Santarus, Inc. (MM) (SNTS) News

2:36AM Santarus and Pharming announce new data from open-label repeat treatment study with RUCONEST (SNTS) 23.22 : Santarus and Pharming Group NV announce that new data from an open-label extension of the pivotal Phase III clinical study with RUCONEST. The median time in minutes to onset of symptom relief following treatment as measured by patient responses to a Treatment Effect Questionnaire for the first five repeat attacks ranged from 62.5 (48, 90) to 134.0 (75, 150) and across all attacks was a median of 75.0 (69, 89). The median (95% CI) time in minutes to minimal symptoms (first three attacks per patient) as measured by a TEQ ranged from 243 (76, 1440) to 304 (150, 719) and for all assessed attacks was 303 (211, 367).

Exposure and Safety Information

Only one dose of RUCONEST was administered for 96% of the 224 attacks.
12 of 44 (27%) patients experienced at least one treatment emergent adverse event within 72 hours of completion of RUCONEST infusion.
TEAEs occurring in 5% of patients were nasopharyngitis, cough, fibrin D-dimer increase, and headache
The percentage of patients experiencing TEAEs did not increase with RUCONEST treatments for repeat attacks.
There were no discontinuations due to adverse events, no thrombotic or anaphylactic events, and no neutralizing anti-C1INH antibodies observed with repeat RUCONEST treatment.
Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with HAE. The Biologics License Application filing for RUCONEST is under review by the FDA with a response expected by April 16, 2014.

7:01AM Santarus announces presentation of SAN-300 Phase I data at 2013 American College of Rheumatology Annual Meeting; plan to initiate Phase IIa clinical study in patients with rheumatoid arthritis by year-end 2013 (SNTS) 24.60 : Co announced that data from its Phase I clinical study with its investigational drug SAN-300, a novel antibody that inhibits very late antigen-1 (VLA-1; a1 1 integrin), will be featured in a poster presentation at the 2013 American College of Rheumatology. Based on the Phase I study results, Santarus is preparing to initiate a multicenter, randomized, placebo-controlled, multiple ascending dose, Phase IIa clinical study with subcutaneous administration of SAN-300 in patients with active rheumatoid arthritis. The co expects to initiate the Phase IIa study in the fourth quarter of 2013.

7:04AM Santarus announces presentation of Phase III data for Rifamycin SV MMX in Travelers' Diarrhea (SNTS) 22.58 : Co announced that new data from its Phase III clinical study with the investigational drug rifamycin SV MMX in patients with travelers' diarrhea will be featured in a poster presentation at IDWeek in San Francisco at the Moscone Center (Poster Hall C) from 12:30 p.m. to 2:00 p.m. Pacific Time on Saturday, Oct 5, 2013. IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).

"The data from this clinical study indicate that rifamycin SV MMX significantly shortened the duration of travelers' diarrhea and was well tolerated, with adverse events similar to that of placebo in the study. In addition, rifamycin SV MMX demonstrated broad activity, and of interest was the possible activity against invasive pathogens," said Herbert L. DuPont, M.D., principal investigator and lead author of the poster. Dr. DuPont is Director of the Center for Infectious Diseases and Professor of Infectious Diseases at the University of Texas -- Houston School of Public Health, Chief of Internal Medicine at St. Luke's Hospital and Vice Chairman, Department of Medicine and Clinical Professor at the Baylor College of Medicine.

The co has previously announced that the Phase III study met the primary endpoint of reducing the time to last unformed stool (TLUS) in the intent-to-treat (ITT) population.

Thanks. I took a very small position at the last breakout point at 24.10 so I will add if we test the 200DMA @ 18.00. From what I have read SNTS may be a good one to watch for the long term. They have a lot in their pipeline and have excellent management.

ALL THE BEST
GULL

SNTS broke below chart support, it could bounce at anytime or just keep dropping, for me too risky to try it at these levels on the long side:

http://stockcharts.com/h-sc/ui?s=snts&p=D&yr=0&mn=6&dy=0&id=p90029751166

I noticed that your timing was magnificent and that you got out near the short term top. What do you think about buying back in at the current price of $22.97 (Closing price on Friday, September 6). Recently , I have been watching SNTS and am considering making a moderate investment for the long term. Do you think the price low made this week of $22.13 will hold in your opinion or should I hold out and try to get in with a larger investment at a lower price?

ALL THE BEST
Gull

Sold out of SNTS.....

Wow, that was an intelligent comment. I bet you flame anyone who doesn't cheer your favorite stock.

I still own my SNTS. I have 1400 shares, which is an insignificant position for me. I couldn't care less what the stock does. I'm interested in my health at the moment. Fortunately I turned the corner yesterday (after 8 awful days of waiting for the prednisone to become effective). My friend has still seen no improvement. He may have to get a Remicade infusion. Again, all of this because we took a chance on Uceris.

I think that you suck shortie!

Uceris sucks, plain and simple. If anyone reading this has ulcerative colitis, DO NOT substitute Uceris for prednisone. I just tried that and it nearly put me in the hospital. Furthermore, I have an acquaintance who also has UC. In an unbelievable coincidence, he is following nearly identical to me right now, except he waited to switch to prednisone a few days longer than I did and he is still in agony. I own SNTS, but I'm so outraged that I am posting this now, even though I still own it. I am so pissed that I will probably sell my SNTS Monday. If you are a UC patient and reading this, avoid Uceris.

JMP-Securities--Healthcare-Conference

Valuable read..
Read here

2:31AM Santarus and Pharming announce FDA acceptance for review of RUCONEST Biologics License Application (SNTS) 21.52 : Santarus and Pharming Group NV announce that the FDA has accepted for filing the Biologics License Application for the investigational drug RUCONEST 50 IU/kg. Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema. The FDA indicated that as part of its review it plans to present the BLA to the Blood Products Advisory Committee. Pursuant to the Prescription Drug User Fee Act guidelines, Santarus and Pharming expect the FDA will complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014.

9:05AM Santarus announces pricing of secondary common stock offering of $18.25 per share for 4.25 mln shares by selling stockholder Cosmo Technologies (SNTS) 20.20 : Jefferies LLC is acting as the sole book-running manager for the offering.

SNTS: Q1 Adj EPS 32c vs 12c Beats 14c Est; Guidance Varies from Consensus

Monday , May 06, 2013 16:27ET


QUARTER RESULTS
Santarus Inc (SNTS) reported Q1 results ended March 2013. Q1 Revenues were $79.40M; +73.06% vs yr-ago; BEATING revenue consensus by +6.31%. Q1 EPS was 25c. Adjusted Q1 EPS was 32c; +166.67% vs yr-ago; BEATING earnings consensus by +128.57%.
Q1 RESULTS Reported Year-Ago Y/Y Chg Estimate SURPRISE
---------- ------------ ------------ ---------- ------------ ----------
Revenues: $79.40M $45.88M +73.06% $74.69M +6.31%
---------- ------------ ------------ ---------- ------------ ----------
EPS: 25c N/A N/A N/A N/A
Adj EPS: 32c 12c +166.67% 14c +128.57%
---------- ------------ ------------ ---------- ------------ ----------

GUIDANCE

FY-13 Revenue Outlook [$330 - $340M]: The FY-13 revenue forecast is in-line with current consensus estimates.
FY-13 Earnings Outlook [$1.03 - $1.15]: The FY-13 earnings forecast is above current consensus estimates.

7:03AM Santarus: CYCLOSET (bromocriptine mesylate) included in American Association of Clinical Endocrinologists comprehensive diabetes management algorithm (SNTS) 17.75 : Co announced the inclusion of CYCLOSET (bromocriptine mesylate) as a therapy for patients with type 2 diabetes in a new comprehensive diabetes management algorithm published by the American Association of Clinical Endocrinologists (AACE). The AACE created the algorithm to guide primary care physicians, endocrinologists and other health care professionals in the treatment of prediabetes and type 2 diabetes patients. For patients with entry hemoglobin A1c (HbA1c) = 7.5%, the AACE algorithm recommends dual therapy to include CYCLOSET as one option in combination with metformin or another first-line agent. CYCLOSET is also listed as a treatment option for patients that need triple therapy and for those patients without symptoms that present with an HbA1c > 9.0%.

1:21AM Santarus and Pharming Group submit BLA to FDA to obtain marketing approval for RUCONEST (SNTS) 18.67 : Santarus and Pharming Group NV announce the submission of a Biologics License Application to the FDA to obtain marketing approval for RUCONEST 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema.

The safety and efficacy of RUCONEST for the treatment of HAE attacks were evaluated in a clinical program that included a Phase III randomized placebo-controlled study conducted under a Special Protocol Assessment agreement with the FDA. The pivotal Phase III clinical study showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms for RUCONEST compared with placebo. The RUCONEST clinical program also included two additional randomized placebo-controlled studies and four open label treatment studies. In total, the BLA dossier includes ten clinical studies covering 940 administrations in 236 subjects.

Santarus licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE as well as other potential future indications. Under the terms of the license agreement, a $5 mln milestone is payable to Pharming upon FDA acceptance for review of the BLA for RUCONEST.

Not sure why this board is so quiet with the way this stock has been performing of late.

7:05AM Santarus and VeroScience announce publication of AACE expert panel recommendations for CYCLOSET; Experts conclude that favorable cardiovascular profile of CYCLOSET suggests it may be useful in the treatment of patients with type 2 diabetes with significant risk factors or history of cardiovascular disease (SNTS) 15.33 : Co announced publication of a review article and recommendations of an American Association of Clinical Endocrinologists (AACE) expert panel on the role of bromocriptine-QR in the management of type 2 diabetes. The panel concluded that treatment with CYCLOSET (bromocriptine mesylate), also referred to as bromocriptine-QR, may be useful in the treatment of patients with type 2 diabetes, both early and late in the life cycle of the disease, and especially for patients with a history of cardiovascular disease or who have significant risk factors for cardiovascular disease.

Adjunctive administration of CYCLOSET in the dosing range of 1.6 mg/day to 4.8 mg/day may result in a mean reduction in A1c levels of 0.69%. A 24-week completer analysis performed among efficacy subgroups of patients from the CYCLOSET safety study stratified based on the patient's baseline A1c levels yielded the following results: in the subgroup treated with metformin, treatment with bromocriptine-QR was associated with a significantly higher proportion of subjects achieving a Week 24 A1c level =7 compared with placebo when baseline A1c levels were =7.5 to <8.0 or 8.0 to 8.5.

The large (n=3,070) placebo-controlled 12-month safety study provides the most detailed and systematic information on the long-term tolerability of CYCLOSET in the treatment of type 2 diabetes. Nausea was the most common adverse event (32.2%), and was associated with premature study discontinuation in 7.6% of patients

7:02AM Santarus announces commercial launch of UCERIS (budesonide) extended release tablets (SNTS) 13.38 : UCERIS was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. Upon first commercial sale of UCERIS, $7 mln is payable to Cosmo in cash or Santarus common stock, at Cosmo's option.

7:01AM Santarus and VeroScience announce publication of 'positive' data from pivotal CYCLOSET (bromocriptine mesylate) efficacy study; CYCLOSET add-on therapy provided significant improvement in glycemic control versus placebo in patients with type 2 diabetes poorly controlled on one or two oral anti-diabetes medications (SNTS) 12.37 : Co and VeroScience announced publication of positive data from a double-blind, placebo-controlled, multi-center pivotal study with CYCLOSET (bromocriptine mesylate) tablets. Patient groups in the evaluable per protocol (EPP) population that added CYCLOSET to their treatment regimen achieved a 0.60% to 0.70% reduction in HbA1c (p<0.0001) relative to placebo after 24 weeks, the primary endpoint of the study. These results appear in the Nov/Dec 2012 print edition of Endocrine Practice, a peer-reviewed medical journal. Additionally, among the EPP population with no concomitant change in diabetes medication, treatment with CYCLOSET resulted in reductions in HbA1c levels of 0.69% to 0.83% (CYCLOSET vs. placebo between group difference, p<0.0001) as well as five to seven times more subjects reaching the goal of HbA1c =7.0 in the CYCLOSET treated groups compared with placebo (32%-42% vs 5%-7%, respectively) (p<0.0001).

1:34AM Santarus sees FY12 and FY13 revs above consensus; co also announced it received FDA approval of UCERIS (SNTS) 11.28 : Co issues upside guidance for FY12 (Dec), sees FY12 (Dec) revs of ~$210 mln vs. $209.33 mln Capital IQ Consensus Estimate. Co issues upside guidance for FY13 (Dec), sees FY13 (Dec) revs of ~$320-325 mln vs. $301.25 mln Capital IQ Consensus Estimate. Financial Outlook for 2012 and 2013 For the full year in 2012, co expects to meet or exceed the financial guidance provided on its November 7, 2012 third quarter financial results conference call of:

Net income of ~$12-14 mln, which includes the impact of the ~$4 mln success-based regulatory milestone expense in the first quarter of 2012 related to UCERIS and a $10 mln expense for the success-based clinical milestone for RUCONEST in the fourth quarter.
Adjusted EBITDA of ~$29-32 mln.
Co is introducing its financial outlook for full year 2013 as follows:
Net income of approximately $50-54 mln.
Adjusted EBITDA of ~$73-79 mln.
*Co also announced it received FDA approval of UCERIS for the induction of remission in patients with active, mild to moderate ulcerative colitis.
1:30AM Santarus receives FDA approval of UCERIS for the induction of remission in patients with active, mild to moderate ulcerative colitis (SNTS) 11.28 : Co announces the FDA has approved UCERIS extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The co expects to commence the commercial launch of UCERIS in March 2013.

7:03AM Santarus announced publication of new analysis of CYCLOSET; CYCLOSET demonstrated a significant 52% relative risk reduction in cardiovascular events (SNTS) 9.03 : Co disclosed 52-week, randomized safety study with CYCLOSET tablets were published in the Journal of the American Heart Association, an online publication. CYCLOSET is a unique, quick release form of bromocriptine, a dopamine D2 receptor agonist, and is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In this safety study, a total of 3,070 patients on stable doses of up to two antidiabetes medications with HbA1c = 10.0 (average baseline HbA1c=7.0) were randomized 2:1 to CYCLOSET or placebo for a 52-week treatment period. Patients with heart failure (New York Heart Classes I and II) and precedent myocardial infarction or revascularization surgery were allowed to participate in the trial.

Regarding the MACE endpoint, there were 14 events (0.7%) among 2,054 CYCLOSET-treated subjects and 15 events (1.5%) among 1,106 placebo-treated subjects, yielding a significant, 52% reduction in relative risk in cumulative percent of cardiovascular events over time of this MACE endpoint. With respect to the cardiovascular death-inclusive cardiovascular endpoint, there were 39 events (1.9%) among 2,054 CYCLOSET-treated subjects versus 33 events (3.2%) among 1,016 placebo subjects, yielding a significant, 39% reduction in relative risk in the cumulative percent over time of this composite cardiovascular endpoint.

"Our analysis indicated that bromocriptine-QR, or CYCLOSET, significantly reduced the cardiovascular death-inclusive composite cardiovascular endpoint by 39% in type 2 diabetes patients after one year of treatment. Importantly, this observed relative risk reduction was consistent regardless of age, race, sex, duration of disease or preexisting macrovascular disease...Furthermore, among patients in the study, CYCLOSET significantly reduced the relative risk for the composite cardiovascular endpoint of myocardial infarction, stroke and cardiovascular death by 52%."

1:28AM Santarus and Pharming announce positive top-line Phase III results for RUCONEST in acute hereditary angioedema (SNTS) 9.17 : Co and Pharming Group NV announce that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema met the primary endpoint of time to beginning of symptom relief. A statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population between RUCONEST and placebo; the median time to beginning of symptom relief was 90 minutes for RUCONEST patients and 152 minutes for placebo patients. The time to beginning of symptom relief was defined as the time from the beginning of infusion of study medication until the beginning of a persistent beneficial effect, based on the patient's responses to a Treatment Effect Questionnaire for the primary attack location. RUCONEST was generally well tolerated in this Phase III clinical study and the frequency of patients experiencing at least one treatment emergent adverse event in the RUCONEST treated group was less than in the placebo group. Within 72 hours of the completion of infusion of study medication, four RUCONEST patients (7%) experienced six adverse events: sneezing, procedural headache, back pain, skin burning sensation, an increase in fibrin D-dimer and lipoma. Within the 72 hour period four placebo patients (22%) experienced four adverse events: sinus congestion, vasomotor rhinitis, diarrhea and dyspepsia.

SNTS should be hitting the high 9's tomorrow~

$8s printing in AH...

2:43PM Santarus confirms appellate court reversal in part of ZEGERID invalidity decision (halted) (SNTS) 6.39 +0.21 : Co confirmed that the U.S. Court of Appeals for the Federal Circuit reversed in part a lower court decision of invalidity involving certain asserted patent claims covering ZEGERID(R) Capsules and ZEGERID Powder for Oral Suspension. The Federal Circuit found that certain claims of asserted U.S. Patent numbers 6,780,882 and 7,399,772, which Par Pharmaceutical (PRX). had been found to infringe, were not invalid due to obviousness. The Federal Circuit also upheld the District Court's finding that there was no inequitable conduct. The case will be remanded back to the U.S. District Court for the District of Delaware for further proceedings consistent with the appellate decision. We plan to aggressively pursue all remedies available to us, including damages as well as seeking an order halting further sales of Par's generic product."

SNTS PDUFA 505B2
Tue, October 16, 12am – Wed, October 17, 12am
Calendar
FDA Calendar

snts keeps rollin, rollin, rollin...

r
u
n

SNTS still bringing me profits. I think this slow climb continues up to October's decision.

1:17AM Santarus partner Pharming updates on study 1310 and shares in issue (SNTS) 6.87 : Biotech company Pharming Group NV provides a short update from its press release dated June 12, 2012. Study 1310, the Phase III clinical study with RUCONEST that is intended to support the submission of a Biologics License Application to the FDA, continues to recruit with additional patients enrolled this week. Currently 70 of the 75 patients required for the completion of Study 1310 have been treated. RUCONEST is partnered with SNTS in North America where the drug is undergoing Phase III clinical development.

runnnnnnnnnnnnnnnnnnnnnnnnn

run

grabbed some 6.50s. lookin good...anyone around???

Santarus to Hold First Quarter 2012 Financial Results Conference Call on May 8
Business WirePress Release: Santarus, Inc. – Thu, Apr 26, 2012 4:00 AM EDT

SAN DIEGO--(BUSINESS WIRE)--

Santarus, Inc. (SNTS - News) today announced that it will release first quarter 2012 financial results after market close on Tuesday, May 8, 2012. Santarus management will host an investment-community conference call at 4:30 p.m. Eastern time (30 p.m. Pacific time) to discuss the financial results and provide a corporate update.

Individuals interested in participating in the conference call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of the company’s website at www.santarus.com.

A webcast replay will be available on the Santarus website for 14 days. A telephone replay will be available for 48 hours following the conclusion of the call by dialing 855-859-2056 for domestic callers, or 404-537-3406 for international callers, and entering reservation code: 70617723.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol.

Santarus has a diverse product development pipeline. A New Drug Application for UCERIS™ (budesonide) tablets for induction of remission of mild to moderate active ulcerative colitis is under review by the FDA with a response expected in October 2012. The pipeline also includes two late-stage investigational drugs: RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, both of which are being evaluated in Phase III clinical studies. In addition, the company’s investigational monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical program. More information about Santarus is available at www.santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ businesses, including, without limitation: difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; and other risks detailed in prior press releases as well as in public periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus®, FENOGLIDE® and UCERIS™ are trademarks of Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a trademark of VeroScience LLC. MMX® is a trademark of Cosmo Technologies Limited. RHUCIN® is a trademark of Pharming Group NV.

Contact:
Santarus, Inc.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
or
Debra P. Crawford, 858-314-5708
Chief Financial Officer
or
Investor Contact:
LHA
310-691-7100
Jody Cain, jcain@lhai.com
Bruce Voss, bvoss@lhai.com
@LHA_IR_PR

~ Friday! $SNTS ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $SNTS ~ Earnings expected on Friday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=SNTS&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=SNTS&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=SNTS
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=SNTS#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=SNTS+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=SNTS
Finviz: http://finviz.com/quote.ashx?t=SNTS
~ BusyStock: http://busystock.com/i.php?s=SNTS&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=SNTS >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

5:54AM On The Wires (WIRES) : Santarus (SNTS) announced that it has begun patient enrollment in a multicenter, randomized, double-blind, placebo-controlled Phase IIIb clinical study with the investigational drug UCERIS tablets 9 mg to evaluate whether there is an incremental benefit when UCERIS 9 mg is added to current oral aminosalicylate therapy for patients with mild or moderate active ulcerative colitis who are not adequately controlled on background 5-ASA therapy.

5:37AM On The Wires (WIRES) :Santarus (SNTS) announced that it has commenced promotion of prescription FENOGLID. Co has Completed its sales force expansion to 150 representatives.

Santarus(SNTS_) is a specialty biopharmaceutical company focused on acquiring, developing and commercializing products that address the needs of patients treated by physician specialists. This stock is trading up 7% at $4.09 in recent trading after hitting a 52-week high of $4.10 earlier in the day.

Today's Range: $3.78-$4.10

52-Week Range: $2.40-$3.84

Volume: 452,000

Three-Month Average Volume: 276,948

Santarus has a market cap of $246.53 million and an enterprise value of $183.79 million. The stock trades at a trailing price-to-earnings of 368.18 and a forward price-to-earnings of 21.32. Its estimated growth rate for this year is 131.8%, and for next year it's pegged at 171.4%.

From a technical standpoint, SNTS has triggered a big breakout today now that the stock has taken out some past overhead resistance at $3.70 with big volume. This stock now has a chance to fill a big gap down from back in 2010 that could take the stock back towards $5.67 to $5.82.

Look for SNTS to close near today's highs and remain above $3.70 to signal that long-biased trades are the best play from here.

http://www.thestreet.com/story/11373439/6/5-stocks-hitting-new-52-week-highs.html

Santarus, Inc. and Pharming Group NV announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN (recombinant human C1 inhibitor) under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application (BLA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema.

November 4, 2011
Santarus and Pharming Announce Presentation of Retrospective Analyses of Data from Clinical Studies of RHUCIN
Findings to be presented at the annual meeting of the American College of Allergy, Asthma & Immunology

SAN DIEGO & LEIDEN, Netherlands--(BUSINESS WIRE)-- Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that a retrospective analysis of integrated efficacy data from patients with Hereditary Angioedema (HAE) undergoing treatment with the investigational drug RHUCIN® (recombinant human C1 inhibitor, or C1INH) for acute attacks of HAE will be presented in an oral presentation at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, MA on November 6, 2011. The findings of a separate retrospective analysis of immuno-safety data will be presented in the poster sessions at the ACAAI meeting. The data analyzed were derived from placebo-controlled and open-label clinical studies conducted with RHUCIN in patients with HAE.

"We were pleased to have the integrated efficacy data accepted for oral presentation and to have the opportunity to present the poster on immuno-safety of RHUCIN at this major U.S. medical meeting of physicians who treat patients with HAE," said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.

The abstract Clinical Efficacy of Recombinant Human C1 Inhibitor in North American Patients with Acute Hereditary Angioedema Attacks (R. Levy, et al) is scheduled for an oral presentation at the ACAAI meeting. This integrated efficacy dataset included 70 HAE patients treated for 179 angioedema attacks with 50 U/kg RHUCIN, including patients treated for repeated attacks. Median time to the primary endpoint of onset of symptom relief was 60 minutes and median time to minimal symptoms was 240 minutes. Abdominal attacks had the fastest onset of relief (36 min), followed by urogenital (56 min), oro-facial-pharyngeal-laryngeal (65 min), and peripheral attacks (84 min). In addition, 96% of attacks (172/179) had a clinical response within 4 hours.

A second abstract Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema: An Integrated Analysis (C. Hack, et al) will be discussed in a poster presentation. Data from 155 patients in the RHUCIN acute treatment studies with 424 administrations of RHUCIN were analyzed. The frequency of anti-C1INH antibodies was low and similar in pre- and post-exposure samples (1.7% and 1.8%, respectively). Occurrence of anti-C1INH antibodies did not correlate with repeated treatment or time since last treatment. No neutralizing antibodies were detected. A total of 5/155 (3%) RHUCIN-treated patients had confirmed anti-host-related impurities (HRI) antibodies, which included one patient with anti-HRI antibodies prior to exposure to RHUCIN. The presence of anti-C1INH and anti-HRI antibodies was not associated with clinical symptoms.

RHUCIN Phase III Study

Pharming is conducting a Phase III clinical study with RHUCIN under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the third quarter of 2012.

About RHUCIN (RUCONEST® in European countries) and Hereditary Angioedema

RHUCIN (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RHUCIN is produced through Pharming's proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONEST for treatment of acute angioedema attacks in patients with HAE. RHUCIN has been granted orphan drug designation in the U.S. for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (RHUCIN® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, www.pharming.com.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Santarus also has a diverse development pipeline, including three investigational drugs in Phase III clinical programs: UCERIS™ (budesonide) Tablets for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers' diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available at www.santarus.com

Santarus BID for dutch Pharming is coming soon

2:07AM Santarus and Pharming presents retrospective analyses of data from clinical studies of RHUCIN (SNTS) 2.99 : Co and Pharming Group present data of a retrospective analysis of integrated efficacy data from patients with Hereditary Angioedema undergoing treatment with the investigational drug RHUCIN. A second abstract Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema. Data from 155 patients in the RHUCIN acute treatment studies with 424 administrations of RHUCIN were analyzed. The frequency of anti-C1INH antibodies was low and similar in pre- and post-exposure samples (1.7% and 1.8%, respectively). Occurrence of anti-C1INH antibodies did not correlate with repeated treatment or time since last treatment. No neutralizing antibodies were detected. A total of 5/155 (3%) RHUCIN-treated patients had confirmed anti-host-related impurities (HRI) antibodies, which included one patient with anti-HRI antibodies prior to exposure to RHUCIN. The presence of anti-C1INH and anti-HRI antibodies was not associated with clinical symptoms.

1:05AM Santarus provides supportive top-line results from Budesonide MMX extended use study (SNTS) 2.97 : Co announces that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application for budesonide MMX 9 mg to the FDA for the induction of remission of mild or moderate active ulcerative colitis. A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of budesonide MMX 6 mg. Top-line results indicate: The frequency of treatment related adverse events for budesonide MMX 6 mg (21.0%) was similar to placebo (21.3%). Mean morning plasma Cortisol levels remained within normal limits at all visits for both budesonide MMX 6 mg and placebo. There were no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end-of-study between budesonide MMX 6 mg and placebo.

Santarus: Weighing A Promising Pipeline Against Patent Challenges

http://seekingalpha.com/article/294152-santarus-weighing-a-promising-pipeline-against-patent-challenges?source=yahoo

6:12AM On The Wires (WIRES) :

Santarus (SNTS) and Depomed (DEPO) announced that they have entered into a new commercialization agreement for GLUMETZA(R) (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008.

http://www.insidercow.com/history/company.jsp?company=snts&B1=Search!

http://quotes.barrons.com/snts/ownership

http://www.secform4.com/insider-trading/1172480.htm

Santarus and Pharming Announce Special Protocol Assessment (SPA) Agreement with FDA for RHUCIN Phase III Clinical Study

Press Release Source: Santarus, Inc. On Thursday August 4, 2011, 1:00 am

SAN DIEGO & LEIDEN, Netherlands--(BUSINESS WIRE)-- Specialty biopharmaceutical company Santarus, Inc. (NASDAQ:SNTS - News) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN® (recombinant human C1 inhibitor) under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application (BLA).

RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. The Phase III study was initiated in February 2011, but the FDA subsequently requested modifications to the study protocol.

Following discussions with the FDA and implementation of the Agency’s recommended changes to the study protocol, the FDA has confirmed that Pharming’s proposed trial design, clinical endpoints and statistical analyses are acceptable to the FDA. As a result of the discussions with the FDA, the changes to the study design include, as previously announced, a modification to the way the primary endpoint will be assessed and an increase in the number of patients from 50 to approximately 75. The protocol will also be changed to allow the introduction of open-label doses of RHUCIN as a rescue medication. The study is still expected to be completed by the third quarter of 2012.

“We are pleased to have reached agreement with the FDA under an SPA on the protocol for the Phase III clinical study to support a BLA for RHUCIN in the U.S. Over the past months we have continued to open additional investigational sites and to screen patients for eligibility who can now be randomized into the amended trial,” said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.

Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study.

About the Special Protocol Assessment Process

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design of proposed protocols that are intended to form the basis for a BLA or New Drug Application (NDA). Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in all the data contained in the BLA or NDA submission.

About Rhucin (Ruconest in European countries) and Hereditary Angioedema

RHUCIN (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RHUCIN is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONEST® for treatment of acute angioedema attacks in patients with HAE. RHUCIN has been granted orphan drug designation in the U.S. for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.

Santarus CEO Discusses Q2 2011 Results - Earnings Call Transcript

http://seekingalpha.com/article/284456-santarus-ceo-discusses-q2-2011-results-earnings-call-transcript?source=yahoo

SNTS $3.27 with new data release!