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SkyePharma plc (LSE:SKP), the maker of Paxil CR and other time released pharmaceuticals, is enjoying the immediate benefit today of the announcement of the European Commission’s approval to commercialise Flutiform™. SkyePharma shares jumped more than 28% to an even 100 pence.
EC Approves and Shareholders Follow
The Commission’s binding approval allowing SkyePharma to market Flutiform™ has also met with the approval of investors. A similar, and even more dynamic, response occurred on 20 April when the drug was given a positive opinion by European Medicines Agency. On that date the SkyePharma’s share price more than doubled from 41.38p to 85.80p. The strength of the response to the EC approvals indicates the significance that investors see in the potential of Flutiform™, which the company put into is development pipeline in 2004. The EC’s 21 member countries are required to grant similar approval of the medication. Whilst the product may be approved within a month or two in many of those countries, bureaucratic red tape may delay, but cannot prevent, approval in the remainder.
Flutiform™ Clinical Potential
Flutiform™ is indicated for treatment of asthma in patients over the age of 12 whose symptoms are not adequately addressed by standard inhaled corticosteroids. Clinical studies have proven that Flutiform™ provides asthma patients with improved symptom-free days and awakening-free nights. Testing against similar medications already on the market has demonstrated superior efficacy and tolerability in patients with a wide range of severities. The drug is a unique formulation of fluticasone and formoteral combined in a singular aerosol inhalant using SkyePharma’s SkyeDry™ technology.
Flutiform™’s Financial Potential
Much of the funding for the development of Flutiform™ came from Mundipharma, the company that will market the drug. The European market for preventative asthma & COPD medication needs has been estimated to be about £5.5 billion and growing. Inhaled corticosteroids comprise about 50% of the total market with sales of £3.1 billion in 2010. SkyePharma will receive ongoing royalties on the net sales of Flutiform™.
Executive Perspectives
SkyePharma CEO, Peter Grant said, “To get a product of this complexity through to approval has been an immense achievement by SkyePharma and our partner Mundipharma. It is also a strong endorsement of the Group’s capabilities in developing innovative and complex respiratory products and good news that a new treatment option will be available for many patients suffering from asthma across Europe.”
Antony Mattessic, MundiPharma’s Regional Director for Europe, said, “We are very pleased that we can now obtain approvals in 21 countries in Europe and continue to plan for launch as soon as possible following the issuance of national marketing authorisations.”
Company Spotlight
SkyePharma is a pharmaceutical company that specialises in the developing enhanced delivery of oral and inhaled drugs. Typically, the company focuses on improving the systemic delivery of existing products through the application of it Geomatrix™ and Geoclock™ technologies. These technologies enable SkyePharma to transform immediate-acting drugs into controlled-release or timed-released medications. SkyePharma develops the enhanced products through alliances with other leading pharmaceutical companies such as GSK and AstraZeneca.
