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

Top 20 World Pharma News of 2016

Look back at the most prominent moments from the year 2016. We are proud to announce the 20 most popular World Pharma News from 2016, the most commonly viewed news accord...

Read more

New precision medicine tool helps optimize cancer …

Columbia University Medical Center (CUMC) researchers have created a computational tool that can rapidly predict which genes are implicated in an individual's cancer and ...

Read more

Roche's emicizumab for haemophilia A meets primary…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the primary endpoint has been met for the phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 y...

Read more

Sanofi and Boehringer Ingelheim confirm Closing of…

Sanofi and Boehringer Ingelheim confirmed that the strategic transaction signed in June 2016, which consists of an exchange of Sanofi's animal health business (Merial) an...

Read more

Diabetes, heart disease, and back pain dominate US…

Just 20 conditions make up more than half of all spending on health care in the United States, according to a new comprehensive financial analysis that examines spending ...

Read more

FDA approves first drug for spinal muscular atroph…

The U.S. Food and Drug Administration has approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare ...

Read more

Novartis invests in next generation therapies to r…

Novartis announced today a collaboration and option agreement with Ionis Pharmaceuticals, Inc. and its affiliate Akcea Therapeutics, Inc., to license two novel treatments...

Read more

Topical treatment activates immune system to clear…

A combination of two FDA-approved drugs - a topical chemotherapy and an immune-system-activating compound - was able to rapidly clear actinic keratosis lesions from patie...

Read more

Vaccine shows promising results for early-stage br…

Deregulation and inhibition of the immune system contributes to cancer development. Many therapeutic strategies aim to re-stimulate the immune system to recognize cancer ...

Read more

Bristol-Myers Squibb announces immunotherapy clini…

Bristol-Myers Squibb Company (NYSE:BMY) today announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate the combination of Bristol-Myers Squi...

Read more

Anti-aging therapies targeting senescent cells: Fa…

It's an exciting time to be an elderly mouse. Researchers believe that by removing senescent cells (cells with a persistent damage response), which naturally accumulate w...

Read more

Novo Nordisk and Glooko partner to develop digital…

Novo Nordisk and Glooko today announced that the two companies will work together to deliver jointly-developed and branded digital health solutions for people with diabet...

Read more

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 ]