Vifor Fresenius Medical Care Renal Pharma (VFMCRP) will develop and commercialize OPKO Health’s Rayaldee® (calcifediol) in Europe, Canada, Mexico, Australia, South Korea, and selected other ex-U.S. markets, the companies said today.

The collaboration and license agreement could generate up to $282 million-plus for OPKO.

Rayaldee will be developed for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) and vitamin D insufficiency, said OPKO and VFMCRP, a common company of Galenica and Fresenius Medical Care.

VFMCRP has entered into an exclusive license agreement with OPKO to co-develop and commercialize Rayaldee in Europe (except Russia), Canada, Mexico, Australia, and South Korea.

OPKO will retain all rights in the U.S., as well as Latin America (excluding Mexico), Russia, China, Taiwan, and Japan. The two companies will also collaborate to prepare the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA), OPKO and VFMCRP said.

As part of their agreement, the companies will also develop and commercialize Rayaldee for SHPT in dialysis patients, with OPKO granting VFMCRP an option to acquire U.S. rights for treatment of dialysis patients.

Rayaldee is an oral vitamin D prohormone treatment in a modified release capsule being developed by OPKO. An NDA for the Rayaldee was submitted to the FDA last year.

But in March, the FDA issued a Complete Response Letter taking issue with what the agency said were deficiencies at OPKO's third-party contract manufacturer observed during a March 14 field inspection. At the time, OPKO assured the FDA that its third-party manufacturer would address the deficiencies—and emphasized that the CRL did not cite any safety, efficacy, or labeling issues with regard to Rayaldee, nor did it request that any additional studies be conducted prior to FDA approval.

OPKO resubmitted its NDA to the FDA. The agency has set an October 22 date for action on the resubmitted NDA for Rayaldee. The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at 105 U.S. sites. The studies met all primary efficacy and safety endpoints, the companies said.

VFMCRP agreed to pay OPKO $50 million upfront, plus up to an additional $52 million in payments tied to achieving regulatory and launch milestones, and up to $180 million in sales-based milestones.

In addition, VFMCRP agreed to pay OPKO tiered, double-digit royalties on sales of the product. If VFMCRP exercises its option for rights to the U.S. dialysis market, the companies said, VFMCRP will pay OPKO additional commercial-based milestones, as well as double-digit royalties.

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