BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.3/ NEWSLETTER MENSILE 2017

06 apr, 2017

Meiji Seika and Eisai enter into a collaboration for the development and commercialization of safinamide in Parkinson’s disease for Japan and Asia 
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, is pleased to note the news from its partner Meiji Seika Pharma that it has entered into a collaboration with Eisai Co. Ltd.  Eisai and Meiji Seika Pharma announced that they have entered into a license agreement for the commercialization of safinamide for the treatment of Parkinson’s disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan. Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in Asia. Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in Japan. Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia. Meiji will manufacture and supply the product of safinamide to Eisai for Japan and Asia. Furthermore, Meiji will receive an upfront payment from Eisai, as well as developmental milestone and sales royalty payments under the agreement. More info: www.newron.com/en

Tagrisso (osimertinib) receives US FDA full approval
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients. More info: www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html

Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review 
Novartis announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). This is the first BLA submission by Novartis for a CAR-T. The priority review designation is expected to shorten the anticipated review time by the FDA. CAR-T is different from typical small molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen. More info: www.novartis.com/news/media-releases/novartis-announces-first-car-t-cell-therapy-bla-pediatric-and-young-adult
   
ZCube, Research Venture del gruppo farmaceutico Zambon, annuncia un accordo con Italian Angels for Biotech (IAB) per l’individuazione e lo sviluppo di start-up innovative nel campo delle Life Sciences
ZCube è attiva da oltre un decennio nell’esplorazione di tecnologie innovative per piattaforme digitali per la salute del paziente, nella somministrazione di farmaci e dispositivi medicali (digital health, drug delivery systems e medical devices) e lo scorso anno ha lanciato Open Accelerator, il primo programma di accelerazione interamente italiano dedicato alle scienze della vita che identifica e sostiene progetti più promettenti con un finanziamento seed complessivo di 600 mila euro.  IAB è la prima associazione di business angels esclusivamente dedicata alle Life Sciences, composta da membri che hanno attivamente e direttamente partecipato allo sviluppo di start-up innovative di successo. In base all’accordo, i membri di IAB parteciperanno alle fasi valutative dei progetti della seconda “call for ideas” del programma Open Accelerator di ZCube, che è stata aperta a fine marzo 2017 sul sito dedicato www.openaccelerator.it. Inoltre i membri IAB, in base alle loro competenze specifiche, parteciperanno nel percorso di sviluppo delle start-up selezionate come advisors e mentors dalle prime fasi di progettualità. Sia ZCube sia IAB hanno sede nel campus scientifico OpenZone di Bresso, alle porte di Milano, e questa partnership rinforza l’importanza della rete esistente nell’ecosistema OpenZone, dove hanno propri uffici e laboratori 23 realtà di rilievo nel panorama biotech italiano. Per maggiori informazioni: http://www.z-cube.it/news-press-releases/archivio/2017/accordo-di-partnership-tra-zcube-e-italian-angels-for-biotech-iab/

EryDel announces start of ATTEST, a Pivotal Phase III Trial of EDS  in Ataxia Telangiectasia (A-T)
EryDel, a biopharmaceutical company specialized in the development of drugs and diagnostics delivered through autologous red blood cells, announced the initiation of the Ataxia Telangiectasia Trial with the EryDex System (ATTEST) study (http://attest-trial.com), a pivotal Phase 3 trial to evaluate the efficacy, safety and tolerability of EDS in patients with A-T. EDS is an innovative product that delivers dexamethasone sodium phosphate by encapsulating the drug into red cells taken from the patient’s own blood, which are then re-infused into the patient. EDS has received Orphan Drug designation for the treatment of A-T both from the FDA and EMA.  EryDel recently completed a pilot Phase II trial in AT patients that demonstrated the statistically significant efficacy of EDS on both primary and secondary outcome measures. The randomized, double-blind, placebo controlled ATTEST Study is expected to enroll 180 patients (three group of 60) at centers of excellence in the United States, Europe, India, Australia, Tunisia and Israel. The Study protocol was designed following extensive discussions with regulatory authorities in The United States and Europe. More info: http://www.erydel.com/en/press-releases#