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Lilly expects to submit five drugs for US approval in 2013

Hopes FDA submissions will help offset patent losses for Zyprexa and Cymbalta

Eli Lilly HQ

Lilly expects to file five regulatory submissions with the US FDA during 2013 as generics continue to hit sales of key products.

On releasing its financial results for the first quarter of 2013, Lilly said it received fast-track designation from the FDA for the use of ramucirumab as a monotherapy treatment in second-line gastric cancer.

This adds to the existing submission for empagliflozin - an oral drug for type 2 diabetes developed in partnership with Boehringer Ingelheim - while a further three applications are anticipated to be made before the year's end.

Lilly didn't specify what the remaining three submissions are anticipated to be, although drugs in later-stage development include long-acting diabetes medicine dulaglutide and rheumatoid arthritis candidate baricitinib.

If approved, these new medicines could help cushion the impact of the loss of patent exclusivity for key products, such as antipsychotic Zyprexa (olanzapine), first quarter sales of which plummeted 49 per cent compared to the previous year.

Zyprexa's declining performance was partially offset by growth for other drugs, including depression treatment Cymbalta (duloxetine) and erectile dysfunction drug Cialis (tadalafil), meaning Lilly achieved flat total revenues of $5.6bn during the first three months of 2013.

However, sales are expected to take a tumble when Cymbalta, which made $1.33bn during the first quarter of 2013, loses patent protection by the end of the year, while Lilly's $240m-selling osteoporosis treatment Evista (raloxifene) is due to face generic competition in 2014.

The company is preparing for the financial impact of these events by making large cuts to its US sales force, although Lilly is counting on new drugs to support its long-term future.

Growth in other areas, including diabetes and emerging markets, is also expected, and Lilly said it expects revenues during 2013 to be between $22.6bn and $23.4bn.

29th April 2013

From: Sales



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