A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
Amarin’s president and CEO said the company strongly disagrees with the ruling and plans to pursue “all available remedies, including an appeal” of the decision and a preliminary injunction pending an appeal to prevent the launch of a Vascepa generic in the U.S.
Vascepa, Amarin’s lead product, is available by prescription in U.S., Canada, Lebanon, and the United Arab Emirates. No generic litigation is pending outside the U.S., according to Amarin.
Company shares (NASDAQ:AMRN) took a sound beating Tuesday, finishing down 70.54% at $4 per share.
Amarin said the FDA has not approved an ANDA for Vascepa, which the company contends is required to launch a generic product in the U.S. It added that the company felt confident it could obtain an injunction against a generic launch pending an appeal, “subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal.”
At the center of the case were Dr. Reddy’s Laboratories Inc., of Hyderabad, India, and Hikma Pharmaceuticals plc. Hikma acknowledged the judge’s ruling on Tuesday and said it is working with the FDA to get the ANDA of its generic version of Vascepa approved. An at-risk launch is on the table, Hikma officials said, should the district court’s decision be appealed.
There is a lot of money at stake, as Hikma quoted Iqvia Holdings Inc. numbers showing Vasecpa sales were about $919 million in the 12 months ending February 2020.
H.C. Wainwright analyst Andrew Fein wrote Tuesday that he consulted a patent attorney for guidance on the ruling and said the “FDA should issue final approval of the first-filer’s ANDA, which we understand to be Hikma.” Should Hikma opt for an at-risk launch and should a federal circuit judge then overturn the district court’s decision, Fein noted, defendants would be “liable for monetary damages on any sales between now and then. … Assuming that potential generic entrants do await the appeal, we believe it could take well over a year before that decision comes out with Vascepa potentially facing generic competition at that time.”
SVB Leerink analyst Ami Fadia wrote Tuesday that she does not expect an at-risk launch from either of the potential competitors. She added that Vasecpa will most likely face generic competition beginning in 2021, but it will have no impact in key regions such as Europe, China and Canada, where Vascepa will have patents around reduction of cardiovascular risk.
“This new timing for generic competition is much earlier than our previous 2029 estimate, which means that aspiration of a >$4B peak US revenue opportunity is essentially off the table unless Amarin wins on appeal,” Fadia wrote. “While management will use all legal options at its disposal to appeal the unfavorable patent litigation decision, we assume the decision will ultimately stand.”
Addressing potential Matinas Biopharma Holdings Inc. stockholder concerns about the court decision on MAT-9001, a prescription-only omega-3 free fatty acid based combination of primarily eicosapentaenoic acid and docosapentaenoic acid for treating hypertriglyceridemia and cardiovascular and metabolic conditions, CEO Jerome Jabbour noted that the ruling has no impact on the validity of the issued or pending patents covering MAT-9001, which extend until 2033 or even afterward.
In March, Matinas initiated the ENHANCE-IT study, a 28-day crossover, head-to-head pharmacodynamic study of MAT-9001 against Vascepa in patients with elevated triglycerides (150-499 mg/dL). The study is designed to assess MAT-9001’s effectiveness in reducing triglyceride levels and other lipid markers, as well as gather important data on bioavailability and blood levels of eicosapentaenoic acid and other omega-3 fatty acids. About 100 adult men and women are the study’s subjects.
Matinas stock (NYSE:MTNB) also took a hit Tuesday as it finished 14.27% down for the day and closing at 60 cents per share.
Two potential Vascepa competitors, Astrazeneca’s Epanova (omega-3 carboxylic acids) and Acasti Pharma Inc.’s lead candidate, Capre (omega-3 phospholipid), bowed out earlier this year. Based on advice from an independent data monitoring committee, Astrazeneca closed its phase III Strength experiment with Epanova due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidemia who are at increased risk of cardiovascular disease. The effort was a global outcomes study testing the safety and efficacy of Epanova compared to placebo when both are used with standard-of-care statin medicines. Acasti said an unexpectedly large placebo effect foiled statistical significance in top-line results from the phase III Trilogy 1 trial testing Capre in hypertriglyceridemia (triglyceride levels from 500 mg/dL to 1,500 mg/dL).