Check the results of the first Phase III trial so you will have a better Picture of this one.
Started doing my DD. Anybody here following it? Synthetic Biologics. They will have Phase II results in 1H 2014 for Trimesta, an oral formulation of estriol for the treatment of relapsing-remitting multiple sclerosis.
And they have SYN-004 for the prevention of clostridium difficile (C. difficile or C. diff) infections. But this one is still in early stages.
It looks attractive to me, the only problem that I see is they are running out of cash (I guess 2H 2014) so probably dilution soon coming.
This is new to me:
"Pharming and Santarus were recently informed by the FDA that an Advisory Committee is not likely to be required as part of the RUCONEST review" Sounds good!
"For HAE prophylaxis, we submitted, under our investigational new drug application, a protocol to the FDA with a request for a special protocol assessment, or SPA. The FDA has indicated that modifications to the protocol are needed before proceeding with the study and further discussions will be required in order for the protocol to be approved pursuant to the SPA process. We and Santarus are evaluating next steps to move the program Forward"
Sentiment: Strong Buy
- 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."
- Investing / Buying in new drugs/companies
I tried to put the most important catalysts for Santarus together. Of course don't forget the quarterly numbers which are always helpful for the share price.
Q4 2013 / end of 2013:
- Add approximately 25 sales representatives to the sales force
"We believe the impact of these additional sales efforts will be incrementally positive for sales trends starting in 2014. We expect to have the new sales representatives in place by the fourth quarter of this year."
- Plan to initiate a Phase IIa study with SAN-300 in rheumatoid arthritis by the end of this year.
- Results of CONTRIBUTE study (End of 2013 / early next year)
"We also have completed enrollment of our CONTRIBUTE study with UCERIS as add on to 5-ASA therapy for the induction of remission of ulcerative colitis and expect to report top line data by the end of this year, early next year. We believe these data will provide valuable information for physicians who treat patients with active ulcerative colitis."
- Blood Products Advisory Committee for RUCONEST?
- Ruconest: PDUFA date April 16, 2014
(RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
Check the Q2 Earnings Call Transcript.
"Our new estimates; our total revenues were approximately $365 million to $360 million, non-GAAP adjusted earnings of approximately $97 million to $101 million, diluted non-GAAP adjusted EPS of approximately $1.21 to $1.26, net income of approximately $129 million to $132 million and diluted EPS of approximately $1.61 to $1.65.
We are assuming 80 million shares for the fully diluted EPS calculation, up from our prior estimate of 79 million shares. The increase in this entire stock price has resulted in additional in-the-money stock option, which leads to a higher estimated fully diluted average share count for the year."
Of course I can't post a link or something that Looks like a link, thank you Yahoo.
Try and google for example "streetinsider ventrus". You will find an overview of many analyst ratings.
Sentiment: Strong Buy