Amarin plans to add a fourth API maker to its supply chain as it prepares for a potential launch of its triglyceride lowering therapy, AMR101, in the US in 2012.
In a letter to shareholders the Irish biotech said that while it believes existing suppliers Nisshin Pharma, Chemport and Equatec - the latter two of which joined the supply chain last year - can provide enough EPA (icosapent ethyl) to support commerclal launch it is still “working toward the announcement of a fourth API supplier.”
Whether Amarin is already in talks with a potential supplier is unclear, although its statement that: “Each of these additional suppliers will be required to qualify their material and facilities with FDA prior to our use of API produced by them” suggests the process is at an early stage.
The strategy of engaging multiple contractors mirrors the approach Amarin took last year when it called on Catalent Pharma Solutions to provide additional AMR101 API encapsulation services to those provided by original supplier Banner Pharmacaps.
CEO Joseph Zakrzewski discussed this during his presentation at JP Morgan’s Healthcare Conference in San Francisco on Monday, explaining that: “Our global supply chain is set up for supplier diversity and cost competition.
He added that: “Right now we have three API suppliers, two encapsulators and we expect that to grow over time…this product has such a potential that we found it necessary to go to multiple suppliers.”
Expects approval in H2 2012
Zakrzewski also set out the firm’s wider plan for 2012 explaining that it anticipates the publication of data from clinical trials of AMR101 in various indications and subsequent US regulatory approval.
“Looking ahead in 2012, we anticipate getting ANCHOR data published, continued prosecution of our 16 US patent applications. We’ll see an NCE status determination and the MARINE NDA has a PUDUFA data in July…[with] potential [for] second half 2012 approval.”
Whether Zakrzewski's comments about Amarin’s IP strategy are enough to assuage recent concerns about AMR101’s patentability – in October the USPTO issued a "non-final rejection" letter for the drug – remains to be seen.