Hepalink re read
posted on
May 23, 2015 07:14PM
I just read the Shenzhen Hepalink Pharma April 7 press release again and a couple of things (re)struct me (again).
Don may be in the process of layering in 1 or more new regional deals thus adding much more equity to RVX before and as rvx-208 moves through the adaptive BETonMACE trial. I don''t know but I sense Don has a good game of chess happening here.
Keep in mind BETonMACE only needs to achieve 30% RRR for clinical success compared to the 77% achieved in the combined ASSURE/SUSTAIN trials. If you go back and review the combined ASSURE/SUSTAIN trial with the diabetes mellitus with CVD analysis after 210 days of dosing in the test (Crestor only) and test group (Crestor + rvx-208) the MACE events in the control group were 21% and in the test group (Crestor +rvx-208) 6%. So if 1000 people were treated with Crestor only 210 would have had a MACE event (heart attack, death, stroke, etc) at 7 months. However, if 1000 patients were treated with rvx-208 plus Crestor only 60 people had a MACE event at 7 months and the effect was enhanced with every time period. I know where I'd want to be if I had DM with CVD or even if I didn't have CVD yet because we know CVD increases in DM patients.
In terms of the market we know that diabetes mellitus is increasing in epidemic proportions with the rapid growth in obesity in North America and this will continue. Add in the aging factor and the problem compounds.
I've gotten the impression, rightly or wrongly, that at least some BP are bureaucratic, administrative and somewhat risk averse, particularly if their portfolio is strong and their patents have lots of time remaining. AstraZenica, from what I understand, has a few wells that are beginning to dry up, particularly as it relates to Crestor. Do they want to stand alone or be forced to merge?
We know that RVX holds patents for the combination of rvx-208 and rosuvastatin (Crestor) in a number of countries.
In addition (science and medical people help or correct me here) it seems to me that rvx-208 could work on it's own simply by layering over the best in practice treatments as it does not seem to interact negatively with existing treatments as evidenced in all of the previous trials. It's epigenetic platform does not seem to interfer with the non epigenetic, best in practice treatments, although I can't quite recall but rvx-208 did not enhance some of the statins other than Crestor (where it had an extremely positive impact).
The implication is that if RVX does regional distribution (and in some cases production) deals to blanket most major regions it can become a stand alone. Add rvx-208 + rosuvastatin and there's the next combination and it would be very price competitive because of the generic aspect. It seems to me that Hepalink is a take it to market company! (correct me if I'm wrong but that is what I see Hepalink already does and if not rvx-208 will go through their existing channels).
The fact that rvx-208 is an oral drug must be a huge advantage, particularly in certain countries.