Pharmaceutical Business review

USPTO grants NOA to SkyePharma RAYOS delayed-release tablets

The NOA covers the FDA-approved RAYOS, which uses the company’s proprietary Geoclock technology, for the treatment of various diseases including rheumatoid arthritis (RA).

In addition, the drug is US approved for treating polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease (COPD).

SkyePharma said Horizon Pharma has an exclusive license for RAYOS.

Horizon president, chief executive officer and chairman Timothy Walbert said the patent allowance is a critical expansion of the patent estate for RAYOS.

"We are focused on protecting the commercial potential of RAYOS to 2024 and we will begin the RAYOS commercial launch this quarter," Walbert added.

In Europe, RAYOS is known as LODOTRA and is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in nineteen countries.