Celltech Group plc, of Slough, UK, said partner Pharmacia Corp., of Peapack, N.J., completed reformulation of Celltech's CDP 870 and that Phase III development in rheumatoid arthritis will begin next month. The move into Phase III will trigger a milestone payment to Celltech. Celltech also is developing CDP 870, a humanized, pegylated anti-TNF-alpha antibody fragment, in Crohn's disease, and CEO Peter Fellner said planning for Phase III studies in Crohn's is under way. However, the exact timing will depend on the availability of the drug, with priority going to supplying the Pharmacia-run rheumatoid arthritis trials.
F2G Ltd., of Manchester, UK, confirmed the completion of its first-round funding, raising £4.3 million (US$6.7 million). The company will use the money to take on more staff and expand drug discovery efforts based around Mycobank, its functional genomics technology for the rapid identification of genes that are essential for fungi to survive. F2G is particularly focused on finding new treatments for Aspergillus infections.
IT-Omics, the bioinformatics subsidiary of Lille, France-based Genfit SA, entered a technical partnership with the life sciences division of IBM Corp. in France for the development of data manipulation and analysis software based on the DiscoveryLink platform that IBM developed specifically for life sciences research. DiscoveryLink is derived from IBM's DB2 database management system and enables researchers to handle and analyze heterogeneous data simultaneously from their desktop terminal. The object of the partnership is to develop a set of tools that gives researchers complete autonomy in the different phases of managing, analyzing and mining scientific data, using decision-support algorithms to extract the information required for discovering potential therapeutic targets, the company said.
Mobius Genomics Ltd., of Exeter, UK, was awarded a European patent on its technology for high-throughput, real-time human genome sequencing. The technique is so sensitive that whole genomes can be sequenced and compared, down to base-pair resolutions. Daniel Densham, managing director, said he is in discussions with pharmaceutical companies to provide them with sequencing services.
NicOx SA, of Sophia-Antipolis, France, said the FDA accepted its investigational new drug application for a Phase II trial of NCX 701, a nitric oxide-releasing derivative of paracetamol (acetaminophen) it is developing for the treatment of acute pain. That is the fourth product for which NicOx has made a successful IND application in the U.S., and the company plans to embark on a trial of NCX 701 involving 100 patients in October. The study will evaluate the analgesic efficacy and safety of a single administration of the product at two dose levels compared with regular paracetamol and placebo in subjects suffering moderate to severe post-operative dental pain.
NascaCell GmbH, of Tutzing, Germany, acquired a nonexclusive, worldwide license from Applied Molecular Evolution Inc., of San Diego, for patents on directed molecular evolution. The companies declined to disclose financial terms of the agreement. NascaCell will use the technology to generate aptamers, nucleic acids with properties similar to antibodies, that bind to and inactivate specific target molecules. The group of patents, known as "Kauffman patents," comprises six issued U.S. patents and their international counterparts with claims covering methods of stochastically generating proteins and polynucleotides. The first U.S. Kauffman patent was issued in 1998 with a term extending into 2015. AME was granted an exclusive license to the family of patents in 1994. NascaCell is a privately held, venture-backed company launched in May 2000 with scientists from the Munich Gene Center, a part of the Ludwig-Maximilian University of Munich. The company aims to convert functional proteomics data into small-molecule drug targets.
Novozymes A/S, of Bagsvaerd, Denmark, said it entered a joint research project with Neugenesis Corp., of San Carlos, Calif., to develop a new method for producing antibodies, which will draw on its strengths in gene technology and the latter firm's patented monoclonal antibody technology. The partners aim to develop a more rapid and economic alternative to current techniques that rely on mammalian cell culture. The move is part of Novozyme's ongoing strategy of diversifying into pharmaceuticals manufacturing, in addition to its traditional industrial enzymes business.
Pharmagene plc, of Royston, UK, signed a contract giving Boehringer Ingelheim Pharma KG, of Ingelheim, Germany, access to its Phase ZERO compound validation service. That allows companies to profile compounds in human tissues and select candidates for clinical trials. Terms were not disclosed, but Pharmagene will evaluate a number of Boehringer's compounds in human cerebrovascular tissues.
Oxford GlycoSciences plc, of Abingdon, UK, agreed to a research collaboration with the Center for Drug Evaluation and Research of the FDA to use industrial-scale proteomics to find protein markers that are predictive of drug toxicity. The Cooperative Research and Development Agreement aims to identify biomarkers for early detection of myocardial, vascular and liver injuries caused by drug toxicity. FDA researchers will produce biological samples suitable for proteomics analysis by OGS. OGS also announced that Bayer AG, of Leverkusen, Germany, has accepted the first protein targets resulting from a research collaboration using OGS's proteomics technology to identify targets and biomarkers in clinical samples provided by Bayer related to asthma and chronic obstructive pulmonary disease. The move triggers an undisclosed milestone payment to OGS, and the targets will now go into screening.
PharmaMar, a subsidiary of Madrid, Spain-based Zeltia Group, said the drug candidate ET-743 (Yondelis) showed evidence of efficacy in childhood and adult cancers unresponsive to conventional therapy. In one dose-finding study of 13 patients between 3.5 and 18 years, a complete response in a metastatic pretreated Ewing sarcoma was observed. In a second clinical trial involving 55 adults and children with a range of advanced or recurrent solid tumors, objective responses to treatment were seen in five of 28 patients with soft-tissue sarcomas and in two of eight patients with Ewing's sarcoma. Two of the eight children in the study showed a partial response to treatment. The company also reported that a second compound, the anti-angiogenesis candidate Aplidin, was able to selectively target and kill human leukemic cell lines at concentrations that are reachable in patients.
Schering AG, of Berlin, entered into a collaboration with Atugen AG, also based in Berlin, to validate drug targets associated with cancer. The agreement provides for Schering to make an up-front payment to Atugen. Annual license fees, research funding and milestone payments also are included, although exact financial terms of the agreement were not disclosed. The companies completed a five-year agreement, signed in 1997, that included similar validation at Berlex Biosciences, Schering's research subsidiary in Richmond, Calif. In the current collaboration, Atugen will develop specific antisense oligonucleotides to inhibit expression of specific drug target candidates that Schering selects. Spun off from Ribozyme Pharmaceuticals Inc. in 1998, Atugen is privately held and has raised €26 million of funding in two rounds.
SkyePharma plc, of London, said it is on track to move into profitability in 2002 following the launch of Paxil CR, a controlled-release formulation of the antidepressant, by its partner, GlaxoSmithKline plc, of London. Ian Gowrie-Smith, SkyePharma's chairman, said prescriptions of Paxil CR accounted for 19 percent of total Paxil sales in the U.S. as of Aug. 31, and in just over four months since launch, Paxil CR has taken 5 percent of the U.S. market for selective serotonin reuptake inhibitors.
SR Pharma plc, of London, said it received approval for a Phase II trial of SRP 299 in atopic dermatitis (eczema) in children. The trial, involving 120 children aged 5 to 16, is expected to start in the fourth quarter.
Transgene SA, of Strasbourg, France, said it was granted 10 new patents this year protecting its vector technology portfolio, six of them in the U.S. and four in Europe. They cover its technologies for the delivery of viral and nonviral therapeutic genes, as well as corresponding production methods. Six of the new patents cover Transgene's nonviral vectors, which consist of both condensing liposome-type formulations (cationic lipids, polymers, chitosan and peptides) and noncondensing formulations (therapeutic DNA combined with appropriate adjuvant). Three of those patents were awarded in the U.S. and cover the following: lipid compounds and compositions, a transposition assembly for gene transfer in eukaryotes, and the use of polyamines for direct injection of genetic material into target cells in gene therapy. The other three are European patents covering cationic polymers and combinations with hyaluronidase, a natural enzyme that improves a vector's diffusion in the body's tissues. Transgene also was granted four patents for viral vectors, three of them in the U.S. covering the following: a method for preparing a viral aerosol for use in gene therapy, helper viruses for use in the preparation of recombinant viral vectors, and recombinant adenoviral vectors comprising a splicing cassette. The fourth is a European patent covering replication-defective adenoviral vectors deleted in E1 and E4.
Zealand Pharma A/S, of Glostrup, Denmark, said the Type II diabetes drug candidate ZP10 was well tolerated and displayed no side effects in a Phase I/II trial in 28 patients. No safety issues were identified in the double-blind, placebo-controlled study and a dose-dependent lowering of plasma glucose concentration was seen compared to placebo. The compound was well tolerated at doses up to 20 micrograms, close to the top of the dose response. The compound, an analogue of exendin-4 that acts on the GLP-1 receptor, also increased insulin secretion and reduced post-meal increases in glucagon concentration. Zealand now is looking for a partner to further clinical development.