On January 10th, the private biopharmaceutical company InteKrin Therapeutics, founded only two years ago and focused on metabolism and diabetes, announced that they had licensed a promising new drug for type 2 diabetes from Amgen. This drug – known now as INT131, formerly AMG131 – acts as an insulin sensitizer, through the same mechanism as TZDs, but is said to be without the weight gain and edema commonly associated with them. This may be very promising for people with insulin resistance (a huge percentage of people with type 2), and could be useful in preventing diabetes in people with pre-diabetes, an area we think will be increasingly important this decade. An anti-diabetes drug without side effects sounds great, as long as weight gain isn't part of the mechanism that is making it work, like it is said to be with Actos and Avandia (which together garnered well over $4 billion in sales last year)...
We haven't seen confirmatory data, and we're eager to.
By way of background - this drug had been part of Amgen's acquisition of Tularik awhile back - just as we were thrilled to see Amylin buy outright the Leptin portfolio from Amgen, especially since they are so much better equipped to take advantage of it (to us, Amylin has the most promising obesity pipeline out there, full stop), we are excited to see another company take a diabetes compound from Amgen, simply because it undoubtedly will receive more attention and notice and work. Doubters say that the "no-side-effect PPARs" won't have the potency that Actos and Avandia do - we think it's too early to say but we imagine the data has been quite promising, given the interest in InteKrin from early potential investors.
More good news came the next day, when the company announced that they'd received enough financing from investors to take the drug through phase 2 trials. The financing was led by a slew of smart investors, including Soffinova Ventures and Orbimed Advisors, which should be a great advantage for the young company. Equally impressive (and undoubtedly related) is InteKrin's scientific advisory board -- the board includes, for example, Stanford's Dr. Gerry Reaven, who is the father of metabolic syndrome, having identified a group of symptoms caused by insulin resistence in the late 1980s as "Syndrome X" and having given the American Diabetes Associations's prestigous Banting Lecture on the topic in 1988. Also on the board is Dr. David Orloff, formerly head of the FDA diabetes division - could there be anyone more informed to give good clinical trial advice? Dr. Orloff also has very impressive experience at CMS, so he'll know what the payors need to see - judgment that is more and more important over time.
Indeed, exciting. With all the options for type 2 oral medications, side effects (or lack thereof) may prove to be quite important, especially for drugs suitable for combination therapy. Today, only one class, thiazoladinediones, really work on insulin resistance, and we see this as an important mechanism for combination therapy - this should be a very interesting company to watch.
More in the press release below:
January 10 2007
InteKrin Therapeutics Licenses Diabetes Product
Novel Phase II Insulin Sensitizer
PALO ALTO, Calif. - January 10, 2007 -- InteKrin Therapeutics, Inc., a privately held clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity, announced today that it has entered into a license agreement with Amgen Inc. under which InteKrin has obtained worldwide development and commercialization rights to Amgen's PPAR gamma selective modulator and partial agonist, INT131. Formerly known as AMG131 and first developed by Tularik, Inc., this compound utilizes a well-validated and potent target for the treatment of diabetes and insulin resistance.
"We are very excited to pursue the further development of this promising compound for Type II diabetes. INT131 was specifically designed to dial-out side effects while still delivering high efficacy" remarked InteKrin's President and CEO Denny Lanfear. "This molecule is a good example of the type of scientifically superior compound InteKrin will be focused on as it further develops its portfolio."
"Based on the clinical data generated to date, we believe INT131 has the potential to become a highly effective therapeutic for the treatment of Type 2 diabetes, without the weight gain and edema seen with existing therapies." commented InteKrin Co-Founder Christos Mantzoros, M.D., DSc, of Harvard Medical School, "We are looking forward to completing the clinical development program and getting this important product to patients. We expect that its therapeutic profile may also be useful in pre-diabetes, helping patients delay the onset of the disease."
According to a June 2005 analyst report by Merrill Lynch, about 40 million people in the United States have pre-diabetes. An additional 18 million people in the U.S. currently have Type II diabetes, with 1.3 million new diagnoses each year. Morgan Stanley corroborates the magnitude of diabetes, predicting a drug market of $35 billion by 2012, up from $17 billion in 2005.
InteKrin Therapeutics, Inc. is a privately-held clinical stage biopharmaceutical company based in Palo Alto, California developing therapeutics for diabetes, obesity and metabolic disorders. The company was founded in 2005 by Denny Lanfear, former Amgen Vice President and Officer, and Christos Mantzoros, M.D., DSc, renowned clinical endocrinologist and Associate Professor of Medicine at Harvard Medical School. InteKrin's Scientific Advisory Board includes veterans from several successful biopharmaceutical organizations, internationally recognized experts in nuclear receptors and metabolism as well as top scientists formerly with the Food and Drug Administration. The company focuses on high value therapeutics in addressing unmet medical needs. To learn more about InteKrin, visit www.intekrin.com.