Updates: AMRN, YMI, EMIS April 20, 2011March 24, 2017 But first a quiz. Alan S.: “I got 20 and Bob got 26 on this. Out of 30. I think I need a brush-up course (LOL).” ☞ I should say so! (Not that I’m competitive or anything.) And now . . . AMRN AGAIN John: “The research you quote says, ‘very solid effect sizes at both the 2g and 4g doses, which was even better than our “big fish in a big ocean” scenario.’ Well, 2 grams is approx 1/2 teaspoon MOL. That’s a large dose of anything. Getting people to take a full teaspoon of an oil-based medicine could be a neat trick. Those are considered ‘horse pills.’ Even 1000 mg fish oil caplets are only about 1/4 tsp. If a person were to take two or four fish oil caplets, one should expect an effect similar to AMRN, and unfortunately, a similar rate of patient compliance. Hey, if they succeed in business, I’m all for it. Based on their research, I’ll just start taking two caplets in the morning and two at night and see what happens.” Guru responds: “Most fish oils look like Lovaza (which looks to do $1 billion in sales this year) with significant amounts of DHA and EPA. But Lovaza has quite a different effect from Amarin’s drug: Lovaza raises LDL cholesterol (the bad cholesterol), whereas Amarin either does not raise it (2 mg) or lowers it (4 mg). People with high triglycerides would do better to lower their bad cholesterol than to raise it! So you can’t obtain these benefits just by taking over-the-counter fish oil. AMRN has patents on how to formulate the product so it is more than 96% EPA. They go out 15+ years. Thus, AMRN should have a strong franchise: the only drug that lowers triglyceride (for patients >500 and 200-500) AND lowers bad cholesterol. No one in the US will have that claim but them for a long time. Here is one site that shows about an even amount of EPA and DHA in one brand of fish oil caplet. Here is a site that shows the EPA and DHA content of Lovaza. You’ll see it is very similar to the fish oil caplet (and still on track to sell $1 billion), but remember that this combination of EPA and DHA caused INCREASED LDL.” YMI, EMIS UPDATES While we have Guru’s attention: YMI (suggested in December at $1.65, $2.96 last night). Guru writes: “The lead investigators at the Mayo clinic yesterday updated their results at their center from when they first reported them in December. They continue to see a 58% ‘anemia response’ which is very good and not seen with the leading candidate for MPF from INCY. Data from other centers encompassing an additional 80 patients will be presented at ASCO in June. So the story continues to play out. Price targets range from 4 to 6.” EMIS (suggested last August at $1.25, $1.52 last night). Guru: “Novartis announced on their first quarter call today that the second trial in osteoarthritis is still ongoing, but that the ‘strategy’ in osteoarthritis is ‘under review.’ In January, Novartis said they expected to file for approval in osteoarthritis this year, so the announcement today certainly indicates that they are less certain they will do so – but I suppose they haven’t decided one way or another. The problem is that the trials were designed to see if calcitonin could build cartilage and bone so that the spaces in the osteoarthritic joints got smaller (i.e. bones got bigger). In December, they announced that the European trial missed that “co-primary endpoint” but succeeded in demonstrating efficacy on the other ‘co-primary endpoints’ of pain and function. No details have been provided. I’m guessing the data for the US trial – which is ongoing, but should be out in the next several weeks – will look the same. If so, they have two trials that missed this ‘joint space’ endpoint, but showed efficacy on the other two endpoints. They ‘could’ get FDA approval in Europe on this data, but would probably have a hard time getting it in the US. . . . Meanwhile, what Novartis DID reaffirm today is that the osteoporosis trial (the one we’ve always believed in – we were always cautious on osteoarthritis) will be done in 3Q 2011 and they reaffirmed their plan to file for approval. A win on either of these should make the stock go much higher.” SKIN CELLS TO HEART CELLS Ryan Troseth: “I should have mentioned yesterday, the experiment was done with mice.” ☞ Ah. Well, mice, humans – we both like cheese, so this will probably work. Tamara Hendrickson: “I hadn’t seen the Nature Cell Biology paper Ryan highlighted. The really cool thing about heart cells is that they beat in sync with each other just like a natural human heart. I’ve now skimmed this paper, and, as Ryan noted, they were able to convert skin cells to inducible pluripotent stem cells, which they then converted to heart cells. I’ve watched one of their videos, where you see the cells beating – a cell colony (lots and lots of cells) on a solid support that contains media to help the cells stay alive. It blows my mind that they started out as skin cells!!!! Unfortunately, you need a subscription to the Nature journals to see the video (or you can buy a copy for $32).”