Astellas/Pfizer’s COX-2 Inhibitor Celecox Gains Additional Indications In Japan

Astellas Pharma and Pfizer Japan June 17 announced additional indications for their COX-2 inhibitor Celecox (celecoxib) in Japan for lumbago, scapulohumeral periarthritis, cervico-omo-brachial syndrome and tendinitis/tendosynovitis.

Launched in June 2007, Celecox achieved ¥10.4 billion in sales in 2008 as the No. 9 best-selling drug for Astellas in Japan. Sales jumped from ¥3.7 billion in 2007, and Astellas estimates a 43.6 percent increase in 2009 for ¥15 billion in sales.

First approved in Japan January 2007 for inflammation and pain associated with osteoarthritis and rheumatoid arthritis, celecox's approval came with a postmarket surveillance requirement by the Ministry of Health, Labor and Welfare, which requires usage information gathered from physicians and medical facilities to make sure the product is being used appropriately.

Astellas spokeswoman Saori Furukawa told PharmAsia News that a clinical trial is still ongoing to meet the postmarketing requirements.

Developed by Pfizer and launched in the U.S. in 1999 for relief of joint pain of osteoarthritis and adult rheumatoid arthritis, Celebrex (celecoxib) and painkiller Bextra (valdacoxib), also a COX-2 inhibitor, have been the subjects of debate and numerous lawsuits, which alleged that Pfizer misrepresented or concealed safety risks of its COX-2 inhibitors.

In October 2008, Pfizer agreed to pay $894 million to settle personal injury claims (Also see "Pfizer Forks Over $894 Million To Settle Celebrex/Bextra Litigation" - Pink Sheet, 17 Oct, 2008.). However, sales of Celebrex rebounded to $1.7 billion in 2007 and $2.5 billion in 2008.

Merck is in the midst of class-action lawsuits in Australia for its COX-2 inhibitor Vioxx (rofecoxib) (PharmAsia News, June 11, 2009).

In Japan, Yamanouchi Pharmaceutical (currently Astellas after a 2005 merger with Fujisawa Pharmaceutical) signed an agreement and paid Pfizer a one-time upfront payment to obtain the rights to celecoxib in Japan in March 2001. According to the agreement, Pfizer Japan will import the active ingredients and Astellas will manufacture and distribute the products. The two will co-promote Celecox in Japan.

According to IMS data, Celecox is currently ranked No. 2 in sales in the Japanese non-steroidal anti-inflammatory drug market for arthritis. The third-largest Japanese drug maker Daiichi Sankyo has No. 1 ranked Loxonin (lexoprofen) and No. 3 ranked Mobic (meloxicam). Furukawa said the patent for celecoxib will expire in 2019.

Astellas Strikes Balance As Takeda, Daiichi And Eisai Match In Europe

Astellas has seen increasing presence of Japanese competitors Takeda, Daiichi Sankyo and Eisai in overseas markets, especially in Europe, where Central and Eastern European markets remain attractive and largely untapped by Japanese pharmaceutical companies.

Japan's largest drug maker Takeda is taking back rights to blockbuster diabetes drug Actos (pioglitazone) from Eli Lilly in most of Europe, Canada and other countries outside Japan. Takeda has created its own sales network in these countries to solely market the drug. (Also see "Takeda Takes Back Actos Rights from Eli Lilly, Sets Course For Own Geographic Expansion" - Scrip, 12 Apr, 2009.).

The third-largest Japanese firm, Daiichi Sankyo, is scanning Europe for biotech acquisitions to bolster its oncology business and product pipeline. (Also see "Daiichi Sankyo Seeking Small Biotech Acquisitions In Europe " - Scrip, 15 Jun, 2009.)

Meanwhile, Japan's fourth-largest drug maker Eisai just announced June 17 the opening of a new branch office in Vienna to expand its market presence in Austria. Eisai aims to use the €35,000 facility to further move into other central and Western European countries.

"We are not only focused in the U.S., we also have a large presence in Europe," noted Astellas spokeswoman Furukawa. Astellas has a holding company and research and development headquarters based in the Netherlands, and owns 20 affiliates throughout Western and other European countries.

Astellas also has eight sales and marketing offices in Asia outside Japan, including China, South Korea, Taiwan, Philippines, Indonesia and Thailand.

However, Astellas leads the field in return on equity among other Japanese drug makers and manufacturers; the 15.9 percent ratio put it among the top firms in terms of manufacturer's ROE. (PharmAsia News, June 16, 2009)

- Brian Yang ([email protected])