Sanofi and Lilly announce licensing agreement for Cialis® (tadalafil) OTC

SanofiSanofi (EURONEXT: SAN and NYSE: SNY) and Eli Lilly and Company (NYSE: LLY) have 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."

Cialis was first approved by the European Medicines Agency in 2002, then by the U.S. Food and Drug Administration in 2003, for the treatment of erectile dysfunction. 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. 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 butylnitrite, 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.

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).

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.

Most Popular Now

A need for bananas? Dietary potassium regulates ca…

Bananas and avocados - foods that are rich in potassium - may help protect against pathogenic vascular calcification, also known as hardening of the arteries. University ...

FDA awards 15 grants for clinical trials to stimul…

The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to...

Amgen and CytomX Therapeutics announce strategic c…

Amgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc., (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The co...

Novartis and The Max Foundation transform pioneeri…

Novartis announced a new collaboration with The Max Foundation to support continued access to treatment at no cost for nearly 34,000 current patients with chronic myeloid...

Roche launches NAVIFY Tumor Board solution to prov…

Roche (SIX: RO, ROG; OTCQX:RHHBY), has announced the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimises decision-...

AbbVie and Bristol-Myers Squibb announce clinical …

AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) today announced a clinical trial collaboration to evaluate the combination of AbbVie's investigational an...

Tagrisso granted breakthrough therapy designation …

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatm...

Pfizer launches novel programs to put important su…

Pfizer today unveils enhanced offerings to help patients manage their life with cancer. Pfizer Oncology Together is a first-of-its-kind program for patients taking Pfizer...

Novartis and UC Berkeley collaborate to tackle 'un…

Novartis has joined forces with researchers from the University of California, Berkeley, to develop new technologies for the discovery of next-generation therapeutics, pu...

Printed meds could reinvent pharmacies, drug resea…

A technology that can print pure, ultra-precise doses of drugs onto a wide variety of surfaces could one day enable on-site printing of custom-dosed medications at pharma...

Danish discovery can pave the way for more effecti…

More than 600,000 Danes are being treated with cholesterol lowering medicine. 98 per cent of them are treated with statins, which curb the body's own production of choles...

Amgen and Simcere announce strategic collaboration…

Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group have announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. Th...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]