Johnson & Johnson - Index

Johnson & Johnson - report - Index

2007 YEAR IN REVIEW:
Pharmaceuticals
• Delivering on Pipeline With Major Approvals and Submissions
• Nine Products With Sales Over $1 Billion
New Combination Treatment
Slows Progression of
Multiple Myeloma
26
Tibotec Continues Advancements
in the Care of Patients With HIV/AIDS
Tibotec Therapeutics and Tibotec
Pharmaceuticals, Ltd. continued their
commitment to the global response to
HIV and AIDS in 2007 by advancing the
development of new treatments and
seeking innovative ways to expand
global access.
New Drug and Marketing
Authorization applications were
submitted to the U.S. FDA and
European Medicines Evaluation
Agency, respectively, for the
investigational treatment TMC 125
(etravirine). The compound was
granted priority review by the FDA
and was approved in the U.S. under
the brand name INTELENCE TM in January
2008. (See related story on page 18.)
This approval comes as the company’s
protease inhibitor, PREZISTA TM (darunavir),
gained approval for patients diagnosed
Ortho Biotech Products, LP
continued to broaden its
foundation in oncology with the
U.S. FDA approval of the use of
DOXIL ® (doxorubicin HCl liposome
injection) in combination with
VELCADE ® (bortizomib) for
Injection to treat patients with
relapsed or refractory multiple
myeloma. The new combination
treatment meets the needs of
patients who have not previously
received VELCADE ® and have
received at least one prior therapy.
This new regimen was
approved under the FDA’s
priority-review program and was
supported by data that showed
the two medicines in combination
significantly extended the median
time to disease progression over
the use of VELCADE ® alone, from
6.5 months to 9.3 months, an
increase of 43 percent.
Ortho Biotech co-promotes
VELCADE ® in the U.S., and
Johnson & Johnson Pharmaceutical
Research & Development, LLC
co-develops VELCADE ® through
agreements with Millennium
Pharmaceuticals, Inc. Janssen-
Cilag companies market
VELCADE ® in Europe and the
rest of the world.
with treatment-resistant HIV in nearly
60 countries, including Brazil, Thailand and
Ukraine, and is now treating thousands of
patients in the U.S. and Europe.
In 2007, Tibotec entered into
a royalty-free voluntary license
agreement with South African company
Aspen Pharmaceuticals to make
PREZISTA TM available to patients in
sub-Saharan Africa and other Least
Developed Countries at a special
access price. And in an effort to gain
better understanding of the use of
PREZISTA TM in combination with
other antiretroviral treatments in
adult women with HIV, the company
initiated the GRACE study (Gender, Race and
Clinical Experience), the largest study to date
conducted in treatment-experienced, HIVpositive
women to evaluate gender and race
differences in response to an HIV medication.
IONSYS™ Launched
in EU for Postoperative
Pain Management
In January 2008, the Janssen-Cilag
companies in Europe launched
IONSYS™ (fentanyl iontophoretic
transdermal system), a compact,
preprogrammed system for the
treatment of postoperative pain
in a hospital setting. It does
not require needles, pumps,
catheters or intravenous (IV)
pump stands. IONSYS™ has the
potential to make in-hospital pain
management following surgery less
time-consuming for health care
professionals and less intrusive
for patients. The patient activates
IONSYS™ by pressing a button
on the device. The system uses a
virtually imperceptible low-intensity
electrical field to transport the
pain medication fentanyl through
the skin and into the bloodstream
through a process called
iontophoresis.
Licensing Deals
Enhance Commitment
in Key Therapeutic
Areas
Significant licensing deals signed in 2007
will expand our presence in two therapeutic
areas of focus: metabolic disease and
immunology. Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (OMJPI) is
collaborating with California-based Isis
Pharmaceuticals, Inc. to discover, develop
and commercialize drugs to treat metabolic
diseases such as Type 2 diabetes and obesity.
As part of the collaboration, Isis is granting
OMJPI worldwide development and
commercialization rights to two of its
diabetes drugs, both of which represent
novel approaches for the treatment of this
increasingly common disease. OMJPI will
provide Isis with funding to support the joint
discovery of additional drugs to treat
metabolic diseases.
Separately, in immunology, Janssen
Pharmaceutica N.V. and Galapagos N.V.,
a Belgium-based company, have entered into
a worldwide alliance to discover, develop
and commercialize novel small-molecule oral
therapies for the treatment of rheumatoid
arthritis (RA), a chronic, degenerative
disease that mainly affects the joints.
Centocor, Inc., a unit of Johnson & Johnson,
already markets REMICADE® (infliximab),
an intravenously administered biologic
(large-molecule) therapy for RA.
Advancing the Treatment
of Schizophrenia
In 2007, Janssen, LP launched the first
prolonged-release oral atypical antipsychotic,
INVEGA® (paliperidone) Extended-Release
Tablets. INVEGA® has demonstrated
powerful efficacy in many patients living with
schizophrenia. It has now been approved by
regulatory authorities in North America, Latin
America, Asia and Europe.
In 2007, Janssen also filed for U.S.
regulatory approval of paliperidone palmitate,
a monthly intramuscular injection of the
active ingredient in INVEGA® designed
to treat and prevent recurrence of the
symptoms of schizophrenia. (See related
story on page 12.)
J O H N S O N & J O H N S O N 2 0 0 7 A N N U A L R E P O R T