What I hear is that the pharma industry (and Wall Street) is holding its breath for Amylin’s next big thing: Exenatide (produced in partnership with Eli Lilly & Co.). This is another injectable product (derived from lizard saliva, of all things!) that, if approved by the FDA in a few months, will be offered in a pen delivery system. This one’s mainly for Type 2 diabetics, and clinical studies have shown “marked reductions in blood sugar as measured by A1C, a measure that reflects a person’s average blood sugar levels over the prior three- to four-month period.”
Um, any patients out there really excited yet?
Yes, analysts expect the market for Symlin to be $300 million annually, at most, while Exenatide has the potential to become a $1 billion a year drug (!!)
Great, if it can help people. But what bothers me is that the news is all about the commercial potential, and which drug might “outperform” others in terms of sales numbers. Amylin’s stock has jumped, and all the buzz is about when and how much it might climb further once Exenatide hits the streets?!
The FDA approval of Symlin is making big headlines, and last week I had a bunch of relatives contact me, as they tend to do, when something new and “hot” appears on the diabetes scene. The drug is targeted toward Type 1 diabetics who don’t achieve good BG control despite insulin treatments. It was apparently 18 years in the making, and is the first new drug to be marketed to Type 1 diabetics since insulin in the 1920s. It also marks Amylin Pharmaceuticals, Inc. (San Diego, CA) debut as a commercial company -– because it is their first drug to gain FDA approval.
It sounded exciting, until I learned that Symlin is another injection (!) that one uses in combination with insulin (but in a separate syringe), to help lower BG in the three hours following meals. It produces a major risk of hypoglycemia (!).
A respected endocrinologist I’ve been corresponding with had this to say about Symlin:
1) I have no idea how many people with diabetes who are already taking insulin will be willing to take a different shot with every meal. Sounds like a MAJOR challenge to even the best of marketers!
2) I am extremely concerned that no studies have been done in children, hence we have no idea of what effects might be (good or bad) in this age group, yet the label doesn’t restrict its use to adults. I blame the FDA for this.
3) This product took a long time to come to market, because it has very marginal efficacy and major hypoglycemia events (note the black warning box on the label, which is a first for hypoglycemia in a diabetes product, I believe).
I have read that Symlin has gone through rigorous clinical trials, and in fact, I’m trying to get in touch with an acquaintance of mine who was apparently part of a Symlin study. But so far, it sounds like the drug may not be so hot after all?