• Affitech A/S, of Oslo, Norway, and Peregrine Pharmaceuticals Inc., of Tustin, Calif., achieved the first research milestone in one of their collaborations. The milestone involved the identification of an initial panel of fully human antibodies that bind to vascular endothelial growth factor with a defined specificity. Affitech will further optimize the panel of antibodies using its discovery and selection systems. The antibodies are intended to be used in Peregrine's vascular-targeting agent and anti-angiogenesis programs.

• Arrow Therapeutics, of London, said its antiviral for respiratory syncytial virus successfully completed Phase I trials. The compound was shown to be safe and well tolerated with pharmacokinetics indicating once-daily, oral dosing. Phase II trials are planned for the second half of 2004.

• Australian Cancer Technology Ltd., of Sydney, said it completed due diligence on its proposed $5 million acquisition of Galenica Pharmaceuticals Inc., of Birmingham, Ala. Galenica's technology includes three families of adjuvants used to stimulate the immune system. Employed as stand-alone therapeutics, or as vaccine components, the compounds are being used in cancer vaccines in two Phase I trials and one Phase I/II study in the U.S. The transaction - announced by Australian Cancer in May - remains subject to its shareholders' approval. Earlier, Galenica signed a deal with Australian Cancer allowing its lead product, the GPI-0100 adjuvant, to be used by New York-based Memorial Sloan-Kettering Cancer Center in a series of clinical trials. The center intends to use GPI-0100 with specific vaccine antigens in patients with melanoma, sarcoma, neuroblastoma, small-cell lung cancer and cancers of the breast or ovary. If antibody responses are demonstrated, the vaccine adjuvant would move into Phase II trials. Also, Australian Cancer said the SEC declared effective its American depository receipt program, enabling it to access U.S. capital markets and expand its shareholder base. The company hopes to list on the Nasdaq National Market. Global Markets Capital Group, of New York, is managing the program, and the Bank of New York will be the depository bank.

• BioInvent International AB, of Lund, Sweden, entered an agreement with Orbus Medical Technologies Inc., of Fort Lauderdale, Fla., to supply cGMP-quality antibodies that will be incorporated into coated stents undergoing clinical evaluation. The device, which is expected to undergo commercialization in 2005, is designed to prevent thrombosis and to reduce the occurrence of restenosis following stenting procedures. The antibodies are designed to recruit epithelial cells to promote healing in the stent area. Orbus plans to enter a supply agreement with BioInvent for commercial-grade antibodies once process development and product approval are complete.

• Celltech Group plc, of Slough, UK, said the FDA approved Codeprex (codeine polistirex/chlorpheniramine polistirex) extended-release suspension CIII for cough relief. The drug uses Celltech's Pennkinetic extended-release drug delivery technology to provide 12-hour dosing. Codeprex is the first codeine-based cough suppressant to provide such dosing.

• Cobra Biomanufacturing plc, of Keele, UK, said its collaborator, the Cancer Research Institute, formed an agreement with the Ludwig Institute for Cancer Research to produce Coley's Toxin cancer vaccine for clinical trials. Coley's Toxin will be produced from two different bacteria under controlled conditions. The project will take six months, it said.

• Columbia Laboratories Inc., of Livingston, N.J., submitted to gain approval of Striant SR 30 mg under the mutual recognition procedure in the European Union. The mucoadhesive buccal tablets would be indicated as a testosterone-replacement therapy in men with primary or secondary hypogonadism. The UK approved Striant SR in February, and it was launched by Ardana Bioscience Ltd., of Edinburgh, Scotland. Licenses in other European countries are expected to be granted over the next 12 months. Columbia will receive about $1.4 million in milestone payments upon receiving approval in major European countries as part of its 2002 agreement with Ardana and 2003 agreement with Milan, Italy-based Mipharm SpA, which holds rights in Italy.

• Crucell NV, of Leiden, the Netherlands, said its MAbstract technology helped in the discovery of an antibody for protection against severe acute respiratory syndrome virus infection. The next issue of The Lancet will feature study results of the antibody - which was discovered with the technology and produced on the PER.C6 cell line - showing it protects ferrets from SARS. Crucell stopped its oncology program in 2003 and redirected its focus to infectious diseases.

• Elan Corp. plc, of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., said the FDA designated for priority review their biologics license application for Antegren (natalizumab) to treat multiple sclerosis. The next step is for the FDA to formally accept the application. The companies submitted the BLA in May. Antegren, a humanized monoclonal antibody, is the first alpha-4 antagonist in the new selective adhesion molecule inhibitor class.

• Genopole and Biocitech, two French biotechnology science and business parks located in the Paris suburbs of Evry and Romainville, respectively, signed a partnership charter to seal an alliance. The alliance is aimed at enhancing the appeal of the Paris region as a center of biotechnology research and development and at facilitating the creation of start-ups. It represents the first step in the Regional Development Agency's strategy for establishing a life sciences business cluster in greater Paris.

• GPC Biotech AG, of Martinsried, Germany, set the subscription price for the up to about 7.1 million new shares offered in the rights offering at €12.50. The rights offering to existing shareholders was published June 14, and the subscription period ended June 28. GPC Biotech is focused on discovering and developing cancer drugs. Also, the company was awarded a U.S. Patent No. 6,753,329 covering its lead cell-cycle inhibitor, RGB-286199. The patent claims the composition of matter of a family of cell-cycle inhibitors that includes RGB-286199. Claims also include pharmaceutical compositions, as well as methods of treating certain diseases, including cancer. Applications are pending in Europe, Japan and Canada.

• Helsinn Healthcare SA, of Lugano, Switzerland, and MGI Pharma Inc., of Minneapolis, said presentations at the 16th Multinational Association of Supportive Care in Cancer international symposium in Miami described the impact of treatment with Aloxi injection. Data show that significantly more patients who were treated with Aloxi injection reported no impact on their daily living from nausea and vomiting, compared to patients treated with ondansetron or dolasetron. Aloxi also demonstrated that its efficacy is maintained in patients weighing more than 90 kg, and that the therapy is well tolerated with predictable plasma concentration. Aloxi injection is a selective 5-HT3 receptor antagonist approved in July 2003 by the FDA at a fixed dose of 0.25 mg for the prevention of acute nausea and vomiting associated with chemotherapy.

• Intercell AG, of Vienna, Austria, granted a two-year, exclusive license to Solvo Biotechnology Inc., of Szeged, Hungary, to develop a diagnostic product based on progesterone-induced blocking factor (PIBF). PIBF is a human cytokine-like protein secreted by lymphocytes and expressed in tumor cells. Intercell said PIBF secreted by tumor cells and by tumor-infiltrating lymphocytes might participate in host-tumor interaction by suppressing cellular rejection of the tumor tissue, and PIBF serum levels in tumor patients might be correlated with tumor mass. The protein might also play a role in pathological pregnancy states. Financial terms of the agreement were not disclosed.

• IQ Corp., of Groningen, the Netherlands, said its two anthrax therapy products were selected for evaluation by the Centers for Disease Control and Prevention in Atlanta. The first of the fully human monoclonal antibodies to be evaluated is Anthraxumab, an antibody directed against PA, the non-toxic but essential component of the anthrax toxin. The second antibody recognizes LF, the deadly component of the anthrax toxin.

• KuDOS Pharmaceuticals plc, of Cambridge, UK, signed agreements with the University of Cambridge and Cancer Research UK for continuing access to DNA-repair work carried out by KuDOS' founder and chief scientific officer, Stephen Jackson, at the Gurdon Institute of Cancer and Developmental Biology at the university. KuDOS is using the technology to develop small-molecule inhibitors of DNA repair in cancer cells.

• MediGene AG, of Martinsried, Germany, licensed a method of targeting herpes simplex viruses (HSVs) to specific cells from the University of Chicago. MediGene said the method has the potential to increase the efficiency of the company's oncolytic HSVs and expand their range of applications. As part of the license, the company acquired all commercial rights to the versions of HSV that were part of a recent patent application. Financial terms were not disclosed.

• ML Laboratories, of Warrington, UK, said its respiratory division, Innovata Biomed (IB), entered an exclusive agreement with an undisclosed global pharmaceutical company to use IB's dry-powder inhaler to deliver two marketed respiratory drugs. IB will receive fees and milestone payments of £7.5 million (US$13.7 million), and up to £9 million in development fees.

• MorphoSys AG, of Martinsried, Germany, was awarded U.S. patent No. 6,753,136 on its CysDisplay screening technology. The patent, titled "Novel methods for displaying (poly)peptides/proteins on bacteriophage particles via disulfide bonds," describes a technology for selecting high-affinity antibodies based on phage display. The company also has applied for patents on the technology in other jurisdictions.

• Nippon Shinyaku Co. Ltd., of Kyoto, Japan, granted Optimer Pharmaceuticals Inc., of San Diego, exclusive rights to develop and commercialize prulifloxacin in the U.S. Prulifloxacin is a fluoroquinolone antibiotic used in Japan for the treatment of various bacterial diseases, including respiratory and urinary tract infections, skin infections, infectious enteritis, cystitis and prostatitis. Fluoroquinolones are a class of antibiotics designed to be effective against disease-causing bacteria.

• Nonlinear Dynamics Ltd., of Newcastle Upon Tyne, UK, a provider of bioinformatics solutions, reported the release of its flagship product, Progenesis, that now incorporates Cross Stain Analysis technology. The Progenesis software incorporates technology to conduct objective 2DE research using statistically driven proteomics.

• PamGene International BV, of s-Hertogenbosch, the Netherlands, and Jerini Peptide Technologies, a division of Jerini AG, of Berlin, established a collaboration to provide a new technology for kinase studies. PamGene's ability to generate kinetic read-outs of multiple kinase activities on its 3-dimensional microarray platform will be complemented by JPT's peptide expertise and peptide libraries, the companies said. The joint product offering has been designed to benefit signal transduction-focused medicinal chemistry groups.

• Panagene Inc., of Daejeon, Korea, developed a peptide nucleic acid (PNA) chemistry, which leads to the manufacture of PNA monomers and to the efficient synthesis of PNA oligomers at higher purity, the company said. The PNA chemistry is designed to accelerate the development of diagnostic and therapeutic products derived from human genome project sequence data. PNA is a nucleic acid analogue in which the entire phosphate sugar backbone has been replaced by an uncharged polyamide backbone with the side groups, purine and pyrimidine bases, found in biological nucleic acids.

• PharmaMar SA, of Madrid, Spain, said an investigational new drug application was accepted by the FDA for the clinical testing of Aplidin. The IND allows the start of two Phase II studies in the U.S., one in patients with multiple myeloma and another in prostate cancer patients. Aplidin is an antitumor agent derived from the marine tunicate Aplidium albicans. It induces activation of apoptosis combined with blocking of cell division in the G1/G2 phase of the cell cycle in tumor cells. Also, Aplidin was granted orphan drug status by the FDA to treat acute lymphoblastic leukemia (ALL). The compound has orphan drug status in Europe for ALL. Phase II trials of the compound are ongoing for melanoma, colorectal, renal, lung, medullary thyroid, head and neck, and pancreatic carcinomas. It also is in Phase I pediatric trials for solid and hematological tumors.

• Protalix Biotherapeutics Ltd., of Karmiel, Israel, and Icon Genetics AG, of Halle, Germany, signed a two-year strategic collaboration aimed at developing plant cell lines as a general platform system for high-level expression of recombinant proteins. The program combines Icon's amplification technologies with Protalix's expression systems based on plant cell cultures grown in bioreactors.

• Proteome Sciences plc, of Cobham, UK, said data were presented last week at the 5th World Stroke Congress in Vancouver, British Columbia, showing that Proteome's biomarkers can be used to diagnose stroke. The research, carried out at the Cantonal Hospital of the University of Geneva, screened for the biomarkers in serum taken from patients between 60 minutes and 24 hours following stroke, comparing the screens to age-matched controls.

• Schering-Plough Europe, of Brussels, Belgium, reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of a shorter 24-week course of PegIntron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for patients chronically infected with hepatitis C virus genotypes 2 or 3. PegIntron is approved in the European Union for a 48-week course of therapy.

• Serono SA, of Geneva, received a unanimous positive opinion from the Committee of Medicinal Products for Human Use recommending approval of its psoriasis product Raptiva (efalizumab). The committee evaluates medicinal products for human use within the European Union since last month's accession of 10 new member states. Serono added that it expects European regulatory approval next quarter.

• SR Pharma plc, of London, said David Hill, CEO, resigned with immediate effect, one year after joining the immune therapy company. That follows the resignation in May of long-standing Chairman Eric Boyle, and prompted a reshuffle, with Iain Ross, appointed a nonexecutive director in May, stepping up to executive chairman. Last month SR Pharma said it was in merger and acquisition discussions, and Boyle said he planned to cut employees to seven and reduce running costs from about £4 million (US$7.3 million) in 2003 to £1.8 million per annum.

• TopoTarget Prolifix A/S, of Copenhagen, Denmark, gained FDA orphan drug designation for Topotect (ICRF-187), a cryoprotectant for preventing severe tissue damage in cancer patients. Current treatment can involve surgical removal of the damaged tissue followed by plastic surgery. The product gained EU orphan drug status in September 2001.

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