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Janssen Announces License Agreement With Vertex to Develop Novel Treatment for Influenza A

Geschrieben am 18-06-2014

Titusville, New Jersey (ots/PRNewswire) -

Janssen Pharmaceuticals, Inc. (Janssen) announced today that it
has entered into an exclusive license agreement with Vertex
Pharmaceuticals for the worldwide development, manufacturing and
commercialization of VX-787, a novel medicine in Phase II development
for the treatment of influenza A.

VX-787 is an investigational medicine designed to directly inhibit
replication of the influenza A virus, including recent H1 (pandemic)
and H5 (avian) influenza strains, based on in-vitro data. Influenza
is an acute viral infection that spreads easily through respiratory
droplets produced when an infected person coughs or sneezes, or
through contaminated hands and surfaces.[1] Universally, resistance
has emerged to existing antivirals for influenza and, through the
development of VX-787, Janssen hopes to provide an additional
treatment option for patients.

"Influenza infection remains one of the most serious public health
challenges globally. In addition to the burden of seasonal influenza,
the pandemics of the 20th and 21st centuries exemplify the threat the
influenza A virus presents," says Johan Van Hoof, Global TA Head
Infectious Diseases and Vaccines, Managing Director, Crucell. "This
agreement builds on Janssen's legacy of innovation and partnership,
and we are proud to collaborate with Vertex on this novel medicine.
This treatment has the potential to address a significant unmet
medical need and to improve the well-being of patients everywhere."

The license agreement also grants Janssen rights to develop,
manufacture and commercialize VX-787's back-up compound, VX-353, as
well as rights to develop, manufacture and commercialize certain
other back-up compounds for the prevention and/or treatment of
influenza. The agreement is subject to the expiration of the waiting
period under the Hart-Scott-Rodino Antitrust Improvements Act.

Vertex completed a Phase IIA study of VX-787 in 2013. The parties
expect additional clinical trials to begin in the coming months.

###

About VX-787

VX-787 is a first-in-class, influenza A-specific, oral polymerase
inhibitor. It is the first and most advanced example of a novel mode
of action (MOA) direct acting antiviral working through the influenza
virus PB2 polymerase subunit. Targeting an alternative part of the
viral replication process may help ensure that this new medicine can
successfully treat strains of the influenza virus which may be
resistant to existing antiviral drugs with other MOAs.

VX-787 has demonstrated potent and rapid in-vitro antiviral
activity on all Vertex tested influenza A strains to date, including
oseltamivir (Tamiflu(R)) resistant strains.[2] Initial clinical
assessments of VX-787 have also been promising. Phase I studies
demonstrated the molecule was well tolerated in healthy volunteers
providing a pharmacokinetic profile supportive of once daily
dosing.[2] Vertex has also completed a Phase IIA challenge study that
showed statistically significant improvements in viral and clinical
measurements of influenza A infection and demonstrated clinical proof
of concept.[3]

About Influenza

Influenza occurs globally, with an average of 5-10 percent of
adults and 20-30 percent of children becoming infected with the virus
each year. Worldwide, annual influenza epidemics are estimated to
result in about 3 to 5 million cases of severe illness, and about
250,000 to 500,000 deaths.[4] Yearly influenza epidemics can
seriously affect all populations, but the highest risk of
complications occur among children younger than age 2 years, adults
aged 65 years or older, pregnant women, and people of any age with
certain medical conditions, such as chronic heart, lung, kidney,
liver, blood or metabolic diseases (such as diabetes), or weakened
immune systems.[4]

The treatment of influenza consists of antiviral medications that
have been shown in clinical studies to shorten the disease and reduce
the severity of symptoms if taken within two days of infection,
however, there is a significant need for new medicines targeting flu
that provide a wider treatment window, greater efficacy and faster
onset of action.

About Janssen

At Janssen, we are dedicated to addressing and solving some of the
most important unmet medical needs of our time in infectious diseases
and vaccines, oncology, immunology, neuroscience, and cardiovascular
and metabolic diseases. Driven by our commitment to patients, we
develop innovative products, services and healthcare solutions to
help people throughout the world.

Janssen Pharmaceuticals, Inc. is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson.

(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995. The
reader is cautioned not to rely on these forward-looking statements.
These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
the expectations and projections of Janssen Pharmaceuticals, Inc.
and/or Johnson & Johnson.

Risks and uncertainties include, but are not limited to: economic
factors, such as interest rate and currency exchange rate
fluctuations; competition, including technological advances, new
products and patents attained by competitors; challenges inherent in
new product development, including obtaining regulatory approvals;
challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of health care products and
services; changes to governmental laws and regulations and domestic
and foreign health care reforms; general industry conditions
including trends toward health care cost containment; and increased
scrutiny of the health care industry by government agencies.

A further list and description of these risks, uncertainties and
other factors can be found in Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended December 29, 2013, including in
Exhibit 99 thereto, and our subsequent filings with the Securities
and Exchange Commission. Copies of these filings are available online
at http://www.sec.gov, http://www.jnj.com or on request from Johnson
& Johnson. None of the Janssen Pharmaceutical Companies nor Johnson &
Johnson undertakes to update any forward-looking statements as a
result of new information or future events or developments.)

1. World Health Organization. Influenza. Available at: http://www.
euro.who.int/en/health-topics/communicable-diseases/influenza. Last
accessed June 2014

2. Vertex. Data on file.

3. Vertex. VX-787 Showed Significant Antiviral Activity and
Reduced the Severity and Duration of Influenza Symptoms in Phase 2
Challenge Study. Available at:
http://investors.vrtx.com/releasedetail.cfm?releaseid=744857. Last
accessed June 2014.

4. World Health Organization. Influenza (Seasonal). Available at:
http://www.who.int/mediacentre/factsheets/fs211/en. Last accessed
June 2014.

ots Originaltext: Janssen Pharmaceuticals, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
MEDIA Daniel de Schryver, +32 14 60 71 79,
ddschryv@its.jnj.com ; INVESTOR RELATIONS: Stan Panasewicz , +1 732
524
2524 ; Louise Mehrotra, +1 732 524 6491


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