He says plenty of patients have been conditioned to take regular injections for diabetes and rheumatoid arthritis, and they believe the same would be true of obesity. Amylin already has experience with a successful twice-daily injection, Byetta for diabetes.
But, we’re getting ahead of ourselves with commercial questions. This drug still needs more proof that it works in the clinic. The previous study was a mid-stage trial of 177 patients—way too small a pool of patients for the FDA to get an accurate read on the safety profile of a drug that would be taken by the masses.
Amylin is currently conducting another mid-stage trial of different doses of the pramlintide/metreleptin combination. The trial will have 600 patients, and results are expected in mid-2009, Weyer says. If that’s encouraging, then Amylin will go for it in Phase III with a 4,500-patient trial that could lead to FDA approval, he says.
If this pans out in further trials, you can be sure the people at Amgen will be kicking themselves. The world’s No. 1 biotech company, based in Thousand Oaks, CA, paid $20 million back in 1995 to license rights to leptin from Rockefeller University, and then spent untold millions more on development of the drug by itself that fell flat. Amgen licensed the rights to leptin to Amylin in 2006 for an undisclosed fee, and stands to get royalties on sales if Amylin can ever develop it into a product, according to Amylin’s most recent annual report with the Securities and Exchange Commission.
I asked Weyer if they got a fire-sale bargain on this drug since it was on Amgen’s trash heap, and he smiled, saying “we didn’t disclose the rate.”
What this basically means is that Amylin could be in a position to capture most of the revenue for itself, from a blockbuster drug for the biggest public health problem in the U.S. Analysts won’t start projecting out the financial models until more data roll in, but the numbers could get big fast. “If we can deliver on the promise of safely delivering double-digit weight loss, a product like this has a phenomenal opportunity commercially. It would be a huge breakthrough for obesity, and there has never really been a blockbuster drug for this condition,” Weyer says. It sounds like something that could appear on the TV news in a few months if Amylin can deliver in that 600-patient trial. We’ll be watching.
