The US Patent and Trademark Office (USPTO) has issued a patent to Horizon Pharma, Inc., a biopharmaceutical company developing and commercializing innovative medicines. The patent number 8,168,218 titled "Delayed Release Tablet with Defined Core Geometry" that covers RAYOS (5 mg Delayed-Release Prednisone).
Horizon is the licensee of the SkyePharma group of companies in respect of the patent and SkyePharma's related proprietary Geoclock technology.
"This patent issuance for RAYOS is another important milestone as we continue to solidify intellectual property protection for our entire product portfolio," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon.
RAYOS, known as LODOTRA in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The proprietary formulation technology of RAYOS enables a delayed-release of prednisone approximately four hours after administration. RAYOS synchronizes the prednisone delivery time with the patient's elevated cytokine levels, thereby taking effect at a physiologically optimal point to inhibit cytokine production. RAYOS utilizes SkyePharma's proprietary Geoclock technology.
Outside the United States, LODOTRA is approved for the treatment of moderate to severe active rheumatoid arthritis (RA) when accompanied by morning stiffness in 16 European countries and Israel and is marketed in Europe through Horizon's distribution partner Mundipharma International Corporation Limited, who also has commercial rights in certain Asian and Latin American countries. Approval in Europe was based on the CAPRA-1 study, which was a 12-week, double-blind, placebo controlled study evaluating 288 RA patients. CAPRA-1 compared the night-time administration of LODOTRA with the morning administration of immediate release prednisone at the same individual dose (average prednisone dose was 6.7 mg).
Horizon has completed the phase 3 CAPRA-2 study for RAYOS in the United States, Europe and Canada for the treatment of the signs and symptoms of RA and in November 2011, the US Food and Drug Administration accepted for filing and review Horizon's New Drug Application for RAYOS. The PDUFA action date is July 26, 2012 based on a standard 10 month review.