Mayne Pharma Receives FDA Approval For Dofetilide Capsules, A Generic Alternative To TIKOSYN, And Is Awarded 180 Days Market Exclusivity
• The U.S. Food and Drug Administration (FDA) has approved Mayne Pharma’s Abbreviated New Drug Application (ANDA) for dofetilide capsules in 125 mcg, 250 mcg and 500 mcg doses.
• Shipment of all three dosage strengths began today.
• Dofetilide capsules are a generic alternative to Pfizer’s branded Tikosyn®, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.
• Because Mayne Pharma was the first company to file a substantially complete ANDA containing a Paragraph IV patent certification for dofetilide capsules, the company was awarded 180 days of market exclusivity.
• The newly awarded market exclusivity follows the recent FDA withdrawal of the Tikosyn® Risk Evaluation and Mitigation Strategies (REMS) program, which limited the drug’s dispensing to certified prescribers, pharmacies and wholesalers. The removal of the Tikosyn® REMS should make access to dofetilide capsules easier for current and new patients.
June 7, 2016, Greenville, North Carolina: Mayne Pharma Inc. (Mayne Pharma) has received approval from the U.S. Food and Drug Administration (FDA) to market dofetilide capsules, a generic alternative to Tikosyn®, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.
Mayne Pharma was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for dofetilide capsules. As a result, the FDA awarded Mayne Pharma 180 days of market exclusivity for its generic alternatives. The company immediately began selling the product in 125 mcg (0.125 mg), 250 mcg (0.25 mg) and 500 mcg (0.5 mg) doses.
The timing of Mayne Pharma’s market approval coincided with the FDA withdrawing the Tikosyn® Risk Evaluation and Mitigation Strategies (REMS) program, which limited the drug’s availability and dispensation to certified prescribers, pharmacies and wholesalers. The removal of the drug’s REMS program means Mayne Pharma’s dofetilide capsules can be broadly available at pharmacies nationwide — improving accessibility for current and new patients.
“Mayne Pharma has a long history of developing high-quality generic products that offer patients affordable options and improved access to medications that enhance their lives,” said Stefan Cross, president of Mayne Pharma USA. “The launch of Mayne Pharma’s dofetilide capsules with 180 days of market exclusivity represents a large step forward in our company’s growth — underscoring our commitment through our staff and investments to bring complex generic alternatives to the marketplace.”
Dofetilide capsules are a generic version of Pfizer’s Tikosyn® capsules, an anti-arrhythmic agent used to prevent irregular heartbeats such as atrial fibrillation and atrial flutter. According to IMS Health, annual sales of Tikosyn® in the United States were approximately $200 million for the twelve months ended April 2016. Mayne Pharma has an agreement with its long-time partner, Johnson Matthey Inc., which supplies the active pharmaceutical ingredient (API), to share equally the profits from the sale of this product. Tikosyn® is a registered trademark of Pfizer Inc.
Currently, Mayne Pharma has more than 35 generic and branded drug products in development for the market within the United States, including 12 drug applications pending at the FDA.
###
For further information contact:
Karen Stinneford, +1.919.833.9102 or karen.stinneford@maynepharma.com
Lisa Pendlebury, +61.3.8614.7777 or lisa.pendlebury@maynepharma.com
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). The company develops and manufactures branded and generic products globally —either directly or through distribution partners — while applying its drug-delivery expertise for contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems; these technologies have been successfully commercialized in numerous products marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Greenville, North Carolina, USA, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds. Within the United States, Mayne Pharma’s operations consist of:
• U.S. Generic Products, which develops, manufactures, markets and distributes generic drug products,
• U.S. Specialty Brands, which markets and distributes branded pharmaceuticals within the United States,including Doryx®, an oral anti-bacterial drug, and
• Metrics Contract Services, which provides contract pharmaceutical development services to third parties globally.
Learn more about the company online at www.maynepharma.com.
Important Safety Information Regarding Dofetilide Capsules 125 mcg, 250 mcg and 500 mcg (0.125 mg, 0.25 mg and 0.5 mg):
Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one-week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life-threatening ventricular arrhythmias, it should be reserved for patients for whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Dofetilide also is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Dofetilide is contraindicated in patients with congenital or acquired long QT syndromes. Dolfetilide should not be used in patients with a baseline QT interval or QTc greater than 440 msec (500 msec in patients with ventricular conduction abnormalities. Dofetilide also is contraindicated in patients with severe renal impairment (calculate creatinine clearance less than 20 mL/min). The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with dofetilide is contraindicated, as each of these drugs causes a substantial increase in dofetilide plasma concentrations. In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on dofetilide., The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with dolfetilide is contraindicated because this has been shown to significantly increase dofetilide plasma concentration and QT interval prolongation. Dofetilide also is contraindicated in patients with a known hypersensitivity to the drug.
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide should be placed for a minimum of three (3) days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation.
Dofetilide can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration. Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration. The risk of TdP can be reduced by controlling the plasma concentration through adjustment of the initial dofetilide dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval. For more regarding the usage of dofetilide capsules, please refer to the full prescribing information.
• Shipment of all three dosage strengths began today.
• Dofetilide capsules are a generic alternative to Pfizer’s branded Tikosyn®, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.
• Because Mayne Pharma was the first company to file a substantially complete ANDA containing a Paragraph IV patent certification for dofetilide capsules, the company was awarded 180 days of market exclusivity.
• The newly awarded market exclusivity follows the recent FDA withdrawal of the Tikosyn® Risk Evaluation and Mitigation Strategies (REMS) program, which limited the drug’s dispensing to certified prescribers, pharmacies and wholesalers. The removal of the Tikosyn® REMS should make access to dofetilide capsules easier for current and new patients.
June 7, 2016, Greenville, North Carolina: Mayne Pharma Inc. (Mayne Pharma) has received approval from the U.S. Food and Drug Administration (FDA) to market dofetilide capsules, a generic alternative to Tikosyn®, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.
Mayne Pharma was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for dofetilide capsules. As a result, the FDA awarded Mayne Pharma 180 days of market exclusivity for its generic alternatives. The company immediately began selling the product in 125 mcg (0.125 mg), 250 mcg (0.25 mg) and 500 mcg (0.5 mg) doses.
The timing of Mayne Pharma’s market approval coincided with the FDA withdrawing the Tikosyn® Risk Evaluation and Mitigation Strategies (REMS) program, which limited the drug’s availability and dispensation to certified prescribers, pharmacies and wholesalers. The removal of the drug’s REMS program means Mayne Pharma’s dofetilide capsules can be broadly available at pharmacies nationwide — improving accessibility for current and new patients.
“Mayne Pharma has a long history of developing high-quality generic products that offer patients affordable options and improved access to medications that enhance their lives,” said Stefan Cross, president of Mayne Pharma USA. “The launch of Mayne Pharma’s dofetilide capsules with 180 days of market exclusivity represents a large step forward in our company’s growth — underscoring our commitment through our staff and investments to bring complex generic alternatives to the marketplace.”
Dofetilide capsules are a generic version of Pfizer’s Tikosyn® capsules, an anti-arrhythmic agent used to prevent irregular heartbeats such as atrial fibrillation and atrial flutter. According to IMS Health, annual sales of Tikosyn® in the United States were approximately $200 million for the twelve months ended April 2016. Mayne Pharma has an agreement with its long-time partner, Johnson Matthey Inc., which supplies the active pharmaceutical ingredient (API), to share equally the profits from the sale of this product. Tikosyn® is a registered trademark of Pfizer Inc.
Currently, Mayne Pharma has more than 35 generic and branded drug products in development for the market within the United States, including 12 drug applications pending at the FDA.
###
For further information contact:
Karen Stinneford, +1.919.833.9102 or karen.stinneford@maynepharma.com
Lisa Pendlebury, +61.3.8614.7777 or lisa.pendlebury@maynepharma.com
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). The company develops and manufactures branded and generic products globally —either directly or through distribution partners — while applying its drug-delivery expertise for contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems; these technologies have been successfully commercialized in numerous products marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Greenville, North Carolina, USA, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds. Within the United States, Mayne Pharma’s operations consist of:
• U.S. Generic Products, which develops, manufactures, markets and distributes generic drug products,
• U.S. Specialty Brands, which markets and distributes branded pharmaceuticals within the United States,including Doryx®, an oral anti-bacterial drug, and
• Metrics Contract Services, which provides contract pharmaceutical development services to third parties globally.
Learn more about the company online at www.maynepharma.com.
Important Safety Information Regarding Dofetilide Capsules 125 mcg, 250 mcg and 500 mcg (0.125 mg, 0.25 mg and 0.5 mg):
Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one-week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life-threatening ventricular arrhythmias, it should be reserved for patients for whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Dofetilide also is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Dofetilide is contraindicated in patients with congenital or acquired long QT syndromes. Dolfetilide should not be used in patients with a baseline QT interval or QTc greater than 440 msec (500 msec in patients with ventricular conduction abnormalities. Dofetilide also is contraindicated in patients with severe renal impairment (calculate creatinine clearance less than 20 mL/min). The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with dofetilide is contraindicated, as each of these drugs causes a substantial increase in dofetilide plasma concentrations. In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on dofetilide., The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with dolfetilide is contraindicated because this has been shown to significantly increase dofetilide plasma concentration and QT interval prolongation. Dofetilide also is contraindicated in patients with a known hypersensitivity to the drug.
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide should be placed for a minimum of three (3) days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation.
Dofetilide can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration. Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration. The risk of TdP can be reduced by controlling the plasma concentration through adjustment of the initial dofetilide dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval. For more regarding the usage of dofetilide capsules, please refer to the full prescribing information.