Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278

Cork, Ireland (ots/PRNewswire) - Tibotec
Pharmaceuticals today announced its submission of a Marketing
Authorisation Application (MAA) to the European Medicines Agency
(EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational
non-nucleoside reverse transcriptase inhibitor (NNRTI) for the
treatment of HIV. The proposed indication would make TMC278 available
for once-daily use with other antiretroviral agents in
treatment-naïve HIV-1-infected adults.

It is estimated that 33.4 million people are living with HIV
worldwide,[1] 2.3 million of which are in Europe.[2] Research shows
that antiretrovirals have helped to extend life expectancy for people
living with HIV.[3] However, new treatments are needed which suppress
the replication of the virus while also minimizing the occurrence of
unwanted side effects.[4]

The TMC278 filing is based on an extensive global clinical
development programme involving more than 1,350 patients[5] in over
20 countries. If approved, TMC278 would help to expand the treatment
options for people living with HIV.

"Thanks to advances in treatment, people with HIV are living
longer than ever before, which is made possible by continuous
research for new and improved treatments," said Eric Lefebvre,
Medical Director at Tibotec. "The EMA regulatory submission for
TMC278 represents an important part of our ongoing commitment to HIV
and to helping patients receive the treatment and care they need."

Pending EMA approval, Tibotec will commercialize TMC278 in the
European Union. Tibotec has also submitted new drug applications in
the US and Canada, and regulatory submissions for TMC278 in other
countries are expected in the coming months. Tibotec has entered into
a license and collaboration agreement with Gilead Sciences, Inc. for
the development and commercialization of a once-daily fixed-dose
combination of TMC278 and Gilead's Truvada(R) (emtricitabine and
tenofovir disoproxil (as fumarate)).

About TMC278

TMC278 is an investigational NNRTI, which blocks the reverse
transcriptase, a key enzyme the HIV virus uses to replicate. The
regulatory application for TMC278 is based on the 48-week results of
two pivotal Phase 3 double-blind, randomized studies recently
presented at the International AIDS Congress, known as ECHO
(TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215).5 The studies
evaluated the efficacy, safety and tolerability of once-daily TMC278,
in combination with two NRTIs, in treatment-naïve HIV-1-infected
adults, and both reached their primary objective of demonstrating
non-inferiority of TMC278 vs. efavirenz in the percentage of patients
achieving an undetectable viral load (less than 50 copies/mL) at week
48 (with a maximum allowable difference of 12 percent).5 The studies
showed that TMC278 demonstrated significant improvements in
tolerability, with lower rates of discontinuations due to adverse
events including dizziness, abnormal dreams and nightmares, and
rashes.5

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Beerse, Belgium, with
offices in Titusville, NJ, USA. Tibotec is dedicated to the discovery
and development of innovative HIV/AIDS drugs and anti-infectives for
diseases of high unmet medical need.

About Tibotec, a division of Janssen-Cilag

Tibotec, a division of Janssen-Cilag, brings innovative products
for HIV/AIDS to patients in Europe, the Middle East and Africa
focusing on patients' and healthcare providers' specific needs in
this disease domain. The company will also commercialise medicines to
combat other viral diseases in the future.

About Janssen-Cilag

Janssen-Cilag is a leader in traditional and biological medicines
in areas such as gastroenterology, women's health, mental health and
neurology as well as for pain, oncology, haematology and nephrology.

Tibotec Pharmaceuticals and Janssen-Cilag are subsidiaries of the
Johnson & Johnson family of companies.

Truvada is a registered trademark of Gilead Sciences, Inc.

References

---------------------------------

[1] World Health Organization: HIV Global epidemic data and
statistics. Available at:
http://www.who.int/hiv/data/global_data/en/index.html Last accessed:
August 2010

[2] Avert: European HIV and AIDS Statistics. Available at:
http://www.avert.org/hiv-aids-europe.htm Last accessed: August 2010

[3] Lewden C. Responders to antiretroviral treatment over 500
CD4/mm3 reach same mortality rates as general population: APROCO and
Aquitaine Cohorts. 10th European AIDS Conference abstract. 2005.
PE18.4/8.

[4] HIV/AIDS Outlook: The Outlook for a Cure. Available at:
http://virginiahughes.com/2010/07/20/hiv-outlook-for-a-cure/ Last
accessed: August 2010

[5] Cohen C et al. Pooled Week 48 efficacy and safety results
from ECHO andTHRIVE, two double-blind, randomised, Phase III trials
comparing TMC278 versus efavirenz in treatment-naive, HIV-1-infected
patients. IAC abstract. 2010.

ots Originaltext: Tibotec Pharmaceuticals Ltd.
Im Internet recherchierbar: http://www.presseportal.de

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CONTACT: Media Contact: Hans Vanavermaete, Mobile: +32-478-44-72-78