Catalent’s OptiShell® Technology Is Delivery Platform For OPKO Health’s New Chronic Kidney Disease Treatment




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.”

Media Contacts: 
Chris Halling
+44 (0)7580 041073
chris.halling@catalent.com

Richard Kerns
+44 (0) 161 728 5880
richard@nepr.eu 

About Rayaldee

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.

About OPKO

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.

About Catalent 

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

More products. Better treatments. Reliably supplied.™
Forward-Looking Statements

This release contains both historical and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would” or other words or phrases with similar meanings. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent, Inc.’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: participation in a highly competitive market and increased competition may adversely affect the business of the Company; demand for the Company’s offerings which depends in part on the Company’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect the Company’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on our business and subject the Company to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to the operations of the Company; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar and other foreign currencies; adverse tax legislation initiatives or challenges to the Company’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions and other transactions that may complement or expand the business of the Company or divest of non-strategic businesses or assets and the Company’s ability to successfully integrate acquired business and realize anticipated benefits of such acquisitions; offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations; additional cash contributions required to fund the Company’s existing pension plans; substantial leverage resulting in the limited ability of the Company to raise additional capital to fund operations and react to changes in the economy or in the industry, exposure to interest rate risk to the extent of the Company’s variable rate debt and preventing the Company from meeting our obligations under our indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2014, filed with the Securities and Exchange Commission. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent, Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.