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Sanofi plans OTC version of Lilly's Cialis

Deal could see erectile dysfunction drug become available without a prescription once its patents expire

Lilly Cialis tadalafil 

Sanofi has agreed a deal with Lilly to license its erectile dysfunction drug Cialis and pursue approval for non-prescription use.

Under the terms of the deal, Sanofi's consumer health division has acquired exclusive rights to apply for approval of an over-the-counter (OTC) version of Cialis (tadalafil) in the US, Europe, Canada and Australia and then to sell the drug in these regions once its patents expire.

The drug is currently marketed by Lilly and is only available legally via prescription once a doctor has diagnosed erectile dysfunction in a man.

It has been available in Europe since 2002 and in the US since 2003 in this form, recording total global sales of $14bn (€10.2bn) in that time despite competition from the likes of Pfizer's Viagra (sildenafil).

Cialis is set to lose patent protection in 2017, however, opening the market to competition from much cheaper generic rivals, as has happened with Viagra. Despite extending the drug's US exclusivity to 2020, Pfizer faced patent losses in the rest of the world last year, leading to a dramatic fall in global sales for the product.

Lilly faces a similar fate with Cialis and has made the deal with Sanofi – financial terms of which were undisclosed - to maximise the drug's potential.

If approved in an OTC indication it would be the first former prescription erectile dysfunction drug available directly to consumers, giving it a huge advantage over Viagra and Bayer's Levitra (vardenafil), which also faces generic competition.

Pfizer has previously tried to make an OTC switch for Viagra, but withdrew from these efforts in 2008 after regulators raised concerns about the drugs' safety profile in men with underlying conditions such as heart disease.

Lilly and Sanofi will be hoping the process is smoother for Cialis despite the likelihood of coming up against similar safety issues.

David Ricks, senior VP at Lilly and president of Lilly Bio-Medicines, said: "Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous.

“Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."

Article by
Thomas Meek

29th May 2014

From: Sales

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