Ann: Annual Report to shareholders, page-10

Hi All,

Disappointing to see the SP slide again (unless you are buying). PIQ Fundamentals haven’t changed, I agree, some investors are peeved about timelines not being met, but I think one of the reasons for that & possibly the answer to why for PromarkerD is covered in part below.

A couple of things:

FDA priority review for CKD indication for Canagliflozin (application submitted in March 2019 & 6 month process) decision due soon. A recap article:

https://www.prnewswire.com/news-releases/us-fda-grants-priority-review-of-invokana-canagliflozin-snda-for-the-treatment-of-chronic-kidney-disease-in-patients-with-type-2-diabetes-300855112.html


Recently an application for Europe was also submitted with EMA, (MundiPharma are distributors of Invokana in Europe):

http://www.pharmatimes.com/news/ema_accepts_license_extension_submission_for_invokana_and_vokanamet_1298972

A recent independent meta analysis study published in The Lancet on SLGT2 class of drugs & kidney disease:

https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30256-6/fulltext

If the above link doesn’t work this article gives a summary of the study:

https://www.sciencedaily.com/releases/2019/09/190904194443.htm

This possibly may give some added weight to applications both with FDA & EMA, not just for Janssen (J & J), but AstraZeneca & Eli Lilly/Boehringer Ingelheim who have SLGT2 drugs & applying for CKD/CV indications also, but Janssen is first in line with their completed trials & data.

What does it all mean? A new paradigm in treating kidney disease in diabetes is emerging. Canagliflozin is the drug that PIQ have been analysing clinical trial blood samples for Janssen in collaboration.

Yes it’s been a wait, but FDA approval is all important for this class of drugs for big pharma interest for PromarkerD as a companion diagnostic in patients to commence these class of drugs for DKD/CKD, albeit a useful test in it’s own right.

I believe that this is what we are waiting on. PIQ have done the hard yards with Janssen analysing completed trial samples. My guess is that we may have some news in October some time, on whether FDA approves Invokana (Canagliflozin) for DKD/CKD (6 month plus time frame from mid March when the FDA application was announced).

These drugs aren’t without some serious side effects, and are not for all patients with diabetes & DKD/CKD & a reason why I remain invested in Dimerix, with similar numbers in renal function improvement in their Ph2A (now in Ph2B for DKD & Ph2A for FSGS & utilising PromarkerD in clinical trials). All IMO DYOR.

Best Wishes All