In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ($AMLN) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where the med was being manufactured for the European market.
The company has been making some parts of the drug and holding it for final packaging, a spokeswoman told the Middleton Journal. The drug is now being rolled out for delivery to pharmacies this month.
The FDA gave approval of the first once-weekly version of Amylin's diabetes shot last week. It was the third try for the company and its Dublin-based partner Alkermes ($ALKS). The drug uses Alkermes' polymer microsphere technology, manufactured in Wilmington, Ohio, to make it last longer. Alkermes has said it will receive 8% of the drug's net sales and its financial release Thursday it reported it earned $300,000 in the third quarter from sales in the EU.
There are significant expectations for Bydureon, which is intended to replace standard twice-a-day injections, both because of its dosage and the so-called Type 2 diabetes epidemic in the U.S. Most of the estimated 28.5 million people in the country with diabetes have Type 2. The disease costs the nation an estimated $174 billion a year in medical expenses and lost productivity. A federal report in 2010 estimated the disease costing $83 billion annually in hospital fees--23% of total hospital spending.
Deutsche Bank analyst Robyn Karnauskas in New York told Bloomberg Bydureon's U.S. revenue may surpass $1 billion in 2015.
But it is not all upside for the drug. In a head-to-head study with Victoza earlier this year, the rival Novo Nordisk ($NVO) drug had a superior result. Now analysts will be studying whether Amylin's pricing strategy--it intends to charge $323 for a month's supply versus $421 for the high-dose version of Victoza--will help make up the difference.
The Ohio plant, with about 300 employees, started operations in 2009, but approval of Bydureon proved elusive. Amylin's second attempt was thwarted in October 2010, when U.S. regulators expressed concern about irregular heartbeats in patients with impaired kidney functions. It received approval in Europe last June.
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