Active Biotech AB, of Lund, Sweden, gained FDA fast-track status for TTS CD3, which is in a Phase I trial in non-small-cell lung carcinoma. The company also received a notice of allowance from the U.S. Patent Office regarding an application covering the use of TTS CD3 in combination therapy. Its U.S. patent portfolio in support of TTS CD3 comprises six families, three of which have been granted, with three still under review.
AEterna Zentaris Inc., of Quebec, received German approval for Impavido (miltefosine), an orally administered therapy for visceral and cutaneous leishmaniasis. The approval allows the company to market it in Germany, as well as to distribute it to military personnel who have become infected with leishmaniasis while serving in Afghanistan and Iraq. In addition, the approval enables AEterna Zentaris to receive a free sales certificate, which could provide the basis for registration in countries where leishmaniasis is endemic, such as Colombia and Pakistan.
Allergy Therapeutics plc, of Worthing, UK, was granted a UK patent for its family of sublingual allergy vaccines that use monophosphoryl lipid A as an adjuvant. The patent covers all antigens, and could cover mucosally transmitted infections, the company said.
Altana AG, of Bad Homburg, Germany, filed a suit at the Social Court in Berlin against the central association of German statutory health insurance companies with reference to their classification of Pantozol (pantoprazole) as part of a reference price group. Altana believes the therapeutic improvements of Pantozol, such as less interactions with other drugs, have not been taken into account in the establishment of reference price groups for the class of proton pump inhibitors. The suit is directed against that decision, as well as the missing transparency of the proceedings of the Federal Committee, Altana said, adding that reference prices for innovative drugs contravene the objectives of patent protection.
Ark Therapeutics Group plc, of London, received Good Manufacturing Practice approval for its facility in Kuopio, Finland. Approval also was given for Ark to manufacture its adenovirus viral vector product, Cerepro, which is in Phase III trials in malignant glioma.
BioLineRx Ltd., of Jerusalem, said the Israeli Office of the Chief Scientist selected the company as the sole recipient of a $21 million grant for the development of preclinical compounds, as part of an initiative for the advancement of the Israeli biotech industry. The company now has funding of more than $35 million, it said, and plans to use the new funds to expand its development capabilities, including building a factory for preclinical research.
BioMarin Pharmaceutical Inc., of Novato, Calif., filed for European approval of Aryplase (galsulfase), an investigational enzyme-replacement therapy for mucopolysaccharidosis-VI. The company, which last week filed for FDA approval, said the product has received orphan designation in Europe.
BioVision AG, of Hannover, Germany, said CEO Sven Rohmann founded a new company, ImVision GmbH, to develop therapies to cure allergic diseases. ImVision will be an independent company and its lead compound will target cat allergy. Trials are anticipated to start next year.
Chiron Corp., of Emeryville, Calif., and Cubist Pharmaceuticals Inc., of Lexington, Mass., said Chiron submitted a marketing authorization application to the European Medicines Agency for approval of Cubicin (daptomycin for injection) in complicated skin and soft-tissue infections (cSSTI) in which the presence of susceptible Gram-positive bacteria is confirmed or suspected. The filing includes safety data from two pivotal Phase III trials conducted by Cubist that examined the safety and efficacy of Cubicin in the treatment of cSSSI. The EMEA's Committee for Medicinal Products for Human Use will evaluate the application to determine whether to approve the marketing of Cubicin in the 25 EU member states.
Cyclacel Group plc, of Dundee, UK, presented a series of small-molecule, cell-cycle drugs inhibiting Aurora kinase in a poster presentation at the American Association for Cancer Research Cell Cycle and Cancer: Pathways and Therapies conference in Fort Lauderdale, Fla. Cyclacel has advanced a lead compound from the series into preclinical development.
Cytos Biotechnology AG, of Zurich, Switzerland, began a Phase II trial of its Immunodrug candidate CYT005-AllQbG10. The open-label study will include 20 patients with allergic rhinoconjunctivitis and asthma due to house dust mite allergy. The compound combines the Immunodrug carrier QbG10 with the natural allergen extract of dust mites found in the home. Efficacy will be determined by skin-prick tests, conjunctival provocation tests and methacholine challenge, with initial results expected in the fourth quarter.
Elan Corp. plc, of Dublin, Ireland, and its wholly owned subsidiary, Elan International Services Ltd., accepted for payment a total of about $351 million worth of Series B and C guaranteed notes issued by another wholly owned subsidiary, Elan Pharmaceutical Investments III Ltd. The amount includes about $317.4 million of notes previously accepted for payment and paid for. The notes were tendered and related consents delivered pursuant to the previously announced cash tender offer by Elan International to purchase up to $351 million of $390 million of notes and the related consent solicitation by Elan. Final settlement was expected Nov. 30, Elan said.
Epigenomics AG, of Frankfurt, Germany, and Roche Diagnostics, a unit of Basel, Switzerland-based F. Hoffmann La-Roche Ltd., agreed to amend their ongoing collaboration with an expanded validation process. The original agreement included developing tests to diagnose prostate, color and breast cancer; classify the molecular structure of prostate cancer; and predict the likelihood of relapse in women treated with tamoxifen. The new terms increase the number and variation of samples to be evaluated by Epigenomics, which is in line for two additional R&D payments worth up to |2 million (US$2.65 million). The first payment was triggered by Roche's acceptance of the breast cancer tamoxifen response test. Clinical validation data on the colon and prostate cancer screening tests are expected in the second quarter.
Genmab A/S, of Copenhagen, Denmark, reported encouraging efficacy data from a Phase I/II trial of HuMax-EGFr in head and neck cancer. Using a scan known as FDG-PET, which visualizes tumor metabolism, six of 15 patients showed partial metabolic response and three patients showed stable metabolic disease. They received doses of 2, 4 or 8 mg/kg.
The German government put forward its position on the European Union's Seventh Framework Program (FP7), calling for special emphasis on life sciences and biotechnology. FP7 is the EU's general outline for research for 2007-2013. The biotech sector heads a list of six fields the German government would like to see receive additional European support. It also hopes to see greater participation by small and medium-sized companies. Germany also calls for an increased budget for FP7 over the current budget of about |17.5 billion (US$10.1 billion) for the 2002-2006 period. EU member states will finalize the FP7 guidelines in 2005.
Germany's National Genome Research Network will concentrate on fighting widespread diseases. Minister for Education and Research Edelgard Bulmahn presented 182 research projects that the ministry will support over the next three years with about |135 million (US$181 million) in public funds. The network will emphasize projects in circulatory system diseases, cancer, infectious diseases and central nervous system disorders. The first phase of public support began in 2001 and brought |180 million to genome-related research.
Hayashibara Biochemical Laboratories, of Okayama, Japan, and Amarillo Biosciences Inc., of Amarillo, Texas, entered a license and supply agreement for oral interferon-alpha. In the last 20 years, Amarillo has invested nearly $37 million to establish interferon as a therapeutic agent for a number of diseases. HBL has provided the company with more than $16.5 million in loans, grants and an equity investment. It holds 24 percent of Amarillo's shares. Amarillo has orphan drug designation for the product in oral warts in HIV+ patients, Behcet's disease and polycythemia rubra vera.
Iceland Genomics Corp., of Reykjavik, Iceland, entered an agreement in which Aclara BioSciences Inc., of Mountain View, Calif., will use its eTag assays to analyze tumor samples from cancer patients to validate candidate biomarkers. IGC will provide Aclara with tumor and blood samples and blinded-patient data, including treatment histories and outcomes. Aclara will test the samples with its eTag assays and will provide funding to IGC. It will share the data from the study with IGC for incorporation into its database.
Inpharmatica Ltd., of London, signed a nonexclusive Biopendium Online subscription with Shionogi & Co. Ltd., of Osaka, Japan. Biopendium is the protein annotation component of PharmaCarta, Inpharmatica's gene-to-candidate platform. It provides sequence annotation for more than 150 organisms. Shionogi is the third Japanese subscriber this year.
Nautilus Biotech, of Paris, and Angel Biotechnology, of Northumberland, UK, signed an agreement on the GMP manufacture of Nautilus' interferon-alpha product, Belerofon, for Phase I development. The non-pegylated, single-amino-acid variant of natural interferon-alpha offers lower frequency of administration and dosing than marketed pegylated interferon-alpha, Nautilus said. Belerofon is indicated for conditions including chronic hepatitis C and cancer.
NeuroNova AB, of Stockholm, Sweden, named Ulf Ljunberg president and CEO. Ljunberg succeeds Anders Haegerstrand, who became chief scientific officer and vice president. Ljunberg's most recent position was vice president of sales and marketing at the Swedish arm of London-based AstraZeneca plc.
NeuTec Pharma plc, of Manchester, UK, signed a contract for commercial-scale manufacturing of its lead product Mycograb, which is in Phase III trials in the treatment of invasive candidiasis.
Newron Pharmaceuticals SpA, of Milan, Italy, raised European funding from the Cooperative Research Programme to innovate a drug-screening technology by the company and a consortium of small to medium enterprises and academic groups. Newron will coordinate the two-year research project called ION, which is to develop a system for high-throughput screening of molecules for ion channel targets related to neurological and psychiatric disorders.
Novacea Inc., of South San Francisco, presented preclinical data on AQ4N in treating lymphoma, at the American Society for Hematology meeting in San Diego. AQ4N, licensed from KuDOS Pharmaceuticals, of Cambridge, UK, is inactive until it reaches hypoxic tumor cells, at which point it is converted into a cytotoxic form. The product is in Phase I trials in solid tumors in the U.S. and UK.
Pharmaxis Ltd., of Sydney, Australia, filed an investigational new drug application with the FDA to conduct a trial to support a marketing application for Aridol. The trial would be conducted at more than 10 sites in the U.S. and would recruit 130 subjects. The objective would be to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of asthma. Aridol is an inhalable, dry powder that can be administered using a hand-held device.
Prolysis Ltd., of Oxford, UK, announced a drug discovery agreement with Proteom Ltd., of Cambridge, UK, in which Proteom will use its in silico design technology to optimize antibiotic leads discovered by Prolysis.
ProStrakan Group Ltd., of Galashiels, UK, acquired Elfar SA, a pharmaceutical marketing and distribution company, based in Madrid, Spain, for an undisclosed cash sum. Two months earlier, the company made another acquisition in Spain, Devon Farmaceutica SLU, also based in Madrid. It now intends to merge the two, and will look to in-license further products. ProStrakan has R&D programs in skeletal diseases and hormone-related cancers.
Proteo Inc., a unit of Kiel, Germany-based Proteo Biotech AG, signed an exclusive license collaboration with Artes Biotechnology GmbH, of Dusseldorf, Germany, to produce Elafin on a recombinant basis with the yeast strain, Hansenula polymorpha. Using Artes' Hansenula technology as an expression system enables large-scale development of the compound, an inhibitor of human elastase and proteinase 3 that has shown promise in treating tissue and muscle damage, Proteo said.
Sareum Holdings plc, of Cambridge, UK, announced a collaboration with EiRx Therapeutics plc, of Cork, Ireland, to discover new cancer therapeutics. EiRx will provide five novel targets that are involved in apoptosis and cancer-cell survival, to which Sareum will apply its structure-based drug design technology. The two will share payments and royalties from licensing out compounds they discover.
Sinovac Biotech Ltd., of Beijing, said Phase I results showed that its inactivated vaccine for severe acute respiratory syndrome showed no obvious side effects and induced the production of SARS-neutralizing antibodies. The findings were produced after completion of a 56-day observation period of all 36 subjects participating in the trial.
Tissera Inc., of Herzlia, Israel, said its sponsored research team at the Weizmann Institute of Science defined a specific gestational time window for harvesting porcine fetal pancreatic tissue for transplantation purposes. The window of opportunity might explain, in part, previous failures in trials of transplantation of porcine fetal pancreatic tissue into diabetic patients. The results indicate that the growth potential of fetal pancreatic tissue obtained at an appropriate gestational time is superior to that exhibited by pancreatic tissues used in previous studies, the company said.
Transgene SA, of Strasbourg, France, said it is conducting a new Phase II trial of its MVA-HPV-IL2 vaccine candidate in women diagnosed with precancerous lesions of the cervix, cervical intraepithelial neoplasia - CIN 2/3, related to Type 16 human papillomavirus. Based on favorable data obtained from a previous Phase II trial that was conducted on CIN 2/3, the new study will evaluate MVA-HPV-IL2's efficacy after a six-month observation period, which will give patients more time to mount an immune response. Enrollment is under way, and preliminary data are expected during the second half of next year.
The UK government announced new measures to support science-based companies, including an extension of current R&D credits to take in larger companies and changes to income tax to remove barriers that have discouraged academics from setting up start-up companies. It also announced the formation of a science forum under the chairmanship of Tom McKillop, CEO of London-based AstraZeneca plc, to present industry's view of how the government should spend the budget.