Latest news with #Esperion
Yahoo
12-05-2025
- Business
- Yahoo
Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
ANN ARBOR, Mich., May 12, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited (together, Micro Labs). This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs' Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Micro Labs has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur. The pending patent litigation against the remaining defendants (Accord Healthcare Inc; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy's Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040. About Esperion TherapeuticsEsperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding pending patent litigation and other statements containing the words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'predict,' 'project,' 'suggest,' 'target,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'continue,' and similar expressions. Any express or implied statements contained in this press release 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, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. Esperion Contact Information:Investors: Alina Veneziainvestorrelations@ (734) 887-3903 Media: Tiffany Aldrich corporateteam@ (616) 443-8438Sign in to access your portfolio
Yahoo
09-05-2025
- Business
- Yahoo
HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines
HLS Therapeutics has signed an agreement with Esperion Therapeutics for in-licensing and commercialising the oral cardiovascular medicines, Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) in Canada. HLS's agreement with Esperion includes an upfront payment of $1m, another $1m upon Health Canada's approval, customary royalties on future sales, and potential milestone payments related to pricing, reimbursement, and significant commercial sale goals. In addition, Esperion will obtain an upfront payment and be qualified for milestone payments of up to nearly $5m alongside tiered royalties on product sales. HLS plans to fund all upfront and milestone-based payments, as well as related launch expenses, via current cash reserves, negating the need for additional financing. The company also plans to utilise its existing commercial infrastructure, expecting no significant increase in operating costs. HLS is tasked with receiving approval for these medicines from Health Canada, which is anticipated by the end of this year. These medications are currently available in various European nations and the US. The US Food and Drug Administration (FDA) initially approved the medicines in 2020 for cutting low-density lipoprotein cholesterol (LDL-C) levels. In 2024, their indications were expanded to include cardiovascular risk minimisation in individuals who are not to take recommended statin therapy. This decision was supported by data from the CLEAR Outcomes trial. In fourth quarter (Q4) of 2024, Esperion made new drug submissions to Health Canada for both medicines. The brand names for these drugs in Canada will be confirmed upon approval from the country's regulator. HLS noted that more than half a million individuals in Canada could potentially benefit from these treatments, particularly those with elevated levels of LDL-C and those who are either statin intolerant or not meeting LDL-C goals in spite of statins and ezetimibe combination therapy. HLS Therapeutics CEO Craig Millian said: "We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease.' "HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-05-2025
- Business
- Yahoo
HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada
– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians – HLS will leverage existing organizational capabilities and commercial infrastructure – Already approved and commercially available in the U.S. and Europe, NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year – Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives TORONTO, May 8, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ: ESPR) to in-license and commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated. In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial. Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe. "We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease," said Craig Millian, CEO at HLS. "Adding NEXLETOL and NEXLIZET to the HLS product portfolio is aligned with our stated BD strategy and will strengthen our position in the Canadian cardiovascular market." "We are pleased to partner with HLS to provide advanced cardiovascular treatment options to patients across Canada," said Sheldon Koenig, President and CEO of Esperion. "HLS is highly regarded within Canada for their strong capabilities and relationships in the cardiovascular therapeutic area. This collaboration furthers Esperion's commitment to addressing cardiovascular and cardiometabolic diseases globally." The agreement includes an upfront payment of $1 million, an additional $1 million upon Health Canada approval, customary royalties on future sales, and potential milestone payments tied to pricing and reimbursement and achievement of significant commercial sales targets. HLS will fund all upfront and milestone-based payments, along with associated launch costs, through existing cash reserves without requiring additional financing. Furthermore, the company intends to leverage current commercial infrastructure and does not anticipate a significant increase in operating expenses will be required. ABOUT HLS THERAPEUTICS in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: ABOUT ESPERION THERAPEUTICSEsperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on LinkedIn and REFERENCES1: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada to be confirmed upon approval by Health Canada. FORWARD LOOKING INFORMATIONThis release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated May 7, 2025, both of which have been filed on SEDAR+ and can be accessed at Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. SOURCE HLS Therapeutics Inc. View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-05-2025
- Business
- Yahoo
Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada
– Esperion to Receive an Upfront Payment, Near-Term Milestones and Tiered Royalties on Product Sales – – Further Expands Global Access to Bempedoic Acid Products and Provides Opportunity to Bring Innovative Preventative Therapy to 2.6 million Canadians Living with Diagnosed Heart Disease – ANN ARBOR, Mich., May 08, 2025 (GLOBE NEWSWIRE) -- Esperion Therapeutics (NASDAQ: ESPR) today announced it has entered into a license and distribution agreement with HLS Therapeutics (TSX:HLS) for the exclusive rights to commercialize NEXLETOL* and NEXLIZET* in Canada. Under the terms of the agreement, Esperion will receive an upfront payment, near-term milestone and tiered royalties on product sales. Esperion will be responsible for supplying finished product to HLS Therapeutics at a profitable transfer price. According to the Government of Canada, approximately one in 12 Canadian adults aged 20 and over, which represents 2.6 million people, are living with diagnosed heart disease. It is the second leading cause of death in Canada, with approximately 14 Canadian adults aged 20 and over dying every hour due to diagnosed heart disease. 'We are excited about the opportunity to partner with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease,' said Craig Millian, CEO at HLS. 'We're thrilled to collaborate with HLS to expand the reach of our therapies to patients throughout Canada who are at risk of cardiovascular disease,' said Sheldon Koenig, President and CEO of Esperion. 'This collaboration underscores and supports our commitment to expand global access to our potentially life-saving therapies.' Details of the Agreement and Financial TermsUnder the terms of the license and distribution agreement, Esperion will grant HLS Therapeutics exclusive commercialization rights to NEXLETOL and NEXLIZET in Canada. HLS Therapeutics will be responsible for commercialization, including reimbursement and marketing. Esperion will receive an upfront payment and be eligible for milestone payments of up to approximately $5 million along with tiered royalties on product sales. *NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada to be confirmed upon approval by Health Canada. About HLS TherapeuticsFormed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: About Esperion TherapeuticsEsperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'predict,' 'project,' 'suggest,' 'target,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'continue,' and similar expressions. Any express or implied statements contained in this press release 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, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. Esperion Contact Information:Investors: Alina Veneziainvestorrelations@ (734) 887-3903 Media: Tiffany Aldrich corporateteam@ (616) 443-8438
Cision Canada
08-05-2025
- Business
- Cision Canada
HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada
– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians – HLS will leverage existing organizational capabilities and commercial infrastructure – Already approved and commercially available in the U.S. and Europe, NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year – Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives TORONTO, May 8, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ: ESPR) to in-license and commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated. In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET 1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial. Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe. "We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease," said Craig Millian, CEO at HLS. "Adding NEXLETOL and NEXLIZET to the HLS product portfolio is aligned with our stated BD strategy and will strengthen our position in the Canadian cardiovascular market." "We are pleased to partner with HLS to provide advanced cardiovascular treatment options to patients across Canada," said Sheldon Koenig, President and CEO of Esperion. "HLS is highly regarded within Canada for their strong capabilities and relationships in the cardiovascular therapeutic area. This collaboration furthers Esperion's commitment to addressing cardiovascular and cardiometabolic diseases globally." The agreement includes an upfront payment of $1 million, an additional $1 million upon Health Canada approval, customary royalties on future sales, and potential milestone payments tied to pricing and reimbursement and achievement of significant commercial sales targets. HLS will fund all upfront and milestone-based payments, along with associated launch costs, through existing cash reserves without requiring additional financing. Furthermore, the company intends to leverage current commercial infrastructure and does not anticipate a significant increase in operating expenses will be required. ABOUT HLS THERAPEUTICS INC. Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: ABOUT ESPERION THERAPEUTICS Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on LinkedIn and REFERENCES 1: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada to be confirmed upon approval by Health Canada. FORWARD LOOKING INFORMATION This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated May 7, 2025, both of which have been filed on SEDAR+ and can be accessed at Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. SOURCE HLS Therapeutics Inc.
