Latest news with #ZILRETTA
Yahoo
3 days ago
- Business
- Yahoo
Pacira BioSciences Announces Strategic Collaboration to Significantly Expand ZILRETTA Promotional Efforts
Partnership expected to advance 5x30 strategy by increasing ZILRETTA sales calls and extensively expanding patient access BRISBANE, CA, July 22, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced a strategic collaboration1 with Johnson & Johnson MedTech to significantly expand the market reach of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), leveraging its specialized early intervention sales force to co-promote the treatment to existing and new customers. ZILRETTA is Pacira's extended-release treatment for osteoarthritis knee pain. This agreement is expected to significantly expand access and extend reach across a large portion of the seven million intra-articular knee injections administered to patients annually in the U.S. 'This partnership embodies our 5x30 strategy of leveraging innovative, targeted collaborations that drive growth, enhance our commercial presence, and improve the patient journey with safe, effective non-opioid treatments," said Frank D. Lee, chief executive officer of Pacira BioSciences. 'With its proven long-lasting benefits and distinct mechanism of action, ZILRETTA is uniquely positioned to meet a critical need in osteoarthritis pain management, and we believe this agreement will allow us to reach even more patients across the country,' added Mr. Lee. With a significantly expanded promotional effort through a collaboration with Johnson & Johnson MedTech's early intervention sales force, which currently promotes hyaluronic acid injections for osteoarthritis knee pain, this team now has the opportunity to support individualized pain management based on patient needs and preferences. This collaboration extends the reach of ZILRETTA beyond orthopedic practices into additional physician specialties, including sports medicine, pain management and rheumatology. About PaciraPacira 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®°, 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 About ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at Indication and Select Important Safety Information for ZILRETTA Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product. Warnings and Precautions: Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration. Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use. Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs. Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment. Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions. Please see for full Prescribing Information. Forward-Looking StatementsAny 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 growth and future operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation ('NOPAIN') Act, the expected cost savings and benefits of the July 2025 reduction in force and 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 those 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 U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow 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 and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. 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; 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 (the 'SEC'). 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. 1 Co-Promotion Agreement between Pacira Pharmaceuticals Inc. and DePuy Synthes Sales, Inc. CONTACT: Investor Contact: Susan Mesco, (973) 451-4030 Media Contact: Sara Marino, (973) 370-5430 in to access your portfolio
Yahoo
14-03-2025
- Business
- Yahoo
Pacira BioSciences Confirms Receipt of Director Nominations from DOMA Perpetual
-- No Shareholder Action Required at This Time -- PARSIPPANY, N.J., March 14, 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 confirmed that DOMA Perpetual Capital Management LLC ('DOMA') has nominated three candidates to stand for election to the Pacira Board of Directors (the 'Board') at the Company's 2025 Annual Meeting of Stockholders. Pacira issued the following statement in response to DOMA's director nominations: 'Pacira's Board and management team are taking decisive action to enhance shareholder value. We recently completed a comprehensive portfolio review and defined our 5x30 plan as the best plan to deliver shareholder value. The Nominating, Governance and Sustainability Committee of the Pacira Board will evaluate and consider DOMA's proposed candidates, as it does with all director candidates.' The Board will present its formal recommendation regarding director nominees in the Company's definitive proxy statement and other materials, to be filed with the Securities and Exchange Commission and mailed to all shareholders eligible to vote at the 2025 Annual Meeting of Stockholders. The date of the Annual Meeting has not yet been announced and shareholders are not required to take any action at this time. Evercore is serving as financial advisor and Wachtell, Lipton, Rosen & Katz is serving as legal advisor to the Company. 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 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®°, 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, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit Forward-Looking Statements Any statements in this document about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words 'believes,' 'anticipates,' 'plans,' 'estimates,' 'expects,' 'intends,' 'may,' 'will,' 'would,' 'could,' 'can' 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: the 2025 Annual Meeting, '5x30', Pacira's growth and business strategy; Pacira's future outlook, Pacira's intellectual property and patent terms, Pacira's growth and future operating results and trends, Pacira's strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including Pacira's plans with respect to the repayment of Pacira's indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances and 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. Pacira cannot assure you that its estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those 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; risks associated with acquisitions, such as the risk that the acquired 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; Pacira's manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and Pacira's business, including Pacira's revenues, financial condition, cash flow and results of operations; the success of Pacira's 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 Pacira's ability to serve those markets; Pacira's 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 and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. 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; Pacira's plans to evaluate, develop and pursue additional product candidates utilizing Pacira's proprietary multivesicular liposome ('pMVL') drug delivery technology; the approval of the commercialization of Pacira's products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; Pacira's commercialization and marketing capabilities; Pacira's ability to successfully complete capital projects; the outcome of any litigation; the recoverability of Pacira's 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; the anticipated funding or benefits of Pacira's share repurchase program; and factors discussed in the 'Risk Factors' of Pacira's most recent Annual Report on Form 10-K and in other filings that it periodically makes with the SEC. In addition, the forward-looking statements included in this document represent Pacira's views as of the date of this document. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such Pacira anticipates that subsequent events and developments will cause its views to change. Except as required by applicable law, Pacira undertakes 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 Pacira's views as of any date subsequent to the date of this document. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Pacira's actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the 'Risk Factors' of Pacira's most recent Annual Report on Form 10-K and in other filings that Pacira periodically makes with the SEC. Important Additional Information Regarding Proxy Solicitation Pacira intends to file a proxy statement and BLUE proxy card with the U.S. Securities and Exchange Commission (the 'SEC') in connection with its solicitation of proxies for Pacira's 2025 annual meeting of stockholders (the '2025 Proxy Statement,' and such meeting the '2025 Annual Meeting'). BEFORE MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS OF PACIRA ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO THE SEC, INCLUDING PACIRA'S DEFINITIVE PROXY STATEMENT AND ANY AMENDMENTS AND SUPPLEMENTS THERETO, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. These documents, including the definitive 2025 Proxy Statement (and any amendments or supplements thereto) and other documents filed by Pacira with the SEC, are, or will be when filed, available for no charge on the SEC's website at and on Pacira's investor relations website at Participants in the Solicitation Pacira, its directors, director nominees, certain of its executive officers and other employees may be deemed participants in the solicitation of proxies from stockholders in respect of the 2025 Annual Meeting. Information regarding the names of Pacira's directors and executive officers and their respective interests in Pacira by security holdings or otherwise is set forth in Pacira's proxy statement for the 2024 Annual Meeting of stockholders, filed with the SEC on April 22, 2024 (the '2024 Proxy Statement'). Please refer to the sections captioned 'Director Compensation,' 'Executive Compensation,' and 'Stock Ownership Information' in the 2024 Proxy Statement. To the extent holdings of such participants in Pacira's securities have changed since the amounts described in the 2024 Proxy Statement, such changes have been reflected on Initial Statements of Beneficial Ownership of Securities on Form 3 or Statements of Changes in Beneficial Ownership of Securities on Form 4 filed with the SEC: Form 4, filed by Jonathan Slonin on June 5, 2024; Form 4, filed by Daryl Gaugler on June 5, 2024; Form 4, filed by Kristen Williams on June 5, 2024; Form 4, filed by Lauren Riker on June 5, 2024; Form 4, filed by Mark A. Kronenfeld on June 13, 2024; Form 4, filed by Laura Brege on June 13, 2024; Form 4, filed by Kristen Williams on June 13, 2024; Form 4, filed by Alethia Young on June 13, 2024; Form 4, filed by Mark Froimson on June 13, 2024; Form 4, filed by Daryl Gaugler on June 13, 2024; Form 4, filed by Abraham Ceesay on June 13, 2024; Form 4, filed by Michael J. Yang on June 13, 2024; Form 4, filed by Marcelo Bigal on June 13, 2024; Form 4, filed by Christopher Christie on June 13, 2024; Form 4, filed by Jonathan Slonin on June 13, 2024; Form 4, filed by Lauren Riker on June 13, 2024; Form 4, filed by Jonathan Slonin on July 3, 2024; Form 4, filed by Daryl Gaugler on July 3, 2024; Form 4, filed by Jonathan Slonin on August 2, 2024; Form 4, filed by Marcelo Bigal on August 12, 2024; Form 4, filed by Mark Froimson on August 12, 2024; Form 4/A, filed by Marcelo Bigal on August 13, 2024; Form 4, filed by Frank D. Lee on August 13, 2024; Form 4, filed by Michael J. Yang on August 14, 2024; Form 4, filed by Laura Brege on August 19, 2024; Form 4, filed by Marcelo Bigal on August 19, 2024; Form 4, filed by Daryl Gaugler on September 13, 2024; Form 3, filed by Shawn Cross on October 23, 2024; Form 4, filed by Shawn Cross on November 5, 2024; Form 4, filed by Daryl Gaugler on December 16, 2024; Form 4, filed by Lauren Riker on January 6, 2025; Form 4, filed by Daryl Gaugler on January 6, 2025; Form 4, filed by Jonathan Slonin on January 6, 2025; Form 4, filed by Frank D. Lee on January 6, 2025; Form 3, filed by Brendan Teehan on January 28, 2025; Form 4, filed by Lauren Riker on February 4, 2025; Form 4, filed by Brendan Teehan on February 4, 2025; Form 4, filed by Frank D. Lee on February 4, 2025; Form 4, filed by Kristen Williams on February 4, 2025; and Form 4, filed by Jonathan Slonin on February 4, 2025. Additional information can also be found in Pacira's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 27, 2025. Details concerning potential participants in the solicitation, including Pacira's director nominees for election at the 2025 Annual Meeting, will also be included in the 2025 Proxy Statement. These documents, including the definitive 2025 Proxy Statement (and any amendments or supplements thereto) and other documents filed by Pacira with the SEC, are, or will be when filed, available for no charge on the SEC's website at and on Pacira's investor relations website at CONTACT: Investor Contact: Susan Mesco, (973) 451-4030 Media Contact: Sara Marino, (973) 370-5430