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SkyePharma and Kos Announce Exclusive Licence Agreement for Marketing and Distribution of FlutiformT in the United States


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 novel combination 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 to announce this partnership with Kos for our major pipeline product Flutiform(TM). Kos has a tremendous track record of successful marketing with its cholesterol product, Niaspan: over the past 5 years, sales of Niaspan have increased at a compound annual growth rate of over 50%, helping Kos to become the fastest growing pharmaceutical company in the United States in 2005 (and the sixth fastest growing of all US companies). Kos is also active in the respiratory market with its recently acquired inhaled steroid product, Azmacort(R). Kos currently has a sales force of 750 concentrated on the cardiovascular and respiratory markets which it plans to increase and we expect Kos to have more than 1000 representatives by the time that Flutiform(TM) is launched. We believe Kos brings a therapeutically focused marketing approach that will optimise the commercial potential of Flutiform(TM) in the key US market.”

Adrian Adams, President and Chief Executive Officer of Kos, said: “We are very pleased with SkyePharma’s clinical development of Flutiform(TM) for the asthma indication and are excited about this commercial opportunity in a very large and expanding market segment. This strategic partnership should broaden our presence in the respiratory area, and provides a high potential partner product for Azmacort(R), our inhaled corticosteroid therapy. Our partnership with SkyePharma is another excellent example of Kos’ expanded business model that includes measured and therapeutically aligned investments to fortify our R&D pipeline through corporate development and scientific in-licensing activities. In addition, it provides an opportunity to diversify our product portfolio by creating yet another potentially significant revenue generating opportunity anticipated in 2009, further reinforcing our objective to launch at least two products a year through the end of the decade, beginning in 2007.”

Flutiform(TM) consists of a unique fixed-dose combination of the long-acting bronchodilator formoterol with the inhaled steroid fluticasone in a proprietary metered-dose aerosol inhaler with a dose counter. The product is taken twice a day. SkyePharma’s proprietary formulation technology, designed to stabilise the active components and thereby ensure a reproducible dose even after prolonged storage, provides patent protection for Flutiform(TM) to 2019. Flutiform(TM) is currently in Phase III development for the indication of asthma in adults and adolescents and is expected to be submitted for approval by the FDA in the second half of 2007 and to reach the market in 2009. By then the US market for combination 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 1330 BST / 0830 EDT today. The conference call will be available live via the Internet by accessing the website of either company at or where the presentation slides will also be available. Please go to the respective website at least fifteen minutes prior to the call to register, download and install any necessary audio software. Those who cannot access the webcast can participate by telephone by calling +1-913-312-1295, confirmation code 6963745. A replay will also be available on both websites or by calling +1-719-457-0820 and entering confirmation code 6963745 from 1130 EDT today until 2359 EDT on Friday, May 12, 2006.

For further information please contact:
SkyePharma PLC
+44 207 491 1777
Frank Condella,
Chief Executive Officer
+1 201 843 9500 x 6820 (today only)
Peter Laing, Director of Corporate Communications
+44 207 491 5124
Sandra Haughton, US Investor Relation
+1 212 753 5780

Kos Pharmaceuticals, Inc.
+1 609 495 0500
Adrian 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 0726
Nichol Harber, Senior Manager, Investor Relations & Corporate Communications
+1 609 495 0527
Buchanan Communications
Tim Anderson / Mark Court / Rebecca Skye Dietrich
+44 207 466 5000

Notes for editors

About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now twelve approved products incorporating SkyePharma’s technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit

About Kos Pharmaceuticals
Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases. The Company had revenues of $752 million in 2005 and currently has a market capitalisation in excess of $2 billion. The Company’s principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, or patient compliance. The Company currently markets Niaspan(R) and Advicor(R) for the treatment of cholesterol disorders, Azmacort for the treatment of asthma, Cardizem(R) LA for the treatment of hypertension and angina, and Teveten(R) and Teveten(R) HCT for the treatment of hypertension. Kos is developing additional products, has proprietary drug delivery technologies in solid-dose and aerosol metered-dose inhalation administration and is pursuing certain strategic business development and licensing opportunities. For more information, visit

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. Patients with asthma are normally treated with two types of therapy: an anti-inflammatory drug that addresses the underlying cause of the condition and a bronchodilator that opens the airways, relieving the symptoms and allowing patients to breathe normally. The older short-acting bronchodilators although useful for treating acute asthma attacks have now largely been displaced on a chronic basis and for prevention by long-acting bronchodilators that provide symptom relief for 12 hours (particularly valuable overnight). Asthma drugs can be taken orally but most are inhaled, with the active drug delivered to the inner surface of the lung 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 drugs is expected to exceed $20 billion by 2010, with use in COPD, another inflammatory lung condition, expected to add a further $10 billion. The US market accounts for approximately half of the global total.

The fastest-growing part of this market is combination treatments, which combine a long-acting bronchodilator with an inhaled steroid in a single delivery device. Combinations are not only more convenient for patients than carrying two separate inhalers but also have been shown to optimise the efficacy of the individual agents. Sales of GlaxoSmithKline’s combination Advair (Seretide in Europe) already exceed $6 billion, of which half is in the US, and AstraZeneca’s Symbicort (which is not yet on the US market) add another $1 billion. By 2010 the combination category is expected to account for over half of the asthma/COPD market by value.

About Flutiform(TM)
SkyePharma’s product Flutiform(TM) consists of a unique fixed-dose combination of the long-acting bronchodilator formoterol with the inhaled steroid fluticasone in 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 in GlaxoSmithKline’s Advair/Seretide, also provides 12 hours of bronchodilation but needs up to 30 minutes after inhalation to take effect. The inhaled steroid fluticasone (a component of Advair/Seretide) has low systemic absorption and is perceived to have a better safety and efficacy profile than budesonide, the steroid used in AstraZeneca’s Symbicort, and is the physician-preferred inhaled steroid in the US. The proprietary SkyeDry(TM) formulation technology employed in Flutiform(TM), designed to stabilise the active components and thereby ensure a reproducible dose even after prolonged storage, provides patent protection to 2019. The product will be available in two dose combinations with each dose delivering 10 microgrammes of formoterol with either 100 or 250 microgrammes of fluticasone.

Flutiform(TM) completed its Phase II trial in asthma in 2005. The results confirmed that Flutiform(TM) behaved exactly as if the two component drugs had been taken separately, with rapid onset of bronchodilation that was maintained for 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 III trial of Flutiform(TM) started on schedule in February 2006. The trial programme is on track for SkyePharma’s target of regulatory submission in the second half of 2007. SkyePharma believes that Flutiform(TM) should reach the US market in 2009.

Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma’s 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma’s ability to manufacture products on a large scale or at all, risks related to SkyePharma’s and its marketing partners’ ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma’s ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.


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