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23/03/2015 08:00
DGAP-News: Neovacs S.A. / Key word(s): Miscellaneous NEOVACS STRENGTHENS NORTH AMERICAN PRESENCE WITH FORMATION OF U.S. SUBSIDIARY 23.03.2015 / 08:00 --------------------------------------------------------------------- PRESS RELEASE NEOVACS STRENGTHENS NORTH AMERICAN PRESENCE WITH FORMATION OF U.S. SUBSIDIARY Paris, March 23, 2015 - NEOVACS (Alternext Paris : ALNEV, FR0004032746), a leader in active immunotherapies for the treatment of autoimmune diseases, is proud to announce the establishment of its wholly-owned U.S. subsidiary, Neovacs, Inc. Neovacs, Inc. is headquartered in Boston and has been incorporated in Delaware. The creation of this U.S. subsidiary marks an important strategic step for Neovacs, as the Company extends its clinical initiatives for lead product candidate, IFN?-Kinoid, beyond the EU to the U.S. market. The establishment of this subsidiary follows the formation of a U.S. Scientific Advisory Board in October 2013. Arlene Morris, Director of Neovacs and CEO of Syndax Pharmaceuticals, has been named Chairman of Neovacs, Inc. Miguel Sieler, current CEO of Neovacs will also hold the position of CEO of the subsidiary. "We are thrilled to expand our U.S. operations through the formation of Neovacs, Inc., and believe that the subsidiary will be instrumental to our ongoing clinical and regulatory efforts in support of IFN?-Kinoid in systemic lupus erythematosus ("lupus") and dermatomyositis. The United States has the world's highest lupus prevalence, totaling over 1.5 million reported cases[1], and the unsatisfactory treatment options create a substantive opportunity for Neovacs as we continue to advance IFN?-Kinoid for this indication. Based on our analysis of IFN?-Kinoid to date, we believe the compound has significant potential in the treatment of lupus, and look forward to the ongoing development of the product as we work to bring potential relief to this large patient population," commented Miguel Sieler, CEO of Neovacs. Neovacs plans to launch a phase IIa clinical trial of IFN?-Kinoid in this indication in early 2016. The Company is also planning to launch further U.S. trials of IFN?-Kinoid in dermatomyositis, an orphan skin and muscular disease, in the short-to-mid term. The role of Neovacs, Inc. will be to raise the profile of Neovacs with the medical and financial communities in the U.S.. Neovacs, Inc. will work directly with the U.S. Food and Drug Administration as the Company prepares to initiate its planned lupus and dermatomyositis trials, including securing all regulatory approvals and potential orphan drug status for IFN?-Kinoid in dermatomyositis. Additionally, Neovacs, Inc. will co-lead with Neovacs all U.S. clinical trials, in coordination with contractors and research centers, and strengthen also Neovacs' engagement with American investors. Neovacs, Inc. will be located in Boston within the French Tech Hub. [1] Source: Lupus Foundation of America About Neovacs Created in 1993, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company's proprietary technology for inducing a polyclonal immune response (covered by five patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFN?-Kinoid, an immunotherapy being developed for the indication of lupus. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases. For more information on Neovacs, please visit www.neovacs.fr Contacts NEOVACS - Investor Relations Nathalie Trépo +33 (0)1 53 10 93 00 ntrepo@neovacs.com Investor Relations / Financial Communications - NewCap Valentine Brouchot / Pierre Laurent +33 (0)1 44 71 94 94 theradiag@newcap.fr Investor Relations / Financial Communications Germany - MC Services Raimund Gabriel +49-89-210228-30 raimund.gabriel@mc-services.eu Press / U.S. Inquiries - The Ruth Group Melanie Sollid-Penton 1.646.536.7023 msollid@theruthgroup.com --------------------------------------------------------------------- 23.03.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: Neovacs S.A. 3-5, Impasse Reille 75014 Paris France Phone: +33 (0)1 53 10 93 00 Fax: +33 (0)1 53 10 93 03 E-mail: www.neovacs.fr Internet: info@neovacs.fr ISIN: FR0004032746 WKN: A1CVKR Listed: Regulated Unofficial Market in Stuttgart; Open Market in Frankfurt End of News DGAP News-Service --------------------------------------------------------------------- 335729 23.03.2015