$125 million refinancing substantially improves Innocoll's liquidity, enabling further investment in pharmaceutical technology portfolio and growth plan
Innocoll Biotherapeutics plc, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today the successful refinancing of its existing term loan facility with a new $125 million term loan provided by funds managed by Oaktree Capital Management, L.P. ("Oaktree"). The new term loan meaningfully strengthens Innocoll's financial flexibility and enables the Company to further invest in its R&D program and commercial organization for its innovative products.
"The refinancing of our debt significantly improves our liquidity position, which enables us to invest even further into the crucial research and clinical studies required to expand the use of our innovative products in soft tissue surgeries," said Louis Pascarella, Chief Executive Officer of Innocoll. "By continuing to invest in our R&D and building our commercial organization, we are confident that we will position our innovative post-surgical, non-opioid pain products XARACOLL (bupivacaine hydrochloride implant) and POSIMIR (bupivacaine solution) for long-term success. I'm thrilled for our company's future and look forward to the positive impact we will have on hospitals, surgeons and patients by reinvesting this increased liquidity directly into our portfolio."
Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree, said, "We are pleased to partner with Innocoll at this exciting stage in the company's development. We see tremendous opportunity in the business, its portfolio and the leadership team, and believe in its mission to help solve unmet needs in the acute care setting."
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 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 Oaktree
Oaktree is a leader among global investment managers specializing in alternative investments, with $166 billion in assets under management as of December 31, 2021. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 19 cities worldwide. For additional information, please visit Oaktree's website at http://www.oaktreecapital.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-typeor 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 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.
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 DURECT Corporation at 1-844-767-4647 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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