Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Collegium is our competitor and our cousin.

Somebody asked yesterday if Collegium was truly our competitor, and I did not have time to reply but thought it was a great question.

All of these companies that are working on ADF's are our competitors in the upcoming ADF Wars. But at the same time, we are tied to the hip with them. We need them to be successful in getting their ADFs to market, and we need those ADF products to not be disgraceful failures (see Embeda-1). If you do not believe the FDA when it says it will remove non-ADFs when there are viable ADFs, then stop reading now.

I believe that when there are a plethora of available ADFs, then all non-ADFs will be snuffed out like a mafia snitch with his back to the door. The FDA has said so, and there is great pressure from Congress (Manchin et al), state AG's, and various public advocacy groups that will keep the FDA honest on this issue. At some unknown point in the future, every opioid will be an ADF. However, the FDA is not going to hand over to one or two companies a monopoly (or even oligopoly). They will require a healthy market of ADFs, and that is why Collegium is both our competitor and our cousin. We need Collegium and Egalet and Acura to be successful. Once their products are available and every opioid is an ADF, then we can compete with them based on the merits of the ADFs, instead of competing with nonADF generics based on price. And thus will begin the ADF Wars.

What are the ADF Wars? It is not yet well-defined how stringent the FDA will be in approving various ADFs. I tend to believe the FDA will act like a bouncer at a college bar. You have to show him an ID that says you're over 21 but he's not going to pay much attention to the picture or that Ohio is spelled wrong. He's going to let everybody in that can show him an ID, no matter how questionable the ID. But once you get into the bar, now you have to compete with everybody else based on individual merits.

When a drug rep comes to the office to detail a drug, they usually don't just tout their own drug but also throw in a line or two about why they're better than the competitor. An obvious example are the long-acting insulins, Lantus vs. Levimir. I always make time for their reps because there are no generic equivalents and they give me samples. Even with good insurance, the copay can be $100/month. So calling an indigent patient and telling him you have samples is like telling him to come pick up a $100 bill. In my district, the Lantus rep and Levimir rep are brothers, so its a very friendly rivalry, but they never see me without mentioning at least one reason why their drug is superior to the other, usually with a graph.


Recent Lantus sales pitch:




That's how it will be with ADF Wars. There will be a great rivalry between the types of ADFs, i.e. mechanical barrier vs. aversive agent vs. pharmacologic. There will be graphs. "Ours is better than theirs because..."

Also, too, this is why we should all be rooting for Embeda-2 and its oxy sister, ALO-02. I see some posters on this MB hoping for a repeat failure of Embeda, but that would be the worse thing that could happen for Elite's technology. Not only do we want Pfizer out there pressing the issue of why pharmacology-based ADF is superior to mechanical barriers, but we also do not want our competitors out there pointing out that pharmacology-based ADFs with antagonists are inherently unstable. Our modular 2 bead technology is great because it is interchangeable, but if naltrexone ADF gets a bad name because Embeda-2 and ALO-02 are miserable failures, then no physicians are going to give a crap about our 2 beads. They will not use it. (Failure of Embeda-2 and ALO-02 is the second biggest risk to my ELTP investment). I can't believe I'm saying this, but I'm rooting for Pfizer on this. GO PFIZER!!

As for Collegium specifically, they have an interesting ADF. More on that some other time.