Biotech Values

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Shionogi - deal terms with Roche for flu drug

[Just showing the PR from back in 2016 that details the terms Shionogi received from Roche for this novel flu drug. Shionogi kept full rights in Japan and Taiwan; has certain co-invest rights in the U.S.; and will get royalties elsewhere.]

http://www.shionogi.co.jp/en/company/news/2016/pmrltj0000002mfp-att/e160229.pdf

Shionogi Enters into a License and Collaboration Agreement with Roche for its Anti-Flu Drug, S-033188

Osaka, Japan, February 29, 2016 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that it has entered into a license and collaboration agreement with F. Hoffmann-La Roche Ltd. (Head Office: Basel, Switzerland; CEO: Severin Schwan, L.L.D.; hereafter “Roche”) for the development and commercialization of its oral anti-influenza drug S-033188, discovered by Shionogi.

S-033188 is a cap-dependent endonuclease inhibitor*1, with a novel mechanism of action. It is expected to be a one-time, single-dose therapy for influenza, having the potential to be both more convenient and, with its novel mechanism of action, more effective than existing marketed anti-influenza products, which are neuraminidase inhibitors*2. In October, 2015, S-033188 has been designated for priority review by the Ministry of Health, Labour, and Welfare of Japan, as a “Sakigake fast-track review candidate.” A Phase II study is currently ongoing in Japan, and S-033188 is projected to be launched in Japan in Shionogi’s fiscal year 2017, which ends March 31, 2018.

Under the terms of this agreement, Shionogi will conduct development of S-033188 in collaboration with Roche worldwide, with the exception of Japan and Taiwan which will be retained exclusively by Shionogi. Shionogi received an undisclosed upfront payment from Roche and is also eligible to receive milestone payments upon successful completion of key development and registration milestones, including marketing approval. Roche will have the right to commercialize S-033188 worldwide (excluding Japan and Taiwan), with Shionogi retaining certain co-promotion rights in the US. Shionogi shall be entitled to receive royalties from Roche on S-033188 sales.

Influenza virus causes an acute and severe respiratory tract infection and is prevalent primarily during the winter season. In the elderly and other high risk populations, influenza infection is associated with significant morbidity and mortality. Roche has previous successful experience in the development of treatments for influenza. Through this cooperation, Shionogi’s goal, consistent with its overall mission, is to supply an innovative and effective medicine to patients worldwide suffering from influenza virus infection.