring urinary tract infection indications.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., named Leslie Browne president and CEO. Most recently, he was the chief operating officer of Iconix Pharmaceuticals Inc., of Mountain View, Calif. Pharmacopeia, a chemistry-based collaborative drug discovery company focused on creating new small-molecule therapeutics, is a spin-off from the former Pharmacopeia Inc. The remaining entity was renamed Accelrys Inc. to better reflect its focus on the scientific software business. (See BioWorld Today, Dec. 22, 2003.)

• PharmaMar SA, of Madrid, Spain, began Phase II trials of Kahalalide F in non-small-cell lung cancer and melanoma. The primary endpoint of the open-label lung cancer study is response rate. Secondary objectives include further analysis of the product's pharmacokinetics and safety profile. The endpoints of the open-label advanced malignant melanoma study are the same.

• PolyNovo Biomaterials Pty. Ltd., of Perth, Australia, formed an alliance with Imperial College London to further develop aspects of the company's polymer technology for bone repair. PolyNovo was established in May by CSIRO, Australia's national research agency, and Xceed Biotechnology Ltd., also of Perth; both own 50 percent of the company. PolyNovo is developing biocompatible and biodegradable polymers that can be formulated as an injectable gel that cures in situ or on demand, promotes tissue growth and controls the rate of degradation.

• Prana Biotechnology Ltd., of Melbourne, Australia, said data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed that it is the inappropriate interaction of beta amyloid with brain metals copper and zinc that leads to disease progression. The company's co-founder detailed how an FDA-approved antibiotic called clioquinol detects amyloid pathology in brain tissue and how the drug arrives at the appropriate biochemical target in living transgenic mice and in post-mortem tissue from patients with Alzheimer's disease.

• Protein Design Labs Inc., of Fremont, Calif., and Morphotek Inc., of Exton, Pa., formed a multiyear research and commercialization agreement that provides PDL access to the Morphodoma and Suppressor of Immunoglobulin Production technology, and Morphotek access to technology for antibody humanization. Each party will receive research licenses to the technologies and options to exercise commercial licenses for antibodies in all therapeutic areas. Financial details were not disclosed.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it would refine its business plan to focus on the development of its pipeline products and divest its operations in Israel, including its Bio-Technology General (Israel) Ltd. subsidiary. The company's pipeline includes two Phase II products - prosaptide for peripheral neuropathic pain and Puricase for severe, refractory gout. Savient also plans to concentrate on in-licensing clinical-stage compounds.

• Sequenom Inc., of San Diego, formed a collaboration with the Agricultural Research Service of the U.S. Department of Agriculture to develop and validate a genetic marker panel for swine identification. The agreement includes a Sequenom MassArray Compact system placement, as well as further development of a beef carcass quality panel assay. The agreement expands an ongoing multiyear relationship for the identification and screening of disease susceptibility markers and favorable breeding traits in cattle.

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said it plans to pursue regulatory approval for IoGen in Canada. The company requested a pre-new drug submission meeting with regulatory authorities in that country. Symbollon plans to seek clearance to submit a new drug submission covering the use of IoGen as a treatment for moderate to severe cyclic breast pain and tenderness associated with fibrocystic breast. The specialty pharmaceutical company expects the meeting to be held late this summer.

• Symyx Technologies Inc., of Santa Clara, Calif., extended its research and development collaboration for another year with BP Petrochemicals, a unit of BP plc, of London, to discover new and improved materials relevant to BP's commodity chemical businesses. The focus will be on the discovery of catalysts to produce certain commodity chemicals. The parties originally began a two-year research collaboration in January 2003. BP will continue to have exclusive rights to commercialize materials discovered within the collaboration, and Symyx will receive royalties in connection with the sale of products commercialized.

• TargeGen Inc., of San Diego, said it plans to begin a Phase I/II trial this fall to evaluate TG100-115, after its first investigational new drug application was declared active by the FDA. The privately held company, which plans to test the selective kinase inhibitor in 100 patients, said TG100-115 has demonstrated the ability to suppress vascular leakage and significantly reduce infarct size in preclinical models of acute myocardial infarction.

• ViaCell Inc., of Boston, and the International Netcord Foundation, a network of nonprofit public cord blood banks, said findings published in the July 19, 2004, issue of The Journal of Experimental Medicine showed that researchers using neonatal somatic stem cells were able to grow bone, cartilage, hematopoietic, neural, liver and heart tissue in in vivo studies. The cells are found in human umbilical cord blood.

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