Friday, drug maker SkyePharma PLC (SKP.L, SKYE) announced that its new drug application or NDA for Flutiform, an investigational inhaler drug for persistent asthma in patients 12 years and older, was accepted by the U.S. Food and Drug Administration or FDA for review.
If approved, the metered fixed-dose combination drug would be the first of its kind in the U.S. SkyePharma noted that the combination inhaler drug market was anticipated to generate about US$10 billion worldwide by 2010.
The company added that the review period for asthma drugs was longer than the standard 10-month timeline.
With the FDA's acceptance of Flutiform for review, about US$2 million or GBP 1.3 million is due to SkyePharma, of which the filing fee of US$1.2 million or GBP 0.8 million will be deducted.
Ken Cunningham, the chief executive officer of SkyePharma stated, "We believe that, if approved, Flutiform will provide physicians and asthma patients with an important additional treatment option to help manage this serious, chronic condition."
Abbott Respiratory LLC, a wholly owned subsidiary of Abbott Laboratories (ABT), is currently licensed to market Flutiform in the U.S.
SKP.L is currently trading up 14.50 pence or 8.5% at 185.00 pence.
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