ATHLONE, Ireland, May 31, 2016 (GLOBE NEWSWIRE) -- Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, announced financial and operating results for the three months ended March 31, 2016. We manufacture and supply a range of pharmaceutical products and medical devices using our proprietary collagen-based biodegradable and fully bioresorbable technology platform.
“2016 is off to a momentous start for Innocoll with the achievement of several important and exciting milestones,” said Tony Zook, Chief Executive Officer of Innocoll. “Last week, we reported that both of our Phase 3 studies for XARACOLL met their primary endpoint for the reduction of post-operative pain. Furthermore, both trials demonstrated that XARACOLL significantly lowers total opioid consumption. In light of this positive data, we plan to submit an NDA to the U.S. Food and Drug Administration (FDA). The results provide validation for our collagen technology and indicate strong promise for our pipeline. We expect to deliver Phase 3 results for COGENZIA later this year, and COLLAGUARD is undergoing two small non-clinical studies and we plan on filing an IDE package later this year. Additionally, we have attracted strong commercial and technical talent to prepare the company for an anticipated commercial launch in late 2017. In March, the company re-domiciled to Ireland, and we transitioned Innocoll’s NASDAQ listing from ADSs to ordinary shares. In another achievement related to the expansion of our manufacturing facility in Saal, Germany, after a thorough review of our new laboratories and expanded manufacturing facility, we anticipate a positive recommendation for approval of the laboratories from the Upper Bavarian Field Inspectorate. We also received an extension of our GMP compliance certificate. Innocoll remains on track to transition successfully into a commercial stage company.”
