Other News To Note.

* Ablynx NV, of Ghent, Belgium, opened recruitment in its Phase II study of anti-von Willebrand factor Nanobody in acquired thrombotic thrombocytopenic purpura. The study is expected to enroll more than 100 patients and will test the Nanobody as an adjunct to standard plasma exchange therapy. The primary endpoint will be the time to response, defined by the normalization of platelet count for the blood marker lactate dehydrogenase. In separate news, Ablynx said it will receive further milestone payments totaling ?3 million (US$4.1 million) from Boehringer Ingelheim GmbH, of Ingelheim, Germany, triggered as part of the companies alliance to develop and commercialize Nanobodies.

* Affitech AS, of Copenhagen, Denmark, and Peregrine Pharmaceuticals Inc., of Tustin, Calif., agreed to amend certain terms of their July 2009 worldwide license agreements for Brazil, Russia and other countries of the Commonwealth of Independent States (CIS) to expedite the development of a fully human antibody called AT001/r84 for those territories. Under the amended terms, Peregrine and Affitech will reinvest their respective portions of any future milestone payments to be received under the agreements for the countries of Brazil, Russia and the CIS toward the further advancement of AT001/r84. In the event Affitech enters into a licensing deal for AT001/r84 in a major pharmaceutical market, the company has agreed to reimburse Peregrine for its milestone payments that were applied to the program, while Affitech would be eligible to be reimbursed for up to 50 percent of its development costs in Brazil, Russia and CIS territories. The remaining terms of the original license agreements remain unchanged, including milestone and royalty payments. Additional terms were not disclosed.

* BAC BV, of Naarden, the Netherlands, completed a feasibility study with positive results under its collaboration with Genmab AS, of Copenhagen, Denmark. BAC developed CaptureSelect custom affinity ligands for use in monitoring drug candidates in preclinical studies and clinical trials based on Genmab's UniBody antibody technology.

* Benitec Ltd., of Melbourne, Australia, commenced a research and development program for an expressed RNAi product for chronic intractable pain associated with diseases such as cancer and HIV, or neuropathic pain. There currently is no treatment to prevent the development of neuropathic pain, nor to adequately, predictably and specifically control established neuropathic pain.

* Circassia Ltd., of Oxford, UK, which started Phase II testing with its grass allergy therapy, began the final stage of Phase II testing with its ragweed allergy treatment and progressed Phase III development plans for its cat allergy therapy. All three programs emerged from the company's ToleroMune technology, which uses the T-cell vaccine approach to combat allergies.

* Cosmo Pharmaceuticals SpA, of Lainate, Italy, and Santarus Inc., of San Diego, reported top-line results from a Phase III trial of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis, which showed that the drug, taken once daily, met the primary endpoint of superiority to placebo (p = 0.0143) in achieving clinical remission as measured by the ulcerative colitis disease activity index score after eight weeks of treatment. A European Phase III is ongoing and, pending positive data from that trial, Santarus anticipates submitting a new drug application in the second half of 2011. Budesonide MMX is a locally acting corticosteroid developed in a tablet formulation using Cosmo's MMX multimatrix system technology.

* CureVac GmbH, of Tuebingen, Germany, reported data from a Phase I/IIa trial of its mRNA vaccine, CV9103, in hormone-refractory prostate cancer patients, showing that the vaccine was safe, well tolerated and biologically active. More than 70 percent of patients responded to at least one antigen out of the four antigens in CV9103. The trial evaluated a five-dose regimen delivered via intradermal injection in 44 patients.

* Galapagos NV, of Mechelen, Belgium, started a Phase II trial of GLPG0269, a drug designed to target protein kinase MAPKAPK5, in rheumatoid arthritis. About 180 patients with insufficient response to standard-of-care treatment with methotrexate will be enrolled for the 12-week study and divided into four groups, all continuing to receive a stable background of MTX. Three groups will receive a different once-daily dose of GLPG0259 while the fourth group will get placebo. Interim results are expected in the middle of next year, and the trial will likely be completed by the end of 2011 .

* Horizon Discovery Ltd., of Cambridge, UK, a translational genomics and personalized medicine company, has closed a [pounds sterling]6.25 million (US$9.88 million) Series C financing led by European venture capital firm DFJ Esprit. The funds will enable Horizon to further improve its core GENESIS and X-MAN technology platforms, address new markets and begin to target therapeutics markets outside of its historical cancer focus. The third round of financing for Horizon was also subscribed to by past investors Roche Venture Fund, Jonathan Milner and David Evans.

* Kinaxo Biotechnologies GmbH, of Martinsried, Germany, and Daiichi Sankyo Co. Ltd., of Tokyo, entered a long-term partnership in cancer research under which Daiichi will employ Kinaxo's technology platform to support the development of its targeted cancer drugs. Financial terms were not disclosed.

* MediGene AG, of Martinsried, Germany, is restructuring its business, which includes cutting its work force from 107 employees to 55 and reducing costs, in an effort to strengthen its drug pipeline through a strategic transaction. The estimated one-off restructuring cost will incur in full in 2010 and is estimated to be about ?1 million (US$1.36 million), with cost savings of at least ?5 million per year.

* Mucosis BV, of Groningen, the Netherlands, will partner with nonprofit organization Path to develop oral vaccines for diarrhea using Mimopath technology. Mucoosis will establish proof of concept in animals with Path providing research costs up to $600,000. Positive results in the early trial may lead to further collaboration. Path promotes research to solve health problems in developing countries. Severe dehydrating diarrhea is the second leading cause of death among children in developing countries.

* Neovacs SA, of Paris, said its data safety monitoring board authorized the firm to proceed to the next higher dose of INFalpha-Kinoid in its ongoing Phase I/II trial in lupus after reviewing the data for patients administered the second dose level. The firm is now recruiting up to 28 patients for the next dose. Preliminary results of the placebo-controlled, double-blind study are expected during the first half of 2011.

* NovaBiotics Ltd., of London, is partnering with Isogenica Ltd., of Cambridge, UK, to develop new applications for NovaBiotics' anti-infective drugs. As part of the agreement, NovaBiotics will work with Isogenica on two research projects, one concerning peptide selection and the other will be peptide maturation with the aim of expanding the company's product portfolio.

* PharmaMar SA, a subsidiary of Grupo Zeltia SA, of Madrid, Spain, and its partner, Centocor Ortho Biotech Products LP, of Horsham, Pa., a Johnson & Johnson company, said Yondelis (trabectedin), a tris tetrahydroisoquinoline alkaloid, was approved in combination with pegylated liposomal doxorubicin hydrochloride for the treatment of patients with platinum-sensitive ovarian cancer in Brazil, India and Argentina.

* Prana Biotechnology Ltd., of Melbourne, Australia, designated a lead compound for development as a Parkinson's therapy. Compound PBT434 is thought to address Parkinson's by preventing the loss of substantia nigra cells, preventing elevation of iron and preventing the accumulation of alpha synuclein, and has demonstrated efficacy in mouse models of the disease. Those data were presented at the World Parkinson's Congress in Glasgow, Scotland.

* Proteome Sciences plc, of London, said it will receive an $11 million settlement under a breach claim involving contractual and statutory obligations of Sanofi-Aventis Deutschland GmbH, part of Sanofi-Aventis Group SA, of Paris, arising from or in connection with an agreement of sale and transfer for a share in Xzillion Proteomics Vewaltungs GmbH and concerning a limited partnership interest in Xzillion.

* A placement of $14 million will help QRxPharma Ltd., of Sydney, Australia, to fund a Phase III labeling claim study for MoxDuo IR, an immediate-release dual-opioid pain therapy. The issue price will be 85 cents per share, which is a 15 percent discount over the closing price of QRxPharma (ASX:QRX) on Sept. 28.

* Synosia Therapeutics, of Basel, Switzerland, presented Phase I data showing that SYN-118 (CL02) was well tolerated and significantly improved motor scores in Parkinson's disease patients. The data were presented at the World Parkinson Congress. A randomized Phase II trial is ongoing. SYN-118 inhibits hydroxyphenylpyruvate dioxygenase.

* Tasly Pharmaceutical Co. Ltd., of Tianjin, China, and ProteoTech Inc., of Kirkland, Wash., have agreed to co-develop ProteoTech's small-molecule therapeutic, Exebryl-1, for the treatment of mild-to-moderate Alzheimer's disease. Exebryl-1 has been shown to inhibit beta-amyloid protein aggregate formation in the brain, as well as disaggregate amyloid plaques that are already present. The alliance will focus on moving the development of Exebryl-1 through the regulatory process in both China and the U.S. Terms were not disclosed, but will include an up-front payment, development costs and research funding to ProteoTech. Tasly will gain rights for Exebryl-1 for China, and ProteoTech will retain rights for the U.S. and the rest of the world.

* Teva Pharmaceuticals Industries Ltd., of Jerusalem, and OncoGenex Pharmaceuticals Inc., of Bothell, Wash., began a Phase III trial of custirsen for castrate-resistant prostate cancer (CRPC). The study will enroll about 800 men with metastatic CRPC and will compare treatment with docetaxel/prednisone plus custirsen to docetaxel/prednisone alone, evaluating overall survival as the endpoint. Phase II trials showed clinical benefits of custirsen with an overall survival of 23.8 months compared to 16.9 months. Custirsen has been given fast-track status by the FDA.

* ThromboGenics NV, of Leuven, Belgium, signed a 10-year supply deal with UK-based MSD Biologics Ltd., part of the Merck BioManufacturing Network, for the production of microplasmin. Financial terms were not disclosed. ThromboGenics recently reported positive data from Phase III trials in vitreomacular adhesion and is targeting regulatory filings in the U.S. and Europe by mid-2011.

* Trophos SA, of Marseille, France, started clinical development of TRO40303, a mitochondria pore modulator in development to reduce cardiac reperfusion injury after myocardial infarction. The Phase I trial will enroll 64 healthy volunteers to compare a single dose of TRO40303, administered via intravenous infusion, to placebo.

* Vivalis SA, of Nantes, France, said Mymetics Corp., of Epalinges, Switzerland, signed a research license agreement to evaluate the replication of an undisclosed virus in Vivalis' EB66 cell line for the manufacturing of human vaccines developed by Mymetics. Terms were not disclosed.

* Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi-Aventis SA, of Paris, disclosed top-line results from the Phase III GETGOAL-L-ASIA trial testing lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin. Results showed that the drug, when dosed once daily, significantly improved glycemic control with no specific safety concerns in patients with Type II diabetes. The 24-week, 311-patient study met its primary endpoint, with the addition of lixisenatide to basal insulin reducing A1C levels by 0.88 percent vs. placebo (p < 0.0001). Zealand and Sanofi reported positive top-line data from the first GETGOAL study in April.