DUBLIN and BRIDGEWATER, N.J. - Amarin (NASDAQ:AMRN) Corporation plc (NASDAQ:AMRN) announced today that its partner, EddingPharm, has received approval from China's National Medical Products Administration (NMPA) for VASCEPA® (icosapent ethyl), a medication aimed at reducing cardiovascular risk.
The approval is specific to adult patients with elevated triglyceride levels (≥150mg/dL) who are already undergoing statin therapy and have established cardiovascular disease or diabetes with additional risk factors.
This regulatory milestone enables VASCEPA to be used as an adjunct to statin therapy to lower the risk of cardiovascular events in a population that is increasingly affected by cardiovascular diseases (CVD). Statistics indicate that CVD accounts for nearly half of all deaths in urban and rural China, with an estimated 330 million Chinese patients suffering from the condition.
The approval of VASCEPA is seen as a significant advancement in addressing the unmet clinical needs of Chinese patients at risk of cardiovascular events. In anticipation of increased demand, EddingPharm is working towards including VASCEPA on the National Reimbursement Drug Listing (NRDL), which would facilitate broader access by providing full or partial reimbursement at the national level.
As part of the approval process, NMPA has requested a post-approval study from EddingPharm to verify the efficacy of VASCEPA in reducing cardiovascular risk among Chinese patients. This study is a requirement for the product's renewal five years post-approval.
Under the terms of their partnership, EddingPharm will manage development and commercialization within China, while Amarin is tasked with supplying the finished bulk product. Amarin is set to receive a $15 million regulatory milestone payment and will earn tiered double-digit percentage royalties on net sales of VASCEPA in China.
VASCEPA is the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, and has been prescribed more than 20 million times since its initial launch. The medication is also approved and sold in several other countries, including Canada and members of the European Union under the brand name VAZKEPA.
This report is based on a press release statement from Amarin Corporation plc.
In other recent news, Amarin Corporation has seen a series of significant developments. The company announced a major leadership change, with Aaron Berg stepping in as the new President and CEO. Berg, who brings over three decades of experience in the biopharmaceutical industry, has been with the company since 2012 and has held various leadership roles.
The company's drug, VAZKEPA, gained reimbursement approval in Greece, marking the seventh such approval in Europe. This decision allows statin-treated adult patients with elevated triglycerides and high-risk factors for cardiovascular events to access the medication as a preventive treatment. The company has partnered with Vianex S.A., a Greek pharmaceutical company, for the distribution and commercialization of VAZKEPA in Greece.
On the financial front, Amarin reported mixed Q1 2024 results with net revenue declining to $56.5 million due to generic competition. However, the company experienced a 65% growth in European in-market sales, particularly in Spain and the UK.
Despite facing a net loss of $10 million in Q1, Amarin maintains a strong cash position of $308 million and has initiated a shareholder-approved $50 million share repurchase program. These recent developments reflect Amarin's strategic focus on expanding in key European markets and driving profitability.
InvestingPro Insights
Following the approval of VASCEPA in China, Amarin Corporation plc (NASDAQ:AMRN) is poised to expand its international footprint in a substantial market. As investors consider the implications of this development, key financial metrics and analyst insights from InvestingPro offer a deeper understanding of the company's current position. Amarin's market capitalization stands at $302.6 million, reflecting the market's valuation of the company after considering its outstanding share count.
Amidst the challenges, Amarin holds more cash than debt on its balance sheet, according to an InvestingPro Tip, which could provide financial flexibility as they navigate new territory in the Chinese market. Additionally, while analysts anticipate a sales decline in the current year, another InvestingPro Tip notes that the company is trading at a low revenue valuation multiple, which might suggest that the stock is undervalued relative to its revenue.
From a financial standpoint, the company's price-to-book ratio as of the last twelve months ending Q1 2024 is 0.55, indicating that the stock may be trading below the value of its assets. Furthermore, despite a revenue decline of 23.04% over the last twelve months as of Q1 2024, Amarin boasts a gross profit margin of 63.61%, which highlights its ability to maintain profitability on the cost of goods sold.
For investors interested in a comprehensive analysis of Amarin's financials and future outlook, InvestingPro provides additional tips, with the full list available at: https://www.investing.com/pro/AMRN. Don't forget to use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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