Eirion Therapeutics, an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer.

Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis (excessive sweating) that is currently in Phase 2 clinical trials, as well as in their liquid injectable neuromodulator product candidate being developed for glabellar wrinkles, AI-09.

As part of the agreement, HTL will build, validate and operate a botulinum manufacturing facility in the US. In the future, HTL expects to apply to the CDC to have the facility certified to manufacture botulinum and later apply to the FDA to have it certified as a GMP plant.

"We are thrilled to have HTL as our long-term manufacturing partner. Their biologic manufacturing skills are respected and admired around the globe and will serve us well as we pursue international commercialization for our aesthetic products.  The integrity and manufacturing experience of the HTL team is unparalleled and I believe they will contribute materially to Eirion's future success," said Eirion CEO Jon Edelson, MD.

Under the agreement, HTL will pay for the construction, validation and operation of the US manufacturing facility, which is expected to become operational in 2022. In exchange, Eirion will begin paying manufacturing fees to HTL in 2023, with HTL also later sharing in the potential commercial success of ET-01 and AI-09, if approved.  

"This agreement marks an important expansion of HTL's biotechnology platform beyond our already industry-leading work in hyaluronic acid and bio-polymer manufacturing, as well as a key milestone in HTL's expanding footprint in North America," commented HTL CEO Yvon Bastard. "HTL believes that Eirion's products could be game-changers in the aesthetic field thanks to their substantial benefits for patients," added Charles Ruban, HTL deputy CEO.