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NEWS 2013

August 29, 2013 Pharmaceuticals
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Cialis® Becomes #1 Share in the Worldwide Erectile Dysfunction (ED) Drug Market

Nippon Shinyaku Co., Ltd. and Eli Lilly Japan K.K. announces that erectile dysfunction (ED) treatment Cialis® Tablets (general name: tadalafil) achieved the #1 share in the worldwide market.

According to U.S. Eli Lilly & Company’s first half 2013 business results, Cialis® maintains the world’s largest sales among phosphodiesterase type-5 (PDE-5) inhibitors for two consecutive quarters and showed a 12 percent increase in the first half 2013 over the same period of the preceding year, attaining 1.04 billion US dollars (or approximately 102 billion yen), an all-time high. According to IMS Health[1], the worldwide share of Cialis® reached 42 percent of the PDE5 inhibitor market.

Erectile dysfunction (ED) is defined as “a condition where an erection sufficient for satisfactory sexual intercourse cannot be obtained or maintained”[2]. It is reported that five to 20 percent of the world’s adult men suffer moderate or severe ED[3], and an epidemiological survey estimated that more than 11.3 million Japanese men suffer from ED[4]. As Japan is aging at a remarkable pace, the morbidity is expected to grow.

Cialis®, which is not impacted by meals, has shown to be effective in erectile function under sexual stimulation for approximately 36 hours, enabling patients to receive an ED treatment in a natural manner without feeling impatient or pressured regarding the timing of taking the medication. First launched in 2003 in Europe, the drug was made available shortly after in the United States, before launching in Japan in 2007. At present, Cialis® is commercially available in more than 100 countries in the world, and its share in the ED market is growing.

Commenting on the factor behind this success, Eli Lilly Japan President Alfonso G. Zulueta says, “Cialis® achieving the number one share in the worldwide market reflects the value of providing an innovative medicine for patients with ED since its launch in 2003 in the area of men’s health.”

In addition, Nippon Shinyaku President Shigenobu Maekawa says, “We are very pleased that Cialis® achieved the position of the sales leader among ED treatments in the world and that our company made a contribution to the achievement.” Nippon Shinyaku is the company that sells Cialis® in Japan. In the fiscal year ended June 2013, the company recorded an increase of 15.3 percent over the preceding fiscal year in terms of sales of the drug.

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[1] May 2013, IMS Health IMS MIDAS. Worldwide market shares are calculated in US dollars, including the following countries in the IMS MIDAS database: Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico, Poland, Portuguese, Saudi Arabia, South Africa, Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom, Venezuela, United States. Sales in these countries occupy roughly 90 percent of the worldwide sales of PDE5 inhibitors for ED treatment.

[2] Impotence: NIH Consensus Development Panel on Impotence. JAMA, 1993 Vol. 270, pp83 – 90

[3] Kubin M et al. Int. J. Impot. Res. 2003; 15:63-71

[4] Eiji Marui “History of Medicine” 2002; 201: 397 - 400