CVTX » Topics » Ranexa Development Status

This excerpt taken from the CVTX 10-K filed Feb 28, 2008.

Ranexa Development Status

In order to potentially broaden the product labeling for Ranexa beyond its current approved indication, we conducted the MERLIN TIMI-36 clinical study. This study was conducted under a SPA agreement with the FDA. If treatment with Ranexa is not associated with an adverse trend in death and arrhythmia compared to placebo, the study could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary efficacy endpoint was not achieved. As part of this SPA agreement, we conducted a separate clinical evaluation of higher doses of Ranexa in order to obtain broader angina labeling (if any).

MERLIN TIMI-36 was a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 was time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes receiving standard therapy. The safety of long-term treatment with Ranexa compared to placebo also was evaluated in the study.

Within 48 hours of the onset of angina due to acute coronary syndromes, eligible hospitalized patients were enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient

 

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treatment with oral Ranexa or placebo. All patients also received standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.

Topline data from MERLIN TIMI-36 were presented as a late breaking clinical trial on March 27, 2007 at the American College of Cardiology Annual Scientific Session in New Orleans and subsequently published in the April 25, 2007 issue of the Journal of the American Medical Association.

The data and results published in JAMA from the MERLIN TIMI-36 study showed that patients with ACS receiving Ranexa had no adverse trend in death or arrhythmias and had statistically significant reductions of clinically significant arrhythmias (p<0.001) and recurrent ischemia (p=0.03), compared to patients receiving placebo. Despite a trend towards a reduction in the composite primary endpoint of cardiovascular death, myocardial infarction and recurrent ischemia, the study did not meet the primary efficacy endpoint with statistical significance (p=0.11).

Ranexa Marketing Approval Applications in the United States

Based on the results of the MERLIN TIMI-36 study, we submitted a NDA for Ranexa to the Division of Cardiovascular and Renal Products of the FDA in September 2007, seeking to modify the existing product labeling and expand the indication to include first line angina treatment.

Additionally, the FDA requested that we pay a second PDUFA user fee and officially notified us that the Division of Metabolism and Endocrinology Products of FDA would undertake a formal review of the clinical diabetes data, as a separate new drug application, or NDA. Specifically, the new NDA was “administratively unbundled” from the parent sNDA to provide for clinical review of the proposed labeling change to add reduction of HbA1c in coronary artery disease patients with diabetes.

In December 2007, the FDA requested that we pay a third PDUFA user fee and officially notified us that the Division of Cardiovascular and Renal Products also will evaluate the approval of potential anti-arrhythmic claims for Ranexa under a separate sNDA.

The two sNDAs and the NDA all relating to Ranexa that are under review have been accepted for filing and review by the FDA and all have an FDA PDUFA action date of July 27, 2008.

Ranexa Marketing Authorization Application in Europe

In December 2006, we submitted a marketing authorization application, or MAA, under a centralized procedure to European regulatory authorities seeking approval of ranolazine for the treatment of chronic angina in Europe. A previous European approval application for ranolazine (not including data from the MERLIN TIMI-36 study) was withdrawn.

We currently expect potential action on our MAA in the first half of 2008.

This excerpt taken from the CVTX 10-K filed Feb 27, 2007.

Ranexa Development Status

In order to potentially broaden the product labeling for Ranexa beyond its current approved indication, we have conducted the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes, or MERLIN TIMI-36, clinical study. This study has been conducted under a special protocol assessment, or SPA, agreement with the FDA. If treatment with Ranexa is not associated with an adverse trend in death and arrhythmia compared to placebo, the study could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary efficacy endpoint is not achieved. As part of this SPA agreement, we must conduct a separate clinical evaluation of higher doses of Ranexa in order to obtain broader angina labeling (if any). In addition, if statistical significance on the primary efficacy endpoint for the MERLIN TIMI-36 study is achieved, Ranexa could also gain approval for hospital-based and long-term prevention of acute coronary syndromes.

The study’s duration was event driven. It was designed to continue until at least 730 cases of cardiovascular death, myocardial infarction or severe recurrent ischemia had been observed, and at least 310 deaths from any cause had occurred. In September 2006, we announced that the required number of endpoints had accumulated. There were more than 310 deaths and more than 1,400 cases of cardiovascular death, myocardial infarction or severe recurrent ischemia. The MERLIN TIMI-36 study was initiated in October 2004 and has been conducted by the Harvard-based TIMI Study Group.

MERLIN TIMI-36 has been a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes receiving standard therapy. The safety of long-term treatment with Ranexa compared to placebo also has been evaluated in the study.

Within 48 hours of the onset of angina due to acute coronary syndromes, eligible hospitalized patients were enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also received standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.

We currently expect data from MERLIN TIMI-36 late in the first quarter of 2007. The study has been accepted for presentation as a late breaking clinical trial at 8:50 a.m. Central time on Tuesday, March 27 at the American College of Cardiology Annual Scientific Session in New Orleans.

This excerpt taken from the CVTX 10-K filed Mar 10, 2006.

Ranexa Development Status

In order to potentially broaden the product labeling for Ranexa beyond its current approved indication, we are conducting the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes, or MERLIN TIMI-36, clinical study. This study is being conducted under a special protocol assessment, or SPA, agreement with the FDA. If treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the study could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. As part of this SPA agreement, we must conduct a separate clinical evaluation of higher doses of Ranexa in order to obtain broader angina labeling (if any). In addition, if statistical significance on the primary endpoint for the MERLIN TIMI-36 study is achieved, Ranexa could also gain approval for hospital-based and long-term prevention of acute coronary syndromes.

MERLIN TIMI-36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes receiving standard therapy. The safety of long-term treatment with Ranexa compared to placebo is also being evaluated in the study.

Within 48 hours of the onset of angina due to acute coronary syndromes, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.

In addition to performing periodic safety assessments, an independent data safety monitoring board, or DSMB, overseeing MERLIN TIMI-36 conducted an interim efficacy analysis when approximately half of the

 

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anticipated major cardiovascular events occurred. A significant drug treatment effect on the rate of cardiovascular death with a p-value of less than 0.001 was pre-specified as being required for the DSMB to consider a recommendation to stop the study early. In February 2006, we were informed that the DSMB recommended that the study continue as planned.

The study’s duration is event driven. It is expected to continue until at least 730 cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and at least 310 deaths from any cause have occurred. Currently there are approximately 500 study sites worldwide with study drug. The MERLIN TIMI-36 study was initiated in October 2004 and is being conducted by the Harvard-based TIMI Study Group. We expect data from MERLIN TIMI-36 in the fourth quarter of 2006 or the first quarter of 2007.

This excerpt taken from the CVTX 10-K filed Mar 24, 2005.

Ranexa Development Status

 

Our new drug application, or NDA, for Ranexa seeking FDA approval for the treatment of chronic angina was submitted to the FDA in December 2002. The NDA contained data from more than 3,300 angina patients and subjects, and from more than 25,000 electrocardiograms. Our two Phase III clinical trials of Ranexa, the Monotherapy Assessment of Ranolazine in Stable Angina trial, or MARISA, and the Combination Assessment of Ranolazine in Stable Angina trial, or CARISA, were randomized, double-blind, placebo controlled trials. MARISA evaluated Ranexa when used in patients who were not receiving other anti-anginal drugs. CARISA evaluated Ranexa when used in patients who were receiving either a beta-blocker or a calcium channel blocker. In both of these trials, Ranexa statistically significantly increased patients’ symptom-limited exercise duration at trough drug concentrations compared to placebo. Additionally, in CARISA, Ranexa significantly reduced the frequency of angina attacks and the use of nitroglycerin to relieve angina pain, both secondary endpoints of the study. In both of these trials, Ranexa had no clinically meaningful impact on heart rate or blood pressure, either at rest or following exercise. In these trials, the most common adverse events included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). Adverse event frequency increased as dose increased. In addition, small but statistically significant increases in the corrected QT measurement on the electrocardiogram, or QTc, were observed compared to placebo.

 

On October 30, 2003 we received an approvable letter from the FDA for our NDA for Ranexa for the treatment of chronic angina. In the approvable letter, the FDA indicated that Ranexa is approvable, that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. After a meeting with the FDA’s Cardiovascular and Renal Drugs Advisory Committee of the FDA and subsequent discussions with the FDA, we reached written agreement with the FDA in June 2004 on a protocol for a clinical trial of Ranexa which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA’s special protocol assessment, or SPA, process.

 

The SPA process creates a written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application. In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise. However, even with an SPA in place, the FDA retains broad discretion in interpreting the data and making regulatory decisions, and there is no guarantee of regulatory approval.

 

We initiated this potentially approval-enabling clinical study, known as the Evaluation of Ranolazine In Chronic Angina, or ERICA, in August 2004 and completed patient enrollment in November 2004. We expect that initial data from the ERICA study are likely to be available in April or May 2005; however data may be available later than May 2005. ERICA is a multi-national, double-blind, randomized, placebo-controlled, parallel

 

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group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients were randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period. Prior to entering the study, patients were required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have had documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina. Physicians were able to include long-acting nitrates as background therapy at the start of the study.

 

The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, ERICA is estimated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo, in a secondary endpoint of the CARISA study.

 

Other objectives of ERICA are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and on quality of life.

 

If the ERICA study is successful, we would expect to submit an amendment to our Ranexa NDA to the FDA in the second half of 2005, seeking approval of Ranexa for the treatment of chronic angina in a restricted patient population.

 

In July 2004, we also reached written agreement with the FDA on a second, separate SPA for a study, the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes study, or MERLIN TIMI-36. This SPA agreement defines a path to potential approval of Ranexa as first-line therapy in the chronic angina population. Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based and long-term prevention of acute coronary syndromes. In addition, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the study could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. However, in order to obtain potential approval as first-line angina therapy, under the SPA we also need to perform a separate successful clinical evaluation of higher doses of Ranexa.

 

The MERLIN TIMI-36 study was initiated in October 2004 and is being conducted by the Harvard-based TIMI Study Group.

 

MERLIN TIMI-36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes receiving standard therapy. The study also is evaluating the safety of long-term treatment with Ranexa compared to placebo.

 

Within 48 hours of the onset of angina due to acute coronary syndromes, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have been studied in previous Phase III clinical trials.

 

In addition to performing periodic safety assessments, an independent data safety monitoring board overseeing MERLIN TIMI-36 will conduct a blinded interim efficacy analysis, based on the endpoint of

 

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cardiovascular death, which is anticipated to occur after approximately half of the specified cardiovascular events have been observed. A p-value of 0.001 would be required to stop the study early at the time of the interim efficacy analysis. We believe it would be unlikely for MERLIN TIMI-36 to achieve this with only approximately half of the patients enrolled, and so we do not expect the study to be stopped at the time of the interim efficacy analysis. In addition, a blinded interim assessment of sample size also will occur, which will permit the overall study size to expand to approximately 6,500 patients if the overall mortality rate needed to complete the study is significantly lower than anticipated.

 

The study’s duration will be event driven. It is expected to continue until 730 cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and 310 deaths from any cause have occurred. Approximately 500 to 600 study sites worldwide are expected to enroll patients. Based on historical clinical trial information from the TIMI Study Group, preliminary data could be available by the end of 2006.

 

In March 2004, we filed a Marketing Authorization Application, or MAA, seeking approval of ranolazine for the treatment of chronic angina with the European Medicines Agency. The MAA was filed for review under the European regulatory authorities’ centralized procedure by our European subsidiary, CV Therapeutics Europe Limited.

 

While we believe that the safety and efficacy of Ranexa have been well characterized as part of our clinical development program, the final determination of the safety and efficacy of Ranexa will be made by the FDA and other relevant health authorities. Ranexa has not been determined by the FDA or any other regulatory authorities to be safe or effective in humans for any use.

 

This excerpt taken from the CVTX 10-K filed Mar 14, 2005.

Ranexa Development Status

 

Our new drug application, or NDA, for Ranexa seeking FDA approval for the treatment of chronic angina was submitted to the FDA in December 2002. The NDA contained data from more than 3,300 angina patients and subjects, and from more than 25,000 electrocardiograms. Our two Phase III clinical trials of Ranexa, the Monotherapy Assessment of Ranolazine in Stable Angina trial, or MARISA, and the Combination Assessment of Ranolazine in Stable Angina trial, or CARISA, were randomized, double-blind, placebo controlled trials. MARISA evaluated Ranexa when used in patients who were not receiving other anti-anginal drugs. CARISA evaluated Ranexa when used in patients who were receiving either a beta-blocker or a calcium channel blocker. In both of these trials, Ranexa statistically significantly increased patients’ symptom-limited exercise duration at trough drug concentrations compared to placebo. Additionally, in CARISA, Ranexa significantly reduced the frequency of angina attacks and the use of nitroglycerin to relieve angina pain, both secondary endpoints of the study. In both of these trials, Ranexa had no clinically meaningful impact on heart rate or blood pressure, either at rest or following exercise. In these trials, the most common adverse events included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). Adverse event frequency increased as dose increased. In addition, small but statistically significant increases in the corrected QT measurement on the electrocardiogram, or QTc, were observed compared to placebo.

 

On October 30, 2003 we received an approvable letter from the FDA for our NDA for Ranexa for the treatment of chronic angina. In the approvable letter, the FDA indicated that Ranexa is approvable, that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. After a meeting with the FDA’s Cardiovascular and Renal Drugs Advisory Committee of the FDA and subsequent discussions with the FDA, we reached written agreement with the FDA in June 2004 on a protocol for a clinical trial of Ranexa which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA’s special protocol assessment, or SPA, process.

 

The SPA process creates a written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application. In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise. However, even with an SPA in place, the FDA retains broad discretion in interpreting the data and making regulatory decisions, and there is no guarantee of regulatory approval.

 

We initiated this potentially approval-enabling clinical study, known as the Evaluation of Ranolazine In Chronic Angina, or ERICA, in August 2004 and completed patient enrollment in November 2004. Initial data from the ERICA study are expected in the second quarter of 2005. ERICA is a multi-national, double-blind,

 

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randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients were randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period. Prior to entering the study, patients were required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have had documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina. Physicians were able to include long-acting nitrates as background therapy at the start of the study.

 

The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, ERICA is estimated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo, in a secondary endpoint of the CARISA study.

 

Other objectives of ERICA are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and on quality of life.

 

If the ERICA study is successful, we would expect to submit an amendment to our Ranexa NDA to the FDA in the second half of 2005, seeking approval of Ranexa for the treatment of chronic angina in a restricted patient population.

 

In July 2004, we also reached written agreement with the FDA on a second, separate SPA for a study, the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes study, or MERLIN TIMI-36. This SPA agreement defines a path to potential approval of Ranexa as first-line therapy in the chronic angina population. Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based and long-term prevention of acute coronary syndromes. In addition, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the study could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. However, in order to obtain potential approval as first-line angina therapy, under the SPA we also need to perform a separate successful clinical evaluation of higher doses of Ranexa.

 

The MERLIN TIMI-36 study was initiated in October 2004 and is being conducted by the Harvard-based TIMI Study Group.

 

MERLIN TIMI-36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes receiving standard therapy. The study also is evaluating the safety of long-term treatment with Ranexa compared to placebo.

 

Within 48 hours of the onset of angina due to acute coronary syndromes, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have been studied in previous Phase III clinical trials.

 

In addition to performing periodic safety assessments, an independent data safety monitoring board overseeing MERLIN TIMI-36 will conduct a blinded interim efficacy analysis, based on the endpoint of

 

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cardiovascular death, which is anticipated to occur after approximately half of the specified cardiovascular events have been observed. A p-value of 0.001 would be required to stop the study early at the time of the interim efficacy analysis. We believe it would be unlikely for MERLIN TIMI-36 to achieve this with only approximately half of the patients enrolled, and so we do not expect the study to be stopped at the time of the interim efficacy analysis. In addition, a blinded interim assessment of sample size also will occur, which will permit the overall study size to expand to approximately 6,500 patients if the overall mortality rate needed to complete the study is significantly lower than anticipated.

 

The study’s duration will be event driven. It is expected to continue until 730 cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and 310 deaths from any cause have occurred. Approximately 500 to 600 study sites worldwide are expected to enroll patients. Based on historical clinical trial information from the TIMI Study Group, preliminary data could be available by the end of 2006.

 

In March 2004, we filed a Marketing Authorization Application, or MAA, seeking approval of ranolazine for the treatment of chronic angina with the European Medicines Agency. The MAA was filed for review under the European regulatory authorities’ centralized procedure by our European subsidiary, CV Therapeutics Europe Limited.

 

While we believe that the safety and efficacy of Ranexa have been well characterized as part of our clinical development program, the final determination of the safety and efficacy of Ranexa will be made by the FDA and other relevant health authorities. Ranexa has not been determined by the FDA or any other regulatory authorities to be safe or effective in humans for any use.

 

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