- Initiate two clinical prgrams with UCERIS (pedatric study and microscopic colitis)
"The commercial launch of UCERIS for the treatment of acute ulcerative colitis is well underway and we’ve now turned our attention to two clinical programs with UCERIS that we expect to initiate in 2014"
"One is a pediatric Phase III study with UCERIS. We believe there are approximately 50,000 to 60,000 pediatric patients with ulcerative colitis in the U.S., which qualifies the indication for orphan designation. We expect to meet with the FDA in the coming months to reach agreement on a protocol to investigate UCERIS from the induction of remission of active mild to moderate ulcerative colitis in patients of five years to 17 years of age."
"The second UCERIS program will be focused on microscopic colitis, which we believe offers the potential for label expansion. The prevalence of this disease in the U.S. is about half of that of ulcerative colitis serve about 300,000 to 350,000 patients. Microscopic colitis is an inflammation of the colon and more typically occurs in patients over 50 years of age. It is a condition that affects women more often than men, with symptoms that include frequent watery stools and abdominal pain. There are no drugs currently approved to treat microscopic colitis in the U.S."
Rifamycin SV MMX
"We are pleased to announce that Dr. Falk Pharma has recently received approval from the Indian regulatory authorities to begin enrolling an additional 250 patients in the Phase III clinical study probably being conducted in India. Once patient enrollment has been reinitiated we will be able to provide an estimate for the timing of study completion and the availability of top line data."
"We’ve also requested separate meetings with the FDA to discuss the pathways for other potential indications of RUCONEST, such as the treatment of acute pancreatitis and the prophylaxis treatment of HAE."
Good advice! After the earnings report next week we will rejoice and watch our young lady advance from her early twenties to her late twenties. Almost $100M in the 3rd Quarter 2013, beats estimates once again.
Upcoming catalysts in the next 8 months:
SAN 300 Phase IIa
Santarus will raise long-term guidance
Santarus will raise peak sales of it's drugs
Uceris becomes highly profitable in the 4th Q after $50M in sales
Many pipeline advancements
Ruconest PDUFA for Acute HAE
Potential PAR news coming.
Exploring geographic expansion
Impact of 25 new representatives
Much to look forward to in the next 14 months. Good luck to all.