Under the terms of the agreement, Cialis would be exclusively promoted and sold by Nippon Shinyaku in Japan starting July 1, 2009. Cialis was launched in Japan in September 2007 for the treatment of Erectile dysfunction (ED). Nippon Shinyaku would exclusively promote and sell Tadalafil's pulmonary arterial hypertension (PAH) indication after receiving regulatory and pricing and reimbursement approval. As for the benign prostatic hyperplasia (BPH) indication, Nippon Shinyaku and Eli Lilly Japan agree to co-market Tadalafil in Japan. Eli Lilly and Company would supply Cialis and other Tadalafil brands to be approved in the future to Nippon Shinyaku. Eli Lilly Japan would continue to retain Tadalafil manufacturing marketing licenses.
The two new Tadalafil indications are developing for pulmonary arterial hypertension 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.
Deal Type Partnership Sub-Category Co-Marketing,Sales,Acquisition of Rights Deal Status Announced: 2009-04-09
Deal Participants
Partner 1 (Company) Nippon Shinyaku Co., Ltd. Partner 2 (Company) Eli Lilly and Company Partner 3 (Company) Eli Lilly Japan KK
Deal Rationale
This agreement would enhance Nippon Shinyaku's urology product line-up.

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