The FDA has approved Rayos in the U.S. for the treatment of rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD) and other related diseases. Rayos, known as Lodotra in Europe, is a delayed-release formulation of low-dose prednisone and uses SkyePharma's Geoclock technology. This is exclusively licensed to Horizon for use in rheumatoid arthritis.
"Our initial focus will be on the launch of Rayos in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of this year. Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD," said Timothy P. Walbert, chair, president and CEO of Horizon Pharma.
The U.S. approval is based on data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The product, as Lodotra, is approved in 16 countries in Europe and in Israel. However, despite this approval, FierceBiotech notes that, "Horizon's shares were down by more than 12% in after-hours trading on Thursday afternoon."
SkyePharma gets a low- to mid-single digit percentage royalty on net sales in North America and a mid-single digit percentage royalty elsewhere. In a note to investors, according to in-Pharma Technologist, Singer Capital Markets analyst Shawn Manning predicted that the drug could generate annual sales in the U.S. of $50 million in the next 5 years, and 3% of this would go to SkyePharma.