DEERFIELD, Ill., May 29, 2012 /PRNewswire/ -- Horizon Pharma, Inc. (NASDAQ: HZNP) announced today that the U.S. Patent and Trademark Office has issued 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). Results from CAPRA-1 demonstrating a statistically significant reduction in the duration of morning stiffness associated with RA compared to patients in the immediate release group, the primary outcome of the trial (22.7 percent for LODOTRA compared to 0.4 percent for immediate release prednisone [p-value = 0.045]), were published in The Lancet 2008 (371: 205-214).
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 U.S. 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.
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.
This press release contains forward-looking statements, including statements regarding Horizon and its business prospects. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Burns McClellan, Inc.
SOURCE Horizon Pharma, Inc.