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Pacira BioSciences Presents Updated Three-Year Data Demonstrating Sustained Efficacy and Safety of PCRX-201 Gene Therapy for Patients with Moderate-to-Severe Osteoarthritis of the Knee
Globenewswire· 2025-10-28 12:00
Core Insights - Pacira BioSciences, Inc. announced updated three-year results for PCRX-201, a gene therapy for knee osteoarthritis, showing sustained clinical improvements in pain, stiffness, and function for up to 156 weeks following a single injection [1][12][8] Study Details - The open-label Phase 1 trial involved 72 patients aged 30 to 80 with moderate to severe knee osteoarthritis, assessing safety and efficacy of PCRX-201 at three different doses over 156 weeks [4][6] - Patients were evaluated using the WOMAC-A pain score, WOMAC-B stiffness score, and KOOS for function [4] Key Findings - PCRX-201 demonstrated sustained, clinically meaningful reductions in pain and stiffness, and improvements in function across all doses for three years [6][7] - The treatment had an acceptable safety profile with no serious treatment-related adverse events reported [6][7] - In the corticosteroid pretreated cohort, patients with K/L grade 2 osteoarthritis showed greater pain reduction compared to those with advanced grades [6] - Pre-existing neutralizing antibodies did not affect the treatment's effectiveness [6][7] Regulatory Designations - PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency, marking it as the first gene therapy candidate in osteoarthritis to achieve these designations [8][9][12] Future Developments - A Phase 2 study (ASCEND) of PCRX-201 is currently underway, focusing on a lower dose with corticosteroid pretreatment [10][12] - The innovative high-capacity adenovirus vector platform used in PCRX-201 allows for efficient gene delivery and potential for redosing [14]
Pacira BioSciences Notified of Abbreviated New Drug Application Filing from Qilu Pharmaceutical (Hainan) Co., Ltd. for EXPAREL®
Globenewswire· 2025-10-27 12:00
Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from Qilu Pharmaceutical, indicating Qilu's intent to file a generic version of EXPAREL, which may challenge Pacira's patent rights [1][2]. Company Overview - Pacira BioSciences is focused on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [5]. - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, utilizing a unique multivesicular liposome technology [6]. Patent and Legal Context - Qilu Pharmaceutical claims that 18 patents related to EXPAREL are invalid or unenforceable, which could allow them to market a generic version [2]. - The contested patents belong to two families, with expiration dates in 2041 and 2044 [3]. - Pacira has 45 days to respond to the PIV Notice and may file a lawsuit to protect its intellectual property, which would trigger a 30-month stay on FDA approval for Qilu's ANDA submission [4].
Pacira BioSciences to Present New Data from Three Real-World Studies with EXPAREL®
Globenewswire· 2025-10-23 12:00
Core Insights - Pacira BioSciences, Inc. is presenting real-world evidence on the clinical effectiveness and economic benefits of EXPAREL at the AMCP Nexus 2025 Annual Meeting [1][3] - The company aims to advance understanding of postsurgical pain management and reduce reliance on opioids through multimodal pain pathways [3] Company Overview - Pacira specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications [5][6] - The company is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [5] Research Presentations - The AMCP Nexus 2025 will feature presentations on the impact of liposomal bupivacaine on healthcare resource utilization and costs in total knee arthroplasty [4] - Additional presentations will cover outcomes related to intraoperative liposomal bupivacaine and its effects on opioid use and functional outcomes [7] Product Details - EXPAREL utilizes multivesicular liposome technology to deliver bupivacaine over time, achieving significant reductions in cumulative pain scores and opioid consumption [8] - The product is indicated for postsurgical local and regional analgesia in patients aged 6 years and older [6]
Pacira BioSciences Notified of Abbreviated New Drug Application Filing from The WhiteOak Group for EXPAREL®
Globenewswire· 2025-10-21 12:30
Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from The WhiteOak Group, which has filed an Abbreviated New Drug Application for a generic version of EXPAREL, claiming that the patents are invalid or not infringed [1][2] Patent and Legal Context - WhiteOak alleges that 19 patents related to EXPAREL are invalid, unenforceable, or will not be infringed by their product [2] - The contested patents are from two families, with expiration dates of January 22, 2041, and July 2, 2044 [3] - Pacira has 45 days to file a lawsuit to protect its intellectual property rights, which would trigger a 30-month stay of FDA approval for WhiteOak's ANDA submission [4] Company Overview - Pacira specializes in non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, significantly reducing opioid consumption by up to 78% [6]
Pacira BioSciences to Present 3-Year Data Demonstrating Sustained Pain and Function Improvements in Knee Osteoarthritis with Investigational PCRX-201 Gene Therapy
Globenewswire· 2025-10-20 20:01
Core Insights - Pacira BioSciences, Inc. is set to present new data from its Phase 1 clinical trial of PCRX-201, a gene therapy for knee osteoarthritis, at the ACR Convergence 2025 meeting [1] - A Phase 2 study, known as the ASCEND study, is currently ongoing for PCRX-201 [2] Group 1: Clinical Data and Efficacy - PCRX-201 has shown sustained improvements in knee pain, stiffness, and function over two years in a Phase 1 study involving 72 patients, with a well-tolerated safety profile [4] - The therapy has received RMAT designation from the FDA and ATMP designation from the EMA, marking it as the first gene therapy to achieve such results in knee osteoarthritis [4] Group 2: Technology and Platform - The high-capacity adenovirus vector platform acquired from GQ Bio Therapeutics enables efficient gene delivery, addressing challenges in gene therapy for common diseases like osteoarthritis [5] - The HCAd vector can carry up to 30,000 base pairs of DNA, allowing for the potential administration of multiple or larger genes compared to traditional AAV vectors [6] Group 3: Company Overview - Pacira specializes in innovative, non-opioid pain therapies, with three commercial-stage products including EXPAREL, ZILRETTA, and iovera [6][7] - The company is advancing PCRX-201 as a locally administered gene therapy aimed at treating prevalent diseases such as osteoarthritis [7]
PharmaCorp Rx Inc. Files Final Short Form Base Shelf Prospectus
Globenewswire· 2025-10-17 11:30
Core Viewpoint - PharmaCorp RX Inc. has filed its Final Short Form Base Shelf Prospectus, allowing the company to raise up to $100 million through various securities over a 25-month period, enhancing its capacity for strategic acquisitions and growth [2][3]. Company Overview - PharmaCorp is a Canadian pharmacy acquisition and ownership platform focused on empowering pharmacists as equity partners and supporting succession for retiring pharmacy owners [5]. - The company operates seven pharmacies under the PharmaChoice Canada banner and aims to expand its network by acquiring both bannered and independent pharmacies across Canada [5]. Financial Strategy - The Prospectus enables PharmaCorp to qualify the distribution of common shares, preferred shares, warrants, debt securities, subscription receipts, units, or any combination thereof [2]. - The specific terms of any future offerings will be determined in a Prospectus supplement, which will be filed with Canadian securities regulatory authorities [2]. Growth and Expansion Plans - The filing of the Prospectus is seen as a significant step in PharmaCorp's growth journey, providing the flexibility to access capital efficiently for strategic acquisitions and expansion opportunities [3]. - The company is positioned to accelerate its national growth strategy and strengthen its operational platform through its alliance with PharmaChoice Canada [3].
PharmaCorp Refiles Q2 2025 Financial Statements
Globenewswire· 2025-10-10 23:56
Core Viewpoint - PharmaCorp RX Inc. has restated and refiled its financial statements for the interim period ended June 30, 2025, following a review by its Auditor, with certain accounting adjustments made that do not affect the overall financial position of the Corporation [1]. Financial Adjustments - The Amended Q2 2025 Statements show significant changes, including an increase in intangible assets from $4,847,651 to $6,937,651 and the addition of an acquired charter valued at $2,090,000 [2]. - The purchases of property and equipment were adjusted from $2,145,438 to $55,438, indicating a significant revision in asset reporting [2]. - The total assets and net cash used in investing activities remained unchanged despite these adjustments, indicating minimal impact on the overall financial health [3]. Notes and Revisions - Changes were made to the notes of the Amended Q2 2025 Statements, including a working capital adjustment for the acquisition of Atlantic Canada 1 amounting to $1,019,014 and the addition of the acquired charter as a line item [5]. - A footnote was added to clarify ownership restrictions under Ontario's Drug and Pharmacies Regulation Act, and amortization amounts were revised accordingly [5]. - Subsequent event notes were added to reflect the closing of the purchase of two pharmacies in Western Canada and one in Eastern Canada, as announced on October 2, 2025 [5]. Company Operations - PharmaCorp operates seven PharmaChoice Canada bannered pharmacies and plans to continue acquiring more pharmacies under this brand, as part of its strategic alliance with PharmaChoice Canada [4]. - The Corporation is also open to acquiring independently owned pharmacies and transitioning them to the PharmaChoice Canada banner [4]. - PharmaCorp actively seeks discussions with pharmacy owners regarding succession or sale, emphasizing a commitment to seamless transitions that protect legacies and serve communities [6].
PharmaCorp Closes Acquisitions of Three Pharmacies Across Canada
Globenewswire· 2025-10-02 21:00
Core Insights - PharmaCorp RX Inc. has completed the acquisition of three community pharmacy businesses, enhancing its presence in both Western and Eastern Canada [1][4] Western Canada Acquisitions - The company acquired two PharmaChoice Canada bannered pharmacies in Western Canada for an aggregate purchase price of $3,400,000, with 75% paid in cash and 25% through the issuance of common shares [2] - The common shares were priced based on the volume weighted average trading price on the TSX Venture Exchange over a specified period prior to the closing date [2] Eastern Canada Acquisition - PharmaCorp also acquired a PharmaChoice Canada bannered pharmacy in Eastern Canada for $5,300,000, funded through cash on hand and available credit [3] - No finder's fees were incurred in connection with these acquisitions [3] Strategic Growth - The acquisitions are part of PharmaCorp's disciplined growth strategy and strengthen its strategic alliance with PharmaChoice Canada [4] - The company aims to expand its national footprint while preserving independent legacies and ensuring continuity of care for patients [4] - PharmaCorp plans to remain active in pursuing further acquisitions in the near future [4] Company Overview - PharmaCorp currently operates seven PharmaChoice Canada bannered pharmacies and intends to continue acquiring both PharmaChoice and independently owned pharmacies [5] - The company is open to discussions with pharmacy owners considering succession or sale, emphasizing a commitment to seamless transitions [6]
PharmaCorp Rx Inc. Files Preliminary Short Form Base Shelf Prospectus
Globenewswire· 2025-09-29 11:30
Core Viewpoint - PharmaCorp RX Inc. has filed a preliminary short form base shelf prospectus to qualify the distribution of up to $100 million in various securities over a 25-month period, enhancing its ability to access capital markets for growth and acquisitions [2][3]. Company Overview - PharmaCorp is a Canadian pharmacy acquisition and ownership platform focused on empowering pharmacists as equity partners and supporting succession for retiring pharmacy owners [5]. - The company operates four pharmacies under the PharmaChoice Canada banner and aims to acquire more pharmacies, rebranding them under its platform [5]. Financial Strategy - The base shelf prospectus will allow PharmaCorp to issue common shares, preferred shares, warrants, debt securities, subscription receipts, units, or any combination thereof, based on financial requirements and market conditions [2]. - The specific terms of any offerings will be detailed in prospectus supplements filed with Canadian securities regulatory authorities [2]. Corporate Development - The filing of the base shelf prospectus is seen as a milestone in PharmaCorp's corporate development, providing flexibility to access capital markets as acquisition opportunities arise [3]. - The strategic alliance with PharmaChoice Canada is highlighted as a key factor in advancing the company's national growth and operations platform [3].
PharmaCorp to Acquire a Pharmacy in Ontario for $5,300,000, New Non-Binding Letter of Intent to Acquire Two Pharmacies in Eastern Canada, Updates on Previously Announced Non-Binding Letters of Intent and Filing of Q2 Investor Presentation
Globenewswire· 2025-09-08 11:30
Acquisition Overview - PharmaCorp has signed a definitive share purchase agreement to acquire a 100% interest in a PharmaChoice Canada bannered pharmacy business in Ontario for a purchase price of $5,300,000, expected to close around October 1, 2025 [2][3] - The company has also entered into a non-binding letter of intent to acquire two additional pharmacies in Atlantic Canada for an aggregate purchase price of approximately $6,480,000 [4][5] Strategic Importance - This acquisition is a significant milestone for PharmaCorp as it represents the first transaction completed under its charter company structure established earlier in 2025 [3] - The acquisition strategy is supported by a Strategic Alliance Agreement with PharmaChoice Canada, which is expected to enhance the company's growth and operational capabilities [3][8] Financial Details - The funding for the Ontario acquisition will be sourced from cash on hand and available funds under the corporation's credit facility [2] - The proposed acquisition in Atlantic Canada will be financed through a combination of cash, issuance of common shares, and funds from the credit facility [5] Progress on Previous Transactions - PharmaCorp has successfully closed or entered into definitive agreements for three out of four pharmacies previously announced in May 2025, with an aggregate purchase price of approximately $11,100,000 [9] - The fourth transaction, valued at approximately $1,400,000, will not proceed following due diligence [9] Future Outlook - The company remains committed to expanding its national footprint through strategic acquisitions and aims to deliver long-term value to shareholders [8]