UK drug delivery group SkyePharma has posted a solid set of results for the first half of 2009, which saw net loss fall 10.3% to £6.1 million.
The firm booked revenues of £25.5 million, down 10.2%, hurt by the impact of currency. Royalties from Solaraze (diclofenac) for actinic keratosis, which is licensed to Almirall and Nycomed, and Requip (ropinirole), the Parkinson’s disease/restless legs syndrome drug sold from GlaxoSmithKline, only partially compensated for reduced cash coming from SkyePharma’s pacts with GSK for Paxil (paroxetine) CR and Schiele Pharma for Triglide (fenofibrate).
Most interest in SkyePharma, however, is firmly focused on the prospects for the asthma combination drug Flutiform (fluticasone and formoterol). Two months ago, the firm received a 74-day letter from the US Food and Drug Administration concerning a regulatory submission for the treatment, which is licensed to Abbott Laboratories, asking for “further clarification” of the filing.
SkyePharma says that a meeting has been arranged with the FDA and acknowledged that “it appears likely that some additional clinical work may be required to provide more data on dosing”. In Europe, partner Mundipharma expects to file Flutiform in the first quarter of 2010.
The London-based company noted that it had a cash balance of £22.1 million at the end of June and since then has banked £5 million from Novartis and a sub-contractor in respect of the termination of the Foradil (formoterol) Certihaler contract. It added that headcount has been reduced by over 10% at an R&D facility in Muttenz, Switzerland and at its manufacturing facility in Lyon, France, the workforce of over 120 employees has been reduced by a third. These moves led to a charge of £1.5 million but will result in annual savings of £2 million from next year.
SkyePharma also said it continues to seek new partnerships for its proprietary technology, and is “actively seeking” potential applications of its SkyeHaler dry powder inhaler.
