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HTL Biotechnology becomes the exclusive API manufacturer for Eirion Therapeutics





Today, Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, 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 are 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, the validation and the 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. Providing leading, innovative companies with the solutions that will empower them to change the lives of patients is our core purpose, which explains why we are particularly excited by this partnership" added Charles Ruban, HTL deputy CEO.

About Eirion Therapeutics, Inc. Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. Earlier this year, Eirion closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Ltd in China.

To learn more about Eirion: www.eirionthera.com

About HTL HTL is a leading biotech and industrial player in the development and production of innovative, pharmaceutical-grade biopolymers that are used by leading pharmaceutical and medical device companies to transform the lives of millions of patients in multiple therapeutic areas such as ophthalmology, dermatology, medical aesthetics, rheumatology, and urology. A pioneer in the bioproduction of hyaluronic acid, HTL has developed and refined its innovative functional biopolymer platform that has enabled it to produce "custom", pharmaceutical grade products for customers worldwide for over 25 years.

HTL is at the forefront of innovation in the biopolymer industry to meet tomorrow's medical needs by creating new types of biopolymers and chemical modifications, while exploring the untapped potential of biopolymers in innovative applications such as bioprinting or drug delivery.

To learn more about HTL: https://htlbiotech.com/