Piramal in twin-site agreement

Under a newly signed manufacturing and supply arrangement, Piramal Pharma Solutions (PPS) will development and validation services for sofpironium bromide, the API in Botanix’s dermatology drug candidate Sofdra at its site in Riverview, Michigan. If this achieves regulatory approval, the two will consider validating the process at PPS’s facility at Aurora, Canada.

“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,” Piramal noted. Both facilities have decades of experience in drug substance development and manufacturing and have seen recent investment that would enable them to execute such an arrangement.

PPS has also just unveiled the new payload-linker suite at Riverview (pictured). The company called this a key element of the broader $90 million investment plan it announced last year to extend US-based manufacturing capabilities, alongside commercial-scale manufacturing at the sterile injectables facility in Lexington, Kentucky. Riverside acts as PPS’s dedicated payload-linker supplier, making it critical to the ADCelerate approach to Phase I ADC development.