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

PR57109

TITUSVILLE, New Jersey, June 18/PRN=KYODO JBN/ --

    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.