Pacira BioSciences Licenses Novel Long-Acting Ropivacaine Formulation AMT-143 for Postsurgical Pain Management
核心洞察
Pacira BioSciences (搜索) has entered an exclusive worldwide licensing agreement with AmacaThera (搜索) for AMT-143, a novel long-acting formulation of ropivacaine that demonstrated sustained drug release for up to 14 days in Phase 1 trials.
The deal includes $5 million upfront payment and up to $225 million in potential milestone payments, with Phase 2 clinical development expected to begin in 2026.
AMT-143 leverages AmacaThera (搜索)'s innovative hydrogel-based drug delivery platform that transforms from liquid to gel at body temperature, enabling precise localized drug delivery for postsurgical pain (搜索) control.
Pacira BioSciences (搜索) has secured exclusive worldwide rights to develop and commercialize AMT-143, a novel long-acting formulation of the non-opioid analgesic ropivacaine, through a licensing agreement with AmacaThera (搜索) valued at up to $230 million. The partnership advances Pacira's strategy to expand its pipeline with complementary assets that address unmet needs in postsurgical pain (搜索) management.
Clinical Development and Timeline
AMT-143 has completed Phase 1 clinical testing, demonstrating sustained release of ropivacaine through 14 days. The companies expect to initiate a Phase 2 program in 2026, with Pacira funding clinical development through commercial launch. AmacaThera (搜索) will collaborate on Phase 2 clinical development before Pacira assumes full responsibility for subsequent development, manufacturing, and commercialization.
"We are encouraged by the Phase 1 data and confident in AMT-143's potential to address a critical unmet need in the market," said Jonathan Slonin, MD, MBA, Chief Medical Officer of Pacira BioSciences (搜索). "This unique long-acting formulation of ropivacaine is easy to use and locally administered with the potential to provide several days of safe and effective opioid-sparing postsurgical pain (搜索) control."
Innovative Drug Delivery Technology
AMT-143 leverages AmacaThera (搜索)'s breakthrough hydrogel-based drug delivery platform, which combines two well-established polymers to create a fast-gelling physical hydrogel. The formulation is administered via instillation at the time of surgery using a conventional syringe and rapidly forms a depot as it warms to body temperature, enabling slow-release while minimizing systemic side effects.
"Our platform combines two well-known, biocompatible polymers into an elegant hydrogel that enables precise, localized, and sustained drug delivery," said Molly Shoichet, Chief Scientific Officer of AmacaThera (搜索). "It is compatible with a wide range of therapeutics, from small molecules to biologics, and can be precisely adjusted to meet the unique needs of each clinical application."
Strategic and Financial Terms
Under the agreement, AmacaThera (搜索) receives $5 million upfront with potential for future development- and sales-based milestone payments totaling up to $225 million, plus tiered royalties on future net sales. The partnership provides non-dilutive funding for AmacaThera while allowing the company to preserve ownership and long-term value in its platform technology.
"Expanding our pipeline with this novel formulation of ropivacaine builds on our leadership in innovative opioid-sparing pain management," said Frank D. Lee, Chief Executive Officer of Pacira BioSciences (搜索). "We believe this franchise-enhancing asset is highly complementary to EXPAREL and underscores our commitment to personalizing and improving the patient journey with a range of options."
Market Opportunity and Strategic Alignment
The agreement aligns with Pacira's 5x30 growth strategy to prioritize clinical-stage, derisked opportunities complementary to its existing call points in pain management. Lee noted that given its strong commercial synergies with the company's existing product offering, AMT-143 has the potential to be meaningfully accretive to cash flow and earnings within the 5x30 timeframe.
The partnership addresses what both companies identify as a significant unmet need for safe and effective opioid-sparing pain control, including an easy-to-use longer-acting therapy to serve a broader range of patients and physicians. AMT-143's hydrogel platform offers advantages in manufacturing simplicity, ease of application, and tunable, long-lasting effects compared to existing alternatives.
Mike Cooke, CEO of AmacaThera (搜索), emphasized the validation aspect of the partnership: "This partnership with Pacira is a major validation of our tunable hydrogel platform and our approach to developing long-acting therapies. This partnership allows us to accelerate AMT-143's development while demonstrating the strength, versatility, and commercial appeal of our technology to future partners."