Snipits taken from the AZ patent:
A pharmaceutical composition, comprising: EPA, in a weight percent amount of 50% to 60%; DHA, in a weight percent amount of 17% to 23%; DPA, in a weight percent amount of 1% to 8%; wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form.
In a first aspect, the present disclosure provides DPA-enriched pharmaceutical compositions of omega-3 polyunsaturated fatty acids in free acid form. Enrichment in DPA content was an unintended and unexpected consequence of the commercial-scale production process. These DPA-enriched pharmaceutical compositions have been demonstrated to have exceptional pharmacological and clinical efficacy in in vitro experiments and in human clinical trials.
A further challenge in designing an optimal composition is variation in bioavailability of orally administered PUFA compositions. Absorption of PUFAs in the form of ethyl esters is known, for example, to depend on the presence of pancreatic lipase, which is released in response to ingested fats. Absorption of PUFA ethyl esters is therefore inefficient, and is subject to substantial variation, both among subjects and in any individual subject, depending on dietary intake of fat. See Lawson et al., "Human absorption of fish oil fatty acids as triacylglycerols, free acids, or ethyl esters," Biochem Biophys Res Commun. 152:328-35 (1988); Lawson et al., Biochem Biophys Res Commun. 156:960-3 (1988). Absorption is particularly reduced in subjects on low-fat diets, a diet advocated for subjects with elevated serum triglyceride levels or cardiovascular disease.
Example 7 presents the results of the ECLIPSE clinical trial, an open-label, single dose, randomized 4-way-crossover study comparing the bioavailability of a 4 g dose of Lovaza.RTM. to bioavailability of a 4 g dose of the DPA-enriched pharmaceutical composition of omega-3 PUFA in free acid form described herein (hereinafter, "Epanova.RTM."), under both high fat and low fat dietary conditions. According to the FDA-approved product label, each 1-gram capsule of Lovaza.RTM. contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils, predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA--approximately 465 mg) and docosahexaenoic acid (DHA--approximately 375 mg). The batch of Epanova.RTM. used in the trial comprised 57.3% (a/a) EPA, 19.6% (a/a) DHA, and 6.2% (a/a) DPA, each substantially in free acid form.
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Correct me if I am reading this wrong but it sounds as if AZ has gone back to the FDA and said opps this is really our formulation so sorry for the screw up. So all of our previous testing is still valid we just need to update the formulation part right guys. Since it is the same drug name I would think they still have to inform Amarin 30 days prior to launch, but it does sound like they will be able to launch sooner rather that later?
They also put in the part that this drug goes hand in hand with the FDA low fat diet recommendation better than EPA, which needs fat in the diet to work. I will let JL elaborate more on this especially since EPA does convert to DPA in some amount?
This gets under the Matina's patent which is 160mg to 800mg of DPA and optionally EPA and DHA. This is with an engineered DPA that is supposed to be identical in every way to the natural DPA. Notice since this has happened MTNB as now gone back under a dollar.
Hope this helps and look forward to hearing the views of others.
