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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIs Eli Lilly and Co. about to have another Effient experience?
Lilly and its development partner are trying to get approval for a once-weekly version of the anti-diabetes drug Byetta. The new drug will be called Bydureon.
But the U.S. Food and Drug Administration last week pushed its self-declared deadline for rendering a decision on the drug to Oct. 22. The previous deadline was in March.
Bydureon is key for keeping Lilly competitive in the diabetes game. Earlier this year, the FDA approved a Byetta competitor called Victoza, which is manufactured by Lilly’s diabetes nemesis, Denmark-based Novo Nordisk N/S.
Victoza is a once-daily injectible medicine, compared with the twice-daily injections required with Byetta.
Analysts expect Byetta sales to peak this year at more than $800 million (although Lilly shares that revenue with San Diego-based Amylin Pharmaceuticals Inc.) and then start falling off. But they expect Bydureon sales to reach $800 million to $1 billion by 2015.
Lilly needs to ramp up any new drug as soon as possible so it can build up revenue before Lilly’s bestselling anti-psychotic Zyprexa faces generic competition in October 2011.
Lilly had hoped that the blood thinner Effient would help offset the loss of Zyprexa sales. But the FDA took a year longer than promised to render a decision on the drug. And, because of a severe warning about bleeding causes by the drug, sales so far have been paltry.
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