BioInItaly Newsletter

La vetrina del biotech italiano all’estero


12 apr, 2016

Ongoing Phase II Study of Evenamide (NW-3509) May Suggest an Alternative Approach to the Treatment of Schizophrenia
Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced that it presented at the 5th Biennial Schizophrenia International Research Society Conference the abstract “Evenamide (NW-3509), a Putative Antipsychotic, Targets Abnormal Electrical Activity and Glutamatergic Abnormalities in Improving Psychotic Symptoms in Patients with Schizophrenia in a Phase II, Placebo-controlled Trial”. Evenamide (NW-3509) is a new generation antipsychotic that acts through pathways that are not targeted by current treatments or other putative antipsychotics. It is associated with a functional blockade of voltage-gated sodium channels that inhibits glutamate release by reducing the firing rate of hyper-excited neurons and may normalize aberrant cortical and hippocampal activity. A Phase II, placebo-controlled study in patients with schizophrenia experiencing breakthrough symptoms while on adequate doses of risperidone or aripiprazole is ongoing, in which Evenamide is being evaluated at doses of 15-25 mg bid as add-on therapy for reducing positive symptoms and psychotic worsening. Ravi Anand, MD, Newron’s Chief Medical Officer, stated: “Evenamide (NW-3509) has demonstrated in preclinical models that it provides inhibition of voltage-gated sodium channels without any effect on receptors, enzymes and transporters targeted by most antipsychotics and yet is active in most animal models of psychosis. Intriguingly, in animal models of psychosis, the addition of ineffective doses of both NW-3509 and typical or atypical antipsychotics, showed significant benefit. This finding, if confirmed in poorly responding patients, would suggest that the current practice of switching non-responding patients to another antipsychotic be replaced by the addition of NW-3509 to their regimen. This would avoid such issues as discontinuation effects, need to hospitalize patients, anti-dopaminergic, metabolic, and sexual side effects.”

GSK receives positive CHMP opinion in Europe for Strimvelis™, the first gene therapy to treat very rare disease, ADA-SCID 
GlaxoSmithKline announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has issued a positive opinion recommending marketing authorisation for Strimvelis to treat patients with a very rare disease called ADA-SCID (severe combined immunodeficiency due to adenosine deaminase deficiency). The medicine is a stem cell gene therapy created for an individual patient from their own cells which is intended to correct the root cause of the disease. If approved by the European Commission, the medicine - currently known as GSK2696273 (autologous CD34+ cells transduced to express ADA) - will be commercialised under the brand name Strimvelis, for the treatment of patients with ADA-SCID for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. The gene therapy for the treatment of ADA-SCID was originally developed by Ospedale San Raffaele (OSR) and Fondazione Telethon (Telethon), through their joint San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) and was taken forward by GSK through a strategic collaboration formed in 2010 between GSK, OSR and Telethon.  Within the partnership GSK, working with the biotechnology company MolMed S.p.A, has applied its expertise in product development to optimise, standardise and characterise a manufacturing process that was previously only suitable for clinical trials into one that has been demonstrated to be robust and suitable for commercial supply. 

Diasorin Shopping in USA
DiaSorin S.p.A. and Quest Diagnostics announced that they have entered into a purchase agreement under which DiaSorin will buy Quest’s Focus Diagnostics, Inc. immunodiagnostic and molecular diagnostic products business (“Focus”). Under the terms of the purchase agreement, DiaSorin will pay to Quest Diagnostics $300 million in cash for all the tangible and intangible assets of Focus used by the Company to develop, manufacture and distribute its molecular diagnostic products and its traditional immunoassay ELISA products, including among other relevant intellectual property, contracts and customer list. Today, Focus’ product lines include the Simplexa™ molecular product line, HerpeSelect® HSV serology, and the line of DxSelect™ IFA and ELISA assays. DiaSorin expects to continue to manufacture Focus products from the company’s base facility in Cypress, California, USA with the approximately 180 Focus employees currently employed in manufacturing, research and development, sales and marketing, and administration. The acquisition will be carried out by DiaSorin also through a newly created U.S. affiliate and it is expected to be completed in the second quarter 2016, subject to customary closing conditions. As a result of this acquisition, DiaSorin will have access to a new set of molecular products cleared for distribution both in the US and Europe, significantly increasing its presence in the growing market of Infectious Disease molecular testing.

MolMed and Genenta Science sign a collaboration agreement in the field of gene therapy for the treatment of tumors 
MolMed S.p.A. (MLM.MI) and Genenta Science (Genenta) signed an agreement on a multi-year cooperation to develop and manufacture a gene therapy product for the treatment of multiple myeloma. 
In accordance to this agreement, MolMed will develop and validate the manufacturing and analytical methods of the Genenta product that constitute part of the preparatory activities to enter in the clinical trials. Furthermore, MolMed will support Genenta to file the application dossier required for the authorisation to proceed with trials. The agreement extends the collaboration by ensuring MolMed exclusive product manufacturing for the clinical trials, in which the gene therapy for multiple myeloma will be investigated.

Menarini announces the founding of Vaxynethic, joint venture with Biosynth
The Menarini Group announces the founding of VaxYnethic, a joint venture between Menarini NewTech and BiosYnth, pioneer company operating in the field of technologies for the production of conjugated vaccines. VaxYnethic, taking full advantage of the technological know how of BiosYnth and Menarini, will be engaged in a medium to long term research project on an innovative technological platform for the production of biopharmaceuticals. The objective of the project is to work on a new technology which will allow researchers to expedite the production processes of biopharmaceuticals, as well as co-operate with other market players in order to reduce the manufacturing time for vaccines and satisfy the ever growing demand on a worldwide scale. Menarini’s interest in high technology is not new. In 2013 The Menarini Group acquired the Silicon Biosystems Menarini start up, a company which operates in the field of personalised medicine and holder of the patent on the DEPArray™ system which allows researchers to carry out a precise analysis of rare tumour cells. Later, in 2014, Menarini Biomarkers was founded, a company which currently conducts research projects on new biomarkers for the development of personalised medicine with the support of the DEPArray™ system.