Key Developments: Santarus Inc (SNTS.O)
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Latest Key Developments (Source: Significant Developments)
Santarus Inc and Pharming Group NV Announce FDA Acceptance for Review of RUCONEST (Recombinant Human C1 Esterase Inhibitor) Biologics License Application
Santarus Inc and Pharming Group NV announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 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 (HAE). 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 (PDUFA) guidelines, Santarus and Pharming expect the FDA will complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014. 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 RUCONEST clinical program also included two additional randomized placebo-controlled studies and several open label treatment studies. 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 million milestone is payable to Pharming as a result of the FDA acceptance for review of the BLA for RUCONEST. Full Article
Santarus Inc Announces Exercise In Full Of Option To Purchase Additional Shares And Completion Of Secondary Common Stock Offering
Santarus Inc announced the completion of a secondary underwritten public offering of 4,887,500 shares of its common stock, including 637,500 shares sold pursuant to the full exercise of an option to purchase additional shares previously granted to the underwriter. All shares were offered by Cosmo Technologies Limited at a price to the public of $18.25 per share. Santarus did not sell any shares and will not receive any proceeds from the offering. Jefferies LLC acted as the sole book-running manager for the offering. Full Article
Santarus Inc Announces Pricing Of Secondary Common Stock Offering By Selling Stockholder
Santarus Inc announced the pricing of a secondary underwritten public offering of 4,250,000 shares of its common stock at a price to the public of $18.25 per share. All shares were offered by Cosmo Technologies Limited. The selling stockholder has granted the underwriter an option for 30 days to purchase up to 637,500 additional shares of common stock. Santarus will not sell any shares or receive any proceeds from the offering. The offering is expected to close on May 15, 2013, subject to the satisfaction of customary closing conditions. Jefferies LLC is acting as the sole book-running manager for the offering. Full Article
Santarus Inc Announces Launch of Proposed Secondary Common Stock Offering By Selling Stockholder
Santarus Inc announced a proposed secondary underwritten public offering of shares of its common stock. All shares will be offered by Cosmo Technologies Limited. Santarus will not sell any shares or receive any proceeds from the offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies LLC is acting as the sole book-running manager for the offering. Full Article
Santarus Inc Raises FY 2013 Guidance
Santarus Inc raised its fiscal 2013 guidance and expects total revenues of approximately $330 million to $340 million, compared with its prior estimate of total revenues of approximately $320 million to $325 million. Net income of approximately $57 million to $64 million, and diluted EPS of $0.72 to $0.81, increased from its prior estimates of net income of approximately $50 million to $54 million, and diluted EPS of $0.63 to $0.68. Non-GAAP adjusted earnings of approximately $81 million to $91 million and diluted non-GAAP adjusted EPS of $1.03 to $1.15, up from its prior estimates of non-GAAP adjusted earnings of approximately $73 million to $79 million and diluted non-GAAP adjusted EPS of $0.92 to $1.00. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $339 million, net income of $59 million, EBITDA of $60 million and EPS of $0.76 for fiscal 2013. Full Article
Santarus Inc and Pharming Group NV Announce Submission of RUCONEST Biologics License Application to FDA
Santarus Inc and Pharming Group NV announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). 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 million milestone is payable to Pharming upon FDA acceptance for review of the BLA for RUCONEST. Full Article
Santarus Inc Announces Publication In Gut Of Results From UCERIS (budesonide) European Pivotal Clinical Study
Santarus Inc announced that results from its CORE II clinical study, one of two of the Company`s pivotal Phase III clinical studies with UCERIS (budesonide) extended release tablets in patients with ulcerative colitis, have been published online in the peer-reviewed journal Gut. The results from CORE II indicate that UCERIS 9 mg had a statistically significant benefit over placebo in the primary endpoint of inducing combined clinical and endoscopic remission at week 8 among patients with active, mild to moderate ulcerative colitis. A total of 410 patients across four treatment groups (placebo, UCERIS 9 mg, UCERIS 6 mg and Entocort EC 9 mg) were evaluated for efficacy in the CORE II study. The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was significantly greater than that seen in the placebo group (17.4% vs. 4.5%, p= 0.0047; odds ratio (OR): 4.49). The U.S. Food and Drug Administration (FDA) approved UCERIS 9 mg for the induction of remission in patients with active, mild to moderate ulcerative colitis on January 14, 2013. UCERIS 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo in the CORE II study. The CORE I and CORE II clinical studies were powered to show a statistical difference between the two UCERIS treatment arms and placebo. Full Article
Santarus Inc Issues FY 2013 Revenue And Net Income Guidance; EBITDA And EPS Guidance Above Analysts' Estimates
Santarus Inc announced that for fiscal 2013, it expects total revenues of approximately $320 million to $325 million, net income of approximately $50 million to $54 million, and diluted EPS of $0.63 to $0.68, adjusted EBITDA, or non-GAAP adjusted earnings, of approximately $73 million to $79 million and non-GAAP adjusted diluted EPS of $0.92 to $1.00. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $323 million, net income of $50 million, EBITDA of $60 million and EPS of $0.70 for fiscal 2013. Full Article
Santarus Inc And VeroScience, LLC Announce Publication Of Positive Data From Pivotal CYCLOSET (Bromocriptine Mesylate) Study
Santarus Inc and VeroScience, LLC 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 November/December 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); 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). The study included 515 patients with type 2 diabetes with baseline HbA1c of ≥7.5% and ≤10.0% (average baseline HbA1c: 8.3) taking one or two oral anti-diabetes medications (metformin, sulfonylurea and/or thiazolidinediones). These poorly controlled patients were randomized 2:1 to CYCLOSET add-on (1.6 mg/day to 4.8 mg/day) or placebo add-on for a 24-week treatment period. Study investigators were allowed to adjust patient anti-diabetes medications during the study to attempt to achieve glycemic control in case of glycemic deterioration. Full Article
Santarus Inc Expects To Meet Or Exceed Prior FY 2012 Guidance-Conference Call
Santarus Inc announced that for fiscal 2012, it expect to meet or exceed the guidance that provided on the Company's third quarter financial results call on November 7, 2012. The Company expected total revenues of approximately $210 million, net income of approximately $12 million to $14 million and adjusted EBITDA of approximately $29 million to $32 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $210 million, net income of $14 million for fiscal 2012. Full Article
Santarus raises full-year forecast as diabetes drug sales jump
- Pharmaceutical company Santarus Inc raised its full-year outlook for the second time this year driven by strong first-quarter sales, especially of its diabetes drug Glumetza, sending its shares up 11 percent after the bell.
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