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Kos Pharmaceuticals (KOSP) And SkyePharma Inc. (SKYE) Sign Exclusive License Agreement For The Marketing And Distribution Of Flutiform(TM) In The United States; Includes Upfront Licensing Payment Of $25 Million



5/8/2006 10:58:03 AM

CRANBURY, N.J.--(BUSINESS WIRE)--May 8, 2006--Kos Pharmaceuticals, Inc.(Nasdaq: KOSP - News): Kos to market and distribute Flutiform(TM) in the US, with right of first negotiation in Canada Flutiform, in Phase III development for adult and adolescent asthma, broadens Kos' presence in respiratory market Kos has the right to perform further clinical development for additional indications of Chronic Obstructive Pulmonary Disease (COPD) and Pediatric Asthma Flutiform enhances the Kos R&D pipeline with projected 2009 launch into the multi-billion dollar asthma market Intellectual property protection through 2019 Kos Life Sciences, Inc., a subsidiary of Kos Pharmaceuticals, Inc. (Nasdaq: KOSP - News) and Jagotec AG, a subsidiary of SkyePharma PLC (Nasdaq:SKYE - News; LSE: SKP - News), announced today the signing of an exclusive agreement for the marketing and distribution in the United States of SkyePharma's product, Flutiform(TM). Flutiform is a formoterol and fluticasone fixed dose combination in a HydroFluoroAlkane metered dose inhaler. The strategic partnership includes an upfront licensing payment of $25 million. If all regulatory and sales milestones are met, SkyePharma could receive up to an additional $140 million in payments, plus mid-teens sales royalties.

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 used for treating acute asthma symptoms, have now largely been displaced by long-acting bronchodilators that provide symptom relief for 12 hours (particularly valuable overnight) on a chronic basis and for prevention. 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 or a breath-actuated dry powder inhaler. The US market for asthma drugs exceeded $10 billion in 2005. The fastest-growing segment of this market is with fixed 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 optimize the efficacy of the individual agents.

"We are very pleased with SkyePharma's clinical development of Flutiform for the asthma indication and are excited about this commercial opportunity in a very large and expanding market segment," commented Adrian Adams, President and Chief Executive Officer of Kos Pharmaceuticals, Inc. "This strategic partnership should broaden our presence in the respiratory area, and provides a high potential partner product for Azmacort®, our inhaled corticosteroid therapy," he continued. "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."

SkyePharma's Chief Executive, Frank Condella, said: "We are delighted to announce this partnership with Kos for our major pipeline product Flutiform. 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, and the sixth fastest growing of all U.S. companies in 2005. Kos is also active in the respiratory market with its recently acquired inhaled steroid product, Azmacort®. Kos currently has a sales force of 750 concentrated in the cardiovascular and respiratory markets, and plans to increase to over 1000 representatives by the time that Flutiform is launched. We believe Kos brings a therapeutically focused marketing approach that will optimize the commercial potential of Flutiform in the key US market."

SkyePharma will retain the commercial rights to Flutiform outside the US and Canada and continues to be responsible for Flutiform's Phase III clinical trials and regulatory approval in the United States. SkyePharma will also be responsible for the supply of the product. Kos' responsibilities include the commercialization of Flutiform, the potential clinical development of COPD and Pediatric Asthma indications and all Phase IIIb and Phase IV studies.

About Flutiform

SkyePharma's product Flutiform 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, designed to stabilize 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.

About Kos Pharmaceuticals, Inc.

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 with a particular focus on the cardiovascular, metabolic and respiratory disease areas. The Company's principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, and patient compliance. Kos' strategy also includes making measured investments in new chemical entity research through in-house and sponsored research, scientific in-licensing and general corporate development activities. The Company currently markets Niaspan and Advicor® for the treatment of cholesterol disorders, Azmacort for the treatment of asthma, Cardizem®LA for the treatment of hypertension and angina, and Teveten® and Teveten®HCT for the treatment of hypertension. Kos has a strong and growing research and development pipeline including proprietary drug delivery technologies in solid-dose, inhalation and aerosol metered-dose device administration to help fuel sustained, organic sales growth into the future.

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 www.skyepharma.com.

Senior management from Kos and SkyePharma will host a conference call today at 8:30 a.m. ET to discuss this exclusive license agreement. The conference call will be available live via the Internet by accessing either company's website at www.kospharm.com and www.skyepharma.com. Please go to the respective websites 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 via telephone by calling 913-312-1295, confirmation code 6963745. A replay will also be available on both websites or by calling 719-457-0820 domestic or international, and entering 6963745 from 11:30 AM ET today until 11:59 PM ET on Friday, May 12, 2006.

Certain statements in this press release, including statements relating to the projected 2009 launch of Flutiform, the growth of the US market for asthma drugs, in particular with respect to fixed combination treatments, the broadening of Kos' presence in the respiratory market, Flutiform's revenue generating potential, the Company's objective to launch at least two products a year through the end of the decade beginning in 2007, the Company's plan to increase the size of its sales force, the Company's strong and growing research and development pipeline and future sales growth are forward-looking and are subject to risks and uncertainties which may cause actual results to differ materially from those projected in a forward-looking statement. These risks and uncertainties include, the protection afforded by the Company's patents and those related to its acquired and licensed products, including but not limited to Flutiform, the ability to build awareness for the Company's products within the medical community, the continuing growth of the cardiovascular and respiratory markets, the Company's ability to increase the size of its sales force and to attract and retain sales professionals, the Company's and its licensors' ability to achieve regulatory approvals for products under development in a timely manner including Flutiform and others, the Company's ability to enter into additional new business development and scientific licensing opportunities, the progress of the Company's research and development pipeline, the Company's ability to ensure compliance with prescription drug sales and marketing laws and regulations, changes in the regulatory environment governing the Company's compliance with the FDA, PTO, tax and competition issues, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks. A more detailed discussion of risks attendant to the forward-looking statements included in this press release are set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission, and in other reports filed with the SEC. All information in this press release is as of May 8, 2006 and the Company undertakes no duty to update this information

Contact: Kos Pharmaceuticals, Inc John J. Howarth, 609-495-0726 or Nichol Harber, 609-495-0527 or SkyePharma PLC Peter Laing, 44-207-491-1777 Plaing@skyepharma.co.uk or Buchanan Communications Tim Anderson or Mark Court or Rebecca Skye Dietrich 44-207-466-5000

Source: Kos Pharmaceuticals, Inc.


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