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J O H N S O N & J O H N S O N 2 0 0 6 A N N U A L R E P O R T
On June 23, 2006, when the FDA granted
accelerated approval of PREZISTA™
(darunavir), also known as TMC114, for
the treatment of HIV/AIDS in
antiretroviral (ARV) experienced
adults, our pharmaceuticals
business launched more than its
first HIV treatment: It launched an
entire new growth engine in virology—
a business devoted to fighting some of
the world’s most deadly diseases.
The launch of this important new
virology franchise began just four years earlier
with the acquisition of a promising young
Belgian company, Tibotec-Virco (see page 16).
Today, Tibotec Pharmaceuticals Ltd., Tibotec
Therapeutics Division of Ortho Biotech
Products, LP and Virco BVBA are the backbone
of a highly innovative virology business
based on evolving science and combining
pharmaceutical and diagnostic approaches.
Thanks to strong internal development
capabilities and in-licensing of important
early-stage products, the virology franchise
has been launched with a strong pipeline and
promising growth for years to come.
PREZISTA™ is a potent protease inhibitor
that has demonstrated significant activity
against both wild-type and drug-resistant
strains of HIV. Experts in the field agree that
this drug offers new hope for treatment-
experienced patients. PREZISTA™ is the first
ARV in a decade to receive FDA accelerated
approval based on Phase IIb data. Phase III
studies in early experienced and treatment-
naive patients are ongoing and will form part
of a traditional filing within the next year.
During 2006, approvals also were granted
in Canada, Russia, Argentina and Switzerland.
Further, conditional marketing authorization
was received from the European Commission
in February 2007.
The near-term pipeline in
virology holds two other late-stage
HIV medicines:
· TMC125, in Phase III, is the first
investigational NNRTI to show
significant activity in patients with prior
NNRTI failure.
· TMC278, in Phase IIb dose-finding studies,
is one of the most potent NNRTIs ever
developed and as such has the potential to
become a backbone in a range of fixed-dose
combinations.
The virology franchise also has
early-stage development efforts and
complementary in-licensing focused
on hepatitis C (HCV), tuberculosis (TB)
and respiratory syncytial virus (RSV).
The first clinical data on TMC207 in
TB patients was presented in 2006.
TMC207 is one of the first potential
new TB drugs in more than 40 years,
and the emerging profile appears very
attractive. In 2006 a licensing agreement
with Vertex Pharmaceuticals for
VX-950, now called Telaprevir, added a
promising novel protease inhibitor for
the treatment of HCV to the virology
pipeline. The virology franchise will
work in close partnership with Vertex
on the development of this important
molecule and will have commercial rights
outside the U.S. Telaprevir is currently
in Phase IIb for treatment of adults with
chronic HCV. Hepatitis C is a blood-
borne liver disease caused by infection
with the hepatitis C virus.
2006 YEAR IN REVIE W:
Pharmaceuticals
Pharmaceutical and Diagnostic Strengths
Combine in New Virology Franchise
• Four New Prescription Medicines Approved
• New Growth Platform in Virology Launched
• Important New Indications for Leading Rxs
• In-licensing Adds Four New Products to Pipeline
26
Near-Term
Pipeline
In 2005, we communicated to the
investment community plans to file or
secure approval of between 10 and 13
new molecular entities (NMEs) by the
end of 2007. Four NMEs—PREZISTA™,
IONSYS™, JURNISTA™ (EU) and
INVEGA™—were approved in 2006,
and a fifth, Doripenem, was filed.
Our performance is on track
with seven additional filings expected by
the end of 2007:
PROJECTED FILINGS, 2006–2009
as of January 23, 2007
CNS Paliperidone
Palmitate
Carisbamate*
PAIN Tapentadol (U.S.)*
I.M.I.D. CNTO 1275
CNTO 148
ONCOLOGY ZARNESTRA®
DACOGEN™ (EU)*
YONDELIS® (U.S.)*
VIROLOGY TMC 125
Telaprevir (EU)*
ANTIBACTERIALS Doripenem*
Ceftobiprole*
CARDIOVASCULAR Rivaroxaban (U.S.)*
UROLOGY Dapoxetine
(selected EU)*
HEMATOLOGY ICA 17043*
* Carisbamate licensed from SK-Bio Pharmaceuticals.
Doripenem licensed from Shionogi & Co. Tapentadol licensed
from Grunenthal GmbH. YONDELIS® licensed from
PharmaMar. Ceftobiprole licensed from Basilea Pharmaceutica.
Rivaroxaban licensed from Bayer Healthcare. ICA 17043
licensed from Icagen. Dacogen licensed from MGI Pharma.
Telaprevir licensed from Vertex Pharmaceuticals Inc.
Dapoxetine licensed from PPD-GenuPro.
Est. filing: 2007 Est. filing: 2009
Est. filing: 2008 Filed