License Agreement of Nippon Shinyaku & Eli Lilly on “Cialis ®”(generic name: Tadalafil) and its new indications under development
Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa), Eli Lilly Japan K.K. (Headquarters: Kobe, Japan; President: Alfonso G. Zulueta) and Eli Lilly and Company (Headquarters: Indiana, USA; President: John C. Lechleiter) announced today that they have agreed to sign a licensing agreement for Cialis (generic name: tadalafil) and its new indications currently under development.
Under the licensing agreement, Cialis which was launched in Japan in September, 2007 for the treatment of erectile dysfunction (ED) will be solely promoted and sold by Nippon Shinyaku in Japan starting July 1, 2009.
The two new Tadalafil indications currently under development are for pulmonary arterial hypertension (PAH) and for urinary disorder caused by benign prostatic hyperplasia (BPH). As for the PAH indications, Eli Lilly Japan submitted its new drug application (NDA) to the Ministry of Health, Labor and Welfare (MHLW) in August, 2008, simultaneous to the US/EU NDA submissions. As for the BPH indications, the Phase II global/domestic clinical trials are on-going.
Nippon Shinyaku will solely promote and sell Tadalafil’s PAH indication after receiving regulatory and pricing and reimbursement approval. As for the BPH indication, Nippon Shinyaku and Eli Lilly Japan agree to co-market Tadalafil in Japan. Eli Lilly and Company will supply Cialis and other Tadalafil brands to be approved in the future to Nippon Shinyaku. Eli Lilly Japan will continue to retain tadalafil manufacturing marketing licenses.
Cialis is an oral ED treatment, and it helps men’s natural ability of maintaining erection by inhibiting an enzyme that disturbs the achievement and maintenance of erection. Cialis may be expected to continuously improve erectile function for 36 hours from its intake without being affected by the intake of meals.
Shigenobu Maekawa, President of Nippon Shinyaku mentions as follows. “It is our honor to have Cialis to our portfolio from Eli Lilly. The approval of new indications for PAH and BPH is planned, and we believe we are able to fully demonstrate our strength in promoting those indications based on our experiences. We will focus on the marketing activities to maximize the value and potential of tadalafil in the Japanese market.”
Alfonso G. Zulueta, President of Eli Lilly Japan K.K. mentions as follows.
“Cialis is an excellent product that many healthcare professionals and patients in Japan and globally believe to be the best ED medication. This agreement with Nippon Shinyaku, a company with vast experience and excellent reputation in the field of urology, will maximize the opportunities of Cialis and of Tadalafil’s future PAH and BPH indications in Japan. This decision is consistent with Lilly’s intent to develop strategic partnerships to ensure success of its products and better serve the unmet medical needs of patients.”
This license agreement will enrich Nippon Shinyaku’s urology product line-up, which is their focus area, and Nippon Shinyaku expect synergy effects on the sales of existing urology products. As for PAH, Nippon Shinyaku are currently performing a clinical trial of NS-304, originally discovered and synthesized by Nippon Shinyaku for the treatment of PAH, and Nippon Shinyuku also expect synergy effects for this as well in the future.
< About Cialis >
Brand Name Cialis® 5mg, 10mg, 20mg
Label Treatment for Erectile Dysfunction
Ingredients Tadarafil 5mg, 10mg, 20mg
Price Not price listed
Approval July 31, 2007
Launch September 12, 2007
Manufactured by Eli Lilly Japan K.K.
Promoted by Nippon Shinyaku Co., Ltd. (from July 1, 2009)
< About Nippon Shinyaku K.K.>
Name Nippon Shinyaku Co., Ltd.
Establishment October 1, 1919
President Shigenobu Maekawa
Location Minami-ku, Kyoto City, Kyoto Prefecture
Number of employees 1,650 (as of March, 2009)
Sales 63 billion yen (2008 fiscal year (not finalized))
< About Eli Lilly Japan K.K. >
Name Eli Lilly Japan K.K.
Establishment November 1, 1975
President Alfonso G. Zulueta
Location Chuo-ku, Kobe City, Hyogo Prefecture
Number of employees 1,800 (as of March 2009)
Sales 91.773 billion yen (in 2008)
< About Eli Lilly and Company >
Name Eli Lilly and Company
President John C. Lechleiter (Chairman & CEO)
Location Indianapolis, Indiana, USA
Number of employees 40,000
Sales 20.378 billion dollars (in 2008)