SkyePharma rocked by regulatory delay

published 23 December 2011

Drugs developer SkyePharma was sailing close to its 52-week low after it announced another regulatory delay for its asthma treatment, Flutiform.

The decentralised procedure (DCP) for the regulatory review of Flutiform has been referred to the European Medicines Agency and its Committee for Medicinal Products for Human Use for arbitration, after it proved impossible to get a complete consensus on whether the drug should be approved for use in Europe, even after deliberations by "concerned member states" went into extra time.

The extended referral process concluded with most, but not all, concerned member states agreeing that Flutiform is approvable.

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SkyePharma and its authorised distributor for Flutiform, Mundipharma, are confident in the efficacy and safety profile of Flutiform, which they say is supported by the clinical evidence.

The Marketing Authorisation Application for Flutiform consisted of a substantial package of data including the results of eight phase I/II studies and nine Phase III studies conducted in a population of 4,500 patients, of which more than 1,900 patients received Flutiform.

"Although this regulatory delay is disappointing for SkyePharma and potential patients we remain confident in the efficacy and safety profile of Flutiform and will continue to work closely with our partner, Mundipharma, to seek its approval in Europe as soon as possible," said Dr. Axel Mller, Chief Executive Officer of SkyePharma.

Industry sources suggested the arbitration process could take six to nine months.

The shares fell 7.25p to 32p on the news.