Catalent Pharma Solutions, today welcomed the announcement by OPKO Health that the US Food and Drug Administration has accepted for review OPKO’s New Drug Application for a new treatment for chronic kidney disease (CKD) and vitamin D insufficiency, which uses Catalent’s proprietary OptiShell® softgel technology as its delivery platform.
Somerset, N.J. – August 3, 2015 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today welcomed the announcement by OPKO Health that the US Food and Drug Administration has accepted for review OPKO’s New Drug Application for a new treatment for chronic kidney disease (CKD) and vitamin D insufficiency, which uses Catalent’s proprietary OptiShell® softgel technology as its delivery platform.
OPKO Health, Inc.’s (NYSE: OPK) product, calcifediol modified-release capsules with the proposed trade name Rayaldee™, has been developed for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 CKD and vitamin D insufficiency.
Catalent’s OptiShell platform allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell. OptiShell was selected as the optimum delivery method for OPKO’s Rayaldee.
Rayaldee will be manufactured at Catalent’s North American Softgel Center of Excellence in St. Petersburg, FL. Catalent is currently developing multiple OptiShell programs, providing optimal solutions for challenging drug compounds contained within complex fill formulations.
OptiShell capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. As a result, soft capsules containing semi-solid matrices for modified-release of poorly soluble and/or poorly permeable drug compounds are now an option for drug developers. For immediate-release applications, OptiShell technology expands the range of compatible excipients available for developing lipid-based capsule formulations, providing more solutions for unique drug delivery challenges.
“Rayaldee represents the first time that a semi-solid fill drug product has been delivered in a softgel,” commented Dr. Aris Gennadios, Catalent’s President, Softgel Technologies. “We have worked closely on the development of Rayaldee with OPKO to bring this important new therapy to market in the most effective manner, in the shortest possible timeframe.”
“FDA acceptance of this NDA should be cheered by healthcare professionals who care for CKD patients,” commented Dr. Kevin J. Martin, Director of Division of Nephrology at Saint Louis University School of Medicine. “If approved, Rayaldee will provide a new therapeutic option for controlling elevated parathyroid hormone levels in this large and undertreated patient population.”
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Rayaldee (calcifediol modified-release capsules) is an oral vitamin D prohormone treatment being developed for SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24A1, a cytochrome P-450 enzyme which interferes with the desired parathyroid hormone (PTH)-lowering effect. Gradual elevation of serum total 25-hydroxyvitamin D is intended to prevent excessive elevation of serum calcium and related vascular and renal calcification.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 30 facilities across 5 continents, and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
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