• Altana AG, of Bad Homburg, Germany, said its pharmaceutical division Altana Pharma, in partnership with Pfizer Inc., of New York, will submit the registration dossier for its respiratory drug Daxas (roflumilast) for European approval to the European Agency for the Evaluation of Medicinal Products in February. Daxas is being developed as an oral, once-daily, anti-inflammatory, selective phosphodiesterase-4-inhibitor for the treatment of chronic obstructive pulmonary disease and asthma.

• Altus Biologics Inc., of Cambridge, Mass., reached an undisclosed development milestone in its collaboration with the Cystic Fibrosis Foundation's drug development affiliate, Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) in Chapel Hill, N.C., for TheraCLEC. The milestone is part of the agreement reported in February 2001, which covers the development of TheraCLEC to treat malabsorption as a result of exocrine pancreatic insufficiency in people with cystic fibrosis (CF). Altus received the milestone payment from CFFT based on the successful completion of its Phase I study in patients with CF.

• ArQule Inc., of Woburn, Mass., reported an increase in expected revenue for the current fiscal year, as payments anticipated for next month will be paid this month as a result of achieving certain goals in its collaboration with Pfizer Inc., of New York. The company received a $3 million equity investment from Pfizer. ArQule's increased financial guidance for the year ending Dec. 31 includes a revenue range of $63 million to $65 million, up from prior guidance of $58 million to $60 million. It expects to release final financial results and financial guidance for next year in mid-February.

• Australian Cancer Technology, of Perth, Australia, received approval for a Phase II trial of its cancer vaccine, Pentrix. The Human Research Ethics Committee of the Peter MacCallum Cancer Centre approved the trial. The trial will be conducted by Cancer Trials Australia, a collaboration among six internationally renowned Melbourne institutions. A total of 40 patients with hormone-refractory prostate cancer will be enrolled at the three sites to evaluate the clinical efficacy of Pentrix and confirm the safety of the new vaccine formulation in the high-risk group.

• Axonyx Inc., of New York, said that as a result of the scientific input during a recently held symposium on Alzheimer's disease, as well as guidance from the company's steering committee overseeing the ongoing clinical trials of Phenserine, the company will broaden its ongoing Phenserine Phase IIb trial and include a sub-study that will use brain scans of Alzheimer's disease (AD) patients to assess disease progression. The trial is designed to evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein and amyloid-beta in the plasma and cerebrospinal fluid of mild to moderate AD patients.

• Biomira Inc., of Edmonton, Alberta, said it expects to complete final analysis of its Phase IIb study of BLP 25 Liposomal vaccine (L-BLP25) in 171 non-small-cell lung cancer patients toward the end of next year's first quarter, with results expected to be reported shortly thereafter. The company and its collaborator, Merck KGaA, of Darmstadt, Germany, completed enrollment late last year.

• Cel-Sci Corp., of Vienna, Va., filed a $50 million stock shelf statement with the SEC. The company plans to use any proceeds to finance development activities. Cel-Sci's most advanced product, Multikine, manufactured using its cell culture technologies, is being developed for the treatment of cancer.

• Discovery Laboratories Inc., of Doylestown, Pa., filed a registration statement with the SEC to sell up to 6.5 million common shares from time to time. The company said it would use any proceeds primarily for clinical development of Surfaxin, as well as commercialization activities and general corporate and administrative purposes, including working capital and research and development expenses.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pennsylvania, and EpiCept Corp., of Englewood Cliffs, N.J., entered a license granting Endo exclusive worldwide rights to certain patents of EpiCept, as well as exclusive worldwide commercialization rights to EpiCept's LidoPAIN BP product. The license agreement provides for Endo to pay EpiCept undisclosed milestones as well as royalties on the LidoPAIN BP product. EpiCept also has retained an option to co-promote the LidoPAIN BP product.

• Genmab A/S, of Copenhagen, Denmark, said it is filing an investigational new drug application in the U.S. and a CTA in the UK to start an open-label Phase I/II trial using HuMax-CD20 in patients with relapsed or refractory follicular lymphoma. The trial is expected to include 40 patients in what will be a dose-escalation study. The primary objective will be to assess the safety and the efficacy of HuMax-CD20. HuMax-CD20 is a human antibody that is effective at binding to the disease target and releases slowly from the target over time, the company said.

• Ingenium Pharmaceuticals AG, of Munich, Germany, reported an Ingenotyping agreement with the Max-Planck Institute of Immunobiology in Freiburg, Germany. Ingenium will provide genetic mouse models for target genes to the institute using its Ingenotyping platform. The agreement brings the total number of Ingenotyping partnerships signed in 2003 to 10. Separately, Ingenium reported an agreement with the German National Research Center for Environment and Health GmbH in Neuherberg, Germany, to access an additional murine tissue archive.

• Instituto Grifols, of Madrid, Spain, obtained FDA clearance to market intravenous immunoglobulin Flebogamma in the U.S. Clinical trials have been successful in affirming the efficacy, safety and high tolerance of the product indicated for replacement therapies in patients with primary immunodeficiency diseases. Intravenous immunoglobulin is the purified plasmatic fraction where all antibodies are concentrated.

• Medarex Inc., of Princeton, N.J., entered an agreement to gain certain exclusive rights to electrofusion technology belonging to privately held Cyto Pulse Sciences Inc., of Hanover, Md. Medarex will use the technology to derive hybridomas from its UltiMAb Human Antibody Development System for the generation of human antibody producing cells. Financial terms were not disclosed.

• Munich Biotech AG, of Neuried, Germany, reported positive Phase I results showing that treatment with escalating doses of its taxane based antineovascular cytotoxic agent MBT-0206 in patients with metastatic breast cancer produced resistance to anthracycline-containing therapy. Preliminary data revealed a disease control rate of 44 percent, as defined by stable disease over four months or objective response according to RECIST criteria. Another Phase I study showed the combination of MBT-0206 and 5-FU was well tolerated with no signs of additional side effects in patients with advanced, metastatic gastrointestinal cancer. The privately held company also began a Phase I study of MBT-0206 as first-line pancreatic cancer therapy in combination with gemcitabine. In other news, Munich Biotech began Phase I studies of MBT-0312, an antineovascular cytotoxic agent being studied to determine safety and tolerability of escalating doses in patients with advanced, metastatic solid tumors. The study also is designed to evaluate its potential antitumor activity, the maximum tolerated dose and a recommended Phase II dosing regimen.

• Nastech Pharmaceutical Co., of Bothell, Wash., filed a shelf registration statement to offer common stock and warrants from time to time, up to an aggregate of $30 million. The terms of any future offering would be established at the time of the offering. The company plans to use the proceeds for general corporate purposes, including financing its clinical development and research programs, it said. Nastech's portfolio includes products for male and female sexual dysfunction, obesity, pain management, osteoporosis and cancer, among others.

• NeuroSearch A/S, of Ballerup, Denmark, will receive at least 182 million after entering a five-year research and development alliance with GlaxoSmithKline plc, of London, which gained access to NS2359, a Phase II-stage triple monoamine re-uptake inhibitor, the Endovion program and several other ion channel research programs related to central nervous system diseases, including depression, anxiety, and schizophrenia. An existing collaboration in depression disorders is integrated in the new agreement. On signing the agreement, NeuroSearch will receive 129.1 million in up-front and research payments and 117.7 million for 616,000 new shares to be issued to GSK. The shares correspond to an 8.7 percent increase of the share capital, equal to GSK having a strategic equity interest in NeuroSearch of 8 percent after the capital increase. The per-share purchase price reflects a 30 percent premium to the average market price during the 30 days before the agreement was signed. In addition to such guaranteed payments, NeuroSearch also might receive milestones based on continued development of NS2359 and any other candidates accepted by GSK, which also will assume funding responsibility for any program it takes. Such payments may total 198.5 million for NS2359, while for other candidates payments may range from 132.7 million to 190 million, depending upon their stage when accepted by GSK. NeuroSearch also would receive royalties on resulting compounds. Should GSK not exercise its options, NeuroSearch is free to develop the product itself or with another partner.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., entered a collaboration with Pioneer Hi-Bred International Inc., of Des Moines, Iowa, a subsidiary of DuPont, to identify plant genes that influence crop traits in Pioneer's crop variety development program. Paradigm will use its high-throughput GeneFunction Factory platform to analyze genes in Arabidopsis thaliana, a model organism, and identify those genes for Pioneer. Financial terms were not disclosed.

• Pharmos Corp., of Iselin, N.J., closed its previously reported $27 million public offering in which it sold 10.5 million common shares at $2.75 apiece. The stock was offered in a firm commitment underwriting pursuant to an existing shelf registration statement, with C.E. Unterberg, Towbin and Harris Nesbitt Gerard acting as the transaction's underwriters. (See BioWorld Today, Dec. 17, 2003.)

• Pluristem Life Systems Inc., of Haifa, Israel, touted the superiority of its 3-D culture technology for stem cell expansion without differentiation vs. conventional 2-D cultures presently used in research. The company said its success in building a 3-D replica of the physiological bone marrow environment proves that the 3-D structure is essential for the support of hematopoietic stem cells. Pluristem's core technology is designed to expand the cells for bone marrow transplantations using its 3-D PluriX bioreactor.

• Seattle Genetics Inc., of Bothell, Wash., received $10 million after designating additional antigen targets under an existing antibody-drug conjugate collaboration with Genentech Inc., of South San Francisco. Genentech, which paid a $3 million fee and also purchased $7 million of Seattle Genetics' common stock, has rights to use its antibody technology with antibodies against multiple targets selected by Genentech. The original agreement, in which Genentech paid an up-front fee and made an equity investment in exchange for access to an initial number of target antigens, calls for Genentech to pay ongoing research and material supply fees as well as progress-dependent milestone payments and royalties. (See BioWorld Today, April 23, 2002.)

• Serologicals Corp., of Atlanta, said it would receive about $18 million after executing a definitive agreement to sell its therapeutic plasma business to Gradipore Ltd., of Sydney, Australia. Serologicals will receive $3.5 million at closing and another $1.5 million on Feb. 2. The remainder will be represented by a secured promissory note. The therapeutic plasma assets consist of 10 plasma collection centers and a central testing laboratory. Gradipore will retain the majority of its employees, including management.

• SomaLogic Inc., of Boulder, Colo., said Mitsui & Co. Ltd., of Tokyo, is investing $10 million in SomaLogic, while Sumitomo Bakelite Co. Ltd., also of Tokyo, is investing $1 million. Mitsui's investment will support development of SomaLogic's aptamer technology for use in clinical diagnostics and the establishment of a jointly managed division of SomaLogic in Asia. Also, Sumitomo and SomaLogic entered a collaboration to develop special surfaces for SomaLogic's aptamer microarrays.

• SuperGen Inc., of Dublin, Calif., lowered its fiscal-year revenue projections to between $12 million and $12.5 million and raised its fiscal-year net loss projections to between $51 million and $53 million after reporting lower-than-expected demand for Nipent (pentostatin for injection) during this quarter. The company blamed the sales decline on the magnitude of drop-off in underlying demand for Nipent, coupled with wholesaler purchases in the third quarter prior to a Nipent price increase. SuperGen added that it believes that Nipent's maximum revenue potential has not been reached, and it will devote additional resources to drive future sales.

• The Donald Danforth Plant Science Center in St. Louis said its scientists who led the Maize Genomics Consortium published findings in the Dec. 19, 2003, issue of Science detailing their evaluation and validation of a gene-enrichment strategy for genome sequencing. Their work resulted in a sixfold reduction of the effective size of the Zea mays (maize or corn) genome while creating a fourfold increase in the gene identification rate when compared to standard whole-genome sequencing methods.

• The Medicines Co., of Parsippany, N.J., acquired a late-stage development compound called cangrelor from AstraZeneca plc, of London. In exchange for an undisclosed up-front payment, as well as milestone and royalty payments, The Medicines Co. acquired rights to develop, market and sell cangrelor worldwide excluding Japan, China, Korea, Taiwan and Thailand. Cangrelor, a non-thienopyridine that is given by injection, acts directly on the P2Y12 platelet receptor, a clinically validated target to treat or prevent arterial thrombosis. The company initially plans to focus on whether the short onset and offset of action at the P2Y12 receptor might provide advantages over existing oral and parenteral agents in high-throughput cardiac catheterization centers. Several features of the development program will be similar to those followed for its lead product, Angiomax (bivalirudin), and combination studies of Angiomax and cangrelor might be pursued. The Medicines Co. said it also might develop cangrelor in acute coronary syndromes and cardiovascular surgery.