• Bavarian Nordic A/S, of Kvistgard, Denmark, said its U.S. subsidiary BN ImmunoTherapeutics Inc. is set to begin a Phase I/II study of its breast cancer vaccine, MVA-BN-HER-2, in the U.S. in parallel with a similar study in Europe. Both are expected to enroll up to 60 patients to evaluate MVA-BN-HER-2's safety and tolerability, as well as its biological activity by measuring HER-2-specific immune responses in treated patients. In addition, the effect of the vaccine on the clinical progress of the patients and on tumor growth will be explored. MVA-BN-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for metastatic breast cancer, including combination treatment with Herceptin and chemotherapy. In Europe, the vaccine also will be tested in first-line therapy of metastatic breast cancer.

• Crucell NV, of Leiden, the Netherlands, and DSM Biologics, a business unit of Parsippany, N.J.-based DSM Pharmaceutical Products, signed a PER.C6 license agreement with Portuguese firm Biotecnol SA and its U.S. subsidiary, Biotecnol Inc. Terms allow Biotecnol to use the PER.C6 human cell line for preclinical and Phase I development of its antibody products, which are composed of Tribodies and Compact Antibodies. Specific financial details were not disclosed, but Biotecnol agreed to make license payments and annual maintenance fees.

• Galapagos NV, of Mechelen, Belgium, said its service division, BioFocus DPI, has expanded and extended its longstanding drug discovery collaboration with Amgen Inc., of Thousand Oaks, Calif., through this year and 2008. BioFocus DPI will continue to provide biology, computational and medicinal chemistry services and will supply biologically directed library compounds to Amgen's discovery programs. Under the terms of the extended agreement, Galapagos will receive an up-front fee of $2.4 million as a payment for 2007 research costs. Galapagos also may get compensation in the form of library and technology access fees, research fees, milestone payments and bonuses.

• Gentium SpA, of Villa Guardia, Italy, agreed to acquire the Italian marketing authorizations for Defibrotide and related trademarks, as well as certain other related assets, from Crinos SpA, of Como, Italy, for €16 million (US$21.1 million) in cash and other considerations. Gentium will pay in three installments, consisting of €8 million at closing, €4 million by Dec. 31 and €4 million by Dec. 31, 2008. The companies also entered into an agreement for Crinos to distribute only the oral formulation of Defibrotide in Italy until Dec. 31, 2008, and Crinos waived its right of first refusal to market future therapeutic indications for Defibrotide in Europe. Gentium, in return, agreed to pay Crinos a 1.5 percent royalty on net sales of the drug for the treatment and/or prevention of hepatic veno-occlusive disease in Europe for seven years.

• Medivir AB, of Huddinge, Sweden, filed an application to begin a Phase I study in Europe of MIV-701, an inhibitor of cathepsin K that could benefit osteoporosis, osteoarthritis, rheumatoid arthritis, Paget's disease and certain tumors causing bone metastases. The trials are expected to start this quarter.

• Merck Serono SA, of Geneva, was launched after Merck KGaA, of Darmstadt, Germany, successfully closed its share purchase agreement of Serono SA, of Geneva. The new company will have 28 projects in clinical development and a combined research and development budget totaling about €1 billion (US$1.3 billion). The $13.3 billion deal was announced last year.

• Movetis NV, of Belgium, closed a €49 million (US$63.8 million) Series A round, led by Sofinnova Partners (France) and Life Science Partners, with participation from Sofinnova Ventures (US), KBC Private Equity, KBC Private Equity Fund Biotech, GIMV, Quest for Growth and BIP Investment Partners. Movetis, which specializes in gastroenterology, licensed products and technologies from Janssen Pharmaceutica NV, of Belgium, and U.S.-based Ortho-McNeil Pharmaceutical Inc., both of which are affiliates of Johnson & Johnson. The company's late-stage development compound has completed three pivotal trials in chronic constipation, targeting patients who are treated with laxatives without satisfactory results. Other products in development are aimed at treating ascites, pediatric regurgitation, diabetic gastroparesis and severe forms of dyspepsia. Movetis' board includes CEO Dirk Reyn; Staf Van Reet; Antoine Papiernik, of Sofinnova Partners; Martijn Kleijwegt, of Life Science Partners; and Jim Healy, of Sofinnova Ventures. Ruth Devenyns, of KBC, will be an observer.

• Protherics plc, of London, has filed a New Drug Submission to Health Canada for DigiFab, a digoxin antidote already approved in the U.S. for treatment of life-threatening digoxin toxicity or overdose. The company hopes to receive Canadian approval in 2008. It already has filed for approval in the U.K. and in Europe and hopes to have approvals in six to 12 months. Protherics recently announced an agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to replace its digoxin antidote, which is being withdrawn from the market. In other news, Protherics completed its previously announced acquisition of MacroMed Inc., of Sandy, Utah, in an all-share transaction valued at about $25 million. The deal gives Protherics access to MacroMed's lead product, OncoGel, a sustained-release formulation of paclitaxel that is in Phase II development for local administration in esophageal and brain cancers.

• Provid Pharmaceuticals Inc., of North Brunswick, N.J., has signed a definitive agreement to acquire Tripos Discovery Research, the Bude, UK-based drug discovery division of Tripos Inc., for $2 million. The Tripos board of directors has approved the sale. Provid said it will continue to offer the TDR LeadQuest libraries and LeadDiscovery platform to customers. The sale is expected to close in the first quarter.

• Schwarz Pharma AG, of Monheim, Germany, said pivotal Phase III data published in the journal Neurology showed positive results for its once-daily dopamine agonist, rotigotine, in early stage Parkinson's disease. Specifically, the transdermal drug significantly improved patients' symptoms through six months of therapy as measured by parts II and III of the Unified Parkinson Disease Rating Scale, compared to placebo. A decrease in those scores signifies symptom improvement, and patients in the rotigotine group had a mean decrease of 3.98 +/- 0.707, while the placebo group had a mean increase of 1.31 +/- 0.956 (p<0.0001).

• Zyentia Ltd., of Cambridge, UK, entered a research collaboration to allow Louisville, Ky.-based Potentia Pharmaceuticals Inc. access to its AggreSolve platform for characterizing compounds. No financial terms were disclosed. Zyentia plans to seek additional research collaborations to support its internal pipeline. The company anticipates moving into preclinical testing with its lead candidates this year.