BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.10/ NEWSLETTER MENSILE

16 dic, 2016

Sofinnova Partners announces the successful sale of Creabilis to Sienna Biopharmaceuticals for a total consideration of $150 M
Sofinnova Partners, a leading European venture capital firm specialized in Life Science announced the successful sale of portfolio company Creabilis, a dermatology company developing first in class topical treatments, to Sienna Biopharmaceuticals, for up to $150 M including upfront payments and additional payments contingent upon achieving specific milestones. Based on Italian science developed at the BioIndustry Park Silvano Fumero in Ivrea (Italy), Creabilis has developed the proprietary technology platform: “Topical by Design”. Under the management of Alex Leetch, CEO, and Silvio Traversa, CSO, Creabilis has used this innovative technology to build a diversified portfolio of drug candidates which address the treatment of skin conditions such as psoriasis, pruritus (itch) and dermititis. Creabilis is headquartered in Kent (UK), and has its R&D activities in Ivrea (Italy). For more info: http://www.sofinnova.fr/en/sofinnova-partners-announces-the-successful-sale-of-creabilis-to-sienna-biopharmaceuticals-for-a-total-consideration-of-150-m/

Advanced Accelerator Applications Announces European Commission Approval of SomaKit TOC™
AAA announced that following a positive opinion issued by the European Medicines Agency in October 2016, the European Commission has approved SomaKit TOC™ 40 µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNETs) for localizing primary tumors and their metastases. The drug has 10-year orphan market exclusivity in the European territory. For more info: http://www.adacap.com/category/news/

European Commission Grants Intercept's Ocaliva® (obeticholic acid) Marketing Authorization for the Treatment of Primary Biliary Cholangitis
Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, announced that the European Commission has granted conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (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 a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at high levels in the liver and intestine and thought to be a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. For more info: http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=1004114

Axxam executes a transaction with Acousia Therapeutics GmbH
Axxam is proud to announce the closing of a transaction with Acousia Therapeutics GmbH, by which Axxam  becomes a shareholder of Acousia and Dr. Stefan Lohmer, Chairman and Chief Executive Officer of Axxam, joins the Board of Directors of the company. The new investment round of EUR 2.5 million, led by the Boehringer Ingelheim Venture Fund and supported by  Axxam and the KfW, will finance research programs directed towards the development of small molecules to treat sensorineural hearing loss and protecting sensory hair cells of the inner ear to prevent hearing loss in at-risk patients. In connection with this new investment Axxam will also transfer certain therapeutic assets to the R&D programs of Acousia.  These programs will be further progressed by Acousia to generate clinical candidates to be developed subsequently to demonstrate clinical proof of concept. For more info: http://www.axxam.com/news

MolMed coordinates a CAR T-cell immunotherapy project awarded a 5.9 million Euro grant by the European Commission 
MolMed is glad to announce that the European Commission, within the Horizon 2020 - Research and Innovation Framework Programme section reserved to the new therapies for chronic diseases (including cancer), has awarded a 5,903,146 Euro grant to the project called EURE-CART (EURopean Endeavour for Chimeric Antigen Receptor Therapies), of which MolMed is coordinator. Adoptive immunotherapy with T cells genetically modified with a tumour-reactive CAR is an innovative therapeutic concept, promising to eradicate cancer cells, without causing secondary chronic diseases. The main expected impact of EURE-CART is the establishment of CAR T-cell therapy as the ultimate personalised therapy, capable of defeating neoplastic diseases. For more info: http://www.molmed.com/sites/default/files/uploads/press-releases/2995/2995_1481570572.pdf

Neurotrophic keratitis: EMA validates the marketing authorisation application for cenegermin eye drops (Oxervate®) submitted by Dompé
The biopharmaceutical company Dompé announced the acceptance of the registration application submitted to the European Medicines Agency for Oxervate® eye drops, for the treatment of moderate and severe neurotrophic keratitis in adult patients. Acceptance by EMA constitutes the initiation of the dossier's scientific review procedure, in order to obtain authorisation to market the medicinal product, which was designated an orphan drug for the treatment of neurotrophic keratitis by EMA's committee for Orphan Medicinal Products (COMP) in 2015. Cenegermin, the product's active substance, is the recombinant version of the human nerve growth factor (NGF), discovered by Nobel Prize winner Rita Levi Montalcini. It is a protein produced naturally by the human body and that is responsible for the development, maintenance and survival of nerve cells2. Oxervate®, if approved, would be the first biotechnological medicinal product for this indication.For more info: http://www.dompe.com/news-en/613_neurotrophic-keratitis-ema-validates-the-marketing-authorisation.html

Chugai and Berlin-Chemie - the Menarini Group Announce Global License Agreement for an Anti-cancer Agent, PA799
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Berlin-Chemie Menarini, a company of the Menarini Group, announced that both companies have entered into a global license agreement for PA799, class I PI3K inhibitor. PA799 is the PI3K inhibitor originated by Chugai, which conducted phase 1 study for solid tumors in Europe. With its high selectivity for class I enzyme, the drug candidate showed a good safety profile in the clinical trial. “We are pleased to sign a license agreement for PA799 with Menarini Group,” said Chugai’s Representative Director, President and Chief Operating Officer, Tatsuro Kosaka. “PI3K is assumed to be one of the important kinases in the signaling pathway for the proliferation, the differentiation and the survival of tumor cells. We hope that the development of PA799 by Menarini Group will bring benefit to the patients as early as possible.” For more info: http://www.menarini.com/Home/Menarini-News/News/News-details/ArticleId/2332