• Amorfix Life Sciences, of Toronto, reported the discovery of misfiled superoxide dismutase 1 (SOD1) protein in the brains of Alzheimer's disease patients, suggesting that SOD1 is a common link between Alzheimer's and amyotrophic lateral sclerosis. The company previously reported results from pilot studies showing that its antibodies and vaccines targeting misfolded SOD1 demonstrated life extension in a mouse model of ALS, and with the latest discovery, will expand its preclinical investigation to include Alzheimer's disease.

• Amsterdam Molecular Therapeutics BV (AMT), of Amsterdam, the Netherlands, licensed from Digna Biotech SL, of Pamplona, Spain, the right to commercialize gene therapy products developed at the Center for the Study of Applied Medicine at the University of Navarra, Spain. AMT plans to start preclinical studies next year on the first program to emerge from the collaboration, an adeno-associated viral vector delivering insulin-like growth factor I (IGF-I) for late-stage liver cirrhosis. Separately, AMT said it completed enrollment of 14 patients in a clinical trial of its lead gene therapy product, AMT-011, for deficiency of the lipoprotein lipase (LPL) gene. AMT expects to apply for regulatory approval of AMT-011 in the first half of 2008.

• CardioVascular BioTherapeutics Inc., of Las Vegas, said it has engaged the Bruckner Group, of Wakefield, Mass., to find a joint commercialization partner for the biotech's cardiovascular disease drug candidates based on fibroblast growth factor-1 (FGF-1). The firm is studying FGF-1 compounds as potential angiogenic therapies for patients with coronary artery disease.

• Dynavax Technologies Corp., of Berkeley, Calif., published a paper in the December 2007 European Journal of Immunology showing that administration of IRS 954 to lupus-prone mice prevented progression of the disease. The mice exhibited a reduction in autoantibody levels; decreased proteinuria, glomerulonephritis and end-organ damage; and increased survival. IRS 954 is an immunoregulatory sequence oligonucleotide that inhibits two Toll-like receptors, TLR7 and TLR9. Research on IRS 954 is being supported by a $500,000 grant from the Alliance for Lupus Research.

• Fovea Pharmaceuticals SA, of Paris, and Genzyme Corp., of Cambridge, Mass., have entered a research collaboration to develop gene-related therapies for diseases of the eye using targets selected by Fovea and gene delivery technologies developed by Genzyme. The ultimate goal is to offer customized solutions to understand disease mechanisms involved, with the aim of developing new therapeutic strategies to prevent or reduce the severity of blindness. Financial terms were not disclosed.

• Gemin X, of Malvern, Pa., said that an online report published by the journal Proceedings of the National Academy of Sciences confirmed the Bcl-2-mediated mechanism of action of its lead compound, obatoclax (GX15-070), demonstrating that it specifically disrupts the survival of cancer cells as a result of inhibiting the Bcl-2 pro-survival protein Mcl-1. Obatoclax is in Phase II trials in multiple cancer indications that is specifically designed to inhibit all relevant members of the Bcl-2 protein family.

• Introgen Therapeutics Inc., of Austin, Texas, and its subsidiary, Gendux Molecular Ltd., said the European regulatory authorities have accepted the marketing authorization application for Advexin and will now begin their review. Advexin is designed to target p53 for the treatment of Li-Fraumeni syndrome (LFS) cancers. The company anticipates filing additional Advexin submissions in 2007 in the U.S. and Europe for recurrent head and neck cancer.

• Lipid Sciences Inc., of Pleasanton, Calif., received notice from Nasdaq that the firm is not in compliance with the minimum $10 million stockholders' equity requirement or the minimum $50 million market capitalization, total assets and total revenue requirements. Lipid has until Dec. 5 to submit a plan for regaining compliance.

• LipoNova AG, of Hanover, Germany, signed a memorandum of understanding with an unnamed, non-European pharmaceutical company for development and marketing of Reniale, LipoNova's autologous vaccine for renal cell carcinoma. The partner will support a planned Phase III trial with the drug and make milestone and royalty payments in exchange for an exclusive license in an undisclosed non-European country. Specific terms were not disclosed.

• Maxygen Inc., of Redwood City, Calif., plans to consolidate all operations at its U.S. headquarters. By the end of the second quarter of 2008, the company will cease operations of Maxygen ApS, its wholly owned subsidiary in Denmark. The company also plans to add approximately 25 employees at its Redwood City site. As a result, the company expects to save at least $10 million annually beginning in 2008. Maxygen cited the falling value of the dollar as a reason for shutting the Denmark operation. It primarily employs scientific staff engaged in preclinical research at that site.

• Modigene Inc., of Vienna, Va., said its Israeli-based R&D subsidiary has received approval for a special grant from the Israeli Office of the Chief Scientist to support development of hGH-CTP, its longer-acting version of human growth hormone (hGH). In preclinical models a single injection of hGH-CTP has shown the potential to replace seven to 10 daily injections of commercial hGH. Based on an estimated development budget of $10 million, the grant will provide cash reimbursements of 30 percent to 50 percent of expenses.

• Neoprobe Corp., of Dublin, Ohio, entered an exclusive agreement for Cardinal Health, also of Dublin, to market and distribute Lymphoseek, a radioactive lymphatic mapping targeting agent in Phase III trials in breast cancer and melanoma. Under the terms, Cardinal Health will have U.S. rights to distribute Lymphoseek for an initial term of five years following marketing clearance from the FDA. Financial terms were not disclosed.

• Oasmia Pharmaceutical, of Sweden, and Orion Corp., of Finland, have entered a license and distribution agreement for marketing and sales of Paclical (micellar paclitaxel) in the Nordic region, encompassing Sweden, Denmark, Norway, Finland and Iceland. The product is entering Phase III development for ovarian cancer. Under the agreement, Orion will receive the exclusive rights in the Nordic region to distribute and sell the product. It also will have first right of refusal for one more cancer drug candidate in the Oasmia product portfolio in the Nordic region. According to the agreement, Oasmia will receive payments of €4 million (US$5.9 million), partly up front and partly subject to a successful development and regulatory process for Paclical as royalties from the sales. Oasmia will be responsible for the clinical development, registration and production of Paclical. Orion will be responsible for the distribution and sales in the Nordic region after registration.

• Pharmacopeia, of Princeton, N.J., said it has identified two new lead compounds for advancement in its alliance with GlaxoSmithKline, of London, through its collaboration with the Center of Excellence for External Drug Discovery. The first of the lead compounds forms the basis of a new lead optimization program focused on identifying a treatment for respiratory disease. The other newly identified lead compound is the second from a program in inflammatory pain. As a result of the identification of the two lead compounds, Pharmacopeia will receive milestone payments totaling $1 million from GSK. Pharmacopeia has received $10 million from GSK in connection with early discovery activities and is entitled to an additional $5 million payment upon the completion of additional early discovery activities.

• Pluristem Therapeutics Inc. (formerly Pluristem Life Systems Inc.), of New York, said its Placenta Expanded (PLX) cells reduced TNF-alpha and interferon-gamma inflammatory cytokines in in vitro models of autoimmune disorders. PLX cells are mesenchymal stem cells obtained from the placenta and expanded using Pluristem's 3D PluriX technology. Shares of Pluristem (OTC BB:PSTI) fell $2.50, or 36 percent, to close at $4.50 on Tuesday after the company's 200-for-1 reverse stock split.

• Pronova BioPharma ASA, of Lysaker, Norway, said the Federal Patent Court in Munich, Germany, declared the company's patent covering the active pharmaceutical ingredient of Omacor invalid. That decision follows the nullity action brought by KD Pharma Bexbach GmbH and Institute Biochimique SA against Pronova in June 2006. Pronova said it will appeal the ruling and that the decision will not affect its right to supply and sell Omacor in Germany. Omacor, an omega-3-derived drug approved in the U.S. and Europe for hypertriglyceridemia, is distributed through several partners, including Reliant Pharmaceuticals Inc., of Liberty Corner, N.J., which sells the product in the U.S. as Lovaza.

• Sepracor Inc., of Marlborough, Mass., said it has received notice from the Securities and Exchange Commission that an investigation concerning the firm's historical stock option granting practices has been completed and that no enforcement action was recommended.

• Singulex Inc., of Hayward, Calif., is collaborating with researchers at Wyeth Research to develop immunoassays on the company's Erenna system. Singulex has installed the Erenna system at Wyeth as part of its Erenna Technology Access Program and has begun optimizing assays that will allow Wyeth to measure specific biomarkers in human blood.

• Urigen Pharmaceuticals Inc., of Burlingame, Calif., said it has in-licensed Nasobol, an intranasal gel testosterone product for the treatment of male hypogonadism, from Mattern Pharmaceuticals AG, of Switzerland. Under the agreement, Urigen has acquired worldwide rights to develop and commercialize intranasal testosterone for the treatment of males. In exchange, Mattern will receive an undisclosed up-front number of Urigen common shares and will receive additional milestone payments based on certain development and regulatory milestones. In addition, Mattern will receive royalties on net sales of the product until an undisclosed predetermined amount of royalties has been paid.

• Vanda Pharmaceuticals Inc., of Rockville, Md., said the FDA has accepted the new drug application for iloperidone, an investigational atypical antipsychotic for schizophrenia.

• Xenome Ltd., of Brisbane, Australia, signed a joint research collaboration agreement with Amylin Pharmaceuticals Inc., of San Diego, focusing on discovery and development of novel peptide therapeutics for metabolic and musculoskeletal diseases. In addition, Amylin has made an equity investment in Xenome matched by investments from Queensland BioCapital Funds and Innovis Australia. Under the collaboration, Amylin will apply its proprietary screening technologies to evaluate the therapeutic potential of the peptides from Xenome's bioactive peptide library derived from natural sources. Amylin will have the right to select and exclusively license lead candidates resulting from a screening program in metabolic and musculoskeletal disease for further development and commercialization in exchange for milestones and royalties paid to Xenome. Financial details were not disclosed. Separately, Xenome raised $10 million of equity finance. The syndicated funding round includes its major investor, Queensland BioCapital Funds, for $2.7 million, equity funding of $5 million from Amylin and $2.3 million from Innovis Investment Partners.