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Amylin and Lilly say they will present the full dataset from this trial at an upcoming medical meeting. LAR will be filed for approval with the FDA by the end of the first half of 2009, according to both companies. That's a long wait for an FDA filing -- possibly longer than expected -- but the drug is being held up by manufacturing. Amylin is still constructing an LAR manufacturing facility, so the drug can't be filed until the facility is completed. Amylin and Lilly currently market Byetta as a twice-a-day injection for Type 2 diabetes patients. Through the first nine months of 2007, Byetta sales totaled $460 million, an increase of 57% year over year. Most analysts expect Byetta sales growth to slow due to competition from oral diabetes medicines. But LAR, as a convenient once-weekly injection, has the potential to become a blockbuster i.e. a billion-dollar plus product. The most bullish analyst estimates project upwards of $3 billion in peak sales for the drug.
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