——Collaboration Broadens Reach of VAZKEPA to Additional Ten Countries Leveraging Lotus’ Established Commercial Expertise in the RegionCollaboration Broadens Reach of VAZKEPA to Additional Ten Countries Leveraging Lotus’ Established Commercial Expertise in the Region——
Taipei, Taiwan, and DUBLIN, Ireland, BRIDGEWATER, N.J., August 1, 2023–Lotus Pharmaceutical (1795:TT; “Lotus”) and Amarin Corporation plc (NASDAQ:AMRN) today announced that the two companies have entered into a long-term exclusive partnership to distribute and commercialize VAZKEPA® (icosapent ethyl) across 10 countries, including nine in Southeast Asia (the Association of Southeast Asian Nations - ASEAN) and South Korea.
VAZKEPA capsules have been approved and commercialized in a number of global markets, including the U.S. and European markets, as the first prescription treatment comprised solely of the active ingredient, icosapent ethyl, a highly purified form of eicosapentaenoic acid.
Patrick Holt, President & CEO of Amarin, said, "We are excited to announce this exclusive partnership with Lotus, a leading pharmaceutical commercialization partner in Asia, Lotus’ strong commercialization capabilities and footprint across ASEAN markets and South Korea make them the ideal partner to help us expand patient access to VAZKEPA -- an innovative treatment option to reduce cardiovascular risk -- across the region and fuel our international growth.”
Petar Vazharov, Chief Executive Officer of Lotus, commented, "We are thrilled to embark on this strategic partnership with Amarin. This agreement aligns seamlessly with Lotus' strategic objective to bring novel and transformative treatments to patients and allows us the opportunity to further leverage our commercial infrastructure that we have built in key markets across Asia."
The ASEAN region and South Korea includes a total of 14 million statin-treated patients representing a total hyperlipidemia market of approximately $2 billion.[i] The largest markets within the ASEAN region include, Thailand, Malaysia, Philippines.i Cardiovascular disease (CVD) remains the leading cause of morbidity, mortality, and health care costs in South Korea. [ii]
Under the terms of the agreement, Lotus will have exclusive rights to distribution and commercial promotion for VAZKEPA in South Korea and nine countries in ASEAN: Brunei, Cambodia, Indonesia, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. As part of the agreement, Amarin will receive upfront payment as well as pricing and reimbursement and sales milestone payments based on net sales of the product. Amarin will be responsible for supplying finished product to Lotus at a pre-defined supply price.
· VAZKEPA is the first and only pure EPA omega 3 prescription product approved and commercialized in the US and European markets.
· It is an innovative and clinically proven medication designed to reduce the risk of cardiovascular event in patients.
· This will mark a significant advancement in cardiovascular health solutions for patients across the region.
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.
About Lotus Pharmaceutical
Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safer, and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.
About VAZKEPA® (icosapent ethyl) Capsules
VAZKEPA capsules are the first prescription treatment comprised solely of the active ingredient, icosapent ethyl, a highly purified form of eicosapentaenoic acid. Since launch, icosapent ethyl has been prescribed over 18 million times. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, the United Arab Emirates under the brand name VASCEPA. In March 2021, marketing authorization was granted to icosapent ethyl in the European Union under the brand name VAZKEPA to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and established cardiovascular disease or diabetes and at least one other cardiovascular risk factor. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria and the UK.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s regulatory approval in Switzerland and the potential impact in that country; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2022. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Lotus Contact Information:
Susan Liao, IR/PR Director
+886 2 2700 5908
1Vazkepa®(icosapent ethyl): Summary of Product Characteristics. Available from:https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf [accessed Nov 2022]
[i] Source: IQVIA MAT 1Q 2022
[ii] Implementation of National Health Policy for the Prevention and Control of Cardiovascular Disease in South Korea: Regional-Local Cardio-Cerebrovascular Center and Nationwide Registry. Korean Circulation Journal 2021; 51(5): 383-398. Published online: 12 April 2021