Ranbaxy and AstraZeneca Reach Agreement in Esomeprazole Patent Litigation

Companies Also Sign Manufacturing and Distribution Agreement

GURGAON, India and PRINCETON, N.J., April 15 /PRNewswire/ -- Ranbaxy
Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories
Limited (RLL), announced today that it has reached several agreements with
AstraZeneca. Two of these agreements concern Esomeprazole magnesium capsules.
The third agreement pertains to Omeprazole 40mg tablets, and the fourth
agreement pertains to Felodipine ER capsules. All of the agreements are
specific to the U.S. market.
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
Esomeprazole magnesium. Under the settlement agreement, Ranbaxy concedes that
all six patents asserted by AstraZeneca in the patent litigation are valid and
enforceable.
The settlement agreement will allow Ranbaxy to commence exclusive sales of
a generic version of Nexium under a license from AstraZeneca on May 27, 2014.
During the 180-day period following the date, RPI will distribute the only
generic Esomeprazole magnesium product in the US market.
Ranbaxy has filed a Consent Judgment with the U.S. 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.
"We are pleased with the agreement which will provide certainty as to the
launch of a generic formulation of Esomeprazole magnesium in the US market,"
according to Malvinder M. Singh, CEO and Managing Director of Ranbaxy
Laboratories Ltd.
Manufacturing Agreements
AstraZeneca and Ranbaxy have separately entered into an agreement under
which Ranbaxy will formulate a significant portion of AstraZeneca's U.S.
supply of Nexium from May 2010, including provisions for the manufacture of
Esomeprazole magnesium, the Active Pharmaceutical Ingredient (API) from May
2009.
Distribution Agreements
AstraZeneca and Ranbaxy have also entered into two separate agreements
designating Ranbaxy as the U.S. distributor for the authorized generic
versions of Felodipine Capsules and Omeprazole 40mg Tablets. Ranbaxy will be
compensated for its distribution services on standard commercial terms.
In regards to the Distribution Agreements, Mr. Singh added, "It is
anticipated that these products will fulfill the needs of the U.S. healthcare
system in providing a generic formulation as an option, in addition to the
brand. This will support the requirement of patients prescribed these
medications, and supports our long-term efforts to increase our product
portfolio of generic molecules to meet the needs of Americans."
Esomeprazole magnesium 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.
Esomeprazole magnesium 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. Esomeprazole magnesium has been demonstrated to provide
enduring relief from the impact of GERD amongst patients.
Felodipine is a calcium antagonist for the treatment of hypertension and
angina.
Omeprazole was the first PPI and is used for the short-term treatment of
acid-related diseases.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a
wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest
pharmaceutical company. RPI is engaged in the sale and distribution of
generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is
an integrated, research based, international pharmaceutical company producing
a wide range of quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued focus on
R&D has resulted in several approvals in developed markets and significant
progress in New Drug Discovery Research. The Company's foray into Novel Drug
Delivery Systems has led to proprietary "platform technologies," resulting in
a number of products under development. The Company is serving its customers
in over 125 countries and has an expanding international portfolio of
affiliates, joint ventures and alliances, ground operations in 49 countries
and manufacturing operations in 11 countries.
*Nexium(R) is a registered trademark of AstraZeneca

CONTACTS: Charles M. Caprariello Edwige Buteau
Vice President, RF Binder Partners Inc.
Corporate Communications (212) 994-7517
Ranbaxy Inc.
(609) 720-5615
Caroline Mozingo
RF Binder Partners Inc.
(212) 994-7560

SOURCE Ranbaxy Pharmaceuticals Inc.

Charles M. Caprariello, Vice President, Corporate Communications of Ranbaxy
Inc., +1-609-720-5615; or Edwige Buteau, +1-212-994-7517, or Caroline Mozingo,
+1-212-994-7560, both of RF Binder Partners Inc., for Ranbaxy Inc.