Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat

Beerse, Belgium (ots/PRNewswire) -

Janssen-Cilag International NV (Janssen), today announced it has
submitted a Marketing Authorisation Application to the European
Medicines Agency seeking approval for a once-daily single tablet
fixed-dose antiretroviral combination product containing darunavir, a
protease inhibitor developed by Janssen, with cobicistat, a
pharmacokinetic enhancer or boosting agent, developed by Gilead
Sciences, Inc. (Gilead) for use in combination with other human
immunodeficiency virus (HIV-1) medicines.

Once-daily darunavir is marketed as PREZISTA(R) in the European
Union. PREZISTA(R) is always taken with and at the same time as
ritonavir, a boosting agent, with food and in combination with other
HIV medicines. If approved, the fixed-dose combination tablet will be
marketed under a new brand name and will, for the first time, offer
an option that eliminates the need to take a boosting agent in a
separate tablet with once-daily darunavir.

In June 2011, Janssen announced a license agreement with Gilead
for the development and commercialization of a once-daily, single
tablet fixed-dose combination product of darunavir and Gilead's
cobicistat. Under the terms of the agreement, Janssen and its
affiliates are responsible for the formulation, manufacturing,
registration, distribution and commercialization of the darunavir and
cobicistat fixed-dose combination worldwide. Gilead retains sole
rights for the manufacture, development and commercialization of
cobicistat as a stand-alone product and for use in combination with
other agents.

"Over the last six years, Janssen has launched three therapies for
people living with HIV and is committed to further evaluating HIV
therapies for a broad range of patients. We are therefore excited to
be applying for marketing authorization for a single tablet
combination product which includes darunavir, the leading protease
inhibitor worldwide, with an alternative boosting agent," said, Johan
van Hoof, Therapeutic Area Head, Infectious Diseases and Vaccines,
Janssen. "This filing demonstrates our ongoing commitment to develop
new HIV treatment options and fixed-dose treatment regimens for those
living with the disease. The ultimate goal is to help all patients
achieve an undetectable viral load and a better quality of life."

About PREZISTA(R) (darunavir)

Darunavir, co-administered with low dose ritonavir, is indicated
in combination with other antiretroviral medicinal products for the
treatment of human immunodeficiency virus (HIV-1) infection in adult
and paediatric patients from the age of 3 years and at least 15 kg
body weight.

Since its initial approval in 2007, darunavir has also been
indicated for use in HIV-1 infected treatment-naive and
treatment-experienced adult patients, including those who have been
highly pre-treated, in combination with ritonavir and other ARTs. For
treatment-experienced adult patients, the licensed dosing for
darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily
with food or 800 mg taken with 100 mg ritonavir once daily with food
for patients with no DRV Resistance Associated Mutations (RAMs)[1]
and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count
greater than or equal to 100 cells x 106/L. For treatment-naive adult
patients, the licensed dosing for darunavir is 800 mg taken with 100
mg ritonavir once daily with food.

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1. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V

Important Safety Information

In the registrational studies, darunavir was generally well
tolerated. The majority of the adverse reactions reported in patients
who initiated therapy with darunavir co-administered with 100 mg
ritonavir were mild to moderate in severity. The most frequent
adverse reactions reported in clinical trials and as spontaneous
reports are diarrhoea, nausea, rash, headache and vomiting. The most
frequent serious reactions are acute renal failure, myocardial
infarction, immune reconstitution syndrome, thrombocytopenia,
osteonecrosis, diarrhoea, hepatitis and pyrexia. Please see the
Summary of Product Characteristics for a complete list of all
possible side effects.

Before taking darunavir, patients should tell their doctor if they
have any medical conditions, including liver problems, including
hepatitis B or C, diabetes, symptoms of infections, change in body
fat, haemophilia, musculoskeletal problems, or allergy to sulfa
medicines and should tell their doctor if they are pregnant or
planning to become pregnant, or are nursing.

Darunavir should not be used in patients allergic (hypersensitive)
to it or ritonavir or with severe liver problems.

Due to potential drug interactions, patients should talk to their
healthcare provider about all the medicines they are taking or plan
to take, including prescription and non-prescription medicines,
vitamins, and herbal supplements.

Darunavir does not cure HIV infection or AIDS, and does not
prevent passing HIV to others.

Please see full Summary of Product Characteristics for more
details.

About Janssen

At Janssen, we are dedicated to addressing some of the most
important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, 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-Cilag International NV is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson.

More information about Janssen can be found at
http://www.janssen-emea.com.

(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-Cilag International NV,
any of the other Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to,
general industry conditions and competition; economic factors, such
as interest rate and currency exchange rate fluctuations;
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; 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 Exhibit 99 of Johnson
& Johnson's Annual Report on Form 10-K for the fiscal year ended
December 30, 2012. Copies of this Form 10-K, as well as subsequent
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 undertake to
update any forward-looking statements as a result of new information
or future events or developments.)

ots Originaltext: Janssen-Cilag International NV (Janssen)
Im Internet recherchierbar: http://www.presseportal.de

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