Neovacs, a Paris-based biotechnology company focused on autoimmune and inflammatory diseases, has established a wholly-owned U.S. subsidiary, Neovacs Inc. Neovacs Inc. is headquartered in Boston and has been incorporated in Delaware.
The creation of a U.S. subsidiary marks an important strategic step for Neovacs as it extends its clinical initiatives for lead product candidate, IFNα-Kinoid, beyond the E.U. 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 be CEO of the subsidiary.
"We are thrilled to expand our U.S. operations through the formation of Neovacs Inc., and believe the subsidiary will be instrumental to our ongoing clinical and regulatory efforts in support of IFNα-Kinoid in systemic lupus erythematosus (lupus) and dermatomyositis. The U.S. has the world's highest lupus prevalence, totaling over 1.5 million reported cases, and the unsatisfactory treatment options create a substantive opportunity for Neovacs as we continue to advance IFNα-Kinoid for this indication. Based on our analysis of IFNα-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," said Sieler.
Neovacs plans to launch a phase IIa clinical trial of IFNα-Kinoid in this indication in early 2016. The company also plans to launch further U.S. trials of IFNα-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 FDA to initiate its planned lupus and dermatomyositis trials, including securing all regulatory approvals and potential orphan drug status for IFNα-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 Neovacs' engagement with American investors.
Neovacs Inc. will be located in Boston within the French Tech Hub.