AstraZeneca PLC
05 July 2006
AstraZeneca And Abbott To Co-Develop And Co-Market A Single-Pill, Fixed-Dose
Combination Of CRESTOR(R) And Next-Generation TriCor (R) (ABT-335) In The United
States
AstraZeneca and Abbott announced today a collaboration to co-develop and market
a combination treatment that will target three important blood lipids - LDL
('bad' cholesterol), HDL ('good' cholesterol), and triglycerides - in one single
pill as part of a comprehensive treatment regimen for mixed lipid disorders.
The fixed-dose combination therapy will be co-developed for the U.S. market
based on Abbott's proprietary, next-generation fenofibrate (ABT-335) currently
in Phase III clinical trials and AstraZeneca's marketed statin, CRESTOR(R)
(rosuvastatin calcium).
In parallel, a combination product based on Abbott's currently marketed fibrate
TriCor(R) and AstraZeneca's CRESTOR will also be evaluated. Final selection
between the two programmes will be made based upon data generated from the
initial studies.
ABT-335 is part of a class of medications called fibrates, which have been shown
to raise HDL cholesterol and reduce triglycerides, a form of fat or lipid
obtained through food sources. CRESTOR is part of a class of medications called
statins, and has been shown to reduce LDL and raise HDL cholesterol. This
combination could potentially address LDL and HDL cholesterol and triglycerides
simultaneously in a single pill.
More than 100 million Americans suffer from lipid disorders. Of this number, 38
million American adults have LDL, HDL and triglycerides at levels which increase
the risk for coronary artery disease and stroke. Patients with mixed
dislipidaemia are expected to become a more prominent segment of the
dyslipidaemic population due to the increased prevalence of metabolic syndrome
and diabetes.
The overall intention of the agreement is for the two companies broadly to share
development costs and profits over the duration of the collaboration. Abbott
will deliver the jointly designed clinical trial programme and will also be
responsible for regulatory filing of the new combination therapy. AstraZeneca
will hold the New Drug Application (NDA). Following successful completion of
the clinical programme, a regulatory application is anticipated for submission
to the FDA in 2009.
The effectiveness of the agreement is subject to the satisfactory of certain
conditions, including obtaining customary Hart-Scott-Rodino antitrust clearance.
'We're excited by the opportunity this collaboration brings to serve an
important area of patient need,' said Tony Zook, Executive Vice President North
America, AstraZeneca. 'This represents an important further step in broadening
the full, long-tem potential of CRESTOR for the treatment of lipid disorders.'
'Treatment guidelines emphasize the need to manage three important lipids by
lowering bad cholesterol and triglycerides and increasing good cholesterol.
Increasing evidence shows that addressing these three key lipid targets helps to
protect patients from heart disease,' said Eugene Sun, M.D., Vice President,
Global Pharmaceutical Clinical Development, Abbott. 'This collaboration has the
potential to provide physicians and patients with the first statin and fibrate
combination in a single pill to simplify the comprehensive treatment of lipids.'
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription pharmaceuticals
and the supply of healthcare services. It is one of the world's leading
pharmaceutical companies with healthcare sales of $23.95 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4Good Index.
-Ends-
5 July, 2006
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Jorgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.