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Innocoll Announces Co-Promotion Agreement for Hernia Product Portfolio

Positions Innocoll as a comprehensive hernia solutions company including products for surgery and open inguinal hernia repair pain relief

Innocoll Pharmaceuticals Limited (“Innocoll”), a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, today announced an exclusive co-promotion agreement with Ethicon US, LLC (“Ethicon”), a Johnson & Johnson Medical Devices Company, for its comprehensive hernia product portfolio in the United States.

Innocoll is a biotherapeutics company with innovative drug delivery platforms. In July 2021, Innocoll launched XARACOLL (bupivacaine HCl) implant, the first and only nonopioid drug-device to deliver long lasting post-surgical analgesia after open inguinal hernia repair in adults. In addition, Innocoll will be launching POSIMIR for arthroscopic subacromial decompression surgery in the 2nd quarter of 2022, making it the only company with two non-opioid extended release bupivacaine products.

Under the terms of the agreement, Innocoll and Ethicon will work to commercialize Ethicon’s full portfolio of products relating to hernia surgery. Innocoll will utilize its national sales footprint to promote Ethicon’s portfolio of hernia solutions.

“We’re thrilled to be working with Ethicon, one of the world’s most esteemed companies with a tremendous track record and history of creating innovative products in the surgical space.  We are excited to offer our surgeon customers additional solutions to help their patients across all facets of hernia repair, and look forward to a successful collaboration,” said Lou Pascarella, Chief Executive Officer of Innocoll.

“We’re very proud to be making a difference for our customers. This collaboration enables Innocoll to bring a comprehensive hernia portfolio to surgeons and hospitals, as they strive to improve patient care,” said Anthony Galdi, Chief Commercial Officer of Innocoll.

About Innocoll Pharmaceuticals Limited

Innocoll Pharmaceuticals is a global biotech pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll Biotherapeutics Holding Limited.   The Innocoll group of companies is focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges. Innocoll Biotherapeutics Holdings Limited is a portfolio business of Gurnet Point Capital.

About Gurnet Point Capital

Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion Group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution.  With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners. 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.

www.xaracoll.com/xaracoll_pi.pdf

About POSIMIR

POSIMIR® (bupivacaine solution) for infiltrationuse is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product.  At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more. 

Indications and Usage

POSIMIR® (bupivacaine solution) for infiltration use is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.

Limitations of Use

Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.

Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com

Important Safety Information

BOXED WARNING: Risk of Potential Adverse Embolic Effects Resulting From Inadvertent Intravascaular Injection. Inadvertent intravascular injection could cause POSIMIR droplets to be deposited in the pulmonary and other capillary beds.  Administer POSIMIR into the subacromial space at the end of arthroscopic shoulder surgery. Direct arthroscopic visualization must be used to confirm proper placement of the needle tip before injecting POSIMIR.

In POSIMIR clinical studies, no inadvertent intravascular injections were observed. Do not inject POSIMIR intravascularly.

POSIMIR is contraindicated in patients with a known hypersensitivity to any amide local anesthetic, or other components of POSIMIR, as well as in patients undergoing obstetrical paracervical block anesthesia. There is a risk of joint cartilage necrosis with unapproved intra-articular use of POSIMIR. Unintended intravascular injection of POSIMIR may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. As with other local anesthetics, patients should be monitored for central nervous system, cardiovascular, and allergic reactions. Avoid additional use of local anesthetics within 168 hours following administration of POSIMIR. Cases of methemoglobinemia have been reported in association with use of local anesthetics. There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. POSIMIR should be used cautiously in patients with impaired hepatic and cardiovascular function. Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.  Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in soft tissue surgical procedures were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, oropharyngeal pain, post-procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising and vomiting.

To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-844-767-4647 or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

Media Contact

For Innocoll:
Blair Hennessy
(212) 371-5999
bth@abmac.com

For Ethicon:
Meg Farina
mfarina@its.jnj.com
+1 610-724-1079