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Santarus' CEO Discusses Q4 2011 Results - Earnings Call Transcript

We are pleased with the settlement agreement recently announced with GLUMETZA. Under this agreement Lupin has granted the right to begin selling a generic version of GLUMETZA on February 1, 2016. We believe we are taking the right step to lengthen the runway to continue growing GLUMETZA prescriptions and revenues, while advancing our development pipeline.

CYCLOSET net sales in the fourth quarter were $3.8 million, up approximately 81% over third quarter 2011 net sales. We expect the product will continue to growth in 2012 with increased call frequency by our larger sales organization. Turning to our development programs starting with UCERIS. Our NDA for UCERIS was accepted for review by the FDA in mid-February following its submission in December. This sets the PDUFA date for completion of the FDA review at October 16, 2012. We believe that UCERIS has the potential to be an important new therapeutic option in the treatment of ulcerative colitis, a chronic disease that afflicts an estimated 600,000 to 700,000 patients in the U.S.

We also have initiated our Phase IIIb clinical study with UCERIS to evaluate the drug as an add-on therapy to current 5-ASA drugs for the induction of our mission of our active ulcerative colitis in patients who are not adequately controlled on background 5-ASA therapy. We expect to complete patient enrollment for this study in the first half of 2013. We believe this is an important study to explore new indications to UCERIS and to provide additional data to physicians on the performance of UCERIS as add-on therapy.

We are on track this year to report a number of significant milestones with our other clinical development programs. During the first half of the year we expect to complete a Phase I clinical study with SAN-300, our anti-VLA-1 antibody program. We plan to initially evaluate SAN-300 for the treatment of rheumatoid arthritis and ultimately for the treatment of inflammatory bowel disease. By the third quarter, we also expect enrollment to be completed in a Phase 3 study with RHUCIN for the treatment acute attacks of hereditary angioedema, an orphan disease. We hold to rights to RHUCIN in the U.S., Canada and Mexico.

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