11/23/2021 | Press release | Distributed by Public on 11/24/2021 11:20
The selection follows a seven-month formulation development program conducted by Catalent, in which the Active Pharmaceutical Ingredient (API) was screened for ideal formulation conditions, with a number of potential excipients, to come up with a drug product that suits ProtoKinetix's needs. The efficacy testing will be conducted by EyeCRO of Oklahoma City. This study should be completed by mid to late January 2022. The resulting lead formulation will then undergo extensive Good Laboratory Practice (GLP) toxicology examination, to prepare a submission for the U.S. FDA for its approval to conduct clinical trials.
"The relationship with Catalent has been extremely successful, and we believe this relationship will be ongoing for further development," said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. "This is a very exciting phase for the Company as it moves toward the commercialization phase in the Dry Eye Disease sector. The Company's highest priority is to create stockholder value through the development and commercialization of products and delivery technology."
ProtoKinetix is working on staffing key personnel to achieve our growing deliverables. This work incorporates retention of highly specialized personnel to advance the Company's product commercialization plan. To secure regulatory approvals, this includes the execution of the required safety toxicology, clinical trials, and engagements. To achieve these goals, the Company is pleased to have expanded the roles of our advisor and consultant teams to add Dana Nohynek (Regulatory Affairs Consultant & Project Manager) and Christopher Santos (CMC Specialist), both specialists that continue to provide expertise, meeting Company needs for product development:
Their expertise will be essential to the management of the production of ProtoKinetix's AAGP® product and regulatory agency formulation toxicology requirements near term (which will continue to be guided by the Company's expert Toxicologist Consultant, Evelina Rubinchik, PhD). Along with the Company executives and medical science advisors, these specialists will inform and maintain our commercialization plan and industry partnerships.
To find out more information about ProtoKinetix, visit www.protokinetix.com/about
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.
With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.
Catalent's expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.