FACT-MASTER
3 hours ago
ESPR: Esperion Receives Five Year Patent Extension for Bempedoic Acid, Contained in NEXLETOL® and NEXLIZET®
https://finance.yahoo.com/news/esperion-receives-five-patent-extension-120000020.html
Esperion Therapeutics, Inc.
ANN ARBOR, Mich., May 14, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S. Patent and Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE) certificate for bempedoic acid, which is contained in NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.
This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
INDICATION
NEXLIZET and NEXLETOL are indicated:
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
established cardiovascular disease (CVD), or
at high risk for a CVD event but without established CVD.
As an adjunct to diet:
NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
FACT-MASTER
6 days ago
https://www.sec.gov/ix?doc=/Archives/edgar/data/1434868/000162828024021717/espr-20240508.htm
Item 8.01. Other Events.
As previously disclosed, in March and April 2024, Esperion Therapeutics, Inc. (“Esperion”) received notice letters from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL® (bempedoic acid) Tablet and three of which filed with respect to NEXLETOL and NEXLIZET® (bempedoic acid and ezetimibe) Tablet (each, an “ANDA Filer”), notifying Esperion that each company had filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
On May 8, 2024, Esperion filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against Micro Labs USA Inc. (along with an affiliate), an ANDA Filer with respect to NEXLETOL. Esperion’s complaint alleges that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s Orange Book patents included in its Paragraph IV certifications, and seek an injunction preventing FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL until the expiration of the asserted patents. Esperion intends to file similar patent infringement lawsuits under the Hatch-Waxman Act against the other ANDA Filers with respect to NEXLETOL and/or NEXLIZET, as applicable.
The ANDAs each contained Paragraph IV certifications alleging that certain of Esperion’s Orange Book listed patents covering NEXLETOL or NEXLIZET, as applicable, are invalid and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted.
Esperion intends to vigorously defend its intellectual property. The filing of the lawsuit within 45 days of receipt of the notice letter from the applicable ANDA filer triggered a stay of FDA approval of such ANDA for up to 30 months following the expiry of the New Chemical Entity exclusivity in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, statements related to anticipated patent infringement litigation. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: fluctuations in the Company’s stock price, changes in market conditions, and the risks detailed in the Company’s filings with the Securities and Exchange Commission (the “Commission”), including in the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of their respective dates, and the Company disclaims any obligation or undertaking to update or revise any forward-looking statements, other than to the extent required by law.
FACT-MASTER
1 week ago
ESPR: Esperion Reports First Quarter 2024 Financial Results
https://finance.yahoo.com/news/esperion-reports-first-quarter-2024-100000893.html
Esperion Therapeutics, Inc.
– Q1 Total Revenue Grew 467% Y/Y to $137.7 Million, Reflecting Strong Growth Globally –
– Q1 U.S. Net Product Revenue Grew 46% Y/Y to $24.8 Million –
– Q1 Retail Prescription Equivalents Grew 43% Y/Y and 6% Q/Q, Increased Momentum from Label Expansions Expected Throughout 2024 –
– Received U.S. FDA Approval of Broad New Label Expansions for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet, Becoming the First LDL-C Lowering Non-Statins to Prevent Heart Attacks and Reduce Cardiovascular Risk in Primary and Secondary Prevention Patients –
– Received Positive Opinion from the Committee for Medical Products for Human Use (CHMP); European Commission Decision for Expanded Labels Anticipated in Q2 2024 –
– Conference Call and Webcast Today at 8:00 a.m. ET –
ANN ARBOR, Mich., May 07, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the first quarter ended March 31, 2024, and provided a business update.
“We are proud of our strong start to 2024 and the continued momentum and growth we again delivered in the first quarter,” said Sheldon Koenig, President and CEO. “We posted retail prescription equivalent growth of 43% year-over-year, generated our highest level of revenue yet, and ended the quarter with a cash balance that positions us to capitalize on our new label and deliver long term value growth.”
“We also received FDA approval of our highly anticipated label expansions for NEXLETOL and NEXLIZET, which we believe positions us for a meaningful uptick in growth. As the only oral LDL-cholesterol (LDL-C) lowering non-statins approved for reducing cardiovascular risk in both primary and secondary prevention patients, our expanded labels will enable us to potentially reach more than 70 million new patients in need of an alternative therapy. We believe this approval brings us closer to bridging the statin gap, which encompasses an underserved patient population that is unable to reach their LDL-C goal on current therapies alone.”
“We have prioritized investment in our commercial strategy, including ramping up our sales force, launching our new Lipid Lurker consumer campaign, developing a suite of new promotional materials, and initiating partnerships to provide improved interim access with the payer and patient communities. We’re also pleased to report utilization management criteria updates that will be made by two major payers in the next two months that covers 40 million lives, and anticipate additional payers aligning with our new labels on a weekly basis. Looking to our global ex-U.S. franchise., our partner Daiichi Sankyo Europe (DSE) continued to drive increased sales across newly launched territories, signaling the growth potential of these products globally. In summary, with our reinforced commercial infrastructure and recent payer wins, we are poised for significant growth and I look forward to sharing our progress in the coming quarters.”
First Quarter 2024 Key Accomplishments and Recent Highlights
Granted expanded label from the FDA for NEXLETOL and NEXLIZET on March 22, 2024. The label expansion added prevention of heart attacks and reduction of cardiovascular risk as indications and expanded the LDL-C lowering indication to include use with or without a statin. The updates to the label expand accessibility by approximately 70 million patients in the U.S.
Initiated new commercial initiatives to increase patient awareness of NEXLETOL and NEXLIZET’s expanded labels. Expanded our sales force to 150 representatives in the U.S. and developed new promotional materials and tools to supplement salesforce efforts. Initiated partnerships to provide interim patient access while working with payers to update utilization management criteria and streamline transition to the new and expanded labels.
Received positive opinions from the Committee for Medical Products for Human Use (CHMP) of the European Medical Agency (EMA) on March 22, 2024. The opinions were based on the updated label of NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed dose combination), which were recommended for the reduction of LDL-C and cardiovascular risk. The European Commission is expected to deliver its determination on the pending label update applications in the second quarter of 2024.
Reported royalty revenue of $6.6 million in the first quarter, representing a year-over-year increase of 164%. DSE launched in the Netherlands, Czech Republic, and Slovakia during the first quarter of 2024. Daiichi Sankyo Company, Limited (“DS ASCA”) received approvals in Thailand and Myanmar during the first quarter of 2024.
Presented prespecified subgroup analyses from the CLEAR Outcomes trial at ACC 2024. The subgroup analyses evaluated key underserved and understudied populations, including patients with obesity, women, and Hispanics/Latinx. CLEAR Outcomes enrolled 48% women and 17% Hispanic/Latinx patients, setting a new standard for diversity and inclusion in clinical trials. NEXLETOL demonstrated a 23% reduction in major adverse cardiovascular events (MACE-4) versus placebo in obese patients and had clinical benefits in women and Hispanic/Latinx patients with and without cardiovascular disease.
Initiated the technology transfer process for NILEMDO and NUSTENDI tablet manufacturing to DSE for its territories, which we expect to be completed in the second half of 2025. Additionally, as part of our amended partnership, we authorized DSE to proceed with commercialization of a triple formulation product comprising bempedoic acid, ezetimibe, and a statin, which, if approved, has the potential to meaningfully extend the product’s lifecycle in Europe.
Our collaboration with Otsuka in Japan remains on track, with Otsuka’s phase III study expected to close out in Q2 2024, an anticipated Japan New Drug Application (JNDA) filing in late 2024, and approval and National Health Insurance (NHI) pricing in 2025.
First Quarter 2024 Financial Results
Total revenue was $137.7 million, compared to $24.3 million for the comparable period in 2023, an increase of approximately 467%.
U.S. net product revenue was $24.8 million, compared to $17.0 million for the comparable period in 2023, an increase of approximately 46%, driven by retail prescription growth of 43%.
Collaboration revenue was $113.0 million, compared to $7.3 million for the comparable period in 2023, an increase of 1,448%, driven by increased tablet sales to our international partners and sales growth within partner territories along with the settlement related milestone payment.
Research and development expenses were $13.4 million, compared to $31.4 million for the comparable period in 2023, a decrease of 57%. The decrease is primarily related to the close-out of our CLEAR Outcomes study.
Selling, general and administrative expenses were $42.0 million, compared to $29.9 million for the comparable period in 2023, an increase of 40%. The increase is primarily related to the ramp up of our sales force ahead of our commercial launch in addition to bonus payments and promotional costs.
Total net income for the quarter was $61.0 million, compared to a net loss of $61.7 million for the comparable period in 2023.
Basic net income per share was $0.36, compared to basic and diluted net loss per share of $0.79 for the comparable period in 2023. Diluted net income per share was $0.34.
As of March 31, 2024, cash and cash equivalents totaled $226.6 million, which includes our legal settlement and $90.7 million in net proceeds from our underwritten public offering in January 2024, compared with $82.2 million as of December 31, 2023.
The Company ended the quarter with approximately 187.9 million shares of common stock outstanding, excluding 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt financing.
2024 Financial Outlook
The Company still expects full year 2024 operating expenses to be approximately $225 million to $245 million, including $20 million in non-cash expenses related to stock compensation.
Conference Call and Webcast Information
Esperion will host a webcast at 8:00 a.m. ET to discuss financial results and business progress. Please click here to pre-register to participate in the conference call and obtain your dial in number and PIN.
A live audio webcast can be accessed on the investor and media section of the Esperion website at esperion.com/investor-relations/events. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company's website for approximately 90 days.
INDICATION
NEXLIZET and NEXLETOL are indicated:
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
established cardiovascular disease (CVD), or
at high risk for a CVD event but without established CVD.
As an adjunct to diet:
NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in =2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
Adverse reactions reported in =2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence =3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of =2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
FACT-MASTER
3 months ago
Esperion Therapeutics (ESPR) Expected to Beat Earnings Estimates: Can the Stock Move Higher?
Esperion Therapeutics (ESPR) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus Estimate
This biopharmaceutical company is expected to post quarterly loss of $0.53 per share in its upcoming report, which represents a year-over-year change of +30.3%.
Revenues are expected to be $26.84 million, up 42.6% from the year-ago quarter.
Estimate Revisions Trend
The consensus EPS estimate for the quarter has been revised 10.09% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Earnings Whisper
Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Esperion Therapeutics?
For Esperion Therapeutics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +24.53%.
On the other hand, the stock currently carries a Zacks Rank of #2.
So, this combination indicates that Esperion Therapeutics will most likely beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?
Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Esperion Therapeutics would post a loss of $0.42 per share when it actually produced a loss of $0.37, delivering a surprise of +11.90%.
Over the last four quarters, the company has beaten consensus EPS estimates three times.
Bottom Line
An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Esperion Therapeutics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
FACT-MASTER
3 months ago
ESPR: Promotional Schedule - 2024
https://finance.yahoo.com/news/rfk-esperion-therapeutics-announce-2024-190000171.html
NEXLETOL and NEXLIZET to Ride Along RFK Mustangs in Four Races in 2024
CONCORD, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- RFK Racing and Esperion Therapeutics have announced the promotional schedule for the 2024 season, highlighted by a four-race slate, and numerous accompanying campaigns and initiatives, all driving awareness of its two brands – NEXLIZET (bempedoic acid and ezetimibe) and NEXLETOL (bempedoic acid) used for adults on a statin to reduce LDL-cholesterol.
Esperion’s season debut comes in the first race at Richmond this spring (March 31) on the No. 17 of Chris Buescher. Brad Keselowski’s debut with the brand comes at the All-Star Race at North Wilkesboro (May 19). Remaining races include Pocono on the No. 6 (July 14), and the fall Talladega event on the No. 17 (Oct. 6).
RFK and Esperion will collaborate to wave the red flag for uncontrolled cholesterol by promoting a myriad of campaigns, including National Wear Red Day, American Heart Month, Stress Awareness Month, Women’s Health Awareness Month, Men’s Health Awareness Month, a Wellness Walk, Cholesterol Education Month, World Heart Day, National Health Education Week, and Family Health History Day.
In addition, Buescher will attend the annual American College of Cardiology (ACC) session on behalf of Esperion, in April in Atlanta. RFK will also promote the brand’s NASCAR Digital Media buy, which will include various graphics packages on NASCAR.com, as well as an in-car camera on the No. 6 for the second Talladega race.
Esperion is also partnering with Pocono Raceway to host a Wellness Walk the Saturday morning of its race weekend, which will invite fans in attendance to walk a secured route inside the infield alongside Keselowski, all promoting wellness and general awareness for staying in-tune to their cholesterol levels. NEXLIZET should not be used in patients who have had a previous allergic reaction to ezetimibe. NEXLIZET and NEXLETOL can increase levels of uric acid in the blood which can lead to gout.
“Our partnership thus far with RFK has proven to be very successful in many facets, and we’re excited to again embark on a new journey with the team in 2024,” said Sheldon Koenig, CEO, Esperion. “As you can see, we have a robust marketing campaign lined up that highlights our various combined efforts on promoting everything from cholesterol awareness to various additional health awareness months. Our race schedule is exciting with tracks where RFK, Brad and Chris have excelled in the past, and we look forward to seeing the NEXLIZET and NEXLETOL Fords in victory lane very soon.”
Esperion 2024 Promotional Calendar
Feb. 2: National Wear Red Day
Feb. 6: American Heart Month video
Feb. 8: Prize pack giveaway
March 26-April 1: NASCAR.com race center takeover
April 2: Stress Awareness Month video
April 8: Buescher Appearance at ACC
May 1: Women’s Health Awareness video
May 15-21: NASCAR.com paint scheme preview takeover
June 3: Men’s Health Awareness video
July 9: Wellness Walk advance promotion
July 10-16: NASCAR.com paint scheme amplification content
July 13: Wellness Walk at Pocono Raceway
Sept. 1: Cholesterol Education Month video
Sept. 29: World Heart Day video
Oct. 2-8: NASCAR.com paint scheme amplification content
Oct. 6: In-car camera
Oct. 21: National Health Education Week video
Nov. 23: Family Health History Day video
About Esperion
Esperion works hard to make our medicines easy to get, easy to take, and easy to have. We discover, develop, and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren’t being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. We are singularly focused on managing cholesterol so you can improve your health easily. For more information, please visit esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.
FACT-MASTER
4 months ago
ESPR: NY Legal case settled
https://finance.yahoo.com/news/esperion-daiichi-sankyo-europe-announce-120000052.html
– Near term payment to Esperion of $100 million plus $25 million in calendar quarter following EMA’s expected decision on Type II(a) variation approval of NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet –
– Amendment also includes transfer of certain manufacturing and supply rights to DSE and expansion of collaboration in Europe and other territories –
ANN ARBOR, Mich. & MUNICH, January 03, 2024--(BUSINESS WIRE)--Esperion Therapeutics, Inc. (NASDAQ: ESPR) and Daiichi Sankyo Europe GmbH (DSE) the European headquarter organization of the Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. (TSE: 4568), announced today a $125 million amendment to their collaboration, which includes an amicable resolution to their commercial dispute and certain other adjustments to enhance the long-term value of their products.
DSE has agreed to pay Esperion $100 million in mid-January ahead of an anticipated Type II(a) variation approval by the European Medicines Agency (EMA) for NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet. DSE will make an additional $25 million payment to Esperion in the calendar quarter immediately following EMA's decision on the pending application. The legal action pending in the United States District Court for the Southern District of New York will be dismissed.
The parties also agreed, as part of the resolution:
for Esperion to transition to DSE manufacturing and supply responsibilities in Europe and other territories, resulting in significant cost savings and efficiencies for both companies.
to expand their collaboration in Europe and other territories, to include the potential development and commercialization of a triple formulation product comprising bempedoic acid, ezetimibe and a statin, which could represent significant long-term value for the collaboration.
for DSE to now lead all regulatory communications with the EMA regarding the pending applications.
"We are pleased that this settlement creates value for Esperion today through cash payments and includes additional terms that will continue creating value for both companies going forward. Importantly, today’s settlement allows Esperion and DSE to focus on the business at hand – delivering life-saving drug therapies to millions with high cholesterol," said Sheldon Koenig, Esperion’s President and CEO. "Together, we are committed to making bempedoic acid a blockbuster franchise worldwide, based on the differentiating profiles of our products."
"This is a positive resolution for patients. We look forward to continuing to apply our combined strengths around the world to bring innovative pharmaceutical products to patients with cardiovascular disease, the greatest cause of death and disability globally," said Oliver Appelhans, Head of the Specialty Business Unit of Daiichi Sankyo Europe.
Since 2019, Esperion and DSE have worked together to bring bempedoic acid to the eligible patient population and unlock its potential for cardiovascular risk reduction. The partnership continues to grow, with DSE recently gaining approvals for bempedoic acid in the Netherlands, Slovakia, and Spain.
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