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Kiora Pharmaceuticals Granted U.S. Patent Expanding Protection for KIO-104 in the Treatment of Ocular Disease
Newsfile· 2025-07-22 12:55
Core Points - Kiora Pharmaceuticals has been granted a U.S. patent (US Patent No. 12,364,680) for KIO-104, which covers treatment for various ocular diseases, including ocular inflammation, uveitis, and age-related macular degeneration, extending market exclusivity until 2043 [1][2] - The patent enhances Kiora's intellectual property strategy by protecting KIO-104's proprietary structure, delivery methods, and therapeutic applications, positioning it as a significant alternative to existing steroid treatments [2] - KIO-104 is currently undergoing a Phase 2 clinical trial (KLARITY study) to evaluate its efficacy in treating inflammatory retinal diseases, with initial results expected to guide further development [3] Company Overview - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases, utilizing innovative small molecules to address vision loss [5] - KIO-104 is a next-generation, non-steroidal, immuno-modulatory small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH), aimed at treating retinal inflammation [5] - The company is also developing KIO-301 for retinitis pigmentosa and other retinal degenerative diseases, which has the potential to restore vision in affected patients [5]
AIM ImmunoTech Granted U.S. Patent Covering Methods of Manufacturing Therapeutic dsRNA, Including Ampligen®
Globenewswire· 2025-06-12 12:30
Core Viewpoint - AIM ImmunoTech Inc. has secured a significant patent for the manufacturing of its drug Ampligen, extending patent protection until 2041, which enhances its control over the drug's synthesis and use in various therapeutic applications [1][2][3]. Patent Protection - The newly granted U.S. patent No. 12312376 covers methods for manufacturing a range of therapeutic double-stranded RNA products, including Ampligen, thereby strengthening AIM's intellectual property portfolio [1][2]. - AIM's overall patent portfolio includes protections for Ampligen in treating various conditions, with specific patents expiring between 2039 and 2042 [4]. Development and FDA Approval - The patent extension provides AIM with additional time to develop its drug program and pursue FDA approval for Ampligen across multiple indications, including cancers and viral diseases [3][5]. - AIM's intellectual property also includes multiple Orphan Drug Designations from the FDA and EMA, granting market exclusivity for seven to ten years post-approval for various conditions [5]. Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for cancers, immune disorders, and viral diseases, with Ampligen being its lead investigational drug, demonstrating broad-spectrum activity in clinical trials [6].
Halozyme Therapeutics (HALO) 2025 Conference Transcript
2025-05-14 00:20
Summary of Halozyme Therapeutics (HALO) 2025 Conference Call Company Overview - **Company**: Halozyme Therapeutics (HALO) - **Date of Conference**: May 13, 2025 - **Key Speaker**: Helen Torley, President and CEO Core Industry Insights - **Industry**: Biotechnology and Specialty Pharmaceuticals - **Focus**: Drug delivery technologies, particularly subcutaneous (subcu) delivery systems Key Points and Arguments Financial Performance and Growth - Halozyme reported strong first-quarter performance driven by three blockbuster products: DARZALEX, subcutaneous FEZZO, and VIBEKAR HYTRUL, with expectations for continued growth for many years [2][5] - Revenue guidance for the year was increased to $1.2 billion to $1.28 billion, with EBITDA projected between $790 million and $840 million, reflecting a 75% increase in free cash flow [5][6] Product Pipeline and Launches - Four new products have recently launched, including Tecentriq subcutaneous, Ocrevus subcutaneous, Opdivo, and Amivantamab subcutaneous, which are expected to significantly contribute to revenue starting in 2026 as reimbursement processes are completed [3][4] - There are 11 growth catalysts anticipated, including new indications and regions, as well as important reimbursement milestones [4] Mergers and Acquisitions Strategy - The company is considering mergers and acquisitions (M&A) to enhance its drug delivery platforms and create long-term revenue streams [2][6] - Halozyme has historically signed approximately one deal per year, often involving multiple targets, which contributes to a robust ongoing pipeline [18][19] Intellectual Property and Legal Matters - Halozyme's composition of matter patent is set to expire in 2029, but the company has applied for a new patent that could extend royalty rates for DARZALEX and Amivantamab until 2029 [41][42] - Ongoing litigation with Merck regarding KEYTRUDA involves claims of patent infringement related to modified hyaluronidases, with potential for significant royalty income if successful [45][46] Clinical Benefits and Market Position - Halozyme's ENHANZE technology is recognized as the gold standard for rapid large volume subcutaneous delivery, with 10 products approved and over 1 million patients treated [10] - The subcutaneous delivery of drugs like DARZALEX significantly reduces administration time from four to six hours (IV) to three to five minutes (subcu), enhancing patient experience and reducing infusion-related reactions [23][25] Future Trends and Market Dynamics - The shift towards subcutaneous delivery is expected to continue, particularly for oncology therapies, as it allows for more convenient patient administration and reduces the burden on healthcare facilities [57][61] - The company anticipates that the increasing demand for non-IV therapies will drive growth, especially in the context of infusion capacity constraints in healthcare settings [62] Capital Allocation and Share Repurchase - Halozyme has returned $1.55 billion to shareholders since 2019 and announced an additional $250 million share repurchase program, indicating a strong position for capital deployment [6][36] Regulatory Environment - Recent updates to the IRA guidance are seen as favorable for Halozyme, particularly regarding the treatment of fixed combination drugs in price negotiations [21][22] Additional Important Insights - The company is actively engaging with Congress and Senate members to ensure the clinical benefits of their subcutaneous delivery systems are recognized in regulatory discussions [32][33] - The potential for new co-formulation patents is high, with ongoing efforts to innovate in the area of drug delivery technologies [55] This summary encapsulates the key insights and strategic directions discussed during the Halozyme Therapeutics conference call, highlighting the company's growth trajectory, product pipeline, and market positioning within the biotechnology sector.