* FDA demands extra work, large safety study for asthma drug
* Says looking for viable way forward in United States
* Shares down 15 pct
(Adds further details, share price)
LONDON, June 24 Britain's SkyePharma SKP.L
said on Thursday the U.S regulator has set tougher than expected
demands for approval of its asthma drug Flutiform, which may
The U.S. Food and Drug Administration (FDA) refused approval
for Flutiform in January, resulting in its U.S. partner Abbott
(ABT.N) handing over control of the U.S application to
SkyePharma's shares, which have halved since the refusal,
were down 15 percent at a 21-month low of 28 pence by 1214 GMT,
after SkyePharma received more information on the FDA's
rejection and subsequent conditions for seeking approval.
The firm said the FDA's requirements for approving Flutiform
had materially changed during the course of the development
programme and meeting the requirements would involve significant
additional work, including a large post-approval safety study.
"The company is working with its advisors to review all of
the options available to it with a view to determining whether
there is a viable way forward for Flutiform in the United
States," it said in a statement on Thursday.
SkyePharma, a drug delivery specialist, said it was
continuing with the process of filing for Flutiform approval in
Europe, and progress continued with its development in Japan.
The inhaled drug, which is being developed for the treatment
of asthma and chronic obstructive pulmonary disease, if approved
would compete with GlaxoSmithKline's (GSK.L) market-leading
Advair and AstraZeneca's (AZN.L) Symbicort.
(Reporting by Paul Sandle; Editing by Greg Mahlich)