Lilly, Amylin win NICE nod for Bydureon

The U.K.'s cost-effectiveness watchdog is feeling friendly toward Eli Lilly's ($LLY) long-acting diabetes drug Bydureon. The National Institute for Health and Clinical Excellence recommended the injectable medication for use by the National Health Service in combination with two blood-sugar medications.

It's a victory for Lilly and partner Amylin Pharmaceuticals for a couple of reasons. Bydureon is a longer-acting version of the companies' twice-daily therapy Byetta, whose first patent expires in 2013 (a method of use patent expires in 2017). If patients can be persuaded to move to the newer drug--which presumably would be more convenient, dosage-wise--then the loss of Byetta exclusivity won't hurt so much. In addition, Lilly needs all the revenue sources it can get; its top-selling drug Zyprexa goes off patent later this month.

Byetta brought in $430.6 million for Lilly last year, and sales amounted to $710.2 million total, the company's annual report notes. Analysts have predicted Bydureon could best those numbers, peaking at $1 billion, although others are expecting a peak of $500 million by 2019.

But there's a flip side to the story: Byetta has been linked with pancreatitis, which in turn can increase the risk of cancer. In addition, some patients using the drug have developed kidney problems. Data show Bydureon's risk of pancreatitis and kidney impairment aren't any greater than the risks of other drugs in its class, but that's not an enormous selling point. On the other hand, some cardiac safety data show Bydureon doesn't cause a particular heart problem--even at high doses--as the FDA had feared.

A recent study found Bydureon didn't work as well as Novo Nordisk's Victoza at controlling blood sugar, giving the Danish company some marketing ammo against the Lilly/Amylin rival. Meanwhile, the companies are awaiting FDA approval for Bydureon; a decision is expected in January.

- see the NICE statement
- read the story from InPharm
- get more from Bloomberg

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