Mitsubishi Tanabe Pharma Corporation Signs Licensing Agreement with A. Menarini Asia-Pacific for Spedra (Avanafil) in 10 Countries in Asia-Pacific

SINGAPORE–(BUSINESS WIRE)–Mitsubishi Tanabe Pharma Corporation (TSE: 4508), and Singapore-based A.
Menarini Asia-Pacific Holdings Pte Ltd (“Menarini AP”) have entered into
a licensing agreement to commercialize and promote SPEDRA™ (avanafil).
Menarini AP will receive exclusive licensing rights from Mitsubishi
Tanabe Pharma Corporation to market Avanafil in China, Hong Kong,
Macao, Taiwan, Indonesia, Malaysia, Philippines, Singapore, Thailand,

Menarini AP is a member of the Menarini Group, the world’s largest
Italian biopharmaceutical company, and provides physicians and
healthcare professionals with medical and scientific information with
competence, correctness and the highest ethical standards in all its
work processes. Menarini Group has already been licensed to market this
product in over 40 European countries, plus Australia and New Zealand.

SPEDRA™ (avanafil) is a new and innovative phosphodiesterase – 5
inhibitor (PDE5-i) approved by the European Commission in June 2013 for
the treatment of erectile dysfunction. In the U.S., FDA approved
avanafil in April 2012 for the same indication, under the trade name

“A. Menarini Asia-Pacific is an ideal partner in this region. With its
extensive reach to the physicians and urologists/andrologists in the
region, strong core values, and established track record in product
launch, we are delighted to partner with Menarini AP”, commented Mr.
Masayuki Mitsuka, President and Representative Director at Mitsubishi
Tanabe Pharma Corporation.

“The Asia Pacific Erectile Dysfunction (ED) market is poised to grow
strongly in the foreseeable future, driven by improvements in diagnosis
rates, patient’s affordability and improvements in access to quality
healthcare. SPEDRA™ is a welcome addition to our men’s health portfolio
as it represents an innovative treatment option for men with erectile
dysfunction (ED) due to its unique pharmacological characteristics and
rapid onset of action. Together with Priligy, the first approved drug
for premature ejaculation (PE), Menarini AP has further consolidated its
presence in the men’s health space in the region”, said Dr. Luca
Lastrucci, CEO at A. Menarini Asia-Pacific.

About Spedra (Avanafil)

Avanafil is a second generation, highly selective and potent PDE5
inhibitor. Due to its unique pharmacokinetic profile, Avanafil has shown
to be efficacious within approximately 15 minutes of dosing in most
patients, thus representing the only PDE5-I approved in Europe to be
taken 15 to 30 minutes before sexual activity. Along with the fast onset
of action, Avanafil has shown a good tolerability profile with a low
incidence of class related adverse events in clinical trials. SPEDRA™,
the trade name for Avanafil in the EU, has been approved by the European
Medicines Agency for the treatment of erectile dysfunction. Known as
STENDRA in the U.S., it is also approved by the Food and Drug
Administration in the U.S. for the treatment of erectile dysfunction.
Mitsubishi Tanabe Pharma Corporation owns development and commercial
rights to avanafil for the treatment of male sexual dysfunction in
certain Asia-Pacific Rim countries.

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation (MTPC) is a research-driven
pharmaceutical company based in Osaka, Japan. MTPC is taking on the
challenge of drug discovery in the fields of autoimmune disorders,
central nervous system diseases, diabetes and kidney diseases, and
vaccines. To those ends, MTPC is strengthening its R&D pipeline. MTPC
contributes to the healthier lives of people around the world through
the creation of pharmaceuticals.

For more information about MTPC, please visit:

About Menarini Asia-Pacific

Menarini Asia-Pacific is part of the Menarini Group, the world’s largest
Italian biopharmaceutical company with a heritage of over 130 years and
over 16,000 highly trained employees operating in more than 100
countries according to strict ethical principles. Menarini
Asia-Pacific’s vision is to be a leading provider of important
healthcare brands to improve the lives of people in the region. Menarini
Asia-Pacific operates across the entire commercial value chain, from
clinical development, regulatory approval and product launch to
lifecycle management with a diverse portfolio of proprietary and
partnered brands in key therapeutic fields, including Consumer Health,
Dermatology, Allergy/Respiratory, Cardiovascular, Oncology/Specialty
Care and Men’s Health.

For more information about Menarini Asia-Pacific, please visit:


A. Menarini Asia-Pacific Holdings Pte Ltd
Jennifer Lin, +65-64943427
Regional Corporation Branding & Communications Manager