ATHLONE, Ireland I June 23, 2016 I Innocoll Holdings plc (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.
SOURCE: Innocoll Holdings
Post Views: 95
ATHLONE, Ireland I June 23, 2016 I Innocoll Holdings plc (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.
SOURCE: Innocoll Holdings
Post Views: 95
