Prasugrel to lead Japan-origin blockbusters

Now with a key US approval recommendation under its belt, Daiichi Sankyoand Lilly's novel antiplatelet agent prasugrel (Effient) is set to reap peak global annual sales of $2.5 billion. Sales in Japan, where the product is still in Phase II development, could reach ¥40 billion ($438.6 million) a year, a new Japanese analysis predicts.

Prasugrel has just been unanimously recommended for approval by an FDA expert panel, for patients with acute coronary syndromes presenting with either unstable angina/non-ST elevation myocardial infarction, or ST elevation myocardial infarction patients undergoing percutaneous coronary intervention (Scrip Online, February 4th, 2009). The therapy received a positive opinion from the EU's CHMP in December, and is expected to be a key mid-term growth driver at both companies.

The forecast comes in an annual review of Japanese-origin blockbuster drugs in the research journal New Drug Candidates. This year, Japan's largest pharmaceutical company, Takeda, dominated the list, accounting for half of the products in the top 10 by global sales. Its DPP-4 inhibitor for diabetes, alogliptin, is also expected to generate peak global sales of $2.5 billion, but a more modest ¥24 billion in Japan. This is currently awaiting approval both there and in the US, where its action date has been delayed to June. The journal's publisher, Dr Keiji Nakamura of the Pharma Forum Institute, predicts global sales of more than $1 billion for nine molecules originating from Japan. $2 billion is expected for Takeda's antidepressant, Lu AA21004, although this has been licensed in from Lundbeck.

Japanese-origin Blockbuster Peak Sales Forecasts

Product	Type/indication	Company	W'wide^1	Japan^2
prasugrel	antiplatelet	D-Sankyo	2.5	40
alogliptin	diabetes	Takeda	2.5	24
S-2367	obesity	Shionogi	1.8	18
tocilizumab	arthritis	Chugai	1.45	18
DU-176b	Factor Xa inhibitor	D-Sankyo	1.4	24
TAK-783	arthritis	Takeda	1.2	24
dexlansoprazole	PPI anti-ulcer	Takeda	1.1	14
azilsartan	hypertension	Takeda	1.0	32
TA-7284	diabetes	M-Tanabe	1.0	12
sergliflozin	diabetes	Kissei^3	0.9	10
1 $billion, includes sales through licensees; 2 ¥billion; 3 licensed to GlaxoSmithKline worldwide.

Dexlansoprazole has just been approved (as Kapidex) in the US as a follow-on to Prevacid (lansoprazole), for which the patent in this market will expire in November (Scrip Online, February 2nd, 2009). North American sales of Prevacid were $1.1 billion in the first half of this fiscal year alone.

Elsewhere, in the report, Dr Nakamura highlights the patent cliff faced by several major Japanese companies, which over the past 18 months have clamoured to make acquisitions to fill the sales gap. Based on figures for fiscal 2007 (ended March 31st, 2008), Takeda's sales of Prevacid and Actos (pioglitazone, for which the US patent expires in 2011) were ¥554.9 billion, including sales through licensees. This is equal to around 35% of Takeda's forecast pharmaceutical sales for this fiscal year.

ForEisai, the potential impact is even more pronounced. On the same basis, the company's combined sales of Aricept (donepezil) for Alzheimer's disease and the proton pump inhibitor Pariet/Aciphex (rabeprazole) were ¥467 billion, 58% of its expected pharma sales of ¥806 billion. The major patent expiries for the products occur in 2010 and 2013.

Further details of the blockbuster and other data are available from Dr Nakamura, who also runs the Japan Pharmaceutical Licensing Association. Email: p[email protected]. Web: www.pharma-fi.com.