ASTRAZENECA DEVELOPMENT PARTNER, POZEN, INC., SUBMITS NEW DRUG APPLICATION FOR PN400

ASTRAZENECA DEVELOPMENT PARTNER, POZEN, INC., SUBMITS NEW DRUG APPLICATION FOR
PN400

VIMOVO Proposed as trade name

Wilmington, Del. (30 June 2009) - AstraZeneca today announced that its
development partner, Pozen, Inc., has submitted a New Drug Application (NDA) to
the US Food and Drug Administration (FDA) for VIMOVO (PN400) (enteric coated
naproxen /esomeprazole magnesium) tablets, a product under investigation for the
treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis
(RA) and ankylosing spondylitis (AS) in patients who are at risk of developing
NSAID-associated ulcers. PN400 is a fixed-dose combination of enteric coated
naproxen and immediate release esomeprazole. The proposed trade name is VIMOVO,
pending regulatory approval. Upon the FDA's notification of acceptance of the
NDA filing for PN400, a $10 million milestone payment from AstraZeneca will be
payable to POZEN.

If approved, PN400 would offer a new arthritis treatment option for patients at
risk of gastric ulcers, associated with non-steroidal anti-inflammatory drugs
(NSAID). Nearly 27 million US residents and 140 million people worldwide suffer
from osteoarthritis.  The risk factors for NSAID-associated gastric ulcers
include age (>/= 50 years), a documented history of gastric ulcers, or
concomitant use of low-dose aspirin.   

The NDA submission is based on data from a comprehensive clinical trials
programme. The PN400 301/302 studies fully met their primary objective, showing
subjects taking PN400 experienced significantly fewer endoscopically confirmed
gastric ulcers compared to subjects receiving enteric coated (EC) naproxen. The
primary endpoint was the cumulative incidence of gastric ulcers through six
months. In each of the trials, approximately 400 subjects received either PN400
or EC naproxen 500mg, twice daily, over a six-month treatment period. Subjects
underwent upper endoscopies at baseline and at one, three, and six months. 


NOTES TO EDITORS

About VIMOVO (naproxen sodium/esomeprazole magnesium)
VIMOVO is an investigational product under co-development by AstraZeneca and
POZEN, Inc. that combines the pain reliever naproxen (an NSAID) with
esomeprazole, a proton pump inhibitor (PPI). VIMOVO is under investigation for
the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing
spondylitis in patients who are at risk of developing NSAID-associated gastric
ulcers. 
 
About Osteoarthritis 
Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and
eventual loss of the cartilage of one or more joints. Osteoarthritis is the most
common form of arthritis and the most common cause of chronic pain, affecting
nearly 140 million individuals worldwide, and impacting approximately 18% of
women and 9.6% of men aged 60 and above. A combination of factors can contribute
to osteoarthritis, including being overweight, aging, joint injury or stress,
heredity and muscle weakness. Osteoarthritis commonly affects the hands, feet,
spine or large weight-bearing joints, such as the hips and knees. 

About Ankylosing spondylitis
Ankylosing spondylitis is a chronic inflammatory disease that primarily causes
pain and inflammation of the joints between the vertebrae of the spine and the
joints between the spine and pelvis (sacroiliac joints). Ankylosing spondylitis
may also cause inflammation and pain in other parts of the body as well.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful prescription
medicines and supplier for healthcare services. AstraZeneca is one of the
world's leading pharmaceutical companies with healthcare sales of US$ 31.6
billion and is a leader in gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infectious disease medicines.  For more information
about AstraZeneca, please visit: www.astrazeneca.com or www.astrazeneca.se

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