As Reported by Patrick Crutcher
Repligen Corporation (NASDAQ: RGEN) is another attractive biotech that has revenues, cash and pending data in early 2011. with pending Phase 2 and Phase 3 data, Repligen seems set for a transformative 2011.
Specifically, they have 2 important clinical catalysts in Q1 2011: Phase 3 data for RG1068 (pancreatic imaging agent) and Phase 2b data for their bipolar drug (RG2417). Both of these catalysts have the potential to take RGEN to new levels in 2011.
Phase 2a results demonstrated a statistically significant reduction in the symptoms of depression in patients receiving RG2417 (vs. placebo) on the MADRS and on the CGI-BP-C scale over the 6-week course of the study. RG2417 was safe and well tolerated. Repligen has exclusively licensed this patent from McLean Hospital, the largest psychiatric facility of Harvard Medical School. RGEN intends on seeking a partner, since this drug has a potential $2 billion market. Positive results from this trial could result in significant appreciation of their value. Enrollment is complete in this trial and most clinical work should be done by the end of the year. Results are expected in early Q1 2011.another catalyst to look forward to in Q1 2011 is the re-analysis of images from their Phase 3 results RG1068 in Pancreatic Imaging. RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. RG1068 was granted orphan drug status and fast track designation by the FDA. The use of RG1068 in combination with a non-invasive procedure such as MRI can improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas. last year, they reported results from a large, multicenter study that showed significant advantages of using RG1068 with MRI over endoscopy(ERCP) alone, however, the study did not show statistical significance. this was in large part because of errors made by the contract research organization(CRO) during the analysis of trial data, namely, deviating from the trial protocol. Fortunately for Repligen, the FDA and EMA recognized these issues and agreed to have the Phase 3 re-read of the data.