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Co-Principal Investigators : A. Michael Lincoff M.D., Cleveland Clinic, and Stephen Nicholls M.D., Monash University in Melbourne. A randomized, double-blind, placebo controlled study to assess the effects of NEXLETOL on the occurrence of major cardiovascular events in patients with, or at high risk for, CVD who are statin intolerant. INTELLECTUAL PROPERTY FOR BEMPEDOIC ACID Composition of matter through mid-2031(inclusive of available patent term extensions) Various methods of use, manufacturing, and formulation expected to expand coverage through at least 2036 Composition of matter through 2028 (inclusive of available patent term extensions) 10 years of post-approval data market exclusivity (Q2 2030) Various methods of use, manufacturing, and formulation expected to expand coverage through at least 2036 Composition of matter through 2028 (inclusive of available patent term extensions) Eight years of post-approval data market exclusivity (2031/2032) Various methods of use, manufacturing, and formulation expected to expand coverage through at least 2036 31 2020 Esperion Therapeutics, Inc.
Avoid concomitant use with simvastatin (>20 mg/day) or pravastatin (>40 mg/day). Monitor cyclosporine concentrations with cyclosporine. If cholelithiasis is suspected in a patient receiving fenofibrate, consider alternative lipid-lowering therapy. Most common adverse events generally comparable to placebo. Most common adverse reactions in >2% of patients taking NEXLIZET and more frequently than placebo: Upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, fatigue, influenza, sinusitis, and arthralgia Adverse events reported less frequently but still more often than in placebo included benign prostatic hyperplasia and atrial fibrillation This summary does not reflect the full safety profile - see https://pi.esperion.com/nexlizet/nexlizet-pi.pdf 29 2020 Esperion Therapeutics, Inc.
Tendon Rupture: NEXLETOL is associated with an increased risk of tendon rupture. Avoid concomitant use with simvastatin (>20 mg/day) or pravastatin (>40 mg/day) due to increased risk of adverse events. Most common adverse events generally comparable to placebo. Most common adverse reactions in 2% of patients taking NEXLETOL and more frequently than placebo: Upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes Adverse events reported less frequently but still more often than in placebo included benign prostatic hyperplasia and atrial fibrillation This summary does not reflect the full safety profile - please see https://pi.esperion.com/nexletol/nexletol-pi.pdf 27 2020 Esperion Therapeutics, Inc.
Limitations of Use: The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined. Oral, once-daily, non-statin medicines, with no need to titrate dose ACL inhibition, a first-in-class mechanism of action complementary to statins Safety profiles with incidence of most common adverse events generally comparable to placebo Significant additional LDL-C lowering as an add-on to maximally tolerated statin therapy 12 2020 Esperion Therapeutics, Inc.
Any express or implied statements contained in this presentation that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, delays or failures in Esperion's land commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission.