FDA nod fuels Bydureon vs. Victoza bout

Amylin Pharmaceuticals' ($AMLN) projected blockbuster Bydureon has won FDA approval, adding muscle to the San Diego-based drug company's counterpunch against rival Novo Nordisk ($NVO) in the big market for GLP-1 diabetes drugs. Now Amylin CEO Daniel Bradbury has the regulatory nod needed to regain the upper hand in the market.

Amylin has already revealed an aggressive pricing strategy to propel the U.S. launch of Bydureon, a once-weekly version of the company's drug Byetta. Byetta, which is injected twice a day, has been losing ground to Novo's similar drug Victoza, which has been winning over doctors in part because it is injected only once per day. Amylin now has the green light for U.S. and EU sales of Bydureon, which analysts have projected to exceed $1 billion in annual sales.

With key regulatory approvals in place, Amylin now must execute on the marketing end of its Bydureon strategy. And the stakes are high: Amlyin is now tackling the U.S. and European markets without former partner Eli Lilly ($LLY) after the two companies ended a legal scrape over Lilly's diabetes drug pact with Boehringer Ingelheim with a deal that gave Amylin full control over Bydureon. For a price, as Amylin paid Lilly $250 million and agreed to pay $1.2 billion to the Indianapolis-based drugmaker from sales of Bydureon, The New York Times reported.

Amylin is taking Bydureon to the market with a price tag of $323 for a month's supply of the drug--which boosts the body's ability to produce insulin for people with Type 2 diabetes--charging less than the $421 Novo charges for the same supply of Victoza, according to price quotes from Deutsche Bank, as reported by The Wall Street Journal.

Bydureon faces some challenges on the market. Victoza beat Bydureon in Amylin's head-to-head study revealed last year, showing that patients on Novo's treatment had better control of blood sugar than those on Bydureon, the Times reported. Another plus for Victoza is the size of the needles needed for injections of the med, which are smaller than those required for Bydureon.

Diabetics greatly increase their chances of staying healthy if they can control their blood sugar, and poor adherence to doctor's orders has been a major problem in treating the disease. Amylin could win over U.S. patients and doctors who view the less frequent injections of Bydureon as their best chance to keep blood sugar levels in check.

Alkermes ($ALKS), the provider of the tech that allows Bydureon's active drug to be released gradually, will no doubt be rooting for Amylin in its market bout with Novo. Dublin-based Alkermes gets an 8% royalty on sales of Amylin's long-acting drug.

- read the NYT article
- check out Bloomberg's report
- and the WSJ's take

Special Report: Bydureon - 15 top blockbuster contenders

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