Medicure gets FDA approval for Aggrastat HDB dosag
Medicure Inc.
TSX VENTURE : MPH
OTCQB : MCUJF
Medicure Inc.
October 11, 2013 10:28 ET
Medicure Announces Approval of Recommended Dosing Regimen for AGGRASTAT®
FDA Approves Supplemental New Drug Application
WINNIPEG, MANITOBA--(Marketwired - Oct. 11, 2013) - Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE:MPH)(OTCQB:MCUJF), is pleased to announce that the United States Food and Drug Administration (FDA) has approved the AGGRASTAT® (tirofiban HCl) high-dose bolus (HDB) regimen, as requested under Medicure's supplemental New Drug Application (sNDA). The AGGRASTAT HDB regimen (25 mcg/kg over 3 minutes, followed by 0.15 mcg/kg/min) now becomes the recommended dosing for the reduction of thrombotic cardiovascular events in patients with non-ST elevated acute coronary syndrome (NSTE-ACS).
The ability of the AGGRASTAT HDB regimen to achieve >90% platelet aggregation inhibition within 10 minutes is seen as an important feature by interventional cardiologists in settings where rapid platelet inhibition is required for coronary intervention. The HDB regimen has been evaluated in more than 30 clinical studies totaling over 8,000 patients, and is recommended by the ACCF/AHA/SCAI guidelines.
"We are pleased with the FDA approval of the AGGRASTAT HDB regimen," stated Dr. Albert D. Friesen, CEO of Medicure Inc. "The inclusion of the contemporary, guideline-recommended dosing regimen for AGGRASTAT is expected to have a positive impact on sales over the coming months."
AGGRASTAT currently has a 2% share of the approximately $300 million US glycoprotein (GP) IIb/IIIa inhibitor market, but continues to be the leading GP IIb/IIIa inhibitor outside of the US where the Aggrastat HDB regimen has already been approved. The Company is currently enrolling patients in the SAVI-PCI study, which compares the Aggrastat HDB regimen against Integrilin® (eptifibatide) (Merck & Co., Inc.), which has annual US sales of greater than $230 million.
About Aggrastat® (tirofiban HCl)
Indications and Usage
AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg over 3 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg over 3 minutes and then 0.075 mcg/kg/min.
Warnings and Precautions
Bleeding is the most common complication encountered during therapy with AGGRASTAT. Most bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Fatal bleeding events have been reported. Concomitant use of fibrinolytics, oral anticoagulants and antiplatelet drugs increases the risk of bleeding.
Profound thrombocytopenia has been reported with AGGRASTAT. Monitor platelet counts beginning about 6 hours after treatment initiation and daily thereafter. If the platelet count decreases to <90,000/mm3, monitor platelet counts to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, discontinue AGGRASTAT and heparin. Previous exposure to a glycoprotein (GP) IIb/IIIa receptor antagonist may increase the risk of developing thrombocytopenia.
Please see accompanying Full Prescribing Information.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for non-ST elevation acute coronary syndrome in the United States, where it is sold through the Company's US subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
To be added to Medicure's e-mail list, please visit: http://www.medicure.com/news.html.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, including but not limited to those about the Company's ability to increase sales of AGGRASTAT, are based on the current assumptions, estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements.
Such risk factors include, among others, the Company's future product revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its Form 20F for the year ended May 31, 2013.
AGGRASTAT® (tirofiban HCl) is a registered trademark of Medicure International, Inc.
12012 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Unstable Angina/ Non-ST-Elevation Myocardial Infarction (Updating the 2007 Guideline and Replacing the 2011 Focused Update). Jneid H et al. J Am Coll Cardiol 2012;60:645- 81.
2011 ACCF/AHA/SCAI Guideline for Percutaenous Coronary Intervention. Levine GN, et al. Circulation 2012;124:e574-e651.
Contact Information
Medicure Inc.
Dawson Reimer
President & COO
888-435-2220
204-488-9823 (FAX)
info@medicure.com
www.medicure.com
Das konnte man gestern bei Medicure gut beobachten. Der Kurs ist mit relativ kleinen Stückzahlen von 3,13$ im Peak auf 2,51$ zurück gefallen. Im Chart sieht man noch den Knick der den Höchststand anzeigt bei 2,87$ der mit gerade mal 11.800 Stück um knapp 30 Cent gedrückt wurde.
Aber bei Adria ist ja hingegen Null Interesse vorhanden. Zugegeben, ich habe mich mit dem Wert noch nicht beschäftigt, aber so lange keine Aufmerksamkeit der Anleger vorhanden ist, läuft sich der Kurs tot!
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Ruhe vor dem Sturm? In welche Richtung?!
Ich tendiere mal nach oben, da gleich noch ein grosser Kauf kommt ;)
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Wollte bei 1.85 wieder eine Tranche nach- bzw zurückkaufen, habs aber verpasst.
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Werde so bei 1,50 einsteigen, evtl kann er die 1CAD auch nochmal testen oder zumindestens die 1 $ marke...kurzfristig wenn keine News kommen.
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vielleicht weil Cardiome auch die EU märkte mit Agarstat angeht?
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Hat jemand eine Idee, wie es weitergehen könnte? Könnte noch eine Übernahme erfolgen oder ist sie jetzt schon zu teuer? Ich bin leider kein Fachmann und finde auch nichts im Netz was mir ne Richtung aufzeigt. Der Kurs stimmt jedenfalls und der hat ja wohl immer recht;-)
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Quarter Ended August 31, 2014 Highlights:
- Recorded net revenue of $2.1 million during the three months ended August 31, 2014 compared to $747,000 for the same quarter in the previous fiscal year, an increase of 185%;
- Earnings before interest, taxes, depreciation and amortization (EBITDA)(1) for the three months ended August 31, 2014 was $605,000 compared to a loss of $233,000 for the same quarter in the previous fiscal year;
- Net income for the three months ended August 31, 2014 was $1.3 million, which includes $1.1 million of other income, compared to a net loss of $502,000 for the same quarter in the previous fiscal year.
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http://web.tmxmoney.com/article.php?newsid=75110517&qm_symbol=MPH
Quarter One Highlights:
- Recorded net revenue of $3.3 million during the quarter ended March 31, 2015, an increase of 104% compared to $1.6 million for the quarter ended February 28, 2014 and an increase of 101% compared to $1.7 million for the three months ended March 31, 2014;
- Earnings before interest, taxes, depreciation and amortization (EBITDA)1 adjusted for share-based compensation for the first quarter ended March 31, 2015 was $1.1 million compared to $638,000 for the quarter ended February 28, 2014;
In December of 2014, the Company announced a change in its financial year-end from May 31 to December 31. As a result of the change in year-end, results for the current quarter ending on March 31, 2015 are compared to the closest comparable fiscal period, which is the quarter ending on February 28, 2014.
To view this release online and get more information about Medicure Inc. visit: https://www.medicure.com/news.php
Medicure Announces Positive Results for AGGRASTAT® in the FABOLUS-FASTER Trial and Publication in the Journal - Circulation
WINNIPEG, MB, June 29, 2020 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, today announced that results from the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial, using AGGRASTAT®, have been published in Circulation, a peer-reviewed journal of the American Heart Association.
FABOLUS-FASTER studied different regimens of intravenous platelet inhibitors, notably AGGRASTAT® (tirofiban hydrochloride) injection (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI.
"The results published in Circulation are the first to compare the pharmacodynamic effects of cangrelor, with AGGRASTAT®, as well as the pharmacodynamic and pharmacokinetic effects of a chewed or integral pill of prasugrel," said Dr. Albert D. Friesen, CEO of Medicure. "We are pleased with the performance of AGGRASTAT® in the FABOLUS-FASTER trial against cangrelor and look forward to its continued growth as part of our portfolio of cardiovascular products."
The FABOLUS-FASTER study randomized 122 P2Y12-naive STEMI patients to receive tirofiban (n=40), cangrelor (n=40), or a 60 mg loading dose of prasugrel (n=42). Those randomized to prasugrel were sub-randomized to chewed (n=21) or integral (n=21) tablet administration. The study was powered to test the noninferiority of cangrelor compared with tirofiban, the superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel compared with integral prasugrel for the primary endpoint of 30-minute inhibition of platelet aggregation (IPA) after stimulation with (20 µmol/L) ADP.
The results from the FABOLUS-FASTER trial showed cangrelor did not reach non-inferiority with tirofiban; in fact, tirofiban achieved superior IPA over cangrelor at 30 minutes (95.0%±9.0% vs 34.1%±22.5%; P <0.001). Cangrelor and tirofiban were both superior to chewed prasugrel (10.5%±11.0%, P<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3%±11.4%; P=0.47).1
Results from FABOLUS-FASTER were recently presented virtually at the PCR e-Course Scientific Sessions, due to the cancellation of EuroPCR 2020. Complete results from this study were published on June 27, 2020 in Circulation, a peer-reviewed journal of the American Heart Association.
Additional Details About the Study
FABOLUS-FASTER was funded by a grant from Medicure. This study does not imply comparable efficacy, safety, or product interchangeability. *Please note that the use of AGGRASTAT® in STEMI patients has not been approved by the FDA. As of this time, neither AGGRASTAT® nor any of the GP IIb/IIIa inhibitors are indicated for the use in STEMI patients. AGGRASTAT® is approved for use in NSTE-ACS patients. Refer to Important Safety Information below and the U.S. Prescribing Information for complete product information.
About AGGRASTAT®
AGGRASTAT® is an IV antiplatelet medication indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). AGGRASTAT® is currently the most widely used GP IIb/IIIa inhibitor in the U.S.2 and has several administration benefits including room temperature storage, a 3-year shelf life and is available in pre-mixed formats. Please refer to the IMPORTANT SAFETY INFORMATION below.
About Medicure Inc.
Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAGTM (pitavastatin) tablets and the ReDS™ PRO device in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. For more information on Medicure please visit www.medicure.com.
Important Safety Information for AGGRASTAT® (tirofiban hydrochloride)
Indications and Usage
AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
Contraindications
Known hypersensitivity to any component of AGGRASTAT®, history of thrombocytopenia with prior exposure to AGGRASTAT®, active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month.
Warnings and Precautions
AGGRASTAT® can cause serious bleeding. Most bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. If bleeding cannot be controlled, discontinue AGGRASTAT®.
Thrombocytopenia: Discontinue AGGRASTAT® and heparin.
Adverse Reactions
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT®, please refer to Full Prescribing Information available at www.aggrastatHDB.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To be added to Medicure's e-mail list, please visit:
http://medicure.mediaroom.com/alerts
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, include estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, expected future growth in revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its Form 20F for the year ended December 31, 2019.
AGGRASTAT® is a registered trademark of Medicure International Inc.
References
Gargiulo G, Esposito G, Avvedimento M, et al. Cangrelor, Tirofiban and Chewed or Standard Prasugrel Regimens in Patients with ST-Segment Elevation Myocardial Infarction: Primary Results of the FABOLUS FASTER Trial. Circulation. 2020. doi:10.1161/circulationaha.120.046928
SOURCE Medicure Inc.
For further information: James Kinley, Chief Financial Officer, Tel. 888-435-2220, Fax 204-488-9823, E-mail: info@medicure.com, www.medicure.com
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