NEW YORK, Nov. 15, 2021 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Amarin Corporation PLC ("Amarin" or the "Company") (NASDAQ: AMRN) and certain of its officers. The class action, filed in the United States District Court for the District of New Jersey, and docketed under 21-cv-19911, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Amarin securities between December 5, 2018 and June 21, 2021, inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder by the Securities and Exchange Commission.
If you are a shareholder who purchased Amarin securities during the Class Period, you have until December 21, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Amarin is a biopharmaceutical company whose lead product since 2008 is Vascepa® (AMR-101) ("Vascepa"), a prescription grade ultra-pure omega-3 fatty acid derived from fish oil. In July 2012, the U.S. Food and Drug Administration ("FDA") first approved Vascepa to treat patients with very high levels of triglycerides ("TG"), a type of fat found in blood, and in December 2019, expanded the label to include the reduction of cardiovascular disease events, including heart attack, stroke, and cardiovascular death in high-risk patients.
To protect its market share, Amarin sought and obtained dozens of U.S. patents in connection with Vascepa, including for its formulation and method of use. Indeed, going into the Class Period, Vascepa stood to have patent protection until 2030, when the last patent was set to expire. At the same time, Amarin was engaged in patent litigation against applicants who submitted Abbreviated New Drug Applications ("ANDAs") for generic drug products of Vascepa—exposing the Company to real risks related to the validity and scope of coverage in its patent portfolio.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and misleading statements and/or failed to disclose that: (i) there was an increasingly high risk that certain of Amarin's patents would be invalidated; (ii) once the District Court invalidated certain of Amarin's patents, there was little to no chance of reversing that ruling; (iii) the Company's litigation was preventing it from effectuating a successful takeover; (iv) Defendants were downplaying the true threat the ongoing ANDA litigation posed to the Company's business and future prospects; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.
After markets closed on March 30, 2020, Defendants partially revealed the truth about the strength of Amarin's patent portfolio. That day, the Company announced that "the United States District Court for the District of Nevada's rul[ed] in favor of the generic companies in the company's patent litigation against two filers of abbreviated new drug applications, or ANDAs, for Amarin's VASCEPA® (icosapent ethyl) capsule franchise."
On this news, Amarin's share price plummeted over 70.5% to close at $4.00 on March 31, 2020, on heavy trading volume.
Analysts recognized that investors were beginning to learn about weaknesses in the patent protection the Company had touted. As Seeking Alpha ("SA") news editor Stephen Alpher noted in an article titled "Amarin plunges after court decision on Vascepa" on March 30, 2020, the Company "has lost its patent battle against generics."
To allay investor concerns, Defendant Thero provided reassurance that "[w]e believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics' lost profits in the event that generics prevail on appeal." Thus, despite Amarin's loss in the District Court, Defendants expressed confidence in the appeal, and in the strength of their patent portfolio and business prospects, boasting that the Company was continuing to pursue additional regulatory approval in other countries. Consequently, investors saw the potential for a revival of Amarin's key patents and still believed the Company was a viable M&A target.
Then, starting at 10:00 AM ET on September 2, 2020, the U.S. Court of Appeals for the Federal Circuit held an oral argument for the Company's patent litigation. The very next day, the Federal Circuit affirmed the District Court's ruling.
As the oral argument had progressed and the Federal Circuit's ruling had become known to investors, Amarin's share price fell over 34.5% to close at $4.30 on September 4, 2020, on heavy trading volume, as the truth about the Company's patent portfolio continued to emerge.
As SA news editor Douglas W. House noted on September 2, 2020, "arguments by attorneys representing the company are not going that well. Shares are down 27% on almost 7x higher volume 2 1/2 hours into session." Another SA analyst similarly noted on September 6, 2020, "Amarin shares have taken a beating this week during the appellate hearing and especially after the adverse ruling came down on September 3."
Despite the appellate loss, the Company continued to assure investors about the strength of its patent portfolio. On September 3, 2020, the Company issued a press release stating that it would be filing a petition with the U.S. Supreme Court for an en banc review of the Federal Circuit's decision and "continuing to pursue additional regulatory approvals for VASCEPA in China, Europe and the additional countries in the Middle East." The Company further stated that "[g]eographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this litigation and judgment. No generic litigation is pending outside the United States." As a result, the market still believed that the Company was a desirable target and well positioned to effectuate a successful takeover.
Then, on April 12, 2021, Amarin announced the retirement of Defendant Thero as President and CEO and the appointment of the Company's Senior Vice President ("SVP") and Head of Commercial for Europe, Karim Mikhail ("Mikhail"), as his successor, effective August 1, 2021. In announcing the "CEO Succession Plan," the Company highlighted that, previously, Mikhail had been "responsible for reversing [Merck's] decline in the U.S. market and globally, accelerating revenue by an additional $380 million through the launch of ATOZET and driving EBITDA growth through international expansion. Prior to that, Mr. Mikhail led the successful commercial launch of dozens of products, including ezetimibe and various molecules in diabetes, hypertension, immunology, and oncology, and served as Merck's chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets."
On this news, the Company's share price fell over 14.3% to close at $5.08 on April 13, 2021, on heavy trading volume.
As one analyst explained it on April 12, 2021, Amarin "[i]nvestors may be disappointed in the transition and that it may signal no near-term M&A on the table (which is the clear and primary bull case to the stock)." However, the "strategic move could finally unlock the [C]ompany's value" because as noted on April 13, 2021, by another analyst, while Defendant Thero "deserves some credit for overseeing the completion of the landmark REDUCE-IT trial, he also must take responsibility for their legal failures, their underwhelming sales performance, and the share price." For the "new era", Mikhail "brings with him substantial connections in Europe from his time with Merck."
Despite Defendants' consistent reassurances in the strength of Amarin's patent portfolio and its abilities to vigorously defend this critical asset, on June 21, 2021, investors learned "that the Supreme Court rejected the [C]ompany's bid to revive Vascepa patents."
On this news, Amarin's share price fell 8.3% to close at $4.54 on June 23, 2021, on heavy trading volume.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.