Johnson and Johnson 2008 Annual Report Download - page 24

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Sustaining R&D productivity, reducing time
and cost, and maintaining quality have been
fundamental imperatives for our pharma-
ceutical business. Recently the pharmaceutical
industry, while facing growing generic
competition and a more demanding regulatory
environment, has seen its once-strong
pipelines soften. During this time, however,
we have sustained research productivity
and are on track to complete filings for seven
to 10 new products between the beginning
of 2008 and the end of 2010. In doing so,
we’ll meet a goal set back in 2007. We are
demonstrating what can be achieved when
dedicated employees work together in moving
new compounds from concept to reality.
Organic growth, as well as strategic
in-licensing and partnerships, have
contributed to reaching regulatory
milestones. Success has been driven by
research and development where we use
our expertise in biopharmaceuticals and
small molecules to focus eectively on the
discovery and development of new molecular
entities while pursuing innovative platforms
and technologies for drug delivery.
Here are highlights of significant
regulatory milestones in 2008.


• ™ (ustekinumab) is a new biologic
medicine for which Johnson & Johnson
has worldwide marketing rights. It has
been approved by regulatory authorities
in Canada and the 27 European Union
countries for treatment of moderate to
severe plaque psoriasis. ™ is
currently under review by the U.S. Food and
Drug Administration (FDA), and marketing
applications for the treatment of moderate to
severe plaque psoriasis have been filed with
local health authorities in numerous other
regions around the world.
A Biologics License Application (BLA)
•
was submitted to the FDA requesting
approval of golimumab (CNTO 148), a
next-generation human anti-TNF-alpha
monoclonal antibody, as a monthly
subcutaneous treatment for adults with
active forms of rheumatoid arthritis,
psoriatic arthritis and ankylosing
spondylitis. It is being developed as both a
subcutaneous injection and an intravenous
infusion therapy. Other potential claims
and uses being studied include impact on
structural damage related to rheumatoid
arthritis and ulcerative colitis.


• ™ (tapentadol) immediate-
release tablets were granted FDA approval
for the relief of moderate to severe acute
pain in adults age 18 and older. ™
is a centrally acting oral analgesic with a
comprehensive dual mechanism of action,
combining mu-opioid receptor agonism
and norepinephrine reuptake inhibition
to significantly relieve moderate to
severe acute pain with a low incidence of
gastrointestinal side eects. ™
is being co-developed by Grünenthal
and Johnson & Johnson Pharmaceutical
Research & Development, LLC (J&JPRD).

A New Drug Application (NDA) was filed
•
with the FDA for rivaroxaban, an
investigational oral, once-daily anticoagulant
for the prevention of deep vein thrombosis
(DVT) and pulmonary embolism (PE) in
patients undergoing hip or knee replacement
surgery. Initially developed for prevention of
DVT and PE in hip and knee replacements,


   
Pharmaceuticals
 Members of the ustekinumab compound development team (above)
discovered the human monoclonal antibody more than 10 years ago. It has been approved in
Canada and the 27 EU countries and is under review with the U.S. FDA.
JOHNSON & JOHNSON 2008 ANNUAL REPORT