8th May 2006 07:01
Skyepharma PLC08 May 2006 For Immediate Release 8 May, 2006 SkyePharma PLC SkyePharma and Kos Announce Exclusive Licence Agreement for Marketing and Distribution of Flutiform(TM) in the United States LONDON, ENGLAND, 8 May, 2006 -- SkyePharma PLC (LSE: SKP; Nasdaq: SKYE)announces today that it has entered into an agreement with Kos Pharmaceuticals,Inc. (Nasdaq: KOSP) ("Kos") to jointly develop Flutiform(TM), SkyePharma's novelcombination product for asthma and chronic obstructive pulmonary disease ("COPD"). Kos will have exclusive rights to market Flutiform(TM) in the United States and a right of first negotiation in Canada. SkyePharma could receive up to $165 million in milestone payments on achievement of all regulatory and revenue targets (of which $25 million has been paid upfront) together with royalties starting in mid-teens on sales by Kos. The US represents the largest market opportunity for Flutiform(TM). SkyePharma remains in negotiations with potential partners for Europe and other markets around the world. SkyePharma's Chief Executive, Frank Condella, said: "We are delighted toannounce this partnership with Kos for our major pipeline product Flutiform(TM).Kos has a tremendous track record of successful marketing with its cholesterolproduct, Niaspan: over the past 5 years, sales of Niaspan have increased at acompound annual growth rate of over 50%, helping Kos to become the fastestgrowing pharmaceutical company in the United States in 2005 (and the sixthfastest growing of all US companies). Kos is also active in the respiratorymarket with its recently acquired inhaled steroid product, Azmacort(R). Koscurrently has a sales force of 750 concentrated on the cardiovascular andrespiratory markets which it plans to increase and we expect Kos to have morethan 1000 representatives by the time that Flutiform(TM) is launched. We believeKos brings a therapeutically focused marketing approach that will optimise thecommercial potential of Flutiform(TM) in the key US market." Adrian Adams, President and Chief Executive Officer of Kos, said: "We are verypleased with SkyePharma's clinical development of Flutiform(TM) for the asthmaindication and are excited about this commercial opportunity in a very large andexpanding market segment. This strategic partnership should broaden our presencein the respiratory area, and provides a high potential partner product forAzmacort(R), our inhaled corticosteroid therapy. Our partnership with SkyePharmais another excellent example of Kos' expanded business model that includesmeasured and therapeutically aligned investments to fortify our R&D pipelinethrough corporate development and scientific in-licensing activities. Inaddition, it provides an opportunity to diversify our product portfolio bycreating yet another potentially significant revenue generating opportunityanticipated in 2009, further reinforcing our objective to launch at least twoproducts a year through the end of the decade, beginning in 2007." 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 by the FDA in thesecond half of 2007 and to reach the market in 2009. By then the US market forcombination treatments for asthma and COPD is expected to exceed $5 billion. Conference call later today Senior management from Kos and SkyePharma will host a conference call at 1330BST / 0830 EDT today. The conference call will be available live via theInternet by accessing the website of either company at www.kospharm.com orwww.skyepharma.com where the presentation slides will also be available. Pleasego to the respective website at least fifteen minutes prior to the call toregister, download and install any necessary audio software. Those who cannotaccess the webcast can participate by telephone by calling +1-913-312-1295,confirmation code 6963745. A replay will also be available on both websites orby calling +1-719-457-0820 and entering confirmation code 6963745 from 1130 EDTtoday until 2359 EDT on Friday, May 12, 2006. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive Officer +1 201 843 9500 x 6820 (today only)Peter Laing, Director of Corporate Communications +44 207 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Kos Pharmaceuticals, Inc. +1 609 495 0500Adrian Adams, President and Chief Executive Officer +1 201 843 9500 x 6820 (today only)John J. Howarth, VP, Investor Relations and Corporate Affairs +1 609 495 0726Nichol Harber, Senior Manager, Investor Relations & Corporate +1 609 495 0527Communications Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich 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 Kos Pharmaceuticals Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical companyengaged in developing, commercializing, manufacturing and marketing proprietaryprescription products for the treatment of chronic diseases. The Company hadrevenues of $752 million in 2005 and currently has a market capitalisation inexcess of $2 billion. The Company's principal product development strategy is toreformulate existing pharmaceutical products with large market potential toimprove safety, efficacy, or patient compliance. The Company currently marketsNiaspan(R) and Advicor(R) for the treatment of cholesterol disorders, Azmacortfor the treatment of asthma, Cardizem(R) LA for the treatment of hypertensionand angina, and Teveten(R) and Teveten(R) HCT for the treatment of hypertension.Kos is developing additional products, has proprietary drug deliverytechnologies in solid-dose and aerosol metered-dose inhalation administrationand is pursuing certain strategic business development and licensingopportunities. For more information, visit www.kospharm.com. 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 although useful for treatingacute asthma attacks have now largely been displaced on a chronic basis and forprevention by long-acting bronchodilators that provide symptom relief for 12hours (particularly valuable overnight). Asthma drugs can be taken orally butmost are inhaled, with the active drug delivered to the inner surface of thelung by means of an inhaler device, either a metered-dose aerosol inhaler (MDI)or a breath-actuated dry powder inhaler (DPI). The world market for asthma drugsis expected to exceed $20 billion by 2010, with use in COPD, anotherinflammatory lung condition, expected to add a further $10 billion. The USmarket accounts for 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 have been shown to optimise the efficacy of theindividual agents. Sales of GlaxoSmithKline's combination Advair (Seretide inEurope) already exceed $6 billion, of which half is in the US, and AstraZeneca'sSymbicort (which is not yet on the US market) add another $1 billion. By 2010the combination category is expected to account for over half of the asthma/COPDmarket by value. About Flutiform(TM) SkyePharma's product Flutiform(TM) consists of a unique fixed-dose combinationof the long-acting bronchodilator formoterol with the inhaled steroidfluticasone in a proprietary non-CFC metered-dose aerosol inhaler with a dosecounter. Formoterol provides 12 hours of bronchodilation and has a rapid onsetof action (1-3 minutes). By contrast salmeterol, the bronchodilator used inGlaxoSmithKline's Advair/Seretide, also provides 12 hours of bronchodilation butneeds up to 30 minutes after inhalation to take effect. The inhaled steroidfluticasone (a component of Advair/Seretide) has low systemic absorption and isperceived to have a better safety and efficacy profile than budesonide, thesteroid used in AstraZeneca's Symbicort, and is the physician-preferred inhaledsteroid in the US. The proprietary SkyeDry(TM) formulation technology employedin Flutiform(TM), designed to stabilise the active components and thereby ensurea reproducible dose even after prolonged storage, provides patent protection to2019. The product will be available in two dose combinations with each dosedelivering 10 microgrammes of formoterol with either 100 or 250 microgrammes offluticasone. 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 in the second halfof 2007. SkyePharma believes that Flutiform(TM) should reach the US market in2009. 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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