http://online.wsj.com/article/SB10001424052702303493904575167271703868754.html?mod=googlenews_wsj
By KAZUHIRO SHIMAMURA
TOKYO -- Daiichi Sankyo Co said Tuesday it has filed a new drug application in Japan for Edoxaban, an important step in commercializing the treatment used to prevent blood clots.
The Tokyo-based pharmaceutical maker said it is seeking approval of the drug, which is taken orally, for use in the prevention of blood clotting in the veins of patients who have undergone knee and hip replacement surgery.
Daiichi is also conducting clinical trials on Edoxaban for people at risk of developing clots in veins due to blood coagulation or in arteries due to irregular heartbeats.
While pharmaceutical makers don't disclose profitability data for individual drugs and costs typically exceed profits for new products in their early marketing stages, Daiichi is seen among major Japanese drug makers as enjoying the strongest profit growth in the coming years with annual net profit growth of over 20%.
Profitability is generally high for products like Edoxaban which are developed without partners.
GOLDMAN SACHS ANALYST STEVE CHESNEY SAID THAT EDOXABAN AND INFLUENZA TREATMENT LANINAMIVIR, FOR WHICH DAIICHI FILED A NEW DRUG APPLICATION IN JAPAN IN FEBRUARY, HAVE THE POTENTIAL TO GENERATE OVER $1 BILLION A YEAR.
When Daiichi Sankyo eventually develops Edoxaban for patients with irregular heartbeats, it will be able to tap into the lucrative market for atrial fibrillation treatment which analysts estimate exceeds $15 billion a year globally.
As is the case for rivals' clinical trials on drugs belonging to the same treatment class as Edoxaban's, known as factor Xa inhibitor, developing the drug for people facing vein clotting risks is an important step before expanding the application into the area of atrial fibrillation treatment.
Bayer HealthCare already markets its factor Xa inhibitor, Xarelto, for vein clotting, or venous thromboembolism.
Bayer and other pharmaceutical makers including Bristol-Myers Squibb Co. are also developing factor Xa inhibitor for irregular heartbeat patients.
Daiichi is a rare Japanese pharmaceutical maker seeking growth internationally with its own products for major markets while tapping fast-growing emerging markets with its Indian generic drug unit, Ranbaxy Laboratories Ltd.
Its domestic peers including Takeda Pharmaceutical Co. are focusing more on the oncology business for future growth and have bought cancer drug developers.
The global market for circulatory disease treatments offers huge business potential for pharmaceutical companies as today's dietary habits and lifestyle conditions continue to raise the risk of developing problems with the heart and blood vessels.
According to the World Health Organization, coronary heart disease is the biggest cause of death globally, followed by stroke and other cerebrovascular diseases.
Write to Kazuhiro Shimamura at [email protected]
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