Lilly and Sanofi have sealed a deal to peruse regulatory approval of non-prescription Cialis (tadalafil), in the hope of facilitating patient access to the erectile dysfunction (ED) drug.

Specific terms of the deal were not disclosed, but the firms did reveal that the French drugmaker has exclusive rights to apply for approval of Cialis over-the-counter (OTC) in the US, Europe, Canada and Australis, as well as exclusive rights to market the product if regulatory approvals are awarded.

The agreement, says Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi, provides the opportunity "to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare's leading portfolio," and that its successful track record of OTC switches "reinforces consumer health care as a major growth platform" for the firm.

"We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription," added David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines.

To date, more than 45 million men worldwide have been treated with Cialis, which rakes in annual sales of more than $2 billion. 

OTC approvals would mean that patients could pick up Cialis from pharmacies without a prescription, which could substantially boost the drug's target population given that many men with ED avoid seeing their family doctor because of embarrassment.

Though obtaining regulatory backing will be no mean feat, given the opportunity for misuse and also potentially serious safety issues, particularly how it might interact with other medicines, not to mention the fact that ED itself can be an indicator of more serious underlying cardiovascular issues, which would not be as easily picked up it patients are leapfrogging doctors to get the drug.