BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.2/ NEWSLETTER MENSILE 2017

28 feb, 2017

Advanced Accelerator Applications Announces Addition of NETSPOT® to National Comprehensive Cancer Network® Guidelines for Evaluation of NETs
AAA announced that its product NETSPOT® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). NCCN® is a not-for-profit alliance of leading cancer centers in the U.S. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care. NETSPOT® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. AAA and its radiopharmacy partners around the U.S. are now delivering 400 doses of NETSPOT® per month. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017. More info: http://www.adacap.com/category/news/

Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 
Novartis shareholders agreed to the Board of Directors' recommendations for all proposed resolutions at the Group's Annual General Meeting (AGM). A total of 1,805 shareholders were present at the meeting held in Basel, representing approximately 60,6% of the issued shares of Novartis. Shareholders approved the 20th consecutive dividend increase per share since the creation of Novartis in 1996, with an increase of 2% to CHF 2.75 for 2016. Payment for the 2016 dividend will be made on March 6, 2017. The dividend for 2016 is an approximately 69% payout of free cash flow, reinforcing the Company's commitment to a strong dividend yield. In line with the Board of Director's recommendation, shareholders also approved the cancelation of 10,270,000 shares repurchased on the second trading line under the seventh share repurchase program in the financial year 2016 and to reduce the share capital accordingly by CHF 5,135,000, from CHF 1,313,557,410 to CHF 1,308,422,410. More info: www.novartis.com/news/media-library

MolMed and Rocket Pharma establish a collaboration agreement in the field of gene therapy for the treatment of Fanconi Anemia
MolMed S.p.A. and Rocket Pharmaceuticals Ltd. signed a development and manufacturing service agreement on a gene therapy product for the treatment of Fanconi Anemia. Rocket Pharma is a leading US gene therapy company based in New York, with both an advancing clinical program and several preclinical programs. All programs are focused on developing curative treatments for rare genetic conditions with high unmet need. Pursuant to this agreement, MolMed will develop and manufacture the lentiviral vectors to be used for the exvivo transduction of hematopoietic stem cells, as part of the manufacturing process of Rocket’s cellular therapy products intended for clinical trials and in related research and development activities. More info: http://www.molmed.com/sites/default/files/uploads/press-releases/3066/3066_1488138235.pdf

ZS-9 (sodium zirconium cyclosilicate) receives positive CHMP opinion for the treatment of hyperkalaemia
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia, a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases. The recommendation is based on data from three double-blind placebo-controlled trials and one ongoing 12-month open-label trial in adults with hyperkalaemia, representing over 1,600 patients treated to date.
Results from a pivotal Phase III study showed that in patients with hyperkalaemia, sodium zirconium cyclosilicate (oral suspension) significantly reduced blood serum potassium to normal levels (normokalaemia) within 48 hours, which was maintained during 12 days of maintenance therapy.  More info: https://www.astrazeneca.com/media-centre/press-releases/2017/zs-9-sodium-zirconium-cyclosilicate-receives-positive-chmp-opinion-for-the-treatment-of-hyperkalaemia-24022017.html

DiaSorin launches its new Simplexa C. Difficile direct molecular test in the US market
DiaSorin (FTSE Italia Mid Cap: DIA) announced today that they have received clearance from the US Food and Drug Administration to market the Simplexa C. difficile Direct Assay for the detection of Clostridium difficile (C. difficile). The assay, already launched outside of the US in November 2016, was developed by DiaSorin Molecolar to be run on the Liaison Mdx. It is a scalable small bench-top instrument able to provide reliable, clinically validated, real time PCR results for quantitative, qualitative, multi-analyte and sample-to- answer detection needs. More info: http://www.diasorin.com/sites/default/files/allegati_pressrel/press_release_c_diff_dad_2017_eng.pdf

AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada
AstraZeneca announced that it has entered into an agreement with TerSera Therapeutics LLC (TerSera) for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989. TerSera will pay AstraZeneca $250 million upon completion. AstraZeneca will also receive sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of Product Sales. AstraZeneca will also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada. More info: https://www.astrazeneca.com/media-centre/press-releases/2017/astrazeneca-enters-agreement-with-tersera-therapeutics-for-zoladex-in-the-us-and-canada-20022017.html

MolMed and TTY Biopharm entered into a term sheet to commercialise Zalmoxis® in certain Asian territories
MolMed S.p.A. and TTY Biopharm Company Ltd today announce they signed a term sheet defining the main terms and conditions under which MolMed will grant TTY an exclusive license agreement for the commercialization of Zalmoxis in certain Asian territories. Within June 30th, 2017, the terms contained in today’s agreement shall be incorporated into a definitive contract, pursuant to which TTY, under certain terms and conditions, will be granted an exclusive, non-transferable, revocable, sub-licensable license 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. Zalmoxis is conditionally authorised by the European Commission for adult patients affected by leukaemia or other high-risk haematological malignancies, and is the first patient-specific cell therapy used in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT). More info: http://www.molmed.com/sites/default/files/uploads/press-releases/3063/3063_1486481225.pdf

Axxam and Fulcrum Therapeutics Initiate a Partnership for the Provision of Drug Discovery Services for Genetic Diseases
Axxam SpA, an innovative Partner Research Organization (iPRO) and leading provider of discovery services has entered into an agreement with Fulcrum Therapeutics Inc., a U.S.-based biotech founded in July 2016 by Third Rock Ventures. Fulcrum Therapeutics is focused on discovering and developing small molecule therapies to unlock gene control and the collaboration will utilize Axxam’s world-leading screening platform to identify novel targets for regulating gene expression. The programme will initially focus on genetic diseases where no effective treatment options currently exist. More information: http://www.axxam.com/sites/default/files/uploads/news/attachments/207/praxxamfulcrum170201.pdf