Industry Briefs: February 25, 2013

Company News

Althea Technologies and Profectus BioSciences have formed a manufacturing supply agreement for plasmid DNA production. Under the agreement, Althea will provide gram-scale quantities of cGMP manufactured plasmid DNA expressing IL-12 to assist Profectus Biosciences’s DNA vaccine development efforts, which are supported by a contract from the National Institutes of Health. Read More

Covance has entered into an exclusive alliance and services agreement with M2Gen, a subsidiary of the Moffitt Cancer Center. Under the agreement, Covance and M2Gen will work together to offer biopharmaceutical clients the ability to match potential patients for biomarker-driven oncology trials with the right treatment or clinical trial. In addition, Covance will become the preferred provider for M2Gen for DNA/RNA sequencing, gene expression analysis, and genotyping analysis services, which will be conducted at Covance’s genomics laboratory in Seattle, Washington. Read More

Kiadis Pharma a clinical-stage biopharmaceutical company developing treatments for blood cancers, announced today it has received a No Objection Letter from Health Canada for its new clinical study with ATIR. This study will be a Phase II international multicenter study with clinical sites in Canada and Belgium. Up to 23 patients will be treated in this study to corroborate and extend the safety and efficacy results from Kiadis Pharma‘s previous Phase I/II clinical study with ATIR. ATIR is a cell-based product designed to enable stem cell transplantations from mismatched (haploidentical) family donors. Read More

MediciNova has received Fast Track designation from FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA’s Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval. Read More

Merck announced that the Phase III Centric trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). Centric included patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase gene promoter status. The trial was planned and conducted in partnership with the European Organization for Research and Treatment of Cancer. Detailed trial results will be submitted for presentation at the American Society of Clinical Oncology 2013 Annual Meeting and publication in a peer-reviewed journal. Read More

Phenomenex has launched a redesigned website, featuring industry-specific gateways function as complete digital consultants, helping users find answers by providing customized content and newsletters along with product selection and method development tools. Read More

Promis Center, a research center focused on the development of methods for analysis and optimization of pharmaceutical processes, has built continuous processing pharmaceutical production line—the only one of its kind in Europe. The production line, located in the facilities of the University of Eastern Finland, was created for R&D purposes. Read More

Viropro and Oncobiologics have formed a biosimilar collaboration agreement under which Viropro will have the rights to manufacture six monoclonal antibody products being developed by Oncobiologics for commercialization in more than 70 emerging market countries (excluding China). Viropro will have exclusive commercialization rights to the six biosimilars for Malaysia. In addition, the companies will co-manage Viropro’s Penang, Malaysia, Alpha Biologics biomanufacturing subsidiary. The alliance will seek regional partners to drive commercialization. Read More