10.25.21
The clinical-stage psychedelics biotech company PharmaTher has entered into an agreement with global pharmaceutical contract development and manufacturing organization (CDMO) Alcami for the clinical and commercial manufacturing of its proprietary ketamine products.
PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson’s disease and ALS (Lou Gehrig’s disease). The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities.
The company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. It is expected that PharmaTher’s proprietary ketamine drug product(s) will be available for FDA Phase 3 clinical studies and commercial use in the second half of 2022.
On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity. This expansion will also be able to support PharmaTher’s ketamine product development and commercialization plans globally.
“We are thrilled to work with PharmaTher and offer our expertise in GMP sterile fill-finish manufacturing and controlled-substances to support PharmaTher’s ketamine product programs,” said Patrick Walsh, chairman and CEO of Alcami. "The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results.”
Fabio Chianelli, CEO of PharmaTher, said, “PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine allows us to fulfill our objectives in serving these large markets and future partnering opportunities globally.”
PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson’s disease and ALS (Lou Gehrig’s disease). The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities.
The company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. It is expected that PharmaTher’s proprietary ketamine drug product(s) will be available for FDA Phase 3 clinical studies and commercial use in the second half of 2022.
On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity. This expansion will also be able to support PharmaTher’s ketamine product development and commercialization plans globally.
“We are thrilled to work with PharmaTher and offer our expertise in GMP sterile fill-finish manufacturing and controlled-substances to support PharmaTher’s ketamine product programs,” said Patrick Walsh, chairman and CEO of Alcami. "The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results.”
Fabio Chianelli, CEO of PharmaTher, said, “PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine allows us to fulfill our objectives in serving these large markets and future partnering opportunities globally.”
