Posted by Jeff Berk; BOLT International
First, a note on yesterday’s blog. Yes, I really did spot smoke coming from the engine of that boat. We SCREAMED at this father to throw his life-vested baby girl, plus older daughter and wife off the front of the boat. It took less than 1 minute from the time we first saw a little smoke to the time that the craft was totally engulfed in flames. So, Mr. “I’m too cool to make my kid wear a life vest”, take a look at that photo. And no, they didn’t have a chance to “just grab my cell phone”. And yes, we did get them all out safe and sound. And no, the State Police didn’t find any open containers on our boat. Frankly, I don’t know how hard they were looking.
In the psoriasis and psoriatic arthritis world it’s pawn-eat-pawn, and competitors better just watch out! We can see this clearly here; where only two of the competitors are keeping their eyes on the game, and two are keeping their eyes on the 5th competitor – who, truth be told, is actually pretty clueless about the dermatology landscape that’s unfolding. On the surface, treating psoriasis seems to be pretty superficial, and if you go to Goldman Sachs for advice (Jon Corzine, you’re disgusting. Ha ha, Christie sits on your face), they’ll tell you to bet your life savings on the pretty pipeline candidate. But not us. In Psoriasis Thought Leader Panel #20 we include the insights from six internationally recognized psoriasis experts (3 US, 1 Swiss, 1 German, 1 French). And we tell you who YOU should REALLY keep your eyes on.
This Panel drives the following logical road:
1) What are the key unmet needs that warrant payers reimbursing more than $20,000/year for new branded psoriasis/psoriatic arthritis therapies?
2) Will a treatment model structured around induction / maintenance get products within the pharmacoeconomic window?
3) How will the competitive dynamics from related immune diseases affect pricing and commercial viability for new brands for the treatment of psoriasis / psoriatic arthritis?
4) What mechanisms and developmental candidates are most likely to succeed in this environment?
Here’s a free clipping from the report that we just published. If you’re looking for the whole thing, get out your credit cards. You can find it in the “buy it” link on BOLT’s website (www.boltinternational.com). If you’re just here to lurk, cool. Enjoy the nibble.
We asked the Panel to identify the key unmet needs that warrant payers reimbursing more than $20,000/year for new branded psoriasis/psoriatic arthritis therapies.
- 5%-10% of psoriasis patients don’t respond to anti-TNF or anti IL-23 therapy. For these patients, new mechanisms of action are going to be essential.
“I think given the laundry list or Chinese menu of therapies available including all the TNFs and the single IL-12/23 inhibitor and I will throw in methotrexate older drugs too, you can probably treat upwards of 90 to 95 percent of all patients with moderate to severe psoriasis with or without psoriatic arthritis. The unmet need primarily rests in two types of patients. One is 5 to maybe 10 percent who do not respond at all to approved dosing of any of the TNFs – including Remicade which is the most potent and including IL-12/23 inhibitor ustekinumab. That 5-10% remains a very difficult patient that requires either higher unapproved doses, or dose frequencies of the various biologics, or very aggressive combination therapies where you apply a biologic with a drug like methotrexate at a reasonable dose, or in rare cases a biologic with cyclosporin in a low dose. In those patients that are not responsive to aggressive therapy it still would be extremely helpful to have additional mechanisms of action to approach the patient with. How many more mechanisms of action do we need? That is not easy to answer. We probably don’t need ten, but we probably could use a couple of more. Those drugs that are in development hopefully will cover the remaining 5-10 percent or at least 90 percent of that. There is clearly a subset who respond to the newer pipeline medicine that they were somewhat refractory to traditional commercially available biologics. I wouldn’t really hang my hat because the “n” of that number is very low. On the other hand, there is such a large precedent for that phenomenon from prior studies that we are fairly certain there will be patients who are refractory to 12/23 inhibitors, TNFs, 17 inhibitors and JAK kinase inhibitors. This is not going to be the same kind of efficacy that these drugs are seeing in a naïve population. I think there still will be a lower batting average for the drug in these tough to treat patients. That is the pattern. Even the best drugs seem to do less well in treatment-refractory populations. But we would expect that. Not necessarily because it is not necessarily going to occur if there is a completely distinct pathway being targeted with the new drug. I don’t think that is occurring with IL-17 inhibitors. Obviously there is going to be a lot of predictability about how IL-17 responsiveness will be based on IL-12/23 responsiveness. Would you throw IL-22 into that more novel group? Yeah, I think so based on the current state of the knowledge of psoriasis there is likely an IL-22 rests downstream of the 12/23 pathway. That said though we don’t know if other important pathways feed into that that are distinct from the TH17 route. Now JAK kinase is an interesting class because I think the more broadly acting inhibition much like cyclosporin. And it may turn out that JAK kinase inhibitors are very effective drugs in biologic non-responsive patients because of their broad inhibition of a variety of pathways. But of course their toxicity will be, in my opinion, higher and that will relegate them to use behind the newest biologic therapy. So I am one just confident that with the drugs in development from a variety of companies (oops… the free meter just ran out).