5th Jul 2006 16:08
AstraZeneca PLC05 July 2006 AstraZeneca And Abbott To Co-Develop And Co-Market A Single-Pill, Fixed-DoseCombination Of CRESTOR(R) And Next-Generation TriCor (R) (ABT-335) In The UnitedStates AstraZeneca and Abbott announced today a collaboration to co-develop and marketa combination treatment that will target three important blood lipids - LDL("bad" cholesterol), HDL ("good" cholesterol), and triglycerides - in one singlepill as part of a comprehensive treatment regimen for mixed lipid disorders. The fixed-dose combination therapy will be co-developed for the U.S. marketbased on Abbott's proprietary, next-generation fenofibrate (ABT-335) currentlyin Phase III clinical trials and AstraZeneca's marketed statin, CRESTOR(R)(rosuvastatin calcium). In parallel, a combination product based on Abbott's currently marketed fibrateTriCor(R) and AstraZeneca's CRESTOR will also be evaluated. Final selectionbetween the two programmes will be made based upon data generated from theinitial studies. ABT-335 is part of a class of medications called fibrates, which have been shownto raise HDL cholesterol and reduce triglycerides, a form of fat or lipidobtained through food sources. CRESTOR is part of a class of medications calledstatins, and has been shown to reduce LDL and raise HDL cholesterol. Thiscombination could potentially address LDL and HDL cholesterol and triglyceridessimultaneously in a single pill. More than 100 million Americans suffer from lipid disorders. Of this number, 38million American adults have LDL, HDL and triglycerides at levels which increasethe risk for coronary artery disease and stroke. Patients with mixeddislipidaemia are expected to become a more prominent segment of thedyslipidaemic population due to the increased prevalence of metabolic syndromeand diabetes. The overall intention of the agreement is for the two companies broadly to sharedevelopment costs and profits over the duration of the collaboration. Abbottwill deliver the jointly designed clinical trial programme and will also beresponsible for regulatory filing of the new combination therapy. AstraZenecawill hold the New Drug Application (NDA). Following successful completion ofthe clinical programme, a regulatory application is anticipated for submissionto the FDA in 2009. The effectiveness of the agreement is subject to the satisfactory of certainconditions, including obtaining customary Hart-Scott-Rodino antitrust clearance. "We're excited by the opportunity this collaboration brings to serve animportant area of patient need," said Tony Zook, Executive Vice President NorthAmerica, AstraZeneca. "This represents an important further step in broadeningthe full, long-tem potential of CRESTOR for the treatment of lipid disorders." "Treatment guidelines emphasize the need to manage three important lipids bylowering bad cholesterol and triglycerides and increasing good cholesterol.Increasing evidence shows that addressing these three key lipid targets helps toprotect patients from heart disease," said Eugene Sun, M.D., Vice President,Global Pharmaceutical Clinical Development, Abbott. "This collaboration has thepotential to provide physicians and patients with the first statin and fibratecombination in a single pill to simplify the comprehensive treatment of lipids." About AstraZeneca AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $23.95 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. -Ends- 5 July, 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Jorgen Winroth, Tel: +1 (212) 579 0506Ed Seage, Tel: +1 302 886 4065 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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