BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.6/ NEWSLETTER MENSILE

17 giu, 2016

Advanced Accelerator Applications Expands U.S. NETSPOT™ Supply Chain with Two Additional Radiopharmacy Networks
AAA announced that it has further strengthened its U.S. supply chain for NETSPOT(TM) with the addition of two radiopharmacy networks, Triad Isotopes, Inc., the second largest radiopharmaceutical company in the United States, and Nuclear Diagnostic Products, Inc. (“NDP”), a company with three radiopharmacies in the Northeast and a member of United Pharmacy Partners Inc. (“UPPI”), to supply gallium 68 (“Ga 68”) dotatate doses prepared with a novel kit to U.S. hospitals and imaging centers. NETSPOT (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors (“NETs”) in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the FDA. Triad and NDP will each prepare and deliver NETSPOT patient doses to advanced medical imaging sites in selected metropolitan areas. The addition of these partnerships completes the foundation of a robust nationwide supply chain that now includes four radiopharmacy networks. For more information: http://www.adacap.com/category/news/

The European Commission grants the European marketing authorisation to StrimvelisTM, GSK’s stem cell therapy for ADA-SCID patients
The European Medicines Agency (EMA) has approved Strimvelis, the first exvivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID. Strimvelis is the first corrective gene therapy for children to be awarded regulatory approval anywhere in the world. Following agreement on pricing and reimbursement in Italy, patients found eligible for Strimvelis by individual physicians will be able to receive the gene therapy at Ospedale San Raffaele in Milan. GSK’s treatment for ADA-SCID patients is the tangible and encouraging result of the strategic collaboration existing between GSK, the Fondazione Telethon (Telethon) and Ospedale San Raffaele (OSR), acting through their joint San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET) and GSK’s strategic collaboration with MolMed. For more information: http://www.molmed.com/sites/default/files/uploads/news/2873/160616_ema_strimvelis_eng_def.pdf

FDA Grants Accelerated Approval to Ocaliva™ (Obeticholic Acid) for the Treatment of Patients with PBC
Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. For more information: http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=973265

Nouscom concludes successful series A financing of EUR 12 million
Nouscom announced that it has closed a EUR 12 million Series A financing co-led by LSP and Versant Ventures. The funds will be used to support discovery and development of personalized cancer vaccines and tumor selective oncolytic viruses. “We are pleased to partner with investors who support the development of a new immunooncology company with multiple product candidates. We believe we will be able to create immense value as we bring a series of novel, life-changing therapeutics to patients affected by cancer," said Riccardo Cortese M.D., Ph.D., Chief Executive Officer and President of Nouscom. Nouscom’s technology focuses on viral vectors and oncolytic viruses, which infect and kill tumor cells and stimulate an immune response against cancer cells throughout the body. For more information: http://www.nouscom.com/news_posts/nouscom-closes-series-financing/