• Australian Cancer Technology, of Sydney, Australia, signed a second material transfer agreement with New York's Memorial Sloan-Kettering Cancer Center. The agreement relates to the use of GPI-0100, the lead product of its Galenica Pharmaceuticals business, in a study for vaccination of leukemias and lymphomas. The product is being evaluated in two clinical trials, a Phase I and Phase I/II.

• Axxima Pharmaceuticals AG, of Munich, Germany, closed its third private financing round, raising €10 million, and bringing total investment in the company to €64 million. Axxima specializes in using kinase inhibitors to treat infectious diseases and cancer. The investment was led by Techno Venture Management, which also led the two previous rounds. The investment will allow Axxima to initiate preclinical and clinical studies for its existing projects in infectious disease treatment and to embark on two cancer projects with its proprietary kinase inhibitors, it said.

• BioAlliance Pharma SA, of Paris, said preclinical data published in the Journal of Virology detailed a new means of anti-integrase therapy involving styrylquinolines (SQLs). Investigators confirmed the target of SQLs by mutations evidenced in the integrase gene when viruses were grown in the presence of increasing concentrations of SQLs. Treatment of HIV-1-infected cells with SQLs reduced the amount of the late cDNA, suggesting that integrase-targeting molecules might affect the accumulation of DNA during reverse transcription. The data also were reported at last month's International HIV Drug Resistance Workshop in the Canary Islands.

• BioTie Therapies Oyj, of Turku, Finland, obtained €1.4 million in funding commitments from Tekes, Finland's national technology agency, for its integrin research program. The company is seeking inhibitors for alpha-2 integrin for potential application in the prevention of thrombosis and in cancer therapy. The funding amounts to 50 percent of the total project cost.

• Cambridge Crystallographic Data Centre (CCDC) in Cambridge, UK, and SciTegic Inc., of San Diego, reported the availability of integration components that allow CCDC's GOLD docking program to be accessed through SciTegic's data-pipelining software, Pipeline Pilot. That integration allows Pipeline Pilot users to construct automated virtual screening protocols that rely on GOLD's protein-ligand docking and scoring to rank corporate, vendor or virtual compound libraries accessed or generated from within Pipeline Pilot.

• Can-Fite Biopharma Ltd., of Petach-Tikva, Israel, began a Phase I trial of CF101 in the U.S. in patients with solid tumors. Researchers at three Harvard Medical School-affiliated hospitals will investigate combinations of CF101 with three standard chemotherapeutic regimens. The primary objective will be to determine the safety, tolerability and clinical effects of the oral administration of the combination therapy.

• CellFactors plc, of Cambridge, UK, achieved a 37-fold increase in the potency of its Skeletex bone-replacement cell lines, as assessed by industry-standard assays. Skeletex, derived from an immortalized human hypertrophic chondrocyte cell line, has the ability to generate new integrated vascularized bone. CellFactors now will generate preclinical data in in vivo models of bone formation before looking for a licensing partner.

• Combinature Biopharm AG, of Berlin, secured €5.5 million in its second round of private financing. The company optimizes pharmaceuticals based on natural products for preclinical and clinical development. Combinature will use the proceeds of the round to complete the transition to a discovery and development company, with an internal pipeline that focuses on anti-infective compounds. The financing round was led by Aurelia Private Equity GmbH and additional investors included BC Venture GmbH and 3i Group Investments LP.

• DSM Nutritional Products Inc., of the Netherlands, published in its quarterly PUFA newsletter the benefits provided from long-chain omega-3 polyunsaturated fatty acids (PUFA) regarding cardiovascular and inflammatory function, certain types of cancer, and maternal and infant health. The acids are found naturally in fatty fish, but research shows that bioengineered plants can produce them. Plants make the precursors of LC-PUFAs, but are unable to synthesize the long-chain forms. Researchers at Bristol University in the UK introduced three genes involved in converting PUFAs into LC-PUFAs into mouse ear cress (arabidopsis thaliana).

• Eiffel Technologies Ltd., of Sydney, Australia, signed an agreement with NanoMaterials Technology Pte. Ltd., of Singapore, to jointly develop new technology for use in re-engineering drugs. The companies will develop a hybrid technology combining the performance benefits of Eiffel's Super Critical Fluids with the production efficiency of NanoMaterial's High Gravity Controlled Precipitation technology. They are conducting feasibility studies to test the hybrid concept on model anti-inflammatory and asthma drugs.

• Europroteome AG, of Berlin, entered a collaboration to evaluate approaches for molecular profiling of tissue specimens from cancer patients with Altana Pharma AG, of Konstanz, Germany. Europroteome will use its collection of purified human cancer cells to analyze molecular expression of a panel of cancer targets. The molecular data then will be aligned with a selected set of clinical data, such as cancer stage and disease progression, in order to assess disease-associated expression signatures and prioritize molecular target candidates for therapeutic intervention with new drugs and accompanying diagnostics. Financial terms were not disclosed.

• ExonHit Therapeutics SA, of Paris, was granted a patent by the U.S. Patent and Trademark Office covering optimized microarrays for monitoring RNA-splicing events. Titled "Qualitative Differential Screening," the patent describes the various applications of the microarrays in drug discovery, diagnostics and toxicogenomics, as well as more specific applications.

• Flamel Technologies SA, of Lyon, France, said GlaxoSmithKline plc, of London, will use Flamel's Micropump drug delivery technology in a Phase III trial of an undisclosed drug candidate. Flamel declined to confirm that the drug concerned was Coreg (cardevilol), which GSK is developing for cardiovascular conditions such as congestive heart failure. Flamel has produced a once-a-day formulation of Coreg for GSK using its Micropump technology. Micropump is one of two polymer-based drug delivery systems developed by Flamel, the other being Medusa. Micropump is a controlled-release, taste-masking system for the oral administration of small-molecule drugs, while the Medusa nano-particulate system is designed to deliver therapeutic proteins and peptides. Flamel licensed its Micropump technology to GSK in March 2003. In October, GSK informed Flamel that it was terminating an earlier license agreement concluded between Flamel and Beecham Pharmaceuticals Pte. Ltd. which took effect on Jan. 14. That agreement provided for Flamel to use its Micropump technology to develop a powder formulation of Augmentin, an amoxycillin-based antibiotic, for administration to the elderly.

• Genedata AG, of Basel, Switzerland, expanded its collaboration with Altana Pharma, part of Altana AG, of Bad Homburg, Germany, to provide enterprise-wide scientific computing infrastructure for Altana's research programs in Constance, Germany, and Waltham, Mass. The original license was signed five years ago for Genedata's scientific computing platform.

The German government appointed Ulrich Kasparick parliamentary state secretary in the Ministry of Education and Research. As the second-ranking political leader of the ministry, Kasparick will play a role in setting the direction of German public support for the biotech industry, which in the next five years is likely to reach €20 million annually.

The German Research Center for Biotechnology (GBF) granted Zentaris GmbH, a subsidiary of Zentaris Inc., an exclusive global license to develop, manufacture and market disorazoles, a class of natural products that GBF reports having anticancer potential. In return, GBF will receive an up-front payment, annual licensing fees, as well as milestone and royalty payments based on product progress and commercialization. Disorazol inhibits the tubulin system.

• GPC Biotech AG, of Martinsried, Germany, priced its global offering at €12 (US$14.55) per American depository share, raising net proceeds of $95.3 million. The offering consisted of a rights offering to existing holders of GPC's shares; a global offering, including public offerings in Germany and the U.S.; and private placements in other jurisdictions. GPC offered a total of about 7.5 million shares, 2.6 million in the rights offering and 4.5 million in the global offering. GPC also granted underwriters an option to purchase up to an additional 1.1 million shares to cover overallotments. If exercised, the company will have raised a total of $110.6 million. Goldman, Sachs & Co. served as global coordinator and bookrunner, while Lehman Brothers Inc. was a joint-lead manager. Pacific Growth Equities LLC and WestLB AG served as co-lead managers.

• Healthcare Technologies Ltd., of Ashdod, Israel, plans to acquire Evanston, Ill.-based ImmvaRx Inc.'s allergy therapies business, issuing 350,000 shares, a two-year warrant to purchase up to 1 million shares of Healthcare and a 30-month warrant to be issued about 14.7 million ordinary shares of Healthcare. The companies also agreed to negotiate the transfer of ImmvaRx's cancer diagnostics and therapies business to Healthcare against additional shares. ImmvaRx has the right to commence a tender offer for all of Healthcare's outstanding shares no later than 30 months following the closing of the transaction at a price of $1.60 per share. Gamida for Life, Healthcare's largest shareholder, will have the right to purchase all of Healthcare's subsidiaries and affiliates for $7.2 million. ImmvaRx focuses on immune-based therapies for allergies and cancer.

• Helsinn Healthcare SA, of Lugano, Switzerland, and MGI Pharma Inc., of Minneapolis, said data related to palonosetron HCl (Onicit, Aloxi) were presented at the Multinational Association of Supportive Care in Cancer meeting in Miami. Three poster presentations described the impact of treatment with Onicit/Aloxi injection on various quality-of-life parameters, the maintenance of efficacy in patients weighing more than 90 kilograms and the pharmacokinetics and safety of repeat doses.

• HemeBiotech A/S, of Hiller d, Denmark, raised €15 million in new investment, €4.5 million of which it received immediately. The remainder will be provided through a consortium of investors, including current shareholders. In addition, existing shareholders BankInvest and Vaekstfonden converted loans of €17.5 million into equity. HemeBiotech is developing enzyme-replacement therapies for rare genetic diseases. Its lead program, the development of a recombinant form of porphobilinogen deaminase for treatment of acute intermittent porphyria, is undergoing a Phase IIb trial in Europe and the U.S. The product has orphan drug designation in the two regions.

Immuno-Designed Molecules SA, of Paris, appointed Guy-Charles Fanneau de la Horie vice president, director France. Fanneau de la Horie was previously VP of strategic commercial operations and general director of Biogen France, where he was responsible for the development, registration and marketing of the company's late-stage and commercial pipeline in Europe. Before joining Biogen in 1995, he worked for several other biopharmaceutical companies, including Schering-Plough, Baxter and Boehringer Ingelheim.

• Innogenetics NV, of Ghent, Belgium, was added by the European Euronext stock exchange in its Next 150 index of the next largest companies after those comprising the Euronext 100 index. Innogenetics is focused on theranostics.

The Medical Research Council funded a £18 million (US$33.1 million) mouse genomics center in Harwell, UK. The center will house up to 65,000 mice and will work on determining the function of mouse genes with relevance to human health. The center also will offer external services including transgenesis, gene targeting and mutagenesis, and pathology.

• Merck KGaA, of Darmstadt, Germany, said Erbitux (cetuximab) received European approval for metastatic colorectal cancer. More specifically, the monoclonal antibody was licensed for use in combination with irinotecan for patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan, including cytotoxic therapy. Erbitux will be available in all 25 member states of the European Union, as well as Iceland and Norway. Approved earlier this year by the FDA, U.S. sales are booked by ImClone Systems Inc. and Bristol-Myers Squibb Co., both of New York. ImClone noted that it would build on the recent global regulatory approvals by continuing clinical development of Erbitux in earlier-stage colorectal cancer and other tumor types. The approval was expected, said Banc of America Securities Analyst Michael King, who added that ImClone receives a 5 percent royalty on European sales.

• Microscience Holdings plc, of Wokingham, UK, announced positive results in a 30 subject Phase I study of spi-VEC, an oral vaccine for the treatment of chronic hepatitis B infections. The vaccine was safe and immunogenic after one or two doses, with all subjects mounting a cellular immune response. In more than 90 percent of subjects the immune response was characterized by the production of gamma interferon, known to be important in promoting the clearance of hepatitis B. Microscience said the results could pave the way for a range of vaccines to beat chronic viral diseases using the spi-VEC vector. Meanwhile, Microscience missed its deadline of the end of June to complete an initial public offering on London's Alternative Investment Market to raise £40 million. A spokeswoman for the company told BioWorld International that "they are still working on it, despite missing the [June 30] deadline."

• NeuroSearch A/S, of Ballerup, Denmark, said its wholly owned subsidiary Azign Bioscience A/S and the diagnostics company Atonomics ApS, of Copenhagen, Denmark, agreed to merge. Atonomics will acquire all shares of Azign, while NeuroSearch retains the patents, know-how and other relevant assets within drug research through exclusive licensing agreements. Azign's drug discovery technologies will be consolidated within NeuroSearch. NeuroSearch and Vaekstfonden, the Danish Fund for Industrial Growth, will make a net contribution of DKK6.5 million (US$1.1 million) to the new Atonomics, giving NeuroSearch about a 25 percent stake in the company. Other investors will be Japan-based MuRata and a number of private shareholders.

• Nonlinear Dynamics, of Newcastle Upon Tyne, UK, said Proteomic Research Services Inc., of Ann Arbor, Mich., chose Progenesis Discovery to enhance its 2D electrophoresis capabilities. Progenesis Discovery will form the core of PRS' proteomic lab services, delivering 2D spot detection and matching.

• Norwood Abbey Ltd., of Melbourne, Australia, said all the options in the money expiring June 30 have been exercised, and the total amount received from the options' exercise is $10.1 million. As a result, cash holdings for the Norwood Abbey Ltd. Group, including its 83 percent-owned subsidiary, Norwood Immunology Ltd., have increased to more than $20 million. At the same time, Norwood Abbey said the securities of its subsidiary began trading on London's Alternative Investment Market under the symbol "NIM."

• NsGene A/S, of Ballerup, Denmark, received a $3 million grant from New York's Michael J. Fox Foundation to fund a proof-of-concept clinical trial of its encapsulated cell therapy (ECT) technology in Parkinson's disease. Ole Lindvall at Lund University, Sweden, will lead the first human trials of the ECT technology within two years. Centers in Switzerland, Germany and the UK also will be involved.

• NV Organon, of Oss, the Netherlands, and Grupo Uriach, of Barcelona, Spain, entered a global license agreement for the discovery and development of kinase inhibitors for anti-inflammatory diseases such as rheumatoid arthritis. The alliance involves the optimization and selection of p38 MAP kinase inhibitors from Uriach's preclinical portfolio. Organon will perform preclinical and clinical development, and will hold worldwide commercialization rights for any resulting products. Uriach will receive an up-front payment and also would receive milestone payments and royalties. Uriach also receives an option to commercialize in the Spanish market one of Organon's late-stage products. Further terms were not disclosed.

• OctoPlus Technologies BV, of Leiden, the Netherlands, granted Surmodics Inc., of Eden Prairie, Minn., an option to acquire an exclusive license to two classes of biodegradable polymers for use in the site-specific delivery of drugs from medical devices. Biodegradable polymers have the ability to be combined with one or more drugs and applied to a medical device, but naturally are degraded by the body over time. The two families covered under the agreement are PolyActive and OctoDEX.

• Oxford BioMedica plc, of Oxford, UK, licensed exclusive worldwide rights to a LentiVector gene delivery technology to Viragen Inc., of Plantation, Fla. The agreement allows Viragen to use the technology in its collaboration with the Roslin Institute in Edinburgh, Scotland, to develop Avian Transgenic Technology as a platform for manufacturing therapeutic proteins in chicken eggs. In exchange, Oxford received an up-front license fee and annual maintenance payments, and is entitled to milestone payments and royalties. Further financial details were not disclosed.

• Paion GmbH, of Aachen, Germany, and Forest Laboratories Inc., of New York, have agreed to jointly develop and market Paion's stroke product, desmoteplase, in the United States and Canada. The compound is undergoing Phase II trials and has the potential to treat acute ischemic stroke up to nine hours after the onset of symptoms. Forest will make up-front and milestone payments, as well as paying royalties based on sales. In addition, Forest will fund all continuing clinical development activities for the U.S. and Canadian markets. Forest also will have rights for development and marketing for desmoteplase for additional indications in those areas. The FDA recently granted fast-track status to the compound.

• Peakdale Discovery Ltd., of Chapel-en-le-Frith, UK, agreed to collaborate with Cyprotex plc, of Macclesfield, UK. Cyprotex will use its in silico Cloe Screen technology to evaluate the absorption, distribution metabolism and excretion (ADME) properties of 8,500 compounds. The data will be used to design new compounds, enhancing the ADME properties of Peakdale's libraries. Peakdale also completed a G protein-coupled receptor library of 1,000 compounds in collaboration with De Novo Pharmaceuticals Ltd., of Cambridge, UK.

• Peplin Biotech Ltd., of Brisbane, Australia, said investigational new drug applications for PEP005 Topical were filed with the FDA by its development partner, Allergan Inc., of Irvine, Calif. The compound is a topical formulation of its lead compound, PEP005. The applications are for the treatment of the pre-cancerous condition actinic keratosis and basal-cell carcinoma. The filings, which amend applications originally filed by Allergan in March, incorporate a more comprehensive Phase I/II program. Initial studies will evaluate the topical formulation's safety. Allergan will focus its early efforts in actinic keratosis and basal-cell carcinoma and await results from its initial studies before pursuing a program in squamous-cell carcinoma.

• Perigene Inc., of Compeigne, France, entered an agreement to sell antifreeze glycoprotein (AFGP) to ProtoKinetix Inc., of Vancouver, British Columbia. AFGP is a natural compound that enables fish, reptiles and insects to survive freezing temperatures. A scientist at ProtoKinetix has synthesized the AFGP molecule in a stable form. Financial terms were not disclosed.

• Pharminox Ltd., of Oxford, UK, raised £1.5 million (US$2.7 million) in a second funding round to further develop its small-molecule cancer drugs. The company was spun out of Oxford University in 2002 to commercialize platinum-based compounds discovered at the university, and has since obtained rights to a complementary class of heteroaromatic quinols from the medical research charity, Cancer Research UK.

• Provalis plc, of Deeside, UK, entered an option agreement with Chiron Vaccines, a unit of Chiron Corp., of Emeryville, Calif. Chiron was granted an initial 12-month exclusive option (extendable by another 12 months on payment of a fee) to evaluate Provalis' protein-based vaccine candidates to prevent Group B Streptococcus infection. Chiron paid an initial option fee to Provalis and will pay all costs connected with the patents underpinning the vaccine candidates, and has the right to an exclusive license for, or to acquire, the vaccine candidates. Both cases include pre-determined terms that include staged milestone payments and royalty rates for the license.

• Qiagen NV, of Venlo, the Netherlands, sold its synthetic DNA business to a management team previously employed at the company for $24.3 million in cash and in the form of a promissory note. Qiagen will retain a 16 percent stake in the new company, called Operon Biotechnologies Inc. It retains all rights and activities in its siRNA business, including ownership of its TOM-amidite chemistry, and will receive preferred access to Operon's synthetic nucleic acid-manufacturing capacities and preferred purchasing rights. The synthetic DNA business came out of Qiagen's acquisitions of Operon Technologies Inc., of Alameda, Calif., in 2000, and the Sawady Group, of Tokyo, in 2001. In other news, Qiagen entered a supply agreement for siRNA molecules with AstraZeneca plc, of London. Qiagen will be the preferred supplier to AstraZeneca for siRNA products used in gene-silencing applications. Financial terms were not disclosed.

• Swedish International Development Agency and the World Health Organization's office in Beijing signed an agreement under which SIDA will fund a three-year WHO project on HIV/AIDS prevention and care in China. SIDA committed $3.3 million to the project and an additional $1.2 million through Swedish institutions. The main objective of the WHO project is to provide support to develop policies and planning for HIV/AIDS prevention, care, support and treatment.

• TopoTarget A/S, of Copenhagen, Denmark, and CuraGen Corp., of New Haven, Conn., began a Phase I trial of PXD101 in patients with hematologic cancer and solid-tumor cancers. The trial complements the ongoing Phase I study in cancer patients with solid tumors initiated in 2003. The study is a dose-escalating, open-label trial expected to enroll about 15 patients.

• Transgene SA, of Strasbourg, France, manufactured clinical lots of HIV vaccine candidates in the frame of Eurovac (European Vaccine Effort Against HIV/AIDS), a European cluster of 21 laboratories, funded since 2000 by the European Union under the 5th Framework Program. Partners of Eurovac; the Karolinska Institute in Stockholm, Sweden; and Aventis Pasteur, of Lyon, France, selected the company to produce the lots of NYVAC-based vaccines carrying genes of HIV-1.

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