BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.5/ NEWSLETTER MENSILE

25 mag, 2016

Zambon launches XADAGO® (Safinamide) in the U.K. for patients with mid- to late-stage Parkinson’s Disease 
Zambon an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced the availability of Xadago® (safinamide) in the United Kingdom. Andrew Lees, MD FRCP, FMedSci, Professor of Neurology, (The National Hospital for Neurology and Neurosurgery, Queen Square and Emeritus Director, Reta Lila, Weston Institute of Neurological Studies, University College London, Institute of Neurology) said: “After 10 years with no new drugs for Parkinson’s disease I welcome the addition of another effective treatment option for patients”. Maurizio Castorina, CEO of Zambon S.p.A. said: “We are committed to developing innovative therapies for patients suffering from PD and other central nervous system diseases. Xadago® offers PD patients a novel therapeutic option in the treatment of this progressive disease”. The U.K is the latest country launching Xadago®, which is also available in seven other countries: Germany, Switzerland, Spain, Italy, Belgium, Denmark, and Sweden. More information is available at http://www.businesswire.com/news/home/20160522005006/en/Zambon-Launches-Xadago%C2%AE-Safinamide-U.K.-Patients-Mid-

Advanced Accelerator Applications preparing for Lutathera launch by scaling up production in Ivrea, Italy – Company provides update on key European production site
AAA announced that it is scaling up its Ivrea site for Lutathera production. AAA has recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead Neuro Endocrine Tumor therapeutic candidate Lutathera. The EMA has recently granted Accelerated Assessment for Lutathera. The Ivrea extension is in anticipation of the NDA and MAA approvals. The AAA Ivrea site hosts the Headquarters of AAA Italy and is located in the Bioindustry Park Silvano Fumero, between Turin and Milan. AAA started commercial operations on this site in 2008. Since then the site has almost doubled in size and increased headcount by 46 employees. The site currently covers 640sqm of laboratories and 530sqm of office space and employs 52 people. “The AAA Ivrea site is one of Lutathera’s birth places. It is in Ivrea that Lutathera was developed from a radiochemical point of view,” said Stefano Buono, Chief Executive Officer of AAA. “As we ramp up for the Lutathera launch we are putting all of the pieces in place to ensure seamless production and distribution of Lutathera in Europe and in the US. The extension of the AAA Ivrea site is essential to achieve these objectives.” “We are proud to have such an active company in the Bioindustry Park Silvano Fumero. We have helped AAA in its journey and are happy to see that eight years after its arrival the Company is still here and growing”, said Fabrizio Conicella, Director of the Bioindustry Park Silvano Fumero.

Axxam expands to U.S., opens office in Cambridge, Massachusett
Axxam a privately owned innovative Partner Research Organization (iPRO) with a strong and leading expertise for the identification and characterization of bioactive compounds, announced the opening of its first U.S. office, located in the Cambridge Innovation Center (CIC) in Cambridge, Mass. “The CIC was the right choice for our first office in the USA,” said Dr. Stefan Lohmer, co-founder and CEO of Axxam. “We consider the Boston area as a unique ecosystem, a kind of gravitation center for biosciences in which talent, business and investment are present and that would allow us to boost our company growth in the perfect environment. Many early stage companies would benefit from our expertise to identify bioactive compounds for their targets using our HTS/HCS platforms and compound collections. We already have a number of strong clients and partners in the area and through our local presence we want to increase the important direct interaction with start-up companies, VCs and pharma/biotech companies.” Dr. Sarah Murnaghan, Director of Business Development North America, will be managing the U.S. office. More information is available at www.axxam.com.

Revolution in food packaging. The milk carton goes bio 
Imagine a future, very near now, in which cartons for milk, fruit juice and many other foodstuffs will be 100% biodegradable. Bio-on announced a major result achieved with its new collaboration with Tampere University of Technology Finland, one of the most important centres in the world for research and innovation in the use of paper and plastic for food packaging. A joint project launched in 2015 has produced for the very first time tetrapak type containers made of a combination of paper and bioplastic, namely the special grade EC (Extrusion Coating) of the Minerv PHA biopolymer developed by Bio-on. To achieve this extraordinary outcome, researchers at the two laboratories replaced the polyethylene contained in current packaging, maintaining all of its impermeability, and for the first time in history created a material that is totally naturally biodegradable and of renewable origin that can be easily and safely recycled. The Minerv PHA Extrusion Coating project, launched by Bio-on at the end of 2015, aims to develop specific, eco-sustainable and, for the first time, fully biodegradable formulations, in order to make laminates with paper without using films, but instead fusing the biopolymer directly onto the paper using an extrusion process, without losing out on the end product's functionality and aesthetic. Based on Bio-on's revolutionary biopolymer, 100% naturally biodegradable and already tested in dozens of applications, from automotive to design to biomedical, Minerv PHA EC (Extrusion Coating) is safe and particularly suited for use with food. More information is available at http://www.bio-on.it/immagini/comunicati-finanziari/CS_51_BIO_ON_TAMPERE_14_04_2016_eng.pdf