BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.2_2018/ NEWSLETTER MENSILE

06 mar, 2018

AstraZeneca, the European Medicines Agency accepts regulatory submission for Forxiga in adults with type-1 diabetes
AstraZeneca announces that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D. The short-term (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-relevant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses. Forxiga has the potential to become the first selective SGLT-2 inhibitor approved in Europe for the treatment of T1D as an oral treatment adjunct to insulin, helping to address a significant unmet need in this patient population. Forxiga is not currently licensed for use in T1D. More info: https://www.astrazeneca.com/media-centre/press-releases/2018/the-european-medicines-agency-accepts-regulatory-submission-for-forxiga-in-adults-with-type-1-diabetes-05032018.html

Diasorin signs an agreement with the Italian tax authority granting tax relief under the Italian patent box regime 
DiaSorin S.p.A. signs an agreement with the Italian Tax Authority to access the Patent Box regime. The Patent Box is an elective tax regime introduced by the Italian Government with the Stability Law of 2015, which grants a 50% exemption (reduced to 30% for 2015 and 40% for 2016) from corporate income tax, both IRES and IRAP, on income derived from direct exploitation of qualified IP (know-how, trademarks and patents). The regime is characterized by a five-year lock-in period and the election is renewable. The agreement signed today covers the period from 2015 to 2019 and provides DiaSorin an estimated tax benefit for the first three years in a range of about 16 ml to 18 ml euro. More info: http://www.diasorin.com/sites/default/files/allegati_pressrel/pr_diasorin_patent_box.pdf

MolMed and Miltenyi Biotec: EMA approves the utilization of the CliniMACS Prodigy® equipment in the commercial manufacturing process of Zalmoxis®
MolMed S.p.A., a medical biotechnology company focusing on research, development, manufacturing, and clinical validation of innovative therapies to treat cancer, and Miltenyi Biotec GmbH, a global supplier of equipment and services for cell and gene therapy, announce that the European Medicines Agency (EMA) has approved the utilization of the CliniMACS Prodigy®, a closed environment, automated cell production device developed by Miltenyi Biotec, in the GMP manufacturing of Zalmoxis®.  With the positive outcome of the request submitted by MolMed to EMA, CliniMACS Prodigy® for the first time, becomes part of a manufacturing process for a commercial drug, namely Zalmoxis®, which has been authorized for marketing in Europe. Zalmoxis®, MolMed patient-specific cell therapy, is based on engineering of the donor immune system, in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT) for the treatment of leukemia at high-risk of relapse. This therapy is part of the immuno-oncology field that uses modified T-cells to maximize the antitumor effect of the immune system, and is considered one of the most promising frontiers in the treatment of patients suffering from malignancies refractory to conventional therapies. Zalmoxis® was approved for commercial use by the European Community in 2016 and is reimbursable in Germany and also, from March 1st, in Italy.
More info: http://www.molmed.com/sites/default/files/uploads/press-releases/3259/3259_1519811772.pdf

Dompé announces Zalmoxis® product launch in Germany
Dompé, an Italian biopharmaceutical company, announces the submission of the medical dossier for Zalmoxis® to the Federal Joint Committee on 15 January 2018. With this, the company fulfilled an important prerequisite for the launch of the therapy in Germany. Zalmoxis® is developed and produced by MolMed S.p.A., primary medical biotechnology company focused on research, development and clinical validation of innovative therapies to treat cancer, based in Italy. Per a Europe-wide licensing and distribution agreement, Dompé, one of the leading Italian companies in the biopharmaceutical industry, oversees the product’s promotion and marketing in Germany. 
Zalmoxis® is MolMed’s first patient-specific therapy that genetically modifies allogeneic T cells. It is intended as adjunctive treatment in stem cell transplantation (HSCT) of adult patients, who have a high-risk of being affected by diseases that harm the blood system. Zalmoxis® can be now prescribed and reimbursed in Germany at a price valid for twelve months during which the additional benefits of this innovative therapy for patients will be assessed by the German authorities.  More info: http://www.dompe.com/news-en/707_dompe-announces-zalmoxis-product-launch-in-germany.html