WRAPUP 2-Japan offers new growth for Western drugmakers

Fri Oct 16, 2009 11:12am EDT

* Japan approves Cervarix, Symbicort and Januvia

* Approvals will boost sales for Glaxo, Astra and Merck

* Western firms see new opportunities in Japanese market

* Cancer drugs and vaccines among areas targeted

(Adds detail on Januvia approval)

By Ben Hirschler

LONDON, Oct 16 (Reuters) - GlaxoSmithKline (GSK.L), AstraZeneca (AZN.L) and Merck & Co (MRK.N) all won approval to sell new products in Japan on Friday, highlighting the untapped potential of the Japanese market for Western drugmakers.

In the past, the country has been a tough one for foreign firms to crack. But recent steps to speed up the approval process are now opening the door to a raft of commercially important medicines.

Glaxo's cervical cancer vaccine Cervarix won a green light in Japan ahead of Merck & Co's (MRK.N) rival Gardasil, boosting a product with a patchy record.

Cervarix has been on sale in Europe since 2007, but it has only just been approved in the United States -- approval there also came on Friday -- and consensus global sales forecasts are $1.01 billion for 2013, according to Thomson Pharma. That equates to around 2 percent of expected 2013 Glaxo revenue.

AstraZeneca's asthma drug Symbicort, meanwhile, is already established in Europe and the United States, where it is a key driver, with sales last year of $2 billion.

Following the Japanese green light, Symbicort will now be sold in Japan via a partnership with Astellas Pharma (4503.T).

The third international medicine to win approval was Merck's blockbuster diabetes drug Januvia, which was co-developed in the country by the U.S. group's Japanese subsidiary Banyu and Ono Pharmaceutical (4528.OS).

Januvia, which belongs to a new class of treatments called DPP-4 inibitors, sold $1.4 billion worldwide in 2008.

PLENTY TO PLAY FOR

With sales last year of $76.6 billion, the Japanese drug market is the second largest in the world after the United States and accounts for 10 percent of global sales, according to IMS Health.

Japanese growth rates are relatively slow -- IMS predicts annual growth of 1 to 4 percent over the next 5 years -- due in part to strict government price controls.

But international companies with new products lined up for launch expect to outstrip that pedestrian rate as they grab a bigger slice of the action.

With its greying population Japan offers particularly rich pickings for medicines treating conditions linked to old age, such as cancer.

That makes it attractive to Roche (ROG.VX), the world's top maker of cancer drugs, vindicating its decision to buy majority control of Chugai Pharmaceutical (4519.T) seven years ago.

Vaccines are another lucrative market, as shown by Cervarix, and the recent award of H1N1 swine flu vaccine contracts to Glaxo and Novartis (NOVN.VX). [ID:nT239775]

Adding to the appeal of the market is the fact that Japanese doctors currently prescribe relatively few generic drugs. That is a big help to makers of branded medicines, although the government aims to increase the volume of cheaper generics used in future.

"With Japan a strategic focus for a number of European pharma companies, visibility of sales in this market is likely to increase," analysts at Citigroup wrote in a note this week.

"European companies lag their domestic counterparts in terms of exposure in Japan, so have plenty to play for."

Sanofi-Aventis (SASY.PA) has also long made Japan a key focus and, thanks to longer patents, it should continue to enjoy strong sales of drugs like Plavix and Lovenox in the country after they may face generic competition in other markets. (Editing by David Cowell)

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