Core Viewpoint - Pacira BioSciences, Inc. has filed a patent infringement lawsuit against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd. regarding EXPAREL, aiming to protect its intellectual property rights and prevent the sale of generic versions of its product [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, significantly reducing opioid consumption by up to 78% [6]. Legal Action - The lawsuit seeks an injunction to halt the manufacture, use, and sale of generic products linked to the ANDAs filed with the FDA, triggering a 30-month stay on final FDA approval [2]. - Pacira's EXPAREL is protected by 21 patents, with expiration dates ranging from January 22, 2041, to July 2, 2044 [3][4]. Patent Strength - The company expresses confidence in the strength of its patent portfolio and plans to vigorously defend its intellectual property rights against the generic manufacturers [4].

Core Insights - Pacira BioSciences has completed patient enrollment in Part A of its Phase 2 ASCEND study for PCRX-201, a novel gene therapy for knee osteoarthritis, with topline results expected by the end of 2026 [1][6][10] Study Overview - The ASCEND study is a two-part, multicenter trial involving approximately 135 patients aged 45 to 80 with painful knee osteoarthritis at Kellgren-Lawrence Grades 2, 3, or 4 [4] - Part A randomizes about 45 patients to evaluate two doses of PCRX-201, with a 1:1:1 randomization to Dose A, Dose B, or saline, all receiving corticosteroid pretreatment [5][6] - The primary endpoint includes treatment-emergent adverse events and secondary endpoints assess pain and physical function changes at Weeks 38 and 52 [7] Product Details - PCRX-201 is designed to enhance IL-1Ra production locally in the knee joint, targeting chronic inflammation and pain associated with osteoarthritis [2][9] - The therapy utilizes a high-capacity adenovirus vector platform, allowing for efficient gene delivery and the potential for redosing [12][17] - The product has received RMAT designation from the FDA and ATMP designation from the EMA, highlighting its clinical promise [11] Company Background - Pacira BioSciences focuses on innovative, non-opioid pain therapies, with existing products including EXPAREL, ZILRETTA, and iovera° [15] - The company aims to address prevalent diseases like osteoarthritis through advanced gene therapy solutions [15]

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]

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].

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]

Core Insights - Pacira BioSciences is set to present findings from its Phase 1 study of PCRX-201, a gene therapy for knee osteoarthritis, at the ASGCT Annual Meeting on May 15, focusing on the impact of neutralizing antibodies on therapy efficacy and safety [1][2] - The company has reported promising Phase 1 results showing sustained improvements in knee pain and function over two years, leading to regulatory designations from the FDA and EMA [4][5] Company Overview - Pacira BioSciences specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera, alongside the development of PCRX-201 [6] - PCRX-201 utilizes a proprietary high-capacity adenovirus vector platform and targets chronic inflammatory processes in knee osteoarthritis, a condition affecting over 14 million individuals in the U.S. [3][4] Upcoming Events - The presentation titled "Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy" will be delivered by Dr. MiJeong Kim on May 15 [2] - A symposium on "High-Capacity Adenoviral Vectors: Advancing Gene Therapy Beyond AAV to Deliver Cost-Effective Therapies for Common Diseases" is scheduled for May 16 [3]