Ropivacaine Hydrochloride

AmacaThera receives US$5 million upfront and up to US$225 million in potential future milestone payments with Pacira BioSciences for AMT-143, AmacaThera's long-acting non-opioid anesthetic for post-operative pain AMT-143 leverages AmacaThera's breakthrough tunable hydrogel platform, delivering sustained local release of ropivacaine AmacaThera and Pacira will collaborate on the Phase 2 clinical program, and Pacira will fund clinical development, manufacturing, and commercialization , with the program projected to commence in 2026 Partnership marks a major validation of AmacaThera's scalable hydrogel delivery technology and its transformative potential across multiple therapeutic areas TORONTO, Nov. 4, 2025 /PRNewswire/ -- AmacaThera, a leading developer of next generation hydrogel-based drug delivery solutions that enable precise, tunable, and sustained release to improve a wide range of active therapeutics, today announced an exclusive worldwide licensing agreement with Pacira BioSciences, Inc., a leader in non-opioid pain management, for the development and commercialization of AMT-143, an investigational long-acting non-opioid anesthetic for post-operative pain. AmacaThera's innovative hydrogel-based drug delivery platform provides precise, localized, and extended-release capabilities in an easy-to-administer format. AMT-143 has been clinically tested in a Phase 1 trial and delivered sustained release of ropivacaine for up to 14 days. The platform's adaptability supports a wide spectrum of therapeutics, from small molecules to biologics, making it a scalable and customizable solution for today's complex drug delivery needs. Under the terms of the agreement, AmacaThera will receive US$5 million upfront and up to US$225 million in future development- and sales-based milestone payments and a tiered royalty on future net sales. The companies will collaborate on clinical development, with AmacaThera leading select clinical studies. Pacira will fund clinical development of AMT-143 through commercial launch. Pacira and AmacaThera expect to initiate a Phase 2 trial in 2026, after which Pacira will assume full responsibility for the development, manufacturing, and commercialization of AMT-143. "This partnership with Pacira is a major validation of our tunable hydrogel platform and our approach to developing long-acting therapies," said Mike Cooke, CEO of AmacaThera. "This partnership allows us to accelerate AMT-143's development while demonstrating the strength, versatility, and commercial appeal of our technology to future partners." Molly Shoichet, CSO of AmacaThera, added, "Our platform combines two well-known, biocompatible polymers into an elegant hydrogel that enables precise, localized, and sustained drug delivery. 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." Key highlights of the deal and AmacaThera's platform: Platform validation: Partnering with Pacira, a leader in pain management, underscores the clinical and commercial credibility of AmacaThera's hydrogel technology Non-dilutive funding: Through Pacira's support, AmacaThera continues to accelerate its early-stage innovation while preserving ownership and long-term value Superior technology: Compared with competitors, the hydrogel is simpler to manufacture, easier to apply, and delivers tunable, long-lasting effects Commercial scalability: Established manufacturing allows for easy scale-up and technology transfer to partners Revenue potential: Structured milestones and royalties align with AmacaThera's strategy of building a diversified, scalable pipeline through partnerships "We are excited to expand our leadership in innovative, opioid-sparing pain management with the addition of this highly complementary asset to our pipeline," commented Jonathan Slonin, MD, MBA, CMO of Pacira BioSciences. "We are encouraged by the Phase 1 data and confident in AMT-143's potential to address a critical unmet need in the market. 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 control. We look forward to advancing this exciting asset into Phase 2 clinical development in partnership with AmacaThera." This agreement reinforces AmacaThera's unique position in the drug delivery space, where its hydrogel platform can be customized to enable rapid and sustained drug release, low-cost manufacturing, broad therapeutic compatibility, and flexibility for multiple partnership opportunities. Aquilo Partners LP and Osler, Hoskin & Harcourt LLP acted as financial and legal advisors to AmacaThera on this transaction, respectively. About AmacaThera AmacaThera is a leading developer of next-generation hydrogel-based drug delivery solutions. Using a proprietary blend of known polymers, AmacaThera's clinically validated hydrogel platform is transforming drug delivery by enabling the precise, tunable, and sustained release of a wide range of therapeutics, from small molecules to biologics. Transforming from liquid to gel at body temperature, AmacaThera's hydrogel enables drugs to be delivered to and stay precisely where they are needed and released over days or weeks, depending on the specific needs of each therapeutic application. Building on this foundation, AmacaThera leverages its proprietary hydrogel platform to co-develop innovative drug delivery solutions with pharmaceutical and biotechnology partners. The platform's inherent versatility enables the creation of long-acting formulations that enhance therapeutic efficacy, improve patient convenience, and minimize systemic exposure. Scalable and cost-effective to manufacture, AmacaThera's hydrogel technology supports a collaborative business model designed to deliver value across a broad range of therapeutic areas and product modalities. For more information, please visit: SOURCE AmacaThera 21% more press release views with Request a Demo

-- Advances 5x30 strategy by expanding pipeline with a highly complementary asset that has the potential to provide several days of pain control -- -- Phase 2 program for AMT-143 expected to begin in 2026 -- BRISBANE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced an exclusive worldwide license and collaboration agreement with AmacaThera for the development and commercialization of AMT-143, a novel long-acting formulation of the non-opioid analgesic ropivacaine for postsurgical pain control. “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. “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. There remains 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.” “Importantly, this agreement aligns with our 5x30 growth strategy to prioritize clinical stage, derisked opportunities complementary to our call points in pain management. Given its strong commercial synergies with our existing product offering, this asset has the potential to be meaningfully accretive to cash flow and earnings within our 5x30 timeframe,” continued Mr. Lee. About the Agreement Under the terms of the agreement, Pacira will fund clinical development through to commercial launch and the companies will collaborate on Phase 2 clinical development. AmacaThera will receive an upfront payment of $5 million with the potential for future development- and sales-based milestone payments and a tiered royalty on future net sales. About AMT-143 AMT-143 is a long-acting local analgesic for postsurgical pain control. It is administered via instillation at the time of the surgery. In a Phase 1 study, AMT-143 demonstrated sustained release of ropivacaine through 14 days. Pacira and AmacaThera expect to initiate a Phase 2 program in 2026. AMT-143 leverages AmacaThera’s innovative hydrogel-based drug delivery platform, a fast-gelling physical hydrogel composed of two well-established polymers enabling slow-release while minimizing systemic side effects. It is delivered via a conventional syringe and rapidly forms a depot as it warms to body temperature. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com. Forward-Looking Statements Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: '5x30', our growth and business strategy, our future outlook, our intellectual property and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Kim Hamilton, (908) 721-7067 kim.hamilton@pacira.com