Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

Results of implant’s safety, efficacy and pharmacokinetics for use in various open soft-tissue surgeries expected in first quarter 2022

ATHLONE, Ireland--(BUSINESS WIRE)--Innocoll Biotherapeutics plc, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the following clinical trials have been initiated to support a label expansion of its FDA-approved innovative collagen drug-device, XARACOLL (bupivacaine hydrochloride) implant:

• INN-CB-024 is phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a 300-mg dose of the INL-001 (bupivacaine hydrochloride) implant in patients undergoing abdominoplasty; and

• INN-CB-025 is a phase 3 open-label study of the safety and pharmacokinetics of the INL‑001 (bupivacaine hydrochloride) implant in adults following various open soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

“We are thrilled to announce that our non-opioid, fully bioresorbable collagen drug-device product, XARACOLL, which is currently an approved treatment option for acute postsurgical pain following open inguinal hernia repair in adults, has reached the important milestone of being studied in Phase 3 clinical trials for use in soft tissue surgeries,” said Louis Pascarella, Innocoll Chief Executive Officer and President. “Following the clinical success of XARACOLL in open inguinal hernia repair and building upon the supportive Phase 2 data in other soft tissue surgeries, Innocoll is now undertaking the important work of studying the efficacy and safety of XARACOLL in achieving post-surgical pain relief in patients undergoing other soft tissue surgeries. We look forward to sharing data on these studies as we continue to expand the body of clinical data for XARACOLL and develop our unique drug-device combination product for use in additional surgeries.”

INN-CB-024 is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty. On the day of surgery eligible patients will be randomly assigned to treatment in a 1:1 ratio to receive either XARACOLL or placebo collagen implants. Patients will then undergo abdominoplasty under general anesthesia and have either XARACOLL or placebo implanted intraoperatively.

INN-CB-025 is a multicenter, Phase 3, open-label, safety, tolerability and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy and reduction mammoplasty. After a screening period, on the day of surgery, eligible patients will undergo surgery under general anesthesia and have XARACOLL implanted intraoperatively. Efficacy is also an exploratory measure in this study.

Both clinical trials are currently screening and enrolling patients and expect to be fully enrolled by year end, with results expected in the first quarter of 2022. For further details on the clinical studies, please visit the following links for INN-CB-024 and INN-CB0-025.

About Innocoll Holdings Limited

Innocoll Biotherapeutics plc is a global specialty pharmaceutical company headquartered in Athlone, Ireland. Innocoll Biotherapeutics plc and its subsidiaries Innocoll Holdings Limited and Innocoll Pharmaceuticals Limited, are focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges. Innocoll Biotherapeutics plc is a portfolio business of Gurnet Point Capital. www.innocoll.com

About Gurnet Point Capital

Gurnet Point Capital is a unique healthcare fund founded by Ernesto Bertarelli and led by Christopher Viehbacher, who, together, have decades of expertise in an industry for which they share a passion, both as Chief Executives and as investors. With an initial allocation of $2 billion, GPC is investing long-term capital and supporting entrepreneurs in building a new generation of companies. Based in Cambridge, MA, its remit is global, encompassing life sciences and medical technologies. The fund invests across all stages of product development through to commercialization and does so with an approach that is a hybrid of venture and private equity investing strategies. www.gurnetpointcapital.com

About XARACOLL

Xaracoll® (bupivacaine HCl) implant is a bioresorbable collagen implant providing postsurgical pain relief through the delivery of bupivacaine, a local anesthetic, at the surgical site. XARACOLL implant releases bupivacaine after placement at the surgical site through diffusion from the porous collagen implant, which dissolves over time. XARACOLL was approved in August 2020 by the US Food and Drug Administration (FDA). XARACOLL is a registered trademark of Innocoll Pharmaceuticals Limited.

Further Information About XARACOLL

INDICATIONS AND USAGE

XARACOLL contains an amide local anesthetic and is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.

Limitations of Use

Safety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of XARACOLL
• Obstetrical paracervical block anesthesia. The use of bupivacaine in this technique has resulted in fetal bradycardia and death

WARNINGS AND PRECAUTIONS

• Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after placement of XARACOLL
• Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full Prescribing Information for more detail on managing these risks

ADVERSE REACTIONS

Most common adverse reactions in clinical trials (incidence ≥2% and higher than placebo) included incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoesthesia, and post procedural discharge.

To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-833-606-1421 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Local Anesthetics: The toxic effects of local anesthetics are additive. Avoid additional local anesthetic administration within 96 hours following XARACOLL implantation. If additional local anesthetic administration with XARACOLL cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm
• Moderate to Severe Hepatic Impairment: Consider increased monitoring for bupivacaine systemic toxicity

Please see full Prescribing Information. https://xaracoll.com/xaracoll_pi.pdf

Tom Johnson / Blair Hennessy
(212) 371-5999
tbj@abmac.com / bth@abmac.com