Solid quarter for Lilly as patent expiries loom

Eli Lilly has posted a solid set of financials for the third quarter, helped by cost-cutting continuing strong sales of Cymbalta.

Net income fell 9% to $1.20 billion, although the like, year-earlier period included an early payment of $787 million from ex-partner Amylin reglating to the diabetes treatment Byetta/Bydureon (exenatide). Turnover was up 6% to $5.77 billion.

The best performer was the antidepressant/fibromyalgia blockbuster Cymbalta (duloxetine), which rose 11% to $1.38 billion, while the lung cancer drug Alimta (pemetrexed) increased 7% to $690.5 million. The insulin products Humalog and Humulin rose 7% and 8% respectively, to $616.0 million and $307.0 million.

Patent losses hit the antipsychotic Zyprexa (olanzapine), which had turnover of $278.7 million, down 26%. The osteoporosis drug Evista (raloxifene), which is also approved for the prevention of breast cancer for certain postmenopausal women, increased 3% to $255.3 million, while sales of Lilly’s other osteoporosis drug Forteo (teriparatide) was up 6% to $306.7 million.

The erectile dysfunction drug Cialis (tadalafil) rose 9% to $526.7 million, while the attention-deficit hyperactivity disorder drug Strattera (atomoxetine) generated $173.2 million of sales, up 19%. The bloodthinner Effient (prasugrel) which is partnered with Daiichi Sankyo, climbed 14% to $124.9 million.

Chief executive John Lechleiter said that “as we navigate through a period of expiring patents for some of our largest products, Lilly continues to deliver solid financial results and to advance our late-stage pipeline, with four regulatory filings completed this year alone”.

The company has been restructuring and as well as the Zyprexa loss, Lilly is preparing for patent expiries on Cymbalta and Evista in the USA next year. “We are successfully executing our strategy which will enable us to return to growth after 2014,” said Dr Lechleiter.

Key to that return to growth will be ramucirumab and the US Food and Drug Administration has just granted the compound a priority review for patients with advanced gastric cancer following disease progression after initial chemotherapy.

These means the agency will make a decision on approving the drug within eight months and Lilly expects action on its application in the second quarter of 2014. The company has also studied ramucirumab in combination with paclitaxel for advanced gastric cancer and data from that Phase IIItrial will be the basis for separate regulatory applications.

Lilly added that it expects top-line results from three additional Phase III trials of ramucirumab — one each in colorectal, liver and lung cancer — in 2014. Last month, however, the company said it will not submit the drug in breast cancer after a Phase III failure.

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