|
|
|
|
||
Questions re generic IPE vs brand Vascepa Sent these to IR, but no response (I have read that Elisabeth has left Amarin). Some were obliquely addressed by CEO Thero in the 11/19 Jefferies conference. I have read claims that Hikma’s generic IPE product (Icosapent Ethyl – IPE), though certified to be bioequivalent to brand Vascepa, actually has a composition different from that of brand Vascepa and that, despite its TE code of AB (which implies therapeutic equivalence), doubt exists as to whether it actually is therapeutically equivalent (efficacy and/or safety) to brand Vascepa. Is this claim accurate? Hikma’s IPE Material Safety Data Sheet, Section 3, shows its IPE ingredient mixture to be composed of (1) 1,4-anhydro-D-glucitol 10 - 25%, and (or?) Glycerol 10-25%; and (2) Icosapent Ethyl 60-80%. (search for “Icosapent Ethyl” at https://www.hikma.com/products/us-products/, then go to pdf link “MSDS”). How does this composition compare to that of brand Vascepa? Are the differences potentially sufficient to cause variations in efficacy, or safety, vs. the data in MARINE? vs. the data in REDUCE-IT? Are there any doubts or uncertainties about either efficacy or safety of Hikma’s IPE as compared to brand Vascepa? If so, should Amarin be communicating this to doctors and patients? Also if so, should Amarin have a FAQ page devoted to this subject?Relevant to the above, the Orange Book shows Hikma’s Icosapent Ethyl has a TE Code of AB. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=209457#37918 . That “AB” Code means “actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.” See para 1.7 (A)(2) at https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface#TEC . The TE code of AB also means, according to para. 1.7, that the drug is therapeutically equivalent, in FDA’s opinion. So, again, what is Amarin’s opinion? A recently (Oct. 2020) published article may be useful in this analysis. https://www.scirp.org/journal/paperinformation.aspx?paperid=103416 These investigators studied whether branded Epadel (Eicosapentaenoic Acid, a highly purified EPA ethyl ester) yielded different EPA, AA, and EPA/AA ratio levels when compared to generic forms of Epadel. They administered 1800 mg of each daily, for six month periods, sequentially, to 96 Japanese outpatients with known CVD and who were on statins, with blood sampling after each 6 month period. Findings included that: 1. Serum EPA elevations were higher after taking branded EPA vs. generic. 2. Serum AA reductions were greater after taking branded EPA vs. generic. 3. Serum EPA/AA ratios were greater after taking branded EPA vs. generic. There were other findings, but the above-listed show differences in biological effect in pharmacologic circumstances very similar to those posed by the above questions. As you know, these particular parameters are among those believed possibly to be involved in Vascepa’s MOA in CVD risk reduction. Should Amarin be communicating its position on the equivalency issue to insurance companies, emphasizing that Amarin’s position is that doubt exists (if there is doubt) as to the equivalent efficacy or safety of Hikma’s IPE (and why) for the MARINE indication, such that generic substitution where brand Vascepa is prescribed may jeopardize patients? Following up my 10/4/20 email, what measures is Amarin taking with insurance companies (and physicians) to ensure that generic IPE is not dispensed for the CVD risk reduction indication or otherwise in a manner as to infringe on Amarin’s IP? |
return to message board, top of board |
Msg # | Subject | Author | Recs | Date Posted |
7836 | Re: Questions re generic IPE vs brand Vascepa | gly1949 | 0 | 11/24/2020 7:44:55 AM |
7842 | Re: Questions re generic IPE vs brand Vascepa | ex_hacker202 | 0 | 11/24/2020 5:46:58 PM |