On September 26, 2022 Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, and DURECT Corporation ( Nasdaq: DRRX) reported the recent commercial launch of POSIMIR (bupivacaine solution) in the United States (Press release, DURECT, SEP 26, 2022, https://www.durect.com/news/innocoll-and-durect-announce-u-s-launch-of-posimir/ [SID1234621433]). POSIMIR is an FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery.
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"We are excited to bring a potential cornerstone of multi-modal post-operative pain management to surgeons with the launch of POSIMIR," said Louis Pascarella, Chief Executive Officer of Innocoll. "The launch of POSIMIR establishes Innocoll as a leader in non-opioid pain management with two commercialized bupivacaine-based, sustained-release, non-opioid products and we look forward to bringing this new option to patients."
"We are pleased that Innocoll, with its dedicated hospital sales and marketing organization, has launched POSIMIR in the United States and recorded its first sales," added James E. Brown, President and Chief Executive Officer of DURECT Corporation. "Bringing a new non-opioid analgesic option with POSIMIR is a welcome next step in the evolution of pain management for patients."
Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR. Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT. These payments are in addition to the $4 million upfront license fee received in January 2022. As the launch progresses, DURECT will receive tiered, low double-digit to mid-teen royalties on net product sales in the United States, as well as additional milestone payments up to $122 million in the aggregate, depending on the achievement of certain commercial, regulatory and intellectual property milestone payments with respect to POSIMIR.
In addition to the exclusive right to develop and commercialize POSIMIR in the United States, Innocoll also has been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT’s contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world.
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, post-procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising and vomiting.