Her's a link to Synthon's PIII trial presumably needed for European approval:
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE) This study is currently recruiting participants. Verified on December 2011 by Synthon BV
First Received on December 8, 2011. No Changes Posted Sponsor: Synthon BV Information provided by (Responsible Party): Synthon BV ClinicalTrials.gov Identifier: NCT01489254
Purpose The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis
Here’s the Synthon PR on FoB’s you cited from 2010. While Synthon states a corporate goal of being an FoB player, I don’t see anything concrete in this PR to indicate that they are likely to be successful. Comments?
›Synthon to Accelerate Investment in Biosimilars and Novel Biologicals
Nijmegen, the Netherlands, 26 April 2010—Synthon is building on the success of its small molecule generics business by taking a leading role in the development of Biosimilars and Novel Biologicals. Biosimilars benefit the market and patients by making healthcare more affordable, while the targeted Novel Biologicals offer powerful advancements to medical science and treatment delivery. Rudy Mareel, Synthon's CEO believes, "we are uniquely positioned to advance into both Biosimilars and Novel Biologicals as we are able to leverage the outstanding integrated systems and processes created for our small molecule generics - from our R&D excellence through to Intellectual Property, regulatory and clinical affairs, and a solid reliable global supply chain. Synthon is well-prepared to compete".
Today, Synthon dedicates significant scientific and laboratory resources to Biosimilars and our first monoclonal antibody is advancing rapidly toward phase I clinical trials. Our integrated approach includes Cell Line Development, Upstream Processing, Downstream Processing and Bioanalytics. This focused attention, with the involvement of more than 50 scientists, has resulted in one monoclonal Master Cell Bank already completed and a second monoclonal in cell line development. "We have always been first and foremost about science", says Dr. Jacques Lemmens, Synthon's Founder and Chairman. "Our move into biologics is a natural progression that takes advantage of this deep knowledge." In addition, Synthon is in the research phase with a novel class of highly specific therapeutic proteins, which can be taken orally or applied topically (e.g. to the eye, the lung and the skin). These Novel Biologicals should avoid the adverse effects patients encounter with parenterally applied proteins. The primary focus of these proteins is in inflammatory bowel disease, with potential applications in a range of other autoimmune diseases.
To support research and commercialisation of both Biosimilars and Novel Biologicals, Synthon is expanding its scientific infrastructure. New lab facilities are due to come on line in Q2 2011 to accommodate approximately 150 scientists. We are also in the detailed design phase of updating our strategic biologicals' manufacturing capacity, targeted for 2013, so that we are well prepared to deliver these promising products with an accelerated timeline to market.
About Synthon
Synthon is a successful early entrant in the European market for small molecule generics, having released its first product in 1993. Since then, the company has expanded rapidly with now more than 35 molecules and drug products on the market, a promising pipeline and a geographic footprint extended to Latin America, the US, and Asia. Our integrated business model delivers end-to-end solutions for API and Drug Products - from core research, through development, manufacturing, and distribution. Synthon continues to develop and maintain extensive partnerships across the pharmaceutical industry landscape in order to bring our products to the patient.‹
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