Sanofi Targets Counterfeit Viagra Market With OTC Cialis

Men with erectile dysfunction may be able to avoid the awkwardness of a doctor’s visit by buying the drug Cialis without a prescription, under a proposal announced Wednesday by the drug’s maker, Eli Lilly, and the French pharmaceutical company Sanofi.

Under the plan, Sanofi is buying the rights to seek approval to sell Cialis over the counter in the United States, Europe, Canada and Australia after certain patents expire. Cialis is to lose its patent protection in the United States and Europe in 2017, after which sales are expected to drop sharply as cheaper generic alternatives arrive on the market.

If approved for over-the-counter use, Cialis could gain an advantage over prescription competitors like Viagra, sold by Pfizer. But it is not clear whether the Food and Drug Administration or other regulatory bodies overseas would approve such a move: In 2008, Pfizer abandoned an effort to make Viagra available without a prescription after the European Medicines Agency raised concerns.

“Millions of men worldwide trust Cialis to treat E.D.,” or erectile dysfunction, said David A. Ricks, president of Lilly Bio-Medicines, the unit of Lilly that oversees Cialis. “We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from E.D. to obtain convenient access to a safe and reliable product without a prescription.”

Pharma Should be at Heart of European Economic Reform, says EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA)  launched what it called “a landmark paper” outlining steps towards an integrated strategy for the life sciences sector in Europe.

“Health & Growth — Working together for a healthy Europe” calls for a new generation of partnerships to address the EU’s growing health and competitiveness challenges. The paper lays out a case for placing the pharmaceutical industry at the heart of European economic reform and growth.

EFPIA President, Christopher Viehbacher, CEO of Sanofi, said : “We need to better understand the environmental and demographic factors driving healthcare spending… If we want sustainable systems, we can’t revamp just one area; we need to address the system as a whole.”

Richard Bergström, Director General EFPIA, added: “We must start thinking outside the box and ensure our industry is connected not just on debates about wellbeing, but also about jobs, growth and economic stability. A new European life sciences strategy will be vital to achieving the objectives of Europe 2020 and beyond.”

EFPIA is calling for greater political collaboration to agree a comprehensive strategy for life sciences, based on three “separate but interdependent pillars”:

1. Improvement of health outcomes and removal of inequalities to better patient benefits;
2. Support for sustainable and predictable healthcare systems to speed access to medicines;
3. The building of a thriving innovative life sciences sector to promote European competitiveness.