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Co promotion agreement for dapagliflozin

Companies: AstraZeneca
Ono Pharmaceutical
Announcement date: Dec 03 2013
Related contracts: Asset purchase agreement for diabetes joint venture

Details

Announcement date: Dec 03 2013
Industry sectors: Bigpharma
Pharmaceutical
Brand name: Forxiga, Farxiga
Compound name: Dapagliflozin
Asset type: Product
Therapy areas: Metabolic » Diabetes » Type 2
Technology types: Small molecules
Deal components: Co-promotion
Distribution
Stages of development: Marketed
Geographic focus: Asia » Japan

Financials

Upfront, US$m: n/d : undisclosed
Milestones, US$m: n/d : sales related milestones

Termsheet

AstraZeneca and Ono Pharmaceutical announced an agreement to co-promote dapagliflozin, an innovative once-daily oral therapy to treat type 2 diabetes mellitus in Japan.

AstraZeneca simultaneously entered into an agreement with Bristol-Myers Squibb granting AstraZeneca exclusive rights to commercialise dapagliflozin in Japan once approved.

Under the terms of the agreement, Ono will make an up-front payment and further payments relating to the launch and sales-related milestones, which will be shared by Bristol-Myers Squibb and AstraZeneca.

Bristol-Myers Squibb and AstraZeneca will supply dapagliflozin and Ono will be responsible for its distribution.

AstraZeneca and Ono will jointly detail dapagliflozin to healthcare professionals in Japan.

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT-2) that works independently of insulin to help remove excess glucose from the body.

Press Release

ASTRAZENECA AND ONO ENTER CO-PROMOTION AGREEMENT IN JAPAN FOR DAPAGLIFLOZIN

ASTRAZENECA AQUIRES EXCLUSIVE COMMERCIAL RIGHTS TO DAPAGLIFLOZIN IN JAPAN FROM BRISTOL-MYERS SQUIBB Ono Pharmaceutical Co., Ltd. AstraZeneca K.K. Bristol-Myers K.K.

3 December 2013

AstraZeneca K.K. (Osaka, President and Representative Director: Gabriel Baertschi) and Ono Pharmaceutical Co., Ltd. (Osaka, Japan, President, Representative Director, and CEO: Gyo Sagara) today announced an agreement to co-promote dapagliflozin, an innovative once-daily oral therapy to treat type 2 diabetes mellitus in Japan. AstraZeneca simultaneously entered into an agreement with Bristol-Myers Squibb granting AstraZeneca exclusive rights to commercialise dapagliflozin in Japan once approved.

Under the terms of the agreement, Ono will make an up-front payment and further payments relating to the launch and sales-related milestones, which will be shared by Bristol-Myers Squibb and AstraZeneca. Bristol-Myers Squibb and AstraZeneca will supply dapagliflozin and Ono will be responsible for its distribution. AstraZeneca and Ono will jointly detail dapagliflozin to healthcare professionals in Japan.

Bristol-Myers K.K. (Tokyo, Japan, Representative Director and President: Davide Piras) submitted a new drug application for dapagliflozin in Japan in March 2013 to the Ministry of Health, Labour and Welfare.

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT-2) that works independently of insulin to help remove excess glucose from the body.

FORXIGA○R was the first SGLT-2 inhibitor in the world to gain regulatory approval to treat type 2 diabetes. FORXIGA○R was approved in the EU by the European Commission in November 2012 for the treatment of adults with type 2 diabetes, and is currently approved in 37 countries globally (as of end November 2013).

Gabriel Baertschi, President and Representative Director at AstraZeneca K.K. said, “AstraZeneca has an excellent track record of bringing transformative medicines to patients and this collaboration has the potential to benefit many of the estimated nine million people with type 2 diabetes in Japan, a key market for us. Ono has one of the strongest sales and marketing organisations in Japan, complementing our capabilities in market access. This agreement reinforces our focus on diabetes, one of our core therapy areas.”

: According to the National Health and Nutrition Survey made in 2007 by the Ministry of Health, Labor and Welfare, those strongly suspected of having diabetes are approximately 8.9 million people.

Davide Piras, Representative Director and President, Bristol-Myers K.K. said: “We look forward to adding Ono to our collaboration with AstraZeneca in Japan, and are confident that Ono’s commercial organisation will help build on the success we’ve achieved with dapagliflozin globally through our alliance with AstraZeneca.”

News Release

Gyo Sagara, President, Representative Director, and CEO at Ono said: “We are delighted to add dapagliflozin — a novel anti-diabetes drug — to our product portfolio in diabetes, one of our strategic therapeutic areas. We expect to bring this promising drug to patients once approved.”

Financial terms of the agreement were not disclosed.

NOTES TO EDITORS

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About Ono Pharmaceutical Co., Ltd.

Ono Pharmaceutical Co., Ltd. is a R&D-oriented pharmaceutical company specialized in creating innovative medicines in specific areas and is headquartered in Osaka, Japan. For more information about Ono, visit the company’s website at http://www.ono.co.jp/eng/index.html

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business engaged in the discovery, development and commercialisation of prescription medicines. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit: http://www.astrazeneca.com In Japan, we aspire to further contribute to patients health and healthcare advancement with primary focus on oncology, cardiovascular, gastrointestinal, respiratory, diabetic, and neuroscience disease areas. For more information about us, please visit http://www.astrazeneca.co.jp

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