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pivotal clinical trials to demonstrate its effectiveness, and invested in a new factory in Ohio that cost $500 million. Assuming the drug starts generating sales in the fourth quarter of 2012, it could reach $1 billion in U.S. sales in 2015, according to Thomas Russo, an analyst with Robert W. Baird, in a note to clients on November 5.
That’s a long time to wait for the big bucks that Amylin thought would already be flowing in now. But Bradbury says the company has basically been operating at cash-flow break even, and he doesn’t foresee the need to make any major layoffs after making a couple big rounds of cuts in November 2008 and May 2009.
Instead of getting his troops fired up to sell the first once-weekly injection for diabetes, Bradbury says Amylin needs to concentrate for now on finding some new areas of growth for its older drugs—the original twice-daily injection of exenatide (Byetta) and pramlintide (Symlin). In particular, the company’s 325-person sales force will concentrate on getting Medicare to cover more aging patients who use Byetta, Bradbury says.
Much of the effort will be defensive, rather than offensive. Denmark-based Novo Nordisk, the world’s largest maker of diabetes medicines, won FDA approval last January for liraglutide (Victoza), as a new member of the same GLP-1 class of drugs that Byetta is part of. Novo’s product is taken as a once-daily injection, which means fewer needle sticks than what is required with the twice-daily Amylin drug.
Victoza, the new challenger, has been gaining market share against the older Amylin drug. And the regulatory delay for Amylin gives Novo more time to make inroads with patients as they wait for FDA approval of the once-weekly injection (Bydureon). The original Byetta still has about two-thirds of the market share, while Victoza has grabbed about one-third at last count, Bradbury says. The focus of the sales force is in maintaining market share among loyal patients and doctors, and taking some market share back in new populations, like the Medicare group, Bradbury says.
There were a few other things Bradbury wanted to talk about, which I’m sure are of less interest to shareholders and the biotech industry at large. The company is still working on getting the right formulation of metreleptin and pramlintide which can go into Phase III clinical trials for obesity, as part of a partnership with Takeda Pharmaceuticals. Amylin has now formally sought FDA approval of leptin as a treatment for an extremely rare fat disorder known as lipodystrophy. And the company plans to introduce a new drug into clinical trials by the end of this year that connects two peptides together into a single molecule, an internal research project that builds on years of Amylin’s experience, Bradbury says.
If Bradbury is right, and Amylin does go on to win FDA approval of Bydureon sometime in 2012, then it will have the kind of cash flow and market valuation to push ahead with even more ambitious R&D projects to fight diabetes and obesity. But for now, this sounds a lot like hunker-down time. He even joked that while he hopes to win FDA approval of Bydureon, “hope is not a strategy.”
Now it will really take something more like steely determination, which Bradbury says is in the company DNA. “Amylin has always been a very resilient company,” he says.
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