AstraZeneca PLC
15 April 2008
For Business and Financial Media.
AstraZeneca Settles US Nexium Patent
Litigation with Ranbaxy
Companies Also Sign Manufacturing and Distribution Agreements
AstraZeneca today announced it has entered into a settlement agreement in its
Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its
affiliates ('Ranbaxy').
The agreement settles the patent infringement litigation filed by AstraZeneca
following Ranbaxy's submission to the United States Food & Drug Administration
of an Abbreviated New Drug Application for a generic version of Nexium. Under
the settlement agreement, Ranbaxy concedes that all six patents asserted by
AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also
accepts that four of the patents would be infringed by the unlicensed sale of
Ranbaxy's proposed generic product.
The settlement agreement will allow Ranbaxy to commence sales of a generic
version of Nexium under a licence from AstraZeneca on 27 May 2014. This date
marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca's
patents protecting Nexium have expiration dates that range from 2014 through
2019.
AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court
for the District of New Jersey reflecting the terms of the settlement agreement.
With the Court now having entered the Consent Judgment, the settlement agreement
is final, and the patent infringement litigation against Ranbaxy has been
dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's
restructured partnership with AstraZeneca announced in 1998, has also entered
into the settlement agreement.
AstraZeneca's Nexium patent infringement litigations against Teva/IVAX and Dr
Reddy's Laboratories remain ongoing.
'I believe that this agreement is the right business decision and gives
increased clarity and stability to allow us to continue investing substantially
in our growing pipeline of new medicines for patients. We continue to have
confidence in the strength of our patents and will vigorously defend our
intellectual property,' said David Brennan, Chief Executive Officer of
AstraZeneca.
Manufacturing and Distribution Agreements
AstraZeneca and Ranbaxy have separately entered into agreements under which
Ranbaxy will formulate a portion of AstraZeneca's US supply of Nexium from May
2010, including provisions for the manufacture of esomeprazole magnesium, the
active pharmaceutical ingredient in Nexium, from May 2009.
AstraZeneca and Ranbaxy have also entered into two separate agreements
designating Ranbaxy as the US distributor for authorised generic versions of
Plendil (felodipine) and 40mg Prilosec (omeprazole). Ranbaxy will be
compensated for its distribution services on standard commercial terms.
In compliance with the Medicare Modernization Act of 2003, AstraZeneca will file
all of the above agreements with the United States Federal Trade Commission and
the United States Department of Justice.
15 April 2008
Media Enquiries:
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Investor Enquiries US:
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Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518
About Nexium
Nexium belongs to a class of medicines known as proton-pump inhibitors (PPIs).
It works by binding to, and inhibiting, the acid pumps of a particular type of
cell which is found in the stomach. In doing so, it lowers the level of acidity
in the stomach and helps to heal erosions in the esophagus or ulcers in the
duodenum.
Nexium is an effective treatment for patients with gastroesophageal reflux
disease (GERD), but is particularly appropriate for those suffering from
persistent, recurrent GERD which can cause disruptive, long term symptoms.
Nexium has been demonstrated to provide enduring relief from the impact of GERD
amongst patients.
Nexium was first launched in Europe in 2000 and in 2001 in the US.
About Plendil
Plendil (felodipine) is a calcium antagonist for the treatment of hypertension
and angina.
About Prilosec
Prilosec (omeprazole), marketed as Losec in some countries, was the first PPI
and is used for the short-term treatment of acid-related diseases.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research,
development, manufacturing and marketing of prescription pharmaceuticals and
supplier for healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with healthcare sales of US $29.55 billion and is a
leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infection product sales. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
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