Dec 05 2011
DUEXIS is Horizon’s proprietary single-tablet combination of ibuprofen (800mg) and famotidine (26.6mg) for the treatment of pain and inflammation associated with rheumatoid arthritis (RA) and osteoarthritis. DUEXIS was approved by the U.S. FDA in April 2011.
The NDA filing was based on the REDUCE-1 and REDUCE-2 pivotal trials. In the two trials, DUEXIS demonstrated a statistically significant reduction in the incidence of NSAID-induced gastric ulcers and upper gastrointestinal ulcers than treatment with ibuprofen alone.
Horizon’s sales representatives are starting to introduce DUEXIS to physicians across the U.S. starting today. Based on the efficacy data from the pivotal trials, we believe DUEXIS will have strong uptake by physicians.
We remain bullish on shares of Horizon. LODOTRA, another drug candidate for the treatment of RA, is currently under review at the FDA. We are maintaining our estimate of an approval by the FDA in 3Q12 and a subsequent launch in 4Q12. Based on what we believe will be a strong launch for DUEXIS and U.S. approval of LODOTRA, we reiterate our Outperform rating on shares of Horizon Pharma.
Edward Nash
(646) 562-1385
[email protected]