• Amarillo Biosciences Inc., of Amarillo, Texas, agreed to conduct human influenza research with Manfred Beilharz, the chairman of microbiology and immunology in the school of biomedical, biomolecular and chemical sciences at the University of Western Australia. The study will take place in Perth, Australia, and will involve childcare workers, school teachers and hospital workers who will be naturally exposed to influenza and other respiratory pathogens. Subjects will receive either oral interferon at dosages covered under ABI's patents or placebo.

• Anadys Pharmaceuticals Inc., of San Diego, is cutting one-third of its staff, returning rights to investigational hepatitis B drug ANA360 to partner Seoul, South Korea-based LG Life Sciences and halting all work on early discovery projects as part of a restructuring program to focus resources on ANA598, an antiviral for hepatitis C, and ANA773, a TLR7 agonist prodrug for cancer. That move, which follows the company's decision last week to discontinue the development of ANA975 in hepatitis C virus infection due to safety concerns, is expected to generate annual cost savings of between $4 million and $5 million. Anadys will incur a one-time cash charge of $800,000 in severance arrangements. The company reported a net loss of $7 million, or 24 cents per share for the second quarter. As of June 30, its cash balance totaled $68.8 million, which the company said should carry its two ongoing programs to "meaningful clinical milestones." Anadys plans to file an investigational new drug application in the first half of 2008 for ANA598, an oral, small-molecule non-nucleoside inhibitor of the NS5b polymerase for treating HCV. An IND for ANA773, which is being developed as an oral therapy for certain cancers, is expected in the second half of this year.

• Antigenics Inc., of New York, completed the submission of its regulatory application seeking approval to market the therapeutic cancer vaccine Oncophage (vitespen) for kidney cancer in Russia. The submission is based on previously released data from a failed Phase III kidney cancer trial in which a subset of patients at intermediate risk for disease recurrence experienced a clinically significant improvement in recurrence-free survival of about 45 percent. (See BioWorld Today, March 27, 2006.)

• Axcan Pharma Inc., of Mont-Saint-Hilaire, Quebec, submitted a complete new drug application for Ultrase in the treatment of exocrine pancreatic insufficiency. The product previously was granted fast-track status by the FDA, which would allow it to proceed more rapidly through the regulatory process. The NDA is based on Phase III results of Ultrase demonstrating fat absorption effects with minimal adverse events. Axcan also recently completed an additional Phase III trial, included in the NDA, with the currently marketed Ultrase MT20 formulation, which was designed to compare the efficacy and safety of Ultrase MT20 to placebo in the correction of steatorrhea in patients with cystic fibrosis. The formulation of Ultrase designated in the NDA was designed to meet guidelines set by the FDA, which in 2004 ordered that all existing pancreatic insufficiency products must gain approval before April 2008 to remain on the market.

• BrainStorm Cell Therapeutics Inc., of New York, restructured its research and license agreement with Tel Aviv University. The agreement relates to the company's license for NurOwn technology, which allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes. The company also reached an agreement with lender Double U Fund regarding the repayment of debt.

• Cytokine PharmaSciences Inc., of King of Prussia, Pa., said recent experiments with its small-molecule MIF (macrophage migration inhibitory factor) inhibitors showed oral efficacy in animal models and based on those results, the company plans to move one of those compounds into preclinical development. MIF inhibitors were shown to be effective in animal models of multiple sclerosis and arthritis when administered orally, with no signs of toxicity, and research indicated potential in other autoimmune and inflammatory diseases.

• Discovery Laboratories Inc., of Warrington, Pa., said it remains on track to file its formal response to the FDA approvable letter for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants. The approvable letter, issued in April 2006, raised issues concerning manufacturing and stability, which the company said it will address in its response, planned for October. Following that response, Discovery Labs anticipates a six-month review cycle by the FDA for the potential approval of Surfaxin.

• Dyax Corp., of Cambridge, Mass., has licensed its antibody phage display libraries to Cambridge Antibody Technology (CAT), a wholly-owned subsidiary of London-based AstraZeneca, for the discovery of therapeutic antibodies. CAT will receive sublicenses to relevant third-party antibody phage display patents that may be used with Dyax's technology. The agreement allows CAT the ability to commercialize up to 20 royalty-bearing therapeutic antibody products. Financial terms of the agreement are not disclosed.

• Genmab A/S, of Copenhagen, Denmark, regained all rights to the HuMax-TAC antibody following a portfolio review by partner Geneva-based Merck Serono SA. The company previously licensed rights to Merck Serono in May 2005. The news comes a month after Merck Serono returned Genmab's late-stage HuMax-CD4, which is in a pivotal study in cutaneous T-cell lymphoma, with results expected next year. With regard to HuMax-TAC, Genmab said it intends to review that program internally before deciding future plans. (See BioWorld Today, July 2, 2007.)

• GTC Biotherapeutics Inc., of Framingham, Mass., and LFB Biotechnologies, a wholly owned subsidiary of French firm LFB SA, initiated the development of a transgenically produced CD20 monoclonal antibody under a partnership signed last fall. The antibody, which is expected to have target specificity similar to Rituxan (rituximab, Genentech Inc., Biogen Idec Inc.) but with a relatively higher antibody dependent cell-mediated cytotoxicity, will be developed for oncology and autoimmune indications.

• IntelliPharmaCeutics Ltd., of Toronto, said Woodcliff Lake, N.J.-based Par Pharmaceutical Cos. Inc. made a significant equity investment in the company, which will use proceeds for general corporate and working capital purposes. IntelliPharmaCeutics develops, licenses and markets both new and generic controlled-release pharmaceutical products. Under the terms, Par will acquire a 4.2 percent interest in the company. The companies also signed a drug development collaboration under which IntelliPharmaCeutics will apply its technology to the formulation and development of four generic products that are bioequivalent to significant branded drugs. Specific financial terms were not disclosed.

• Invitrogen Corp., of Carlsbad, Calif., saw its shares (NASDAQ:IVGN) rise $7.14, or 10.1 percent, to close at $78.20 on Thursday after issuing second quarter earnings late Wednesday. The company reported earnings of $40.9 million, or 62 cents per share, up from $19.7 million, or 35 cents per share in Q206. Second quarter revenues were $322 million, up from $285 million in the same quarter last year. The company also completed its $500 million share repurchase program initiated last year and approved another $500 million repurchase program. Invitrogen ended the quarter with $570.1 million in cash and short-term investments.

• Kreatech Biotechnology BV, of Amsterdam, the Netherlands, and BioMicro Systems Inc., of Salt Lake City, have formed a partnership in which BioMicro Systems will distribute the Kreatech Universal Linkage System microarrays to laboratories in the U.S. and Canada. The ULS allows for the rapid attachment of a variety of labels directly to DNA, RNA and proteins. The products are centered on a proprietary platinum-based system that produces stable labeling under a wide variety of conditions.

• MethylGene Inc., of Montreal, reported that Whitehouse Station, N.J.-based Merck & Co. Inc. intends to terminate the companies' 2003 research collaboration, returning all rights to the beta-lactamase inhibitor program to MethylGene. The Canadian firm expects no near-term financial impact, and said it plans to seek an alternative partner for the program, which aims to develop small-molecule drugs against beta-lactamase to fight antibiotic resistance. Termination of the agreement will be effective in 90 days.

• Modern Biosciences plc, of London, and the University of Dundee have entered into an agreement to develop a new treatment for cancer, rimcazole. Under the terms of the agreement, the university will grant an exclusive worldwide license to Modern Biosciences to develop rimcazole in cancer, and Modern Biosciences will fund and manage the development program. Revenues generated through commercialization will be shared by the partners. Modern Biosciences expects rimcazole to be in clinical trials in patients within a year. Rimcazole already is in a clinical trial program in schizophrenia, and data from that effort indicated Modern Biosciences will be able to to move into Phase I trials rapidly, the company said.

• Nuvelo Inc., of San Carlos, Calif., is reducing its work force by about 30 percent and realigning its organization to focus on core development programs that it believes will produce nearest-term proof-of-concept data. The company plans to continue development of alfimeprase, its direct-acting thrombolytic, as well as NU206 for the treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease and NU172, a direct thrombin inhibitor. Nuvelo said it will suspend development of rNAPc2 in all indications, including cancer and acute coronary syndrome. Nuvelo, which expects to have fewer than 80 employees as of Aug. 3, anticipates this realignment to reduce annual expenditures by about $15 million. Restructuring charges of about $2.5 million will be incurred in the third quarter. As of June 30, Nuvelo had cash, cash equivalents and short-term investments totaling $120.2 million, not including the $15 million received from Deerfield, Ill.-based Bayer Healthcare this quarter related to the termination of the companies' 2006 collaboration.

• Quark Pharmaceuticals Inc., of Fremont, Calif., presented positive results from preclinical efficacy studies for its systemically administered, siRNA compound, AKIi-5, in acute renal failure. In the study, rats treated with a single bolus injection of rat AKIi-5, Quark's proprietary siRNA compound targeting the p53 gene, were significantly protected from ischemia/reperfusion-induced acute kidney injury. The compound was most efficacious when administered within a well-determined time window of two to four hours post-injury. The study also proved that AKIi-5 has a favorable drug disposition profile, with short local exposure predominantly to the kidney-exhibiting rapid clearance of the drug post-administration. Quark's preclinical studies to date also indicated that AKIi-5 has a favorable safety profile, with a therapeutic index (toxic dose/effective dose) in rats greater than 250.

• Rosetta Genomics, of Rehovot, Israel, has signed a collaboration agreement with Ben Gurion University for development of microRNA-based therapeutic applications for several key viruses, including the Epstein-Barr virus and herpes simplex viruses. A combined research team from Rosetta and the university have identified several virus-specific microRNAs that, when inhibited, lead to a decrease in virus replication in vitro.

• Selexis SA, of Geneva, executed a license renewal agreement with Diosynth RTP Inc., of Research Triangle Park, N.C., allowing for Diasynth's continued access to the SURE technology platform, including the Selexis Genetic Elements. Under the terms, Diosynth will have the right to use SURE, as well as to receive the latest improvements developed by Selexis to enable faster generation of mammalian cell lines. Financial terms were not disclosed.

• Stem Cell Therapy International Inc., of Tampa, Fla., acquired exclusive, worldwide rights to an antirejection umbilical cord blood stem cell technology. Financial terms were not disclosed. Stem Cell Therapy International focused on research, development and the use of stem cell transplantation therapy in degenerative disorders such as Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, leukemia and muscular dystrophy.