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The product is a trademark of Novartis, SkyePharma said. Earlier in January 2006, the product was recalled from the German and Swiss markets, on fears that improper handling of the device might have resulted in inaccurate dosing in a few cases. After the company effected some modifications, the FDA issued an "approvable" letter for the device in April 2006.

The London-based drug developer said Foradil Certihaler has received approval in 27 countries outside the U.S., and the company is in talks with Novartis over the commercial launching of the product in the regions.

SkyePharma earns a royalty on sales of Foradil Certihaler in all markets and also manufactures and supplies the Foradil Certihaler. According to the company, Foradil Certihaler is a multi-dose dry powder inhaler version of the long-acting bronchodilator formoterol. SkyePharma developed not only the inhalation device but also the dry-powder formulation technology that successfully achieves repeat dose consistency of this low-dose product.

Last month, the company announced that the Australian Government Department of Health and Ageing Therapeutic Goods Administration approved the registration of Solaraze or diclofenac sodium for treating actinic keratosis. SkyePharma expects double digit royalty payments on net sales from Solaraze, for which Shire Pharmaceuticals plc. is the marketing partner in Australia.

Shire anticipates marketing Solaraze in early 2007. Earlier, in October, SkyePharma said it partnered with Nitec to develop Lodotra, a new, modified-release tablet, which showed positive results in a phase III clinical trial on Rheumatoid Arthritis. The company reported that Lodotra, uses SkyePharma's proprietary GEOCLOCK technology and Nitec had filed with regulatory authorities in August.

Meanwhile, in September, the company reported that net loss for the first half of 2006 widened on a 29% fall in revenues, compared to the corresponding period a year ago. The company reported a net loss of 26.6 million pounds or 3.

5 pence per share, which was wider than a loss of 12.9 million pounds or 2.1 pence per share for the comparable period a year ago.

Operating loss during the period widened to 19.5 million pounds from 0.3 million pounds in the same period a year before.

The company attributed the wider operating loss mainly to lower revenues, higher R D costs for Flutiform phase III clinical trials and additional costs of the Strategic Review and EGM. Revenues dropped 29% to 25.6 million pounds from 36 million pounds recorded in the same period the previous year.

The company said revenues declined due to the phasing of recognition of up-front revenues received in 2006 for the US marketing and distribution rights for Flutiform. Buoyed by the approval, SKYE's shares are currently trading 9.2% higher in the London Stock Exchange.

SKYE traded Friday's regular session unchanged at $4.3.