BEERSE, Belgium, Oct. 15, 2013 /CNW/ - 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
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
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) and who have plasma HIV-1 RNA
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.
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.)
SOURCE: Janssen-Cilag International NV (Janssen)
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