Mitsubishi Tanabe Pharma Corporation and Singapore-based A. Menarini Asia-Pacific Holdings Pte Ltd (Menarini AP) have entered into a licensing agreement to commercialise 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, Vietnam.

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 US, FDA approved avanafil in April 2012 for the same indication, under the trade name Stendra.

“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 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.

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 US, it is also approved by the Food and Drug Administration in the US 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.