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Highlights
- Exclusive Licensing Secured: Arecor licenses worldwide rights for AT351 to an undisclosed partner, supported by its Arestat platform.
- Milestone-Based Payments: Agreement includes upfront payment, development milestones, and royalties on global sales.
- Regulatory Approval Target: Licensee aims for FDA approval under the 505(b)(2) pathway within three years.
Arecor Therapeutics PLC (AIM:AREC) has announced a landmark exclusive licensing agreement for its innovative ready-to-dilute (RTD) liquid drug formulation, AT351. This development underscores the strength of Arecor’s proprietary Arestat technology platform, designed to deliver superior drug formulations that enhance patient outcomes.
Key Agreement Details
The licensing deal grants the partner exclusive worldwide rights to AT351. While the financial specifics remain undisclosed, the agreement includes an upfront payment, milestone payments tied to development, regulatory achievements, and commercial success, alongside royalties from global sales.
Licensee Responsibilities and Timeline
Under the terms, the licensee assumes responsibility for all development and regulatory activities, aiming to secure approval through the US Food and Drug Administration’s 505(b)(2) regulatory pathway. Filing for approval is anticipated within three years, signaling a clear and focused roadmap for AT351’s market entry.
Strategic Significance for Arecor
Arecor’s chief executive Sarah Howell emphasized the importance of this milestone, noting that the agreement validates the transformative potential of the Arestat platform. "We are delighted to announce this key advancement for AT351," Howell stated.
She highlighted how the partnership reflects Arecor’s commitment to leveraging its proprietary technology to create differentiated medicines. This licensing strategy is a cornerstone of the company’s approach to delivering long-term shareholder value.
The Arestat Advantage
Arestat is central to Arecor’s ability to develop superior drug formulations. The platform enables the creation of ready-to-use and ready-to-dilute liquid formulations that simplify administration, improve stability, and potentially reduce costs for healthcare systems. AT351 exemplifies this innovation, offering enhanced usability and performance.
Future Outlook
This collaboration marks a significant step for Arecor, reinforcing its position as a leading innovator in drug formulation. The milestone payments and royalties tied to the deal highlight the commercial potential of AT351, while the regulatory filing timeline reflects confidence in its development progress.
As Arecor continues to advance its portfolio of differentiated therapies, the AT351 licensing deal serves as a key indicator of its strategic vision and the growing value of its proprietary technology.
