BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.6/ NEWSLETTER MENSILE 2017

14 lug, 2017

SOL Group Acquires Majority Stake in Personal Genomics
Industrial holding group SOL Group announces it has taken a 51 percent stake in genomic services firm Personal Genomics. Financial and other terms of transaction were not disclosed. Established in 2011 and based in Verona, PG has expertise in whole-genome and whole-exome sequencing for the clinical setting. Its two flagship services are Genome Insight, to help healthy people identify their genetic predispositions, and Genome Insight Med, for patients suspected of having genetic disorders. The firm's menu of tests includes genetic panels for cardiovascular disease risk and noninvasive prenatal testing. Additional tests are being developed for the early diagnosis of cancer, pharmacogenomics, and nutrigenetics. SOL will provide resources to PG to further develop its research projects and implement its new facility dedicated to DNA sequencing. SOL will also expand PG's footprint in Europe. 

Xadago® (Safinamide) now available in the U.S. for Parkinson’s disease patients
Alliance partners Newron Pharmaceuticals S.p.A. and Zambon S.p.A. based in Milan, and Louisville-based US WorldMeds announce that XADAGO (safinamide) is now available as an add-on therapy for U.S. patients with Parkinson’s disease (PD) currently taking levodopa/carbidopa and experiencing “off” episodes. It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). XADAGO, a once-daily tablet, is the first New Chemical Entity approved in the U.S. for PD-related motor fluctuations in more than a decade for the estimated 1 million patients currently affected by PD. According to the U.S. Food and Drug Administration (FDA), an “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity, by blocking the breakdown of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.

Diasorin launches iam cbfb-myh11, completing the diagnostic test menu for molecular screening of acute myeloid leukemia by q-lamp     

DiaSorin launches a new CE-IVD molecular diagnostic test, Iam CBFB-MYH11 (not available in the USA) for the ultra-rapid identification of one of the most common genetic causes of Acute Myeloid Leukemia (AML). This new test allows reliable, easy and fast 20 minutes detection and simultaneously discrimination of the CBFB-MYH11 type A/D and E fusion transcripts, one of the common aberrations of AML. Similar to the AML1-ETO, launched in 2016, the CBFB-MYH11 translocation is commonly associated with favorable outcome. Rapid molecular identification of the translocation is therefore crucial for therapeutic decision making. Identification of risk groups in a timely and reliable manner, by genetic means represents in fact a unique opportunity for implementing effective therapy. This is especially important in older patient populations who may not be eligible for bone marrow transplant. The simultaneous discrimination of the type A/D and E fusion transcripts, moreover, will provide a key information to monitor residual disease during therapy, optimizing patients management. The Iam CBFB-MYH11, along with the other assays of the DiaSorin portfolio (Iam BCR-ABL, Iam PML-RARA, Iam AML1-ETO), represents the optimal solution for reliable, rapid and simple molecular screening of AML at diagnosis. More info: http://www.diasorin.com/sites/default/files/allegati_pressrel/diasorin_cbfb-myh11_eng.pdf

MolMed and TTY Biopharm entered into an exclusive agreement to commercialise Zalmoxis® in certain Asian territories 
MolMed S.p.A. and TTY Biopharm Company Ltd announce they signed an exclusive license and distribution agreement which defines all terms and conditions to import, use, market, sell and/or distribute Zalmoxis for the treatment of haematological malignancies in Taiwan, Hong Kong, Singapore, Thailand, Philippines, Vietnam and Malaysia, as anticipated on February 7, when the companies signed a term sheet defining the main terms and conditions. 
Zalmoxis, MolMed’s first patient-specific cell therapy, is conditionally authorised by the European Commission for the treatment of adult patients affected by leukaemia or other high-risk haematological malignancies, in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT). 
Under the terms and conditions of the agreement, the application of Marketing Authorization of Zalmoxis in the interested territories will be carried-out by and at the cost of TTY which will eventually perform further clinical studies, if needed to obtain regulatory approval, and will conduct all associated regulatory activities after marketing authorization including market access and price & reimbursement. Furthermore, TTY may promote TK008 study enrolment and, possibly, be responsible for engaging hospitals and authorities to allow the performance of it in the interested territories. 
More info: http://www.molmed.com/sites/default/files/uploads/press-releases/3121/3121_1498805709.pdf

Axxam coordinates European research project on chronic pain for innovative medicines
Axxam is proud to announce its participation to the NGN-PET project, that will provide a translational platform of rodent and human neuropathic pain models for the identification and validation of new targets and biomarkers, and suitable for the discovery of new drugs. The project investigates neuron-glia interactions for the identification of novel therapeutic approaches, and for the development of innovative drug screening systems including hiPSC systems.
More info: http://www.axxam.com/sites/default/files/uploads/news/attachments/209/pressreleasengn-petpdf170615.pdf

Novartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) 
Novartis announce the European Commission approved expanding the use of Zykadia® (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. Approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP), and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
More info: https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-first-line-use-zykadiar-alk-positive-advanced-non
 
Astra Zeneca - CHMP positive recommendation is based on Phase III data demonstrating a 20% reduction in risk of disease worsening or death over anastrozole 
AstraZeneca announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Faslodex (fulvestrant) for the treatment of hormone receptor-positive (HR+), locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy. The CHMP recommendation is based on pivotal data from the Phase III FALCON trial, where Faslodex 500mg demonstrated superiority over anastrozole 1mg in the treatment of locally-advanced or metastatic breast cancer in post-menopausal women who had not received prior hormonal-based medicine for HR+ breast cancer. The FALCON data show that the delay in disease worsening or death (median progression-free survival, PFS) was 2.8 months longer with Faslodex than anastrozole. The median PFS was 16.6 months in the Faslodex arm compared with 13.8 months in the anastrozole arm. Aromatase inhibitors such as anastrozole are the current standard of care for the 1st-line treatment for postmenopausal women with HR+ advanced breast cancer. More info: www.astrazeneca.com/media-centre/press-releases/2017/faslodex-fulvestrant-receives-positive-chmp-opinion-for-use-in-1st-line-hormone-receptor-positive-advanced-breast-cancer-23062017.html