At the American Diabetes Association's 68th Annual Scientific Sessions began in San Francisco which occurred in June 2008, the late-breaking scientific abstracts contained something that is very likely a glimpse into the future. While the press didn't really cover it at all, but I think we can expect to see a "Humalog Plus" being developed in the coming years. I base this on one of the late-breaking abstracts (see the attached file):
Pharmacokinetics and Glucodynamics of an Insulin Analog Injected with Recombinant Human Hyaluronidase: Fast-Acting Insulin Analog Made Faster (See here for details, I'm not sure how long it will be around online, so if the link doesn't work, check out the attachment below)
RICHARD C. YOCUM, BARRY SUGARMAN, DANIEL VAUGHN, ANDREW VICK, ROCCO BRUNELLE, GREGORY FROST; San Diego, CA, St. Charles, MO, New Palestine, IN
What does this mean? Well, first we need to look at who's behind this abstract. A quick search reveals the following affiliations (as of June 10, 2008, anyway): Richard C. Yocum (Halozyme Therapeutics Inc., San Diego), Barry Sugarman (I'm not sure where he's from), Daniel Vaughn (Daniel Enterprises, Indianapolis, IN), Andrew Vick (Eli Lilly and Company, Indianapolis, IN), Rocco Brunelle (Indianapolis, IN), Gregory Frost (Halozyme Therapeutics Inc., San Diego).
In other words, a bunch of current Lilly or former Lilly people, along with some other biotech people in San Diego did this preliminary study. It seems almost certain (from my perspective, anyway), barring any major adverse events or problems in larger clinical trials (remember, this is based on a study with just 12 people) that we are likely to see a "new and improved" Humalog being tested in the coming years, one that is faster thanks to the addition of recombinant (meaning synthetic) "human" hyaluronidase (rHuPH20). To be sure, a lot could happen, but its also important to keep in mind that we're talking about the addition of already FDA approved ingredients, so this would enable Lilly to extend patent protection for another 7 years on their "Humalog Plus" (MY term, not theirs), as the patent on Humalog expires just a few years from now.
Its unclear when larger-scale trials could emerge, but Lilly is under shareholder pressure because their drug pipeline contains a number of drugs (non-insulin) whose patents are due to expire, and their insulin market share has plunged over the past decade due to a lack of a long-acting insulin analog (FYI, they are also working on one of those according to diaTribe). Assuming this addition works successfully in trials, it would enable the company to apply for a new patent (and another 7 years exclusivity), while also allowing enough time to effectively kill the old products and make doctors and patients view today's state-of-the-art treatments as "bad" or "less effective" than today's insulin analogs. They did that with Regular, and no doubt, they will also do that with Humalog to make everyone want and believe they need the newer, more expensive and patent-protected new product. No doubt, if successful, the price tag will also go up appreciably to reflect this, but keep in mind that a great deal still needs to happen before this becomes a reality. Still, its nice to look into the crystal ball and see what the future may bring!
Thanks for sharing this information Scott!
Without people like you doing the research, we would end up trusting whatever drug companies say! Good to stay informed!