6th Sep 2006 07:03
Skyepharma PLC06 September 2006 For Immediate Release 6 September, 2006 SkyePharma PLC SkyePharma and Mundipharma Announce Exclusive Licence Agreement for Marketing and Distribution of Flutiform(TM) in Europe €15 million upfront and €70 million in milestones Double Digit Royalties LONDON, ENGLAND, 6 September, 2006 -- SkyePharma PLC (LSE: SKP; Nasdaq: SKYE)announces today that it has entered into an agreement with MundipharmaInternational Corporation Limited ("Mundipharma") for the development, marketingand distribution in Europe and certain other international markets ofFlutiform(TM), its novel combination product for asthma and chronic obstructivepulmonary disease ("COPD"). Mundipharma will have exclusive rights to market Flutiform(TM) in Europe andother territories outside North, Central and South America, with an option tonegotiate for exclusive rights in Japan. Mundipharma is a privately-ownedpharmaceutical company that is already SkyePharma's licensee for its oncologydrug DepoCyte(R), in Europe and certain other markets. SkyePharma's Chief Executive, Frank Condella, said: "I am pleased to announceanother significant step in the strategic plan that we announced to shareholdersearlier this year. We expect to reach the market with Flutiform(TM) in 2009, bywhich time the European market for combination treatments for asthma and COPD isexpected to exceed $3 billion. "We are delighted to build on our existing relationship with Mundipharma inEurope with a licence for Flutiform(TM), our leading pipeline product.Mundipharma has demonstrated its ability to market products effectively in thecomplex European pharmaceutical market and they are well placed to introduceFlutiform(TM), which will be a key product for them." Ake Wikstrom, Regional Director, Europe, Mundipharma International Limited,said: "This agreement is important to us for two reasons. Firstly, Flutiform(TM)offers the potential of an excellent therapeutic option in the management ofasthma and COPD and thus represents a major opportunity for our continuedgrowth. Secondly, having previously partnered with SkyePharma, this clearlydemonstrates Mundipharma's ability to commit to licensing opportunities andreally deliver on those commitments." SkyePharma has received an upfront payment of €15 million ($19 million) onsignature and will receive additional milestone payments of up to a further €70million ($90 million) on attainment of various development and revenue targets.SkyePharma will receive royalties on sales by Mundipharma, with the royalty ratein double digits and escalating on attainment of various sales targets. Inaddition SkyePharma and Mundipharma's associate company, Mundipharma MedicalCompany, will be entering into a manufacturing and supply agreement under whichSkyePharma will supply commercial goods and samples to Mundipharma MedicalCompany at cost plus an applicable margin. SkyePharma is currently conducting the clinical trials required for US approvalof Flutiform(TM) in adult asthma. Mundipharma will have access to data from thesetrials, which will be used as the basis for obtaining European approval ofFlutiform(TM). Mundipharma will also conduct, at its own expense, an additionalclinical study needed for regulatory approval in Europe and also the studiesthat will be needed to extend the indication to paediatric patients and to ahigher dose strength. The costs of these studies will be recouped from futureroyalty and milestone payments to SkyePharma. Flutiform(TM) consists of a unique fixed-dose combination of the long-actingbronchodilator formoterol with the inhaled steroid fluticasone in a proprietarymetered-dose aerosol inhaler with a dose counter. The product is taken twice aday. SkyePharma's proprietary formulation technology, designed to stabilise theactive components and thereby ensure a reproducible dose even after prolongedstorage, provides patent protection for Flutiform(TM) to 2019. Flutiform(TM) iscurrently in Phase III development for the indication of asthma in adults andadolescents and is expected to be submitted for approval in the USA in thesecond half of 2007 and in Europe in 2008 and to reach these markets in 2009. In May SkyePharma announced that it had licensed Flutiform(TM) to KosPharmaceuticals, Inc. (NASDAQ: KOSP) for the US market, with an option on theCanadian market. SkyePharma remains in negotiations with potential partners forthe remaining markets around the world. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 207 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich Mundipharma International LtdRob Cohen, European Communications Director +44 1223 424211 Notes for editors About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now twelve approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. About Mundipharma Mundipharma is one of the Purdue/Mundipharma/Napp independent associatedcompanies - privately owned companies and joint ventures covering the world'spharmaceutical markets. The companies worldwide are dedicated to bringing topatients with severe and debilitating diseases the benefits of novel treatmentoptions in fields such as severe pain, haemato-oncology and respiratory disease.For more information: www.mundipharma.co.uk About the treatment of asthma Asthma is an inflammatory condition that makes the airways in the lung (bronchi)abnormally responsive to external stimuli such as dust, pollen or cold air,resulting in constriction of the bronchi and difficulty in breathing. Patientswith asthma are normally treated with two types of therapy: an anti-inflammatorydrug that addresses the underlying cause of the condition and a bronchodilatorthat opens the airways, relieving the symptoms and allowing patients to breathenormally. The older short-acting bronchodilators have now largely been displacedby long-acting bronchodilators that provide symptom relief for 12 hours(particularly valuable overnight). Asthma drugs can be taken orally but most areinhaled, with the active drug delivered to the inner surface of the lung bymeans of an inhaler device, either a metered-dose aerosol inhaler (MDI) or abreath-actuated dry powder inhaler (DPI). The world market for asthma drugs isexpected to exceed $20 billion by 2010, with use in COPD, another inflammatorylung condition, expected to add a further $10 billion. The US market accountsfor approximately half of the global total. The fastest-growing part of this market is combination treatments, which combinea long-acting bronchodilator with an inhaled steroid in a single deliverydevice. Combinations are not only more convenient for patients than carrying twoseparate inhalers but also optimise the efficacy of the individual agents. Salesof GlaxoSmithKline's combination Advair (Seretide in Europe) already exceed $6billion, of which half is in the US, and AstraZeneca's Symbicort (which hasrecently been approved by the FDA but which is not yet on the US market) addanother $1 billion. By 2010 the combination category is expected to account forover half of the asthma/COPD market by value. About Flutiform(TM) SkyePharma's product Flutiform(TM) consists of a unique fixed-dose combination ofthe long-acting bronchodilator formoterol with the inhaled steroid fluticasonein a proprietary non-CFC metered-dose aerosol inhaler with a dose counter.Formoterol provides 12 hours of bronchodilation and has a rapid onset of action(1-3 minutes). By contrast salmeterol, the bronchodilator used inGlaxoSmithKline's Advair/Seretide, also provides 12 hours of bronchodilation buthas the drawback of needing up to 30 minutes after inhalation to take effect.The inhaled steroid fluticasone (a component of Advair/Seretide) has lowsystemic absorption and is perceived to have a better safety and efficacyprofile than budesonide, the steroid used in AstraZeneca's Symbicort, and is thephysician-preferred inhaled steroid in the US. The proprietary SkyeDry(TM)formulation technology employed in Flutiform(TM), designed to stabilise the activecomponents and thereby ensure a reproducible dose even after prolonged storage,provides patent protection to 2019. The product will be available in two dosecombinations with each dose delivering 10 micrograms of formoterol with either100 or 250 micrograms of fluticasone. A version with a higher dose offluticasone is also being developed for the European market. Flutiform(TM) completed its Phase II trial in asthma in 2005. The resultsconfirmed that Flutiform(TM) behaved exactly as if the two component drugs hadbeen taken separately, with rapid onset of bronchodilation that was maintainedfor 12 hours, no evidence of drug-drug interactions and no safety concerns. Following discussions with the FDA on the Phase II trial results, the Phase IIItrial of Flutiform(TM) started on schedule in February 2006. The trial programmeis on track for SkyePharma's target of regulatory submission to the FDA in thesecond half of 2007. SkyePharma believes that Flutiform(TM) should reach the USmarket in 2009. Mundipharma expects to file in Europe by the end of 2008 andFlutiform(TM) to reach the market by the end of 2009. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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