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

June 18, 2014

TITUSVILLE, New Jersey, June 18, 2014 /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.

SOURCE Janssen Pharmaceuticals, Inc.


Source: PR Newswire



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