Acadia Pharmaceuticals Inc., of San Diego, opened a chemistry research and development facility in Malmo, Sweden. The facility consolidates Acadia's presence in Scandinavia and provides increased access to a work force in the biotechnology hub of the Medicon Valley region.
Alkermes Inc., of Cambridge, Mass., said that its partner, Janssen-Cilag SpA, of Italy, received approval from the Italian Regulatory Authorities to market Risperdal Consta (risperidone) long-acting injection, an atypical antipsychotic medication for the treatment of schizophrenia. Alkermes expects its partner to launch the product in Italy before the end of the year. Risperdal Consta is a long-acting injectable form of risperidone that was developed utilizing Alkermes' Medisorb drug-delivery technology.
Bio-Medisinsk Innovasjon AS, of Oslo, Norway, entered an exclusive global license and development agreement with London-based GlaxoSmithKline plc, concerning the 5-HT4 receptor antagonist piboserod (SB 207266). Under the agreement, BMI will be responsible for completing a Phase II program to evaluate the product's effect on heart failure patients. If that trial is successful, GSK has the option to continue development, and eventual marketing of the drug, in exchange for a license fee, milestone payments and potential royalties.
Biomira Inc., of Edmonton, Alberta, completed enrollment of a 20-patient Phase II, single-arm, multicenter, open-label study of BLP25 liposome vaccine, which is being developed with Merck KGaA, of Darmstadt, Germany. The trial will assess the safety of the formulation of L-BLP25 that the companies plan to use in the upcoming Phase III study. Initial results from the trial involving men and women with non-small-cell lung cancer from eight clinical trial sites in Canada are expected before the end of 2005.
Biovitrum AB, of Stockholm, Sweden, said its candidate drug for glaucoma, BVT.28949, entered a Phase I trial this month. The drug was developed within Biovitrum, and the trial will include about 60 healthy volunteers. The study is expected to be completed later in the year.
Crucell NV, of Leiden, the Netherlands, received a €2 million (US$2.4 million) grant from the SenterNovem Innovation Subsidy for Collaborative Projects program of the Dutch Ministry of Economic Affairs. The grant supports a collaborative effort aimed at applying Crucell's MAbstract technology to discovering antibodies to assist in the development of new medicines against antibiotic-resistant bacteria. Crucell intends to exploit its antibody technology together with its vaccine and production platforms.
CuraGen Corp., of New Haven, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started patient dosing in a Phase Ib, open-label, multicenter, proof-of-concept trial evaluating PXD101, a small-molecule histone deacetylase inhibitor, to treat advanced solid tumors, including ovarian cancer. The goal of the proof-of-concept trial is to establish the maximum tolerated dose of PXD101 used in combination with carboplatin and/or paclitaxel in up to 30 patients with advanced solid tumors. Once the maximum tolerated dose is established, an additional 15 ovarian cancer patients in need of relapse treatment will be enrolled.
Cyclacel Group plc, of Dundee, Scotland, agreed to grant an exclusive option to Cambridge, Mass.-based Genzyme Corp. to license two of Cyclacel's preclinical Cyclin-Dependent Kinase inhibitors for further development in renal diseases and certain related conditions. During the option period, the companies could pursue a collaboration and license agreement for development and commercialization of the compounds. Financial terms were not disclosed.
Cytheris SA, of Paris, started a fifth Phase I study in the Memorial Sloan Kettering Cancer Center of its lead compound, a recombinant interleukin-7, in patients with myeloid malignancies who underwent a T cell depleted allogenic hematopoietic cell transplant. The product is a pivotal growth factor that helps to reconstitute the immune system and enhance global and specific immune responses.
Epitome Biosystems, of Waltham, Mass., signed a licensing and development agreement with EMD Biosciences Inc., a unit of Darmstadt, Germany-based Merck KGaA, for products based on Epitome's EpiTag technology. Epitome will develop reagents for the quantitative measurement of key intracellular signaling proteins. It will receive a technology access fee, and could get milestone payments and royalties, while EMD Biosciences would market and sell the products for research applications worldwide.
EvoGenix Ltd., of Melbourne, Australia, received worldwide licensing rights from South Korea-based DiNonA for an antibody for the treatment of leukemia. The antibody, discovered by researchers at the University of Seoul, targets certain forms of acute adult leukemia for which current antibody drugs provide little benefit.
Evotec Technologies GmbH, of Hamburg, Germany, and Genedata AG, of Basel, Switzerland, entered an agreement to combine their strengths in the area of high-content and high-throughput screening. The companies expect synergistic effects in combining Evotec's instrumentation software, Acapella, with Genedata's software system, Genedata Screener.
Galapagos NV, of Mechelen, Belgium, formed a collaboration with Amsterdam Molecular Therapeutics BV in the Netherlands, the Netherlands Institute for Brain Research and the Vrije Universiteit Amsterdam to develop treatments for acute spinal cord and peripheral nerve damage. The collaboration will be funded by a €2 million (US$2.4 million) grant from the Dutch governmental organization Senter. The project will focus on developing therapeutics to promote nerve regeneration and to diminish the effect of neural scarring.
Genmab A/S, of Copenhagen, Denmark, said its Phase I/II study of its HuMax-CD20 significantly reduced leukemia cells in patients with relapsed chronic lymphocytic leukemia. HuMax-CD20 was well tolerated in the open-label dose-escalation trial with 33 patients who had failed previous therapy. The FDA gave HuMax-CD20 fast-track status in December 2004.
Karo Bio AB, of Huddinge, Sweden, completed the first single, ascending-dose portion of its Phase I study for KB2115 in overweight subjects with dyslipidemia. Findings indicated that a single dose of the drug did not cause any adverse effects, and appeared to have positive effects on blood lipids and metabolic markers. The company now has initiated the multidose Phase Ib part of the study. KB2115 is designed to selectively stimulate the thyroid receptor to increase the body's energy consumption and reduce body weight.
NicOx SA, of Sophia Antipolis, France, expanded its existing collaboration with Grupo Ferrer Internacional SA, of Barcelona, Spain, for the research, development and marketing of nitric oxide-donating corticosteroids in dermatology. NicOx is eligible to receive additional milestone payments, commercial success fees and royalties in return for granting Ferrer an option on the U.S. development and marketing rights to any products that result from the collaboration.
Starpharma Holdings Ltd., of Melbourne, Australia, said Dimerix Bioscience Pty. Ltd., of Perth, Australia, closed its Series A financing, led by venture capital firm Foundation Capital, of Menlo Park, Calif., and supported by Western Australia-based Murdoch Westscheme Enterprise Partnership fund. Proceeds will be used to advance the development of the company's compounds targeting chronic gut disorders. Dimerix's compounds, which are being developed in a joint venture with Starpharma, are based on Starpharma's dendrimer nanostructures designed to enable the activation of multiple receptor sites on the cell surface. Following the financing, Starpharma holds 22 percent of Dimerix.
Aeres Biomedical, of London, UK, signed an agreement with Lpath Therapeutics Inc., of San Diego, to humanize Lpath's sphingomab murine antibody. Sphingomab is targeted against sphingosine-1-phosphate, a growth factor known to be involved in the proliferation of many different types of tumor cells. In preclinical models the murine version of the antibody was active against four different tumor types.
NeuTec Pharma plc, of Manchester, UK, recruited the first patients in a Phase Ib study of Mycograb in combination with docetaxel in treating metastatic breast cancer. Mycograb is a recombinant antibody that binds to heat-shock protein 90. The product is also in Phase III trials for invasive candidiasis. The breast cancer trial, taking place in three centers in Serbia and Poland, will recruit around 20 patients.
Onyvax Ltd., of London, was issued a European patent including specific composition of matter claims relating to its prostate cancer vaccine, OnyVax-P. The patent covers all combinations of three prostate cell lines.
York Pharma plc, of Hitchin, UK, raised £5 million (US$9 million) in a placing to advance its portfolio of dermatology products. The company placed 4.7 million shares at £1.06 per share. The new shares will begin trading on the Alternative Investment Market in London on Sept. 22.