• Advanced Viral Research Corp., of Yonkers, N.Y., submitted an investigational new drug application with the FDA last week to initiate a clinical development program for the systemic use of AVR118 in patients with advanced malignancies. AVR118 is a biopolymer that possesses immunomodulator activity. That peptide-nucleic acid complex appears to stimulate the pro-inflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as in patients with rheumatoid arthritis.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, updated its consolidation of Cohesion Technologies. In June, Angiotech purchased NeuColl, giving the company two California subsidiaries in close proximity, and earlier this month, Angiotech said it would make changes in its California operations. Research and development activities will be completely transferred to its Vancouver headquarters by the end of the year, and as a result, Cohesion's general manager and its senior vice president of research and development, George Daniloff, will conclude his employment. Efforts are under way to transfer VitaGEL manufacturing activities to Orthovita Inc., of Malvern, Pa. Commercial launch of VitaGEL in the U.S. will begin in the first quarter of next year, and once manufacturing has been transferred, Cohesion's remaining positions will be eliminated.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Schering AG, of Berlin, signed a cooperation agreement in mouse genetics and genomics. Artemis will generate various genetically engineered mouse models for Schering. Schering will use the mice in its drug discovery research activities to identify novel compounds and therapies for the treatment of severe diseases in various indications in man. The generation of the mouse models will be based on Artemis' proprietary ArteMice and ArteMice Conditional technologies. Financial details were not disclosed.

• Avidia Research Institute, of Mountain View, Calif., entered a multiyear development and manufacturing agreement under which Boehringer Ingelheim Austria GmbH, of Vienna, Austria, will develop manufacturing technology for Avidia's Maxybody proteins. The company also will supply Avidia with Maxybody proteins for use in clinical studies and commercial sale. At the same time, Avidia named Peter Van Vlasselaer its first CEO. The privately held company was founded in July 2003 as a spinoff from Maxygen Inc. Van Vlasselaer came on board following a five-year tenure as the senior vice president of technical operations at InterMune Inc.

• Biolog Inc., of Hayward, Calif., said it will use its Phenotype MicroArray technology to begin broad-scale phenotyping of the Escherichia coli genome, which consists of more than 4,000 genes. Phenotype MicroArrays is designed to allow scientists to test hundreds to thousands of cellular traits simultaneously. Using the E. coli K-12 collection developed at the Nara Institute, Biolog expects to phenotype each gene knock-out and develop a database of phenotypes for all genes.

• BioPartners GmbH, of Zug, Switzerland, filed for European approval of Valtropin (somatropin), its recombinant human growth hormone developed in collaboration with LG Life Sciences Ltd., of Seoul, South Korea. The application is for the treatment of pediatric and adult growth hormone deficiency, and other growth disorders.

• Caliper Life Sciences Inc., of Hopkinton, Mass., and PhyNexus Inc., of San Jose, Calif., integrated PhyNexus PhyTip column technology for protein purification and enrichment into the Caliper Sciclone ALH 3000 Liquid Handling Workstation, followed by rapid detection with the LapChip 90 electrophoresis system. Researchers can now purify and enrich up to 96 engineered proteins or antibodies in 15 minutes, Caliper said.

• Cambridge Bioscience Partnership Ltd., of Cambridge, UK, agreed to provide assay development and screening services to NeurAxon Inc., of Mississauga, Ontario, for research on undisclosed targets. Financial terms were not disclosed.

• Cardiome Pharma Corp., of Vancouver, British Columbia, chose a controlled-release formulation of oral RSD1235 to take forward for further clinical development based on the successful completion of its recent Phase Ia trial. The study was an open-label, cross-over evaluation of two controlled-release formulations of RSD1235 in comparison to immediate-release formulation. Cardiome initiated a Phase Ib study involving the chosen formulation.

• Classen Immunotherapies Inc., of Baltimore, filed a patent-infringement suit against King Pharmaceuticals Inc., of Bristol, Tenn.; South San Francisco-based Elan Pharmaceuticals Inc; and Dublin, Ireland-based Elan Corp. plc. Classen has expertise in the area of discovering adverse event information that drug manufacturers are required to disclose. Classen alleges that the defendants have sold more than $500 million worth of products, specifically, the muscle relaxant Skelaxin (metaxalone), that infringe two of its U.S. patents.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., completed its public offering of about 9.3 million shares of common stock at $11.20 per share, and the underwriters exercised in full their option for another 1.4 million shares. Cubist raised a total of about $120 million in gross proceeds. The proceeds represent a 20 percent increase over the original shelf registration statement filed with the SEC. Net proceeds are expected to be about $112.5 million. Underwriters included Morgan Stanley, Pacific Growth Equities LLC, WR Hambrecht + Co., Harris Nesbitt and Wells Fargo Securities LLC.

• Dyax Corp., of Cambridge, Mass., granted a nonexclusive license to its antibody phage display libraries to Tanox Inc., of Houston. Tanox, which specializes in products for asthma, allergy, oncology, inflammation and infectious disease, intends to use the libraries to identify fully human monoclonal antibodies that bind with high specificity and affinity to a number of its undisclosed targets. In exchange, Dyax will receive an up-front license fee, annual technology license fees, clinical milestone payments and royalties upon successful commercialization of products based on antibodies identified from its libraries. Separately, Dyax acquired a second Flexchip instrument from HTS Biosystems Inc., of Hopkinton, Mass. The Flexchip Kinetic Analysis System is a platform that combines the data quality of surface plasmon resonance with the throughput of advanced chip array technology.

• Eiffel Technologies Ltd., of Sydney, Australia, signed a material transfer agreement with an undisclosed major international pharmaceutical company to evaluate the potential for Eiffel's drug re-engineering technology to improve the performance of two of the pharmaceutical company's drugs. The two drugs, one a product already on the market and the other still in development, both are administered orally.

• Elan Corp. plc, of Dublin, Ireland, stated on its web site that the wholesale acquisition cost of Tysabri to treat multiple sclerosis will be about $1,808 per vial. With each patient requiring about 13 infusions a year, the price means the new MS drug will cost a patient about $23,500 annually. At that price, the drug could reach peak sales of more than $3.5 billion, according to some analysts. The FDA approved the use of Tysabri for relapsing forms of MS last week. The product is partnered with Biogen Idec Inc., of Cambridge, Mass. (See BioWorld Today, Nov. 29, 2004.)

• Genentech Inc., of South San Francisco, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said a randomized Phase III study of Avastin (bevacizumab) plus the Folfox4 chemotherapy regimen (oxaliplatin/5-FU/leucovorin), compared to Folfox4 alone in second-line metastatic colorectal cancer patients achieved its primary endpoint of improving overall survival. Results from an interim analysis demonstrated that patients receiving Avastin plus Folfox4 had a 26 percent reduction in the risk of death, compared to patients who received Folfox4 alone. Median survival in the Avastin group was 12.5 months, compared to 10.7 months in the Folfox4 group, a 17 percent improvement. The study enrolled 829 patients. Avastin was approved last February as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.

• Generex Biotechnology Corp., of Toronto, concluded its discussions with Charmed Capital plc, electing to forego its entitlement to a deposit in respect of the proposed transaction. It essentially was a financial arrangement. In connection with its global clinical and regulatory strategy for Oral-lyn, Generex's flagship product, the company said it would focus its efforts on the pursuit of relationships with pharmaceutical companies to better commercialize the product.

• LAB International Inc., of Laval, Quebec, said that LAB Pharma, its drug development subsidiary headquartered in Finland, secured about C$4.6 million (US$3.9 million) to support its research and development programs. The funding was granted by TEKES, the National Technology Agency of Finland, a government organization that provides funding. The funding was granted for Fentanyl Taifun, an inhaled Fentanyl formulation, as well as for the development of inhaled protein products

• Lipid Sciences Inc., of Pleasanton, Calif., said non-human primate data related to its viral immunotherapy program, recently reviewed at a meeting of its viral advisory board, validated the immune response observed in a prior mouse animal study and demonstrated that a delipidated virus elicits a unique immune response against viral epitopes that are distinct from those induced by untreated virus. The administration of delipidated viral protein was well tolerated by the subject animals. As a result, the company said it began a follow-on study to extend and expand the evaluation of the immune response generated by lentiviruses (HIV and SIV - a surrogate for HIV) that have been delipidated with Lipid Sciences' delipidation process. The study subjects include Indian rhesus macaque monkeys.

• Medarex Inc., of Princeton, N.J., said it will receive an undisclosed milestone payment from its licensing partner, Amgen Inc., of Thousand Oaks, Calif., for the advancement of an antibody into clinical trials. The antibody product was developed using Medarex's UltiMAb technology and is the second UltiMAb-derived antibody in clinical development by Amgen. Medarex may receive future milestone payments and royalties.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said it plans to offer 4.25 million common shares in an underwritten public offering pursuant to an effective shelf registration statement. The company also intends to grant a 637,500-share overallotment option to the underwriters. Citigroup Global Markets Inc. is acting as sole book-running manager. Needham & Co. Inc. is acting as a co-lead manager, with WR Hambrecht + Co. and Delafield Hambrecht Inc. acting as co-managers.

• PharmaMar SA, of Madrid, moved Aplidin into Phase II trials in hematological malignancies such as multiple myeloma, non-Hodgkin's lymphoma (both aggressive and indolent), and adult acute lymphoblastic leukemia. The product already is in Phase II trials in a number of solid-tumor indications, with results expected next year. The company noted that the marine-derived antitumor agent does not present limiting bone marrow toxicity.

• Pharming Group NV, of Leiden, the Netherlands, placed 3 million new shares with professional long-term investors for gross proceeds of €6 million. The proceeds will be used to accelerate development of Pharming's recombinant human lactoferrin and fibrinogen. The issuance represents about 4 percent of the total outstanding shares after the transaction. The new shares were placed through Amsterdams Effectenkantoor BV.

• Quark Biotech Inc., of Fremont, Calif., discovered and validated a therapeutic target for the treatment of ischemia-induced retinopathy. The discovery was published in the journal Investigative Ophthalmology and Visual Science, Vol. 45. In the study, a gene identified by Quark, RTP801, was knocked out in an animal model of retinopathy of prematurity.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said data reported in the Nov. 25, 2004, issue of Nature showed that Thymosin beta 4 reduced tissue damage, ventricular scarring and dilation, and markedly improved cardiac function when administered to laboratory animals immediately following induced heart attack. The research on the naturally occurring peptide was carried out at the University of Texas Southwestern Medical Center.

• Sinovac Biotech Ltd., of Beijing, reported that the American Stock Exchange approved Sinovac's application for listing its common stock. That approval is contingent upon the company being in compliance with all applicable listing standards on the date it begins trading on the exchange. Shares are expected to begin trading under the symbol "SVA" in about 10 days. Sinovac specializes in human vaccines for illnesses such as hepatitis A and hepatitis B, influenza, severe acute respiratory syndrome and avian flu.

• SuperGen Inc., of Dublin, Calif., said the FDA extended until Feb. 26 the Pharmaceutical Drug User Fee Act date for completing its review of the new drug application for Orathecin (rubitecan) capsules. The company submitted additional data from its trial of Orathecin for use as a first-line pancreatic cancer treatment that had been requested by the agency. SuperGen also included several new sets of data analysis to further evaluate Orathecin in second- and third-line patients. Submission of the additional data was classified as a major amendment by the FDA, allowing it to extend its review by three months.

• TM Bioscience Corp., of Toronto, signed a distribution agreement with Gamidor Diagnostics, of Petach Tikva, Israel, a distributor of clinical diagnostics in Israel. Gamidor will have exclusive rights to distribute the Tag-It menu of genetic tests in Israel for a minimum three-year term that can be extended annually. As TM launches new products, they can be rolled into the agreement upon approval of both parties.

• V.I. Technologies Inc., of Watertown, Mass., reached agreement on amended terms of the merger agreement with Panacos Pharmaceuticals Inc., of Gaithersburg, Md. Vitex will issue about 227 million shares to acquire all of Panacos' outstanding shares. Following the closing, shareholders of Panacos will own slightly more than 80 percent of the combined company. The new agreement has no milestones because Panacos achieved the milestones of the original agreement by demonstrating that PA-457 is safe and well tolerated with promising pharmacokinetics in uninfected volunteers and that it has a significant antiviral effect in HIV-infected patients. The companies reported in June that they would merge in a $27 million stock exchange. (See BioWorld Today, June 4, 2004).

• Viral Genetics Inc., of Azusa, Calif., said results of a clinical trial of VGV-1 for HIV was published in HIV & AIDS Review. Investigators observed that in patients failing anti-retroviral drug therapy, treatment with VGV-1 for 60 days was associated with undetectable viral load in half of the patients within three months of treatment. By six months, there was an average one-log drop in virus levels. VGV-1 is a purified protein extracted from mammalian thymus tissue. The trial in Mexico enrolled 10 HIV-positive patients who were failing to respond to their second or third regimen of anti-retroviral drug therapy.

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