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Innocoll Holdings plc Announces the Completion of Enrollment in Two Pivotal Phase 3 Clinical Trials of COGENZIA for the Treatment of Diabetic Foot Infections

ATHLONE, Ireland, June 23, 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, today announced the completion of enrollment of patients in its two pivotal phase 3 trials, COACT-1 and COACT-2, to evaluate the safety and efficacy of COGENZIA (INL-002), a proprietary collagen matrix with gentamicin, in the treatment of diabetic foot infections (DFIs). The company anticipates announcing top line data from these studies in the third quarter or early fourth quarter of 2016, with an NDA submission with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) submission with the European Medicines Agency to follow if data are positive. COGENZIA’s QIDP designation provides potential eligibility for Fast Track designation and priority review by the FDA.

These two phase 3 trials are identical in design, with COACT-1 being conducted solely in the U.S. and COACT-2 in Europe, Australia, and the U.S. The primary endpoint is to demonstrate that for moderate and severe DFIs, COGENZIA as an adjunct to systemic antibiotics and standard wound care, improves the rate of clinical cure, which is evaluated by a clinician 10 days after completion of treatment. Patients are followed for up to an additional 90 days to assess various secondary endpoints, including pathogen eradication, ulcer closure, safety, and health economic components such as reduced rates of hospitalizations and amputations. “We are excited to reach this key milestone, which brings us closer to our objective of developing COGENZIA to help cure diabetic foot infections. We believe that COGENZIA has the potential to fill a critical need for a more effective therapy. If the results are positive, we will have two products in commercialization by the end of 2017, subject to regulatory approvals. These results are a demonstration of the strength of our organization in delivering on our commitments,” said Tony Zook, Chief Executive Officer of Innocoll.

Last month, Innocoll reported positive phase 3 results for XARACOLL as a long-acting anesthetic in the reduction of post-operative pain and total opioid use in patients undergoing hernia repair. With Innocoll's recent financing activities, the company expects that available cash will extend through the anticipated NDA submission for XARACOLL and until its anticipated approval in the second half of 2017. Innocoll is now moving forward with the build-up of its pre-commercialization plans to be prepared to launch its proprietary products by the end of 2017.

About Innocoll Holdings plc

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002 (COGENZIA), a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our current products include: COLLAGUARD®, COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet. All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our plant in Saal, Germany.

For more information, please visit www.innocoll.com.

CollaRx®, Collatamp®, COLLAGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA® LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Forward-looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the development of our product candidates and the timing, conduct, enrollment and outcome of our clinical studies, the availability of data from those studies, our ability to sell any approved products, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "goal," "objective", "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied. Such risks and uncertainties include, among others, those related to success of our COACT-1 and COACT-2 trials in demonstrating the safety and efficacy of COGENZIA in the treatment of DFIs; the timing and submission of an NDA or MAA for COGENZIA; our receipt of positive results for the COACT-1 or COACT-2 trials that achieve primary or secondary endpoints; COGENZIA's eligibility for fast track designation and priority review by the FDA; the ability of COGENZIA to improve the rate of clinical cure in moderate and severe DFIs; COGENZIA's ability to significantly increase the success rate and reduce the incidence of complications and sequelae; the timing for COGENZIA's product approval, if any; whether COGENZIA will be the first topical antibiotic indicated for the treatment of moderate or severe DFIs; our ability to successfully build-up pre-commercialization plans in preparation for a product launch by the end of 2017; the timing and costs involved in developing and commercializing our products and product candidates; the timing for clinical trials and results, delays in potential approvals by FDA; availability of data and results from such trials, timing and expectations for regulatory approvals; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our manufacturing and marketing capabilities; the timing of, and our ability to obtain, regulatory approvals for the expansion of our manufacturing facility; regulatory developments in the United States and foreign countries; our ability to obtain and maintain the scope, duration and protection of our intellectual property rights; or other actions and factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2015, and our other reports filed with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. In addition, the forward-looking statements included in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate: Pepe Carmona Chief Financial Officer (215) 983-3362 pcarmona@innocoll.com Jeannie Sorenson, M.D. Vice President, Investor Relations (314) 458-7355 jsorenson@innocoll.com

Source:Innocoll Holdings plc