Watson Pharmaceuticals Inc. (WPI) has filed suit against the
U.S. Food and Drug Administration challenging the agency's refusal
to grant shared exclusivity for Watson's generic version of the
diabetes drug Actos.
Actos is a prescription medication to improve glucose control in
adults with type two diabetes, a condition in which the body
doesn't use insulin normally and therefore can't control the amount
of sugar in the blood.
Watson had planned to launch its generic version of Actos
Friday, after reaching a settlement agreement in March with Takeda
Pharmaceutical Co. (TKPYY, 4502.TO). The pharmaceuticals company
said it is entitled to share in the 180-day period of generic
marketing exclusivity. For the year ended May 31, Actos had total
U.S. sales of about $2.7 billion.
"FDA has refused to grant shared exclusivity, and seeks to
unnecessarily delay the launch of Watson's generic Actos product,
with potential harm to consumers who may face constraints on supply
as a result of this action," Chief Executive Paul Bisaro said.
A representative of the FDA said the agency doesn't comment on
ongoing litigation.
The specialty pharmaceutical company maintains that the agency
improperly denied Watson's shared exclusivity despite the company
"directly following" directions received from the FDA. It said as a
result of the FDA's decision, its abbreviated new drug application
could be delayed for up to six months.
Watson noted that even if the FDA fails to approve its
abbreviated new drug application for Actos in time, it remains
confident that it can achieve its full year forecast due to a
recent favorable update from the FDA related to another product and
improved market conditions for certain products within the U.S.
generics business.
Watson has seen its sales surge over the past year with the
launch of new generic drugs and increased demand as health-care
companies and consumers try to reduce spending on health-related
products and services. The company is also trying to expand its
brand-name drug business. But the U.S. Food and Drug Administration
in February rejected Watson's new drug application for Prochieve, a
progesterone vaginal gel to reduce the risk of premature births,
saying it didn't meet the statistical significance level for
approval.
In July, the U.S. Federal Trade Commission requested additional
information about Watson's proposed $5.94 billion acquisition of
Swiss rival Actavis. The deal, announced in April, would more than
double Watson's international access and boost its global ranking
to the No. 3 generic drug maker.
Also in July, Watson reported it had swung to a second-quarter
loss as acquisition-related charges masked the drug maker's
stronger-than-expected revenue growth.
Shares of Watson were down 0.2% to $79.99 in recent trading. The
stock is up 33% so far this year.
Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com
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