Espicom View: An experienced partner in this market is important because competition will be tough against domestic giant, Astellas Pharma, with rival drug Xtandi. We expect both drugs to be approved by mid-2014, with Xtandi slightly ahead of abiraterone acetate. There is a good window of opportunity for excellent uptake of the products in this country while prostate cancer therapy options are limited and the market for patented drugs is still strong. Further abiraterone filings are expected for treating earlier stages of prostate cancer in the short- to medium-term for US/EU markets, thus it is likely that similar expanded indications will follow in Japan. We believe that an extension of the licensing arrangement may emerge in China where AstraZeneca is the leading foreign manufacturer.
AstraZeneca has entered into an agreement with Janssen Pharmaceuticals KK (Johnson & Johnson) in Japan to co-promote abiraterone acetate, an innovative oral therapy for the treatment of patients with prostate cancer (PCA). Financial terms of the agreement were not disclosed.
Abiraterone acetate, a CYP17 inhibitor, inhibits the key enzyme that modulates the production of androgens. This helps lower the level of androgens available to the PCA cells, which is the goal of treatment in PCA. Janssen submitted a marketing approval application for the drug to the Japanese Ministry of Health, Labour and Welfare in July for the treatment of PCA. Currently the main treatment option available to patients in Japan is medical castration.
J&J's product was approved in the US by the FDA in April 2011, and in the EU by the EC in September 2011 for the treatment of patients with metastatic castration-resistant PCA (MCRPCA) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen (tradename Zytiga). The drug has been approved in 83 countries and widely been regarded as the most successful oral oncology drug launch in history. In 2012, its first full year on the market, sales reached near blockbuster status at US$961mn (US$301mn in 2011), placing it as second highest behind Velcade in the company's oncology portfolio.
H113 figures suggest that the drug will exceed the 2012 total in the current year. Sales will be boosted by December 2012 US and EU approvals that extended the approved indication to chemotherapy-naÃ¯ve patients with MRCPA. In its May 23 2013 Pharmaceuticals Business Review, J&J stated that Zytiga had a total metastatic CRPCA share in April of over 30%, up approximately three points from Q412.
The following table shows sales of Zytiga in Q213 and H113 across the US and international markets.
As noted in Business Monitor International's Q4 2013 Japan Pharmaceuticals & Healthcare Report, an ageing population, coupled with the country's high expenditure on healthcare, makes Japan a very attractive market for drugmakers. It is the second-largest pharmaceutical market in the world after the US and per capita spending is one of the world's highest (US$1,026 in 2012). Additionally, the very strong patented drugs market accounts for nearly 85% of total drug expenditure, due to the country's wealth and preference for this type of product. J&J and AstraZeneca will need to maximise on this current preference for branded drugs, as government-sector policy becomes increasingly cost-conscious and global generic drug firms begin to take an interest in the Japanese market. One of the threats that BMI has identified in this market is the proposal to link original drug prices and market shares to generic equivalents in order to stimulate price competition to potentially reduce the value of patented as well as overall drug markets.
AstraZeneca has considerable presence and history in Japan, and as at BMI's Q4 report, has strong volume growth counteracting government pricing revisions. Japanese subsidiary AstraZeneca KK has been operational since 2000, is headquartered in Osaka and has ten sales branches across the country. AstraZeneca KK is now 80% owned by AstraZeneca, with the remaining 20% owned by Sumitomo. Marc Dunoyer, Executive Vice President, Global Products and Portfolio Strategy at AstraZeneca stated that '...This deal is a strong strategic fit for AstraZeneca, reinforcing both our focus on oncology as a core therapy area and Japan as one of our key growth drivers.'
A direct competitor for Janssen's drug is Xtandi (enzalutamide), a novel, once-daily oral androgen receptor signalling inhibitor that was filed for approval in Japan by Astellas Pharma for the treatment of PCA in May. Xtandi, the subject of a joint development programme between Astellas and Medivation, is already approved in the US and EU for MCRPCA patients who have previously received docetaxel. Astellas has a home advantage in Japan, currently being the nation's second largest indigenous pharmaceutical producer, and this is the likely reason for J&J opting to use AstraZeneca's presence in this market to adequately rival the competition.
|Agreement Status:||New||Date Announced:||11 Oct 2013|
|Date Last Reported:||Duration:|
|Est Total Value:||Investment To Date:|
|Generic / Brand Name:||abiraterone acetate Zytiga|
|Therapeutic Area:||Antineoplastic and Immunomodulating Agents|