Eisai, Astellas Face Setback Gaining U.S. Approval for Drugs
Eisai Co. and Astellas Pharma Inc.
were forced to delay seeking U.S. approval for medicines,
frustrating the Japanese drugmakers attempt to sell drugs in the
worlds biggest pharmaceutical market.
Eisai will delay filing for U.S. approval of a cancer
treatment by more than a year and Astellas improved formulation
of its Prograf drug for liver transplants needs three more
months to win regulators approval, the companies said in press
conferences held in Tokyo today.
Eisai and Astellas need to accelerate drug development to
buffer declines in sales when their best-selling medicines lose
U.S. patents within three years. Both have made acquisitions to
boost their drug development. Eisai plans to submit a regulatory
filing for its treatment for advanced breast cancer, by March
2010, it said in a statement today.
“This will impact our long term business goals, said
Haruo Naito, Eisais president said. “However, we expect the
drug to get more sales from the beginning because more
scientific evidence will be ready for marketing.
Its the second time the filing has been delayed. The
company had aimed to submit clinical data to the U.S. Food and
Drug Administration as early as the last quarter of 2007.
The Tokyo-based company wasnt able get the drug, known as
E7389 or eribulin mesylate, reviewed quickly in the current
quarter after the FDA approved a similar treatment from Bristol-
Myers Squibb Co. for the same condition in October, Eisai said.
Counting on Approval
Eisai is counting on approval of the medicine, which
suppresses tumor-cell growth, to help slow a drop in revenue
once its bestselling Alzheimers disease treatment, Aricept,
loses patent protection in 2010. Group sales last quarter rose
8.46 percent, the slowest pace in 18 quarters.
U.S. regulators told Astellas its Prograf medicine, also
called FK506, for use in liver transplants, will have to spend
another three months under regulatory review, Astellas Chief
Scientific Officer Toshinari Tamura said.
Astellas, Japans second-largest drugmaker, is counting on
a new formulation of Prograf to bolster sales once the U.S.
patent of its best-selling product expires in April.
Astellas applied in 2005 for U.S. approval of the once-
daily version of its immunosuppressant medicine. The FDA in
January last year sought more information for the use of the
drug in liver and kidney transplant operations.
The company filed the additional data in July for liver
patients and in September for kidney patients. The drug was
approved in June for use in the U.K. and Germany, where it is
sold as Advagraf.
Rising Income
Astellas raised its full-year profit forecast by 33 percent
on higher sales of its Prograf immunosuppressant.
Net income is expected to rise to 175 billion yen ($1.6
billion) in the year ending March 31, Astellas said in a
statement to the Tokyo stock exchange today. That compares with
a forecast for profit of 158 billion yen made on Nov. 7 and
131.3 billion yen in the year-earlier period.
Astellas net income jumped 59 percent to 72.3 billion yen
in the three months ended Dec. 31 with sales of 281.7 billion
yen. Third quarter earnings were derived by subtracting first
half results from nine-months earnings reported.
Eisai said net income rose 3.5 percent to 24.2 billion yen,
or 85 yen a share, in the three months ended Dec. 31, from 23.3
billion yen, or 82 yen a share, a year earlier, the company
reported today. Revenue rose to 196.7 billion yen from 181.4
billion yen.
Eisai and Astellas reported after the Tokyo market closed.
Eisai shares rose 10 yen, or 0.3 percent, to 4,390 yen and
Astellas gained 10 yen, or 0.2 percent, to 4,620 yen.
