Eli Lilly and Co. (NYSE: LLY) has announced a deal with a France-based company involving the marketing of a potential over-the-counter version of Cialis. The agreement gives Sanofi exclusive rights to apply for nonprescription approval in several countries including the U.S. and Canada. If regulators approve, Sanofi would start providing Cialis OTC after certain patent expirations. May 28, 2014

News Release

PARIS and INDIANAPOLIS, May 28, 2014 — Sanofi (EURONEXT: SAN and NYSE: SNY) and Eli Lilly and Company (NYSE: LLY) today announced an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil). Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction (ED).

Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi's receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. Terms of the licensing agreement were not disclosed.

“This agreement provides us with an opportunity to work with Lilly, a leader in men's health, to transform how this important medicine is offered to millions of men throughout the world,” said Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi. “The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare's leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi.”

“Millions of men worldwide trust Cialis to treat ED. 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,” said David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines. “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.”

Ultimately, Cialis has received approval in more than 120 countries for indications that vary by country, including erectile dysfunction and erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (BPH). Cialis reached $2.16 billion USD (?1.58 billion) in worldwide sales in 2013 and has recorded total global sales of more than $14 billion USD (?10.2 billion) since launch. To date, more than 45 million men worldwide have been treated with Cialis.

About Cialis

Currently only available with a prescription, Cialis is a tablet taken to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor treatment that offers men a choice when it comes to treatment for erectile dysfunction – Cialis for use as needed and Cialis for once daily use. To learn more about Cialis, visit www.cialis.com.

Cialis is not for women or children. It is important to note that Cialis is not to be taken with medicines called “nitrates” such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called “poppers” like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.

About Erectile Dysfunction (ED)

ED is a medical condition in which a man has trouble getting or keeping an erection. It is very common: more than half of men over 40 years old have ED.[i]

About Sanofi Consumer Healthcare

Sanofi Consumer Healthcare is committed to providing consumers around the world with self-care solutions that empower them to better manage their health and well-being through leading brands in the areas of Allergy, Digestive health, Feminine care, Cough, cold, flu & sinus and Vitamins, minerals & supplements. We place people at the very heart of everything we do and strive to identify and fulfil their needs by delivering consumer insights-driven innovation, leveraging our medical & scientific heritage and our close collaboration with healthcare professionals, easing consumer access via switching relevant prescription medicines to over-the-counter solutions and applying the pharmaceutical quality standards delivered by our Group's global manufacturing network. In 2013, Sanofi Consumer healthcare achieved a ?3.0 billion ($4.1 billion USD) turnover representing a 5.2% growth vs. 2012 (constant exchange rates) and ranked #3 worldwide consumer healthcare player (Nicholas Hall- 2013).

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). To learn more about Sanofi, please visit us at www.sanofi.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

Source: Eli Lilly and Co.

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