News today, from Yahoo.. "Santarus, Inc. (NASDAQ:SNTS - News) today announced the presentation of an analysis of pooled data from its two Phase III clinical studies indicating that the investigational drug budesonide MMX® 9 mg taken once daily for the induction of remission of mild or moderate active ulcerative colitis was statistically superior to placebo in clinical and endoscopic remission and in symptom resolution. Santarus also announced that it has selected UCERIS™ as the proprietary trade name for budesonide MMX. "
Why is this not good? Stock shot downward, what's up with that?
It is good data. The drug works for induction of remission @ 9 mg daily. This is pooled data from separate US and EU trials presented previously, so the results were likely expected. They will submit NDA application by end of year for induction of remission. The effective dose for "induction of remission" is 9 mg daily for Budesonide MMX. 6 mg was not statistically different from placebo. The company ran a one year safety study per discussions with FDA for the 6 mg per day dose. No exceptional adverse effects were seen (ie Cortisol levels were not adversely effected). Some question why the 6 mg was used in the safety study; this was chosen by the FDA in discussions. Keep in mind the FDA is very knowledgeable about budesonide formulations (ie Entocort EC 9 mg) and that there are no serious safety concerns. The difference between Budesonide MMX 9 mg (Uceris) and Entocort EC is simply where the drug is released in the intestines. Entocort EC is released earlier in the colon and is indicated for Crohn's Disease and Uceris with MMX technology releases drug later to the part of the colon affected by Ulcerative Colitis. As far as safety is concerned for the 9 mg dose, "induction of remission" dosing for long periods of time is not indicated. The drug really works well in patients and is very much needed. Budesonide is designed to act locally in the intestines and does not attain high systemic levels, so it is safer than using oral corticosteroids, which can alter cortisol level, bone density etc.
The company has already had a pre-filing meeting with the FDA, and everything was in order to make the NDA application by end of 4th quarter 2011.
This will be a game changer for SNTS. Good luck to all longs.
As usual, Contrarian is all over this. A poster is just a poster. I'm not even sure that it's news worthy, but as Contrarian said, the news is all good with the drug. To me, that is a big announcement to say with some certainty that they will file the NDA before the end of 2011. A delay may have been viewed with suspect, but now we don't have to worry. The stock went down because the market went down. The small caps get whacked in panic time.
Next Monday evening, SNTS will be showing a nice little profit and handily beat their break even or $.01 per share forecast and this stock will move up very nicely. With this news, we just won't move up or down with the pack.