• Piramal Pharma Solutions has entered into an agreement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited, to support the development and commercial supply of Sofdra®.
• Sofdra is the first and only FDA-approved new chemical entity (NCE) for the treatment of primary axillary hyperhidrosis.
• Through this partnership, Piramal Pharma Solutions will leverage the strength of its North American drug substance facilities to support robust, consistent patient access to Sofdra.

Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), has entered a manufacturing and supply arrangement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited (ABN 70 009 109 755) (ASX:BOT) ("Botanix"), a commercial dermatology company.

Under this arrangement, PPS will initiate development and validation services for Sofpironium Bromide, the active pharmaceutical ingredient (API) in Sofdra®, at its Riverview, Michigan facility. Following successful regulatory approval at Riverview, PPS and Botanix will consider validating the process at PPS's Aurora, Canada facility. This potential twin-site strategy would give Botanix the option to use PPS as a dual-source commercial API supplier, enhancing its long-term supply chain flexibility and security.

With decades of combined experience, the Riverview and Aurora facilities offer exceptional proficiency in drug substance development and manufacturing, spanning R&D through commercialization. Recent investments have provided both facilities with the advanced equipment and unified systems required to execute this program, reinforcing the strengths of their geographic proximity and integration expertise while enhancing their ability to offer cost-efficient solutions.

By maintaining the option for development and validation at both sites, PPS can offer partners redundancy, supply chain continuity, and scheduling flexibility. If geopolitical issues arise, PPS can seamlessly shift production between facilities, ensuring ongoing supply for Botanix and its patients. This proactive approach enables PPS's partners to remain agile and resilient amid global uncertainty, with robust coverage across the US and the rest of the world.

These twin-site capabilities also offer financial benefits, enabling PPS's partners to better balance quality and time. By derisking the Sofdra supply chain, PPS is expected to provide Botanix a significant reduction in cost of goods sold.

"This business partnership demonstrates our ability to deliver tailored, resilient solutions for organizations like Botanix," said Peter DeYoung, CEO, Piramal Global Pharma. "Our North American drug substance facilities are equipped with the expertise, advanced technology, and cutting-edge capabilities required to help derisk the Sofdra supply chain and ensure this breakthrough therapy reaches patients in need with consistency and efficiency."

This phased approach will enable PPS to support future supply needs for Sofpironium Bromide while offering the potential for dual-site production if additional capacity is required. By proactively supporting supply chain continuity, PPS can help improve the quality of life for patients living with primary axillary hyperhidrosis, underscoring and reinforcing its commitment to Patient Centricity.