US biotech Amgen has announced more concrete steps towards re-establishing a presence in Japan, with a long-term alliance with Japanese firm Astellas on development of five pipeline drugs, alongside the formation of a joint venture.
IHS Global Insight perspective | |
Significance | Amgen's and Astellas' alliance relates to four biologics and a small-molecule drug at various stages of development, in the cardiovascular, osteoporosis, and cancer segments, with the first launch expected by 2016. |
Implications | The joint venture (JV) will begin operations from 1 October; Amgen plans to make the JV a wholly-owned subsidiary by 2020. |
Outlook | Amgen sold off its Japanese subsidiary along with the rights to 13 pipeline candidates to Takeda (Japan) in 2008 due to expensive drug development conditions; the firm's return to the market reflects the success of recent regulatory and pricing reforms, as well as Amgen's long-term global growth strategy. |
US firm Amgen has announced a long-term alliance with Japan's Astellas, under which the two firms will first partner on the development and commercialisation of various pipeline drugs, and later in the year will launch a joint venture (JV) in Japan.
Amgen will partner with Astellas on development of five of its drugs that are already in various stages of development in Japan (see table). No financial details were disclosed in relation to this partnership. The first commercial launch is expected by 2016.
Amgen pipeline products for joint development with Astellas | ||||
Development stage | ||||
Molecule name | Indication | Mode of action | Global | Japan |
AMG-145 | Hyperlipidaemia | Anti-PCSK-9 mAb | Phase III | Phase II |
Romosozumab (AMG-785) | Osteoporosis | Anti-Sclerostin mAb | Phase III | Phase II/III |
Rilotumumab (AMG-102) | Gastric cancer | Anti-HGF mAb | Phase III | Phase I |
AMG-337 | Gastric cancer | MET inhibitor | Phase I | - |
Blinatumomab (AMG-103) | Acute lymphoblastic leukaemia (ALL) and non-Hodgkin's lymphoma (NHL) | Anti-CD19 BiTE | Phase II | - |
The firms' JV, to be named Amgen Astellas BioPharma KK, is expected to be operational by 1 October. Amgen plans to take full ownership of the affiliate by 2020; the long-term alliance with Astellas relating to the above five pipeline drugs will continue beyond this point as a standalone deal. No details relating to division of equity or other financial terms were disclosed, although Reuters reports that Amgen will hold a 51% stake in the JV. Amgen's press release can be found here.
Outlook and implications
Amgen revealed in its long-term strategy release in February that it was exploring a partnership opportunity in Japan that would eventually provide a standalone subsidiary (see United States: 8 February 2013: Amgen raises 2013 forecast, plans biosimilars development). The company described its absence from Japan and China as "a noticeable gap" in its operations during a conference call at the time, as quoted by Reuters, and plans to earn USD1 billion from new and emerging markets by 2015. The firm earned only 21% of its revenues from markets outside of the US in 2012 (source: Bloomberg).
Amgen previously sold off a Japanese subsidiary to Takeda in 2008, along with the development rights to 13 pipeline candidates, citing the expense of launching and commercialising drugs independently in Japan as behind its decision (see Japan: 4 February 2008: Takeda Posts 7.2% Nine-Month Sales Growth, Signs US$902-mil. Development Deal with Amgen). Amgen's decision to return to the market reflects changing conditions in the country, which has been the source of strong growth by innovative firms in recent years: the top eight multinational drug firms saw growth ranging from 12% to 31% in 2011, as reported by The Economist. This reflects significantly improved regulatory and pricing conditions since 2008, thanks to Ministry of Health, Labour and Welfare (MHLW) reforms including shorter review timelines, and greater pricing protection for innovative drugs that are encouraging firms to increase research and development activities in the country.
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