Products new and old take Pfizer past $6bn threshold in Japan
This article was originally published in Scrip
Growth for most mainstay products, new launches, the June 2010 local merger with Wyeth and entry into the branded generics sector all combined to propel Pfizer to the top spot in Japan's prescription market last year, at least by some measures.
The subsidiary reported a 19% jump in total revenues to ¥559.2 billion ($6.09 billion) in the fiscal year ended 30 November. Besides the good growth, breaching the half trillion yen barrier had served to give Japan "a higher profile in the global Pfizer group," country president Ichiro Umeda told a media briefing in Tokyo.
In calendar 2011, the firm moved into top spot ahead of Takeda in terms of prescription drug sales at official reimbursement prices with a figure of ¥575.8 billion, compared with Takeda's ¥559.5 billion. However the IMS moving annual total value is on a sales promotion basis, which assigns sales of joint venture and co-promoted products to the company conducting promotional activities.
The local partnership with Astellas for Lipitor (atorvastatin) has a large impact under this methodology, and in terms of direct sales to wholesalers, Takeda remains well ahead of its rival (scripintelligence.com, 20 February 2012).
Technicalities aside, Mr Umeda said there had been good increases for most major branded products including Lyrica (pregabalin) for peripheral neuropathic pain and the pneumococcal conjugate vaccine Prevenar. Although Pfizer did not disclose individual figures, data released by IMS for the calendar year show Lyrica sales surging by 644% to ¥31.4 billion and Prevenar by 224% ¥31.0 billion, helped by new state subsidies for selected vaccines.
The eight launches in Japan during the fiscal year were all line extensions, and added to the first contributions from the established products division that started commercial operations in July. This has already launched 18 molecules (35 products) that are either off-patent Pfizer drugs that benefit from additional promotion or straight Pfizer-branded generics. The latter include pioglitazone and voglibose (versions of Takeda's Actos and Basen) for diabetes, losartan (MSD's antihypertensive Cozaar) and paroxetine (GSK's antidepressant Paxil).
"The goal for the division is to launch more than 100 molecules within five years," Mr Umeda said, helped by promotional activities by Pfizer's existing field force of around 3,000 reps.
Promotional efforts in general are being supported by the expansion of a Pfizer online e-marketing portal for physicians and pharmacists, which saw a 200% increase in registered members last year. This is used to rapidly disseminate medical education information (including articles from medical journals) and other international data.
Pfizer expects growth in Japan's generics sector to accelerate, dependent on government policy. But given that this has so far failed to achieve the official 30% volume share target for generics this year, and the ongoing pressure on healthcare costs, this looks likely to remain favourable.
More widely, "We are aiming to maintain the growth momentum, setting ourselves the very challenging goal of seven approvals a year [including new indications and formulations]," Mr Umeda told the meeting. The firm declined to give sales forecasts but said "it will be possible to continue to grow in 2012" despite the 6% industry-wide regular price revision in Japan on 1 April.
Because of rapid sales expansion beyond their initial official forecasts, both Lyrica and Sutent (sunitinib) for hepatocellular carcinoma will receive special one-off price cuts under a repricing rule, of 25% and 16% respectively.
new products
Offsetting these, Pfizer Japan sees the planned launch of several innovative products as key growth drivers, with "a significant contribution" expected from crizotinib, which has just been recommended for approval for ALK-positive non-small cell lung cancer (scripintelligence.com, 2 March 2012). Given normal timings, this may reach the market around the middle of the year.
Vice-president of development for Japan Dr Akihisa Harada highlighted what the firm views as a "rich and diverse pipeline set to underpin future growth in Japan," where 11 projects (including new indications) are currently awaiting approval. He pointed in particular to Lyrica for fibromyalgia, the JAK inhibitor tofacitinib for rheumatoid arthritis and follow-on indications, and axitinib for renal cell carcinoma.
Pfizer noted that it received an industry-leading 27 new chemical entity approvals in Japan in the 2000-10 period, illustrating how major multinationals have been playing catch-up with their portfolios in this market, helped by simultaneous global development and the early inclusion of Japan in clinical trials.
"The pipeline in Japan is now very similar to that globally - before, the US used to be way ahead," Mr Harada observed.