• Acambis plc, of Cambridge, UK, said the FDA designated its smallpox vaccine, ACAM2000, a fast-track product. The company has delivered 182.5 million doses of ACAM2000 to the U.S. government's strategic national stockpile. It is close to submitting a biologics license application based on data from more than 2,900 subjects in Phase III trials.

• Allergy Therapeutics, of Worthing, UK, agreed to a Canadian marketing deal for its four-shot allergy vaccine Pollinex Quattro with Allerpharma Inc., of Toronto. The companies will collaborate on development of the vaccines, with Allerpharma making milestone payments of up to £8 million (US$14.4 million) up to registration. Allergy Therapeutics will supply the product and would receive royalties on sales. The company raised £15 million when it floated on London's Alternative Investment Market in October at 73 pence per share. The share price rose 11 percent to £1.02 on news of the Allerpharma deal.

• AstraZeneca plc, of London, withdrew its marketing authorization application in Europe for Iressa (gefitinib) to treat non-small-cell lung cancer following a meeting with the European Medicines Agency. The withdrawal was made because the survival results do not meet the approval requirement. Discussions with regulatory authorities in the U.S., Japan and other nations concerning Iressa are continuing.

• Aventis Pasteur, of Paris, has changed its name to Sanofi Pasteur. Aventis Pasteur is the vaccine division of the Sanofi-Aventis Group. The Aventis Pasteur MDS joint venture, equally owned by Aventis Pasteur and Whitehouse Station N.J.-based Merck & Co. Inc. to market vaccines in Europe, also changed its denomination to Sanofi Pasteur MSD.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said David Glover, chief medical officer, is to take early retirement in February after 10 years with the company. He will be succeeded by Patrick Round, who joined CAT from Celltech Group plc in May.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, promoted Neil Clark from finance director to CEO.

• Cerus Corp., of Concord, Calif., received $3 million after signing a letter of intent with BioOne Corp., of Tokyo, for Asian commercialization of the Intercept blood system developed by Cerus and subsidiaries of Deerfield, Ill.-based Baxter International Inc. The companies are negotiating a definitive agreement, but Cerus' right to retain the up-front payment is not contingent upon completion of the agreement. In 2004, BioOne reached an agreement with Cerus to commercialize the Intercept system - designed to enhance safety by inactivating viruses, bacteria and other pathogens in donated blood components - for platelets in several Asian countries. The new agreement would allow the sale of plasma products developed from the Intercept system.

• Chugai Pharmaceuticals Co. Ltd., of Tokyo, and Xencor Inc., of Monrovia, Calif., entered an agreement to create monoclonal antibodies. Chugai will use Xencor's XmAb technology on Chugai's antibodies against a cancer target. Xencor will receive technology access and license fees and is eligible for additional license fees, milestone payments and royalties if Chugai takes compounds into development. Financial terms were not released.

• Co.don AG, of Berlin, which once had shares trading at more than €20 on Germany's Neuer Markt, has staved off insolvency, and the company's leaders are evaluating options for the firm's future. Olivera Josimovic-Alasevic, who became Co.don's chair in the summer of 2003, left the company at the end of 2004. This week the company raised about €250,000 in a new share placement. Co.don also hired MedWork AG, of Appenzell, Switzerland, to find new partners and BioConnect AG, of Frankfurt, Germany, to assess options, including mergers and acquisitions. Roland Alexander, chairman of Co.don's supervisory board, will continue his temporary service. The company specializes in cell-based products for the regeneration of cartilage, bone and intervertebral discs. (See BioWorld International, Aug. 20, 2003.)

• Crucell NV, of Leiden, the Netherlands, said its STAR technology is being evaluated by Genentech Inc., of South San Francisco, for the production of antibodies and other proteins. In a joint evaluation program that is funded by Genentech, the companies are investigating whether STAR can increase the production yields of Genentech's systems. If successful, Genentech has an option to sign a nonexclusive license agreement to the technology.

• Cytos Biotechnology AG, of Zurich, Switzerland, signed an agreement with Pfizer Inc., of New York, for the testing of Cytos' Immunodrugs for animal health applications. Terms of the deal gave Pfizer exclusive access to test two Immunodrug candidates in its models and, if a commercial license agreement is executed, exclusive development and commercial rights to them. Cytos will receive an undisclosed up-front payment, as well as potential milestones and additional fees on commercial license execution, technology transfer for manufacturing, for the drug substance's supply and upon approval. If products are launched, Cytos could earn royalties on Pfizer's net sales. Also, Pfizer has the first claim to negotiate for any further Immunodrug candidates in the same therapeutic area developed by Cytos for animal health.

• DFB Pharmaceuticals Inc., of Fort Worth, Texas, acquired the wound-management activities of EpiSource SA, a subsidiary of Lausanne, Switzerland-based IsoTis OrthoBiologics Co. Financial details were not disclosed. DFB said initial focus will be on Allox, EpiSource's spray delivery platform using live human cells.

• Elan Corp. plc, of Dublin, Ireland, and Generex Biotechnology Corp., of Toronto, completed their agreement with Generex converting $14.3 million of its preferred stock into common stock at about $25.27 per share. The preferred stock was issued to Elan in connection with a joint venture, now terminated, for the development of buccal morphine technology. Elan sold the preferred stock to a third-party purchaser who converted the shares into common stock for an aggregate of 534,085 common shares. Separately, Elan agreed to more broadly license its NanoCrystal technology to F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The deal gives Roche the right to apply the technology, which is designed to improve the clinical performance of poorly water-soluble drugs by transforming them into nanometer-sized particles, to a number of its drug candidates. Elan will receive development milestones and royalties on sales of any product incorporating the use of the technology, though specific financial terms were not disclosed.

• Erasmus Medical Center in Rotterdam, the Netherlands, said The Lancet published results from a large international study showing that peginterferon alfa-2b produced sustained responses in patients with chronic hepatitis B. The study showed that the patients responded to peginterferon alfa-2b, and achieved higher sustained response rates than typically seen with any other antiviral treatment.

• GeneCare Research Institute Co. Ltd., of Kamakura, Japan, received an exclusive license from Alnylam Pharmaceuticals Inc., of Cambridge, Mass., to InterfeRx to discover, develop and commercialize RNAi therapeutics directed against two DNA helicase genes associated with cancer. Terms include up-front, annual and milestone payments in cash, and potential royalties. Alnylam retains the right to negotiate co-development and co-promotion arrangements in the U.S.

• Genfit SA, of Lille, France, reported a three-year partnership deal with the Pierre Fabre Group, of Paris. The companies have been collaborating since October 2001 on the pharmacological characterization of several products and their mechanisms of action in the field of cardiovascular diseases. The new partnership relates to the development of a new family of compounds for which proof of concept already has been obtained. Financial terms of the agreement were not disclosed. Pierre Fabre will pay Genfit research fees, milestones and royalties. It will be the intellectual property owner and have exclusive rights to the sale of the products.

• Genomatica Inc., of San Diego, entered a license agreement with the biochemicals business unit of Kyowa Hakko Kogyo Co. Ltd., of Tokyo, for Genomatica's model of Escherichia coli and its modeling and simulation platform SimPheny. Kyowa Hakko will use the products in its research on producing fine chemicals, such as amino acids. Financial details were not disclosed, but include license fees and milestone payments.

• GenOway SA, of Lyon, France, merged with the transgenic company, Murinus, of Hamburg, Germany, which specializes in the design, production and housing of genetically modified animal models. The new operation in Hamburg, GenOway Germany GmbH, is expected to yield a further 25 percent in addition to GenOway's expected growth in sales in 2005, it said.

• Hadassah University Medical Center in Jerusalem developed a vaccine that arrests autoimmune system destruction following HIV/AIDS infection. The vaccine would be used as a complement to the antiviral (HAART) "AIDS cocktail" that can leave the immune system compromised. A preliminary study of seven patients with advanced AIDS who were followed for two years showed that five of the patients had more than a 50 percent increase in healthy CD4 cells with improved physiological parameters.

• Hemispherx Biopharma Inc., of Philadelphia, said its partner, Esteve Laboratorios SA, of Barcelona, Spain, initiated a clinical program to evaluate the antiretroviral effect of Ampligen in the treatment of patients infected by HIV-1 (with or without co-infection by HCV) and virological failure with a randomized pilot study in Phase II, controlled with standard treatment.

• Intercell AG, of Vienna, Austria, said the FDA approved the company's development plan for its Phase III trials of a prophylactic vaccine against Japanese encephalitis. Intercell plans to launch the vaccine in the U.S. market in 2007. The company specializes in vaccines and also has a hepatitis C vaccine in Phase II trials.

• Kamada Ltd., of Rehovot, Israel, was granted orphan drug status by the FDA and the EMEA for the aerosolized version of its in-development alpha-1 proteinase inhibitor (API) product. The product is designed to be taken by inhalation to treat congenital emphysema, alpha-1-antitrypsin deficiency. Kamada expects to complete development of the inhaled product within three years. At the same time, Kamada also has developed an API product to be given intravenously, which recently completed registration in an unnamed country, and will begin marketing during 2005. API is available for IV, at a cost of $60,000 to $80,000 per patient per year.

• LEO Pharma A/S, of Ballerup, Denmark, and Alliance Pharmaceutical Corp., of San Diego, through its wholly owned subsidiary, PFC Therapeutics LLC, said that an agreement was reached between PFC and LEO to enter a license agreement, subject to continued due diligence by LEO, to develop and commercialize Oxygent in European Union member countries, EU membership applicants, Norway and Switzerland, and Canada. The terms of the agreement include certain initial and future payments to PFC upon completion of regulatory and commercial milestones for Oxygent development in Europe and royalties on commercial sales of Oxygent in Europe and Canada. Through PFC, Alliance is developing Oxygent for the improvement of tissue oxygenation.

• MacroMed Inc., of Sandy, Utah, granted exclusive rights to Diatos SA, of Paris, to develop and commercialize OncoGel (injectable paclitaxel formulation for local, intra-tumoral administration) worldwide except for North America and Korea. Diatos also received rights to sub-license OncoGel and to develop and commercialize second-generation OncoGel products. Both privately held companies will collaborate on the product's clinical development, sharing data from trials conducted in their respective territories. They intend to develop OncoGel for treatment of several types of solid tumors. OncoGel already is in Phase II trials in the U.S. for esophageal cancer. Terms of the agreement call for Diatos to pay MacroMed a license fee, milestone payments and royalties on product sales. In addition, MacroMed retained the right to provide the majority of clinical and commercial supplies of OncoGel to Diatos.

• Morphochem AG, of Munich, Germany, and Alcon Research Ltd., of Fort Worth, Texas, began a research alliance to develop small-molecule drugs that function against ophthalmic targets. Morphochem will make focused libraries for certain Alcon targets. Alcon will retain the rights to any products for ophthalmic and nasal applications, while Morphochem will retain certain rights for other uses. Alcon will make research payments, along with potential milestone payments and royalties on sales of products.

• Neuro3d, of Mulhouse, France, raised €31.5 million (US$42.9 million) in a third round of financing from a consortium of international investors led by Gilde Investment Management's Biotech fund and co-led by AXA Private Equity. New investors Healthcare Private Equity LP and GIMV, as well as existing investors HealthCap, Techno Venture Management Partners, Sofinnova Partners and APAX Partners, also participated. The funds will be used for clinical development of the company's drugs targeting psychiatric disorders, such as ocaperidone in Phase II trials for schizophrenia, and will help accelerate additional candidates to the clinic.

• Nitto Denko, of Ibaraki, Japan, developed a cross-linked polystyrene bead designed to support synthesis of oligonucleotides needed for DNA- and RNA-based gene therapies. The development was achieved in a joint venture with Carlsbad, Calif.-based Isis Pharmaceuticals Inc. The polystyrene bead design will be marketed through Nitto Denko's wholly owned U.S. subsidiary, Kinovate Life Sciences Inc., of Oceanside, Calif.

• Oxford BioMedica plc, of Oxford, UK, licensed its LentiVector gene delivery technology to Biogen Idec Inc., of Cambridge, Mass., for use in research. Oxford BioMedica will receive an up-front license payment and an annual maintenance fee.

• Peplin Ltd., of Brisbane, Australia, reported positive safety and efficacy results from its U.S.-based Phase I trial and confirmed it was on track to start Australian-based Phase I trials this quarter for its product, PEP005, a topical treatment for actinic keratosis of sun spots and non-melanoma skin cancer. The trial demonstrated PEP005's ability to clear lesions with 40 percent of treated lesions either completely cleared or almost cleared. That compared with 15 percent of lesions treated with placebo.

• Prana Biotechnology Ltd., of Melbourne, Australia, received a clinical trials authorization from the UK's Medicines and Healthcare Products Regulatory Agency to initiate a Phase II/III trial of PBT-1 (clioquinol) in Alzheimer's disease. The randomized, double-blind, placebo-controlled study will be conducted over 52 weeks and will enroll 435 patients in the UK, Australia and the Republic of South Africa. The primary endpoint will be to demonstrate a reduction in the progression of AD as measured by the Alzheimer's Disease Assessment Scale-cognition.

• ProMetic Life Sciences Inc., of Montreal, signed a C$1.4 million (US$1.1 million) development agreement with Octapharma AG, of Lachen, Switzerland. The agreement provides Octapharma with access to ProMetic's Mimetic Ligand affinity technology to manufacture high-purity protein drugs. ProMetic said it anticipates additional revenues based on completion of the development program, as Octapharma's protein product moves through clinical trials.

• ProStrakan Group Ltd., of Galashiels, UK, announced that Peter Allen, long-time Celltech Group plc chief financial officer is to become a nonexecutive director. Allen joined Celltech in 1992, and left at the end of 2004, following the company's sale to UCB Pharma, of Brussels, Belgium, for £1.5 billion (US$2.8 billion). Separately, ProStrakan and Cellegy Pharmaceuticals Inc., of South San Francisco, said the Medical Products Agency in Sweden approved Tostrex, a transdermal testosterone gel, for the treatment of male hypogonadism. ProStrakan has licensed the rights to commercialize the product in Europe. Approvals of Tostrex by other member states of the European Union will be sought through the mutual recognition procedure.

• Sankyo Co. Ltd., of Tokyo, and Metabasis Therapeutics Inc., of San Diego, said a Phase IIb trial of CS-917 in Type II diabetics is under way. The study is designed to evaluate the product's effectiveness in lowering blood glucose levels in such patients; efficacy will be evaluated by measuring levels of hemogloblin A1c. Results will be used to select an appropriate dosage of CS-917 for use in Phase III. Sankyo licensed the compound from Metabasis and is responsible for global development.

• Schering AG, of Berlin, said the FDA issued an approvable letter for Bonefos (clodronate), an oral non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical treatment of breast cancer patients. Schering's U.S. affiliate, Berlex Laboratories Inc., of Montville, N.J., plans to request a meeting with the FDA to discuss the information needed to obtain final approval.

• Serono SA, of Geneva, completed patient enrollment in a multinational trial comparing Rebif (interferon beta-1a) to Copaxone (glatiramer acetate, Teva Pharmaceutical Industries Ltd.) in relapsing or remitting multiple sclerosis. More than 700 patients who previously were untreated with disease-modifying therapies have been enrolled in the trial. Rebif was approved in Europe in 1998 and in the U.S. in 2002.

• Sinovac Biotech Ltd., of Beijing, entered a securities purchase agreement for a private placement worth about $1.5 million with institutional investors for units in the capital of the company for $3 per unit. Each unit is comprised of one share of common stock and one common stock purchase warrant entitling the holder to acquire one additional share at $3.35 during the first year. Sinovac said proceeds will be used for the acquisition of the additional 20.6 percent of Sinovac Biotech Co. Ltd., the company's majority-owned subsidiary, and for working capital purposes. The company focuses on research, development, commercialization and sales of vaccines for infection illnesses, such as hepatitis A and B, influenza, severe acute respiratory syndrome and avian flu. Separately, Sinovac said its securities have been listed on the Halter USX China Index, which is exclusively devoted to U.S.-listed securities of companies that derive the majority of their revenues from the People's Republic of China. Sinovac is developing human vaccines for infectious illnesses.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, entered an alliance to further the development and commercialization of a non-flourinated quinolone antibiotic invented by Procter & Gamble Pharmaceuticals, a unit of Procter & Gamble Co., of Cincinnati. TaiGen will be responsible for conducting Phase Ib and II development of the compound to meet worldwide regulatory standards. If Phase II results are positive, P&G, in conjunction with TaiGen, might then seek a pharmaceutical partner for the compound's Phase III development and subsequent commercialization. In addition, TaiGen gained development and commercialization rights within China, Taiwan, Korea and the ASEAN countries.

• Technion-Israel Institute of Technology Department professor Timor Baasov, along with professor Chi-Huey Wong, of the Scripps Research Institute, developed an antibiotic agent that attacks anthrax bacteria and also neutralizes the toxic proteins that the bacteria release into the bloodstream of an infected person. The research was published as a "hot paper" in Angewandte Chemie's international edition.

• Xenova Group plc, of Slough, UK, licensed its TA-CIN vaccine to Cancer Research Technology Ltd., of London, which will facilitate a further Phase II study to evaluate the vaccine in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia. CRT will license TA-CIN patents, procedures and materials from Xenova and will market TA-CIN to potential commercial partners. Net receipts from sub-licensing TA-CIN will be shared between CRT and Xenova after certain direct costs have been recouped.

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