DUBLIN, Ireland and BRIDGEWATER, N.J., June 16, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) announced today a settlement agreement with Apotex Inc. (Apotex) that resolves patent litigation that would have resulted from the previously disclosed abbreviated new drug application (ANDA) filed by Apotex with U.S. Food and Drug Administration (FDA) and amended in May 2020 seeking approval of a generic form of VASCEPA® (icosapent ethyl) capsules based on the MARINE study.
As previously disclosed, Amarin is currently appealing to the U.S. Court of Appeals for the Federal Circuit a March 2020, patent invalidity ruling of the U.S. District Court for the District of Nevada in favor of generic companies, Hikma Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories, Inc. Because Apotex is not a party to that litigation, it is not directly subject to related rulings. As such, patent litigation against Apotex would need to be pursued separately.
As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva)) or earlier under certain customary circumstances. As currently relevant, such circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada district court decision after issuance of the Federal Circuit mandate following any Federal Circuit rehearing or en banc review. The agreement also substantially resolves future litigation with Apotex that could have ensued related to the December 2019 cardiovascular risk reduction indication of VASCEPA based on the REDUCE-IT® study. Other terms of the agreement are confidential. The agreement is subject to review by applicable federal authorities.
“This settlement involves no financial payment from Amarin to Apotex and allows Amarin to avoid incremental litigation expense and distraction associated with Apotex’s participation in patent litigation related to the MARINE and REDUCE-IT indications,” said John F. Thero, president and chief executive officer of Amarin.
For a generic product to be launched in the United States the generic company’s ANDA must be approved by the FDA. In this settlement, consistent with terms of Amarin’s 2018 settlement agreement with Teva, Amarin does not commit to supplying Apotex with icosapent ethyl at any time. Outside of the United States, Amarin holds various patents and regulatory exclusivity rights to icosapent ethyl which are not part of this settlement and not part of any current litigation.
About Amarin
Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times and is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019 based on the results of the landmark REDUCE-IT® trial.
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT
| VASCEPA | Placebo | VASCEPA vs Placebo |
|||
| N = 4089
n (%) |
Incidence Rate (per 100 patient years) |
N = 4090
n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio (95% CI) | |
| Primary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) | 705
(17.2) |
4.3 | 901
(22.0) |
5.7 | 0.75
(0.68, 0.83) |
| Key secondary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke (3-point MACE) | 459
(11.2) |
2.7 | 606
(14.8) |
3.7 | 0.74
(0.65, 0.83) |
| Other secondary endpoints | |||||
| Fatal or non-fatal myocardial infarction | 250
(6.1) |
1.5 | 355
(8.7) |
2.1 | 0.69
(0.58, 0.81) |
| Emergent or urgent coronary revascularization | 216
(5.3) |
1.3 | 321
(7.8) |
1.9 | 0.65
(0.55, 0.78) |
| Cardiovascular death [1] | 174
(4.3) |
1.0 | 213
(5.2) |
1.2 | 0.80
(0.66, 0.98) |
| Hospitalization for unstable angina [2] | 108
(2.6) |
0.6 | 157
(3.8) |
0.9 | 0.68
(0.53, 0.87) |
| Fatal or non-fatal stroke | 98
(2.4) |
0.6 | 134
(3.3) |
0.8 | 0.72
(0.55, 0.93) |
| [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.
[2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. |
|||||
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking statements related to Amarin’s patents and interpretation of related settlement agreements and litigation. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described herein include the following: events that could interfere with the continued validity or enforceability of a patent; and Amarin’s ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties and the company’s understanding of current settlement and litigation positions and potential outcomes. 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 its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor 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.
Amarin Contact Information
Investor and Media Inquiries:
Elisabeth Schwartz
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com (investor inquiries)
PR@amarincorp.com (media inquiries)
Lee M. Stern
Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
