$15MM Strategic Investment Bolsters Innocoll’s Commercialization and Licensing Efforts in Asia
Innocoll Pharmaceuticals Limited (“Innocoll”), a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, announced today an investment from Hillhouse Investment (“Hillhouse”), a global private equity firm focused on sustainable and long-term growth. The $15MM strategic investment will help support the commercialization and licensing of Innocoll’s innovative Xaracoll® (Bupivacaine Hydrochloride) implant across the China market.
“We’re thrilled to receive this strategic investment from Hillhouse, an experienced healthcare investor with an established presence globally and in Asia and a strong track record of fostering value and growth with the companies with which it invests,” said Louis Pascarella, Innocoll Chief Executive Officer and President. “We have conviction in the value and potential of XARACOLL across new geographies and look forward to further expanding its usage in acute postsurgical pain management across an important patient population in East Asia.”
Pascarella continued, “This investment is an important step in the commercialization of our portfolio globally, providing doctors and patients with a viable, non-opioid alternative to traditional pain management. As we continue to move forward with clinical trials intended to expand the indications for XARACOLL, we remain dedicated to the commercialization of XARACOLL worldwide.”
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 received FDA approval in August 2020 for adults undergoing open inguinal hernia repair. It is investigational for use in other soft tissue surgeries, and recently yielded positive topline results in a Phase 3 study, including reduction in pain intensity and opioid use 24 hours post-surgery, to support its expanded use in abdominoplasty.
About Hillhouse Investment
Founded in 2005, Hillhouse Investment is an Asia-focused private equity firm of investment professionals and operating executives who are focused on building and investing in high quality business franchises that achieve sustainable growth. Hillhouse partners with exceptional entrepreneurs and management teams to create value, often with a focus on innovation and growth. Hillhouse manages assets on behalf of institutional clients from across the globe.
About Innocoll Pharmaceuticals Limited
Innocoll Pharmaceuticals Limited 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 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
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) for adults to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair. It is investigational for use in other soft tissue surgeries. 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
- 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
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
Local Anesthetics: The toxic effects of local anesthetics are additive. Avoid additional local anesthetic administration within96 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
POSIMIR (bupivacaine solution) for infiltration use 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. DURECT is in discussions with potential partners regarding the licensing of commercialization rights to POSIMIR, for which DURECT holds worldwide rights.
About Subacromial Decompression Shoulder Surgery
Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is typically performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera lens (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery. The recovery period may extend from weeks to months, but the most intense pain typically occurs during the first 3 days after surgery and is often managed with oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.
In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies.
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.
Important Safety Information
BOXED WARNING: Risk of Potential Adverse Embolic Effects Resulting From Inadvertent Intravascular 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 DURECT Corporation at 1-844-767-4647 or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.