Global Partners Join Forces to Speed Development of New TB Drug Combinations

FDA applauds effort to take years off development of much needed TB treatments

WASHINGTON, March 18, 2010 - Ahead of World TB Day, US Food and Drug Administration Commissioner
Margaret Hamburg helped public and private sector partners launch a new
collaboration to significantly accelerate the development of combination
treatments for tuberculosis - and replace an almost 50-year-old drug regimen.
Created by the Global Alliance for TB Drug Development, the Critical Path
Institute, and the Bill & Melinda Gates Foundation, the initiative could
potentially reduce the time it takes to introduce new combination TB
treatments from as much as a quarter century to as few as six years.

Known as the Critical Path to TB Drug Regimens (CPTR), the initiative
will test promising combinations of individual TB drug candidates from
different companies early in the development pipeline - and identify the best
new treatment regimens. Initial groups engaged in CPTR include scientists
from FDA and the pharmaceutical companies Johnson & Johnson, sanofi-aventis,
Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and
Anacor Pharmaceuticals, Inc. The World Health Organization (WHO) has
expressed its support for the initiative.

"FDA is absolutely committed to working with partners to speed access to
new, safe and highly-effective treatments for TB, which continues to mutate
and spread," said Dr. Hamburg. "I've seen first hand the public health impact
and personal tragedy of drug-resistant TB. This creative approach mirrors
FDA's own investments in innovative regulatory science that ensures the best
new medical technologies - including combination therapies - reach patients
as soon as possible."

Currently, obtaining regulatory approval for completely new TB regimens
could take 24 years as individual candidates are developed and registered
separately and substituted, one at a time, into existing combination
therapies. The CPTR initiative has the commitment of the FDA and regulatory
authorities in Europe to help develop and validate improved, safe, and
accurate regulatory pathways to test and register combination TB treatments.

"This type of collaboration between the public and the private sector is
exactly what's needed to help speed the availability of a shorter and more
effective treatment for TB," said Dr. Tachi Yamada, president of the Global
Health Program, Bill & Melinda Gates Foundation. "A successful drug
combination regimen to fight TB could save millions of lives."

Although it is often thought of as a disease of the past, TB remains one
of the world's deadliest infectious diseases. TB kills approximately 1.8
million people each year, mainly in developing countries. The standard
four-drug course of treatment requires patients to take pills for six months
or longer. These drawbacks contribute to the rise of drug resistance. In 2007
there were more than 500,000 cases of drug-resistant TB globally.

"No single company or institution can do it alone," said Dr. Paul
Stoffels, Global Head, Pharmaceuticals Research and Development, Johnson &
Johnson. "Industry has to continue to focus on innovation and accelerate the
discovery and development of new compounds with new mechanisms of action, and
at the same time work in collaboration with regulators, non-profit
organizations, and other partners to accelerate testing of new combination
regimens as early as possible in development."

Nine promising TB compounds from at least six antibiotic classes are
currently in clinical trials or late preclinical development, offering an
unprecedented opportunity for collaboration. New TB drug combinations could
sharply reduce treatment time and prove effective against both
drug-susceptible and drug-resistant TB strains. However, given the resilient
nature of the TB bacterium and its ability to become resistant to single
drugs, TB treatment will still require a combination of antibiotics.

"TB drug development needs these innovations if we are to offer countries
better and shorter treatments," said Dr. Mario Raviglione, Director, WHO Stop
TB Department. "This initiative has the potential to break new ground and
change the TB landscape radically. WHO is pleased to be a partner in this
effort."

"With its leadership on TB, FDA is poised to repeat its creative
regulatory approach to AIDS drugs in the 1990s, which helped save the lives
of millions without compromising drug quality," added Mark Harrington,
Executive Director of Treatment Action Group. "It's encouraging that drug
companies, FDA, the Gates Foundation and partners are all collaborating to
speed faster, more effective TB regimens to approval and to patients."

CPTR will be coordinated by the Critical Path Institute - an independent,
non-profit organization whose mission is to create innovative collaborations
in regulatory science that enable the most efficient and safe medical product
development. The collaboration will welcome participation from any company
with a promising TB drug candidate in development, as well as other companies
and organizations with the technical expertise or resources to help develop
new TB regimens.

"By working together, CPTR partners can take years off the drug
development timeline for safer new TB drug regimens," said Dr. Raymond
Woosley, President and CEO of the Critical Path Institute. "The commitments
of FDA and regulators in Europe helping to develop new and improved testing
methods, and of companies making their compounds and expertise available,
show leadership and flexibility that could benefit millions of patients."

To facilitate clinical research of combination TB therapies,
collaboration partners are also exploring creative funding mechanisms and
potential trial site support for Phase IIB and Phase III clinical trials.

"New TB drug regimens could simplify the number of pills patients have to
take, shorten the amount of time they have to take them, and be effective
against drug-resistant strains," said Dr. Mel Spigelman, President and CEO of
the TB Alliance. "Donor governments, industry, and other research funders
should support these efforts and help ensure new, more effective TB
treatments are developed as quickly as possible."

For more information about the Critical Path Institute, please visit
www.c-path.org.

For more information about the Global Alliance for TB Drug Development,
please visit www.tballiance.org.

Brad Tytel, +1-917-414-3691, btytel at globalhealthstrategies.com or For C-Path: Richard T. Myers, +1-520-547-3451, rmyers at c-path.org or For the TB Alliance: Joanna Breitstein, +1-917-361-0683, joanna.breitstein at tballiance.org