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08.05.2006 11:00:00
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REPEAT/Kos and SkyePharma Sign Exclusive License Agreement for the Marketing and Distribution of Flutiform(TM) in the United States
-- 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) and Jagotec AG, a subsidiary of SkyePharma PLC(Nasdaq:SKYE; LSE: SKP), announced today the signing of an exclusiveagreement for the marketing and distribution in the United States ofSkyePharma's product, Flutiform(TM). Flutiform is a formoterol andfluticasone fixed dose combination in a HydroFluoroAlkane metered doseinhaler. The strategic partnership includes an upfront licensingpayment of $25 million. If all regulatory and sales milestones aremet, SkyePharma could receive up to an additional $140 million inpayments, plus mid-teens sales royalties.
Asthma is an inflammatory condition that makes the airways in thelung (bronchi) abnormally responsive to external stimuli such as dust,pollen or cold air, resulting in constriction of the bronchi anddifficulty in breathing. Patients with asthma are normally treatedwith two types of therapy: an anti-inflammatory drug that addressesthe underlying cause of the condition and a bronchodilator that opensthe airways, relieving the symptoms and allowing patients to breathenormally. The older short-acting bronchodilators, although used fortreating acute asthma symptoms, have now largely been displaced bylong-acting bronchodilators that provide symptom relief for 12 hours(particularly valuable overnight) on a chronic basis and forprevention. Asthma drugs can be taken orally but most are inhaled,with the active drug delivered to the inner surface of the lung bymeans of an inhaler device, either a metered-dose aerosol inhaler or abreath-actuated dry powder inhaler. The US market for asthma drugsexceeded $10 billion in 2005. The fastest-growing segment of thismarket is with fixed combination treatments, which combine along-acting bronchodilator with an inhaled steroid in a singledelivery device. Combinations are not only more convenient forpatients than carrying two separate inhalers but also have been shownto optimize the efficacy of the individual agents.
"We are very pleased with SkyePharma's clinical development ofFlutiform for the asthma indication and are excited about thiscommercial opportunity in a very large and expanding market segment,"commented Adrian Adams, President and Chief Executive Officer of KosPharmaceuticals, Inc. "This strategic partnership should broaden ourpresence in the respiratory area, and provides a high potentialpartner product for Azmacort(R), our inhaled corticosteroid therapy,"he continued. "Our partnership with SkyePharma is another excellentexample of Kos' expanded business model that includes measured andtherapeutically aligned investments to fortify our R&D pipelinethrough corporate development and scientific in-licensing activities.In addition, it provides an opportunity to diversify our productportfolio by creating yet another potentially significant revenuegenerating opportunity anticipated in 2009, further reinforcing ourobjective to launch at least two products a year through the end ofthe decade, beginning in 2007."
SkyePharma's Chief Executive, Frank Condella, said: "We aredelighted to announce this partnership with Kos for our major pipelineproduct Flutiform. Kos has a tremendous track record of successfulmarketing with its cholesterol product, Niaspan(R). Over the past 5years, sales of Niaspan have increased at a compound annual growthrate of over 50%, helping Kos to become the fastest growingpharmaceutical company in the United States, and the sixth fastestgrowing of all U.S. companies in 2005. Kos is also active in therespiratory market with its recently acquired inhaled steroid product,Azmacort(R). Kos currently has a sales force of 750 concentrated inthe cardiovascular and respiratory markets, and plans to increase toover 1000 representatives by the time that Flutiform is launched. Webelieve Kos brings a therapeutically focused marketing approach thatwill optimize the commercial potential of Flutiform in the key USmarket."
SkyePharma will retain the commercial rights to Flutiform outsidethe US and Canada and continues to be responsible for Flutiform'sPhase III clinical trials and regulatory approval in the UnitedStates. SkyePharma will also be responsible for the supply of theproduct. Kos' responsibilities include the commercialization ofFlutiform, the potential clinical development of COPD and PediatricAsthma indications and all Phase IIIb and Phase IV studies.
About Flutiform
SkyePharma's product Flutiform consists of a unique fixed-dosecombination of the long-acting bronchodilator formoterol with theinhaled steroid fluticasone in a proprietary non-CFC metered-doseaerosol inhaler with a dose counter. Formoterol provides 12 hours ofbronchodilation and has a rapid onset of action (1-3 minutes). Bycontrast salmeterol, the bronchodilator used in GlaxoSmithKline'sAdvair(R)/Seretide(R), also provides 12 hours of bronchodilation, butneeds up to 30 minutes after inhalation to take effect. The inhaledsteroid fluticasone (a component of Advair/Seretide) has low systemicabsorption and is perceived to have a better safety and efficacyprofile than budesonide, the steroid used in AstraZeneca'sSymbicort(R), and is the physician-preferred inhaled steroid in theUS. The proprietary SkyeDry(TM) formulation technology employed inFlutiform, designed to stabilize the active components and therebyensure a reproducible dose even after prolonged storage, providespatent protection to 2019. The product will be available in two dosecombinations with each dose delivering 10 microgrammes of formoterolwith either 100 or 250 microgrammes of fluticasone.
About Kos Pharmaceuticals, Inc.
Kos Pharmaceuticals, Inc. is a fully integrated specialtypharmaceutical company engaged in developing, commercializing,manufacturing and marketing proprietary prescription products for thetreatment of chronic diseases with a particular focus on thecardiovascular, metabolic and respiratory disease areas. The Company'sprincipal product development strategy is to reformulate existingpharmaceutical products with large market potential to improve safety,efficacy, and patient compliance. Kos' strategy also includes makingmeasured investments in new chemical entity research through in-houseand sponsored research, scientific in-licensing and general corporatedevelopment activities. The Company currently markets Niaspan andAdvicor(R) for the treatment of cholesterol disorders, Azmacort forthe treatment of asthma, Cardizem(R)LA for the treatment ofhypertension and angina, and Teveten(R) and Teveten(R)HCT for thetreatment of hypertension. Kos has a strong and growing research anddevelopment pipeline including proprietary drug delivery technologiesin solid-dose, inhalation and aerosol metered-dose deviceadministration to help fuel sustained, organic sales growth into thefuture.
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting fromworld leading drug delivery technologies that provide easier-to-useand more effective drug formulations. There are now twelve approvedproducts incorporating SkyePharma's technologies in the areas of oral,injectable, inhaled and topical delivery, supported by advancedsolubilisation capabilities. For more information, visitwww.skyepharma.com.
Senior management from Kos and SkyePharma will host a conferencecall today at 8:30 a.m. ET to discuss this exclusive licenseagreement. The conference call will be available live via the Internetby accessing either company's website at www.kospharm.com andwww.skyepharma.com. Please go to the respective websites at leastfifteen minutes prior to the call to register, download and installany necessary audio software. Those who cannot access the webcast, canparticipate via telephone by calling 913-312-1295, confirmation code6963745. A replay will also be available on both websites or bycalling 719-457-0820 domestic or international, and entering 6963745from 11:30 AM ET today until 11:59 PM ET on Friday, May 12, 2006.
Certain statements in this press release, including statementsrelating to the projected 2009 launch of Flutiform, the growth of theUS market for asthma drugs, in particular with respect to fixedcombination treatments, the broadening of Kos' presence in therespiratory market, Flutiform's revenue generating potential, theCompany's objective to launch at least two products a year through theend of the decade beginning in 2007, the Company's plan to increasethe size of its sales force, the Company's strong and growing researchand development pipeline and future sales growth are forward-lookingand are subject to risks and uncertainties which may cause actualresults to differ materially from those projected in a forward-lookingstatement. These risks and uncertainties include, the protectionafforded by the Company's patents and those related to its acquiredand licensed products, including but not limited to Flutiform, theability to build awareness for the Company's products within themedical community, the continuing growth of the cardiovascular andrespiratory markets, the Company's ability to increase the size of itssales force and to attract and retain sales professionals, theCompany's and its licensors' ability to achieve regulatory approvalsfor products under development in a timely manner including Flutiformand others, the Company's ability to enter into additional newbusiness development and scientific licensing opportunities, theprogress of the Company's research and development pipeline, theCompany's ability to ensure compliance with prescription drug salesand marketing laws and regulations, changes in the regulatoryenvironment governing the Company's compliance with the FDA, PTO, taxand competition issues, the effect of conditions in the pharmaceuticalindustry and the economy in general, as well as certain other risks. Amore detailed discussion of risks attendant to the forward-lookingstatements included in this press release are set forth in the"Forward-Looking Information: Certain Cautionary Statements" sectionof the Company's Annual Report on Form 10-K for the year endedDecember 31, 2005, filed with the Securities and Exchange Commission,and in other reports filed with the SEC. All information in this pressrelease is as of May 8, 2006 and the Company undertakes no duty toupdate this information
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