re: MARINE indication skinny label and generic icosapent ethyl
the MARINE and ANCHOR trials, focused on the effects of the drug on biomarkers associated with increased risk of pancreatitis and increased risk of cardiovascular events.
Approximately 2 to 3 million adults in the United States have very high triglyceride levels (≥500 mg/dL), the condition for which Vascepa received its initial drug approval from FDA in 2012 based on the MARINE clinical trial.
Guidelines for the management of very high triglyceride levels (≥500 mg/dL) suggest that reducing triglyceride levels is the primary treatment goal in these patients to reduce the risk of acute pancreatitis.
based on the MARINE trial, Vascepa was the first omega-3 based product to demonstrate statistically significant triglyceride reduction without a statistically significant increase in LDL-C in this very high triglyceride population.
the commercial launch of Vascepa in the United States in January 2013.
Prior to the REDUCE-IT results topline announcement in September 2018, our direct sales force consisted of approximately 170 sales professionals, including sales representatives and their managers.
From May 2014 through December 2018, in addition to Vascepa promotion by our sales representatives, Kowa Pharmaceuticals America, Inc. co-promoted Vascepa in the United States in conjunction with its promotion of its primary product, a branded statin for patients with high cholesterol. This co-promotion reached its mutually agreed upon termination date in December 2018. During 2018, as a result of not renewing the agreement, we incurred expense for the accrual of co-promotion tail payments, which were calculated as a percentage of the 2018 co-promotion fee. Kowa Pharmaceuticals America, Inc. will receive $17.8 million in co-promotion tail payments, the present value of which, $16.6 million, was fully accrued as of December 31, 2018 and will be paid over three years with declining amounts each year. We made $7.3 million in tail payments as of December 31, 2019.
In August 2015, we and our co-promotion partner began communicating promotional information beyond MARINE clinical trial data to targeted healthcare professionals. Such qualified communications were made pursuant to the August 7, 2015 federal district court declaration and related March 2016 settlement allowing truthful and non-misleading promotion of the FDA-reviewed and agreed effects of Vascepa demonstrated in the ANCHOR clinical trial. This promotion also included information related to the then current state of scientific research about the potential of Vascepa to reduce the risk of cardiovascular disease, including REDUCE-IT data and previously other peer-reviewed scientific publications of available data. The ANCHOR clinical trial of Vascepa demonstrated the favorable effects of Vascepa on TGs and related lipid, lipoprotein and inflammation parameters in patients on statin therapy and persistent high TGs. After results of REDUCE-IT were available in September 2018 and demonstrated that Vascepa is effective in lowering the rate of major adverse cardiovascular events in statin-treated patients with CV risk factors, we expanded the size of our U.S. direct sales force and continued to expand promotion of Vascepa. After publication of the primary results of the REDUCE-IT study in The New England Journal of Medicine and scientific presentation of REDUCE-IT results at the 2018 Scientific Sessions of the AHA on November 10, 2018, we updated and expanded our communication of REDUCE-IT results to include the publication and the peer-reviewed information presented in an effort to further ensure that our communications remained truthful and non-misleading. Starting December 13, 2019, we began promoting based on the new indication and label expansion.
On December 13, 2019, the FDA approved a new indication and label expansion for Vascepa capsules. Vascepa is the first and only drug approved by the FDA 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 TG levels (≥150 mg/dL) and either established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
2013 revenues - 26,351,000 .............. launched Jan 2013
2014 revenues - 54,202,000 .............. May 2014 Kowa co-promotion begins
2015 revenues - 80,987,000 .............. Aug 2015 began communicating promotional information beyond MARINE
2016 revenues - 128,966,000
2017 revenues - 179,825,000
2018 revenues - 228,371,000 ............. Sept 2018 REDUCE-IT results - expanded the size of U.S. direct sales force and continued to expand promotion of Vascepa
2019 revenues - 427,391,000
based upon this historical revenue ramp up and when marketing materials beyond the MARINE result indication (i.e., management of very high triglyceride levels (≥500 mg/dL) were introduced, i believe a strong case could be made that generic icosapent ethyl will be infringing upon branded vascepa once generic icosapent ethyl sales exceed $200-250M / year.
my question is, what would happen if amarin successfully sued the generic manufacturers for infringement at that point? would the generic manufacturers pull their product from the market to cease infringing? what would this mean to the patients using generic icosapent ethyl? are those patients suddenly forced to use branded vascepa instead?
