Johnson and Johnson 2009 Annual Report Download - page 20

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A steady pace of regulatory
milestones is the mark of
productive R&D eorts,
critical to future growth and
to meeting the needs of
doctors, nurses and patients.
Johnson & Johnson
pharmaceutical operating
companies launched multiple
new products around the
world during, including
four that address significant
unmet medical needs:

• ™ (golimumab)
was approved for the
treatment of moderate to
severe rheumatoid arthritis
with the medicine
methotrexate, active psoriatic
arthritis alone or with
methotrexate, and active
ankylosing spondylitis by
regulatory authorities in
Canada, Europe and the United
States. ™ is
administered subcutaneously
(under the skin) once a month
using a novel autoinjector or a
prefilled syringe. The ecacy
and safety of ™ were
shown in a Phase III
development program with
more than  patients.

• ™ (ustekinumab) is
a first-in-class biologic
treatment for moderate to
severe plaque psoriasis that is
administered subcutaneously
once every  weeks following
two starter doses. Psoriasis is a
chronic immune-related


 disease that aects an
estimated  million people
worldwide and can present in
various forms, ranging from
mild to severe and disabling.
With marketing approvals in
 in Europe, the United
States, Brazil, Mexico, Australia
and Singapore, ™ is
now approved in  countries.
The U.S. Food and Drug
•
Administration (FDA)
approved ®
(tapentadol) Immediate
Release Tablets, the first new
molecule in analgesia in over 
years for the relief of moderate
to severe acute pain in patients
age  or older. ® is a
single molecule with a dierent
approach to pain relief. In
December, a New Drug
Application was submitted to
the FDA for tapentadol
extended release (ER)
tablets for the management
of moderate to severe
chronic pain.
The FDA approved
•
®™
(paliperidone palmitate),
the first once-monthly
atypical antipsychotic for the
treatment of schizophrenia
(see feature on page ).
Our pipeline is robust. We
expect to file several new
compounds between now and
 and expand our core
products with new indications.
See the Pharmaceutical
Pipeline chart at
www.investor.jnj.com.
Doug Benson, a carpenter from Elko, Minn.,
enjoys outdoor activities. Since beginning treatment with
™, he’s been able to work without pain and has logged
 miles on his snowmobile this year.
JOHNSON & JOHNSON 2009 ANNUAL REPORT18