What Happens When Your Golden Goose Teeters on the Edge of the Patent Cliff…?


Lilly is a pharmaceutical company with a problem; many of their top-earning drugs are either free of patent or coming to the end of their protection. Once on the open-market, earnings from the drug will be a tiny proportion of what was generated during the patent-protected window. This phenomenon, known in the pharma world as a “patent cliff”, has been seen in the past, hitting giants such as Sanofi and Pfizer.

On top of Lilly’s woes is the continuing saga of their current golden goose, Alimta, a therapy for lung cancer. Back in June, NICE did not back proposals that this drug could be used in the maintenance of Non-Small Cell Lung Cancer (NSCLC) due to the drug being too expensive. It is approved for first-line treatment, but with a cost of £11’520 per patient (assuming an average treatment of eight cycles) maintenance was deemed too expensive. To work out the cost, NICE calculate the Quality Adjusted Life Year (QALY) to see how a drug will impact on a person’s life as well as how the drug will affect disease progression. The cost of using Alimta in the maintenance of NSCLC was £82’000 and NICE generally do not give backing to anything over £30’000. Lung cancer itself is big business in the pharmaceutical world; in England and Wales alone there are 36’000 new cases diagnosed per year, with 80% of those being NSCLC.

To try and soften the blow, Lilly are currently negotiating with the US government to have an extension to their patent. Alimta is due to be on open license from 2017 but if Lilly get their way this will be extended to 2022. An extra five years of sales (which are forecasted to be $3.5bn per year at the drug’s peak) would certainly buy some time for Lilly’s product portfolio.

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