Johnson & Johnson - Index

Johnson & Johnson - report - Index

have been designed for treatment. However, we are collaborating
with partners to evaluate whether products in our portfolio
could be used in different formulations and combinations
that could help prevent infection in the first place, such as
microbicides or pre-exposure prophylaxis regimens.
Our third goal centers on drug resistance. Our Virco
subsidiary is a diagnostic company that is the leading
resistance expert in the world, with robust data reflecting
hundreds of thousands of patient samples that help us detect
patterns of resistance. We will be partnering with governmental
and non-governmental organizations to help them measure
resistance patterns in large multinational treatment access
programs. This will allow policymakers and physicians to
make better informed choices on which drug regimens are
most likely to work in their parts of the world.
Our fourth goal is to develop pediatric formulations for
all of our HIV/AIDS drugs. We are interested in working with
other drug companies, and other organizations with a particular
interest in this area, to share our learning and identify strategies
that are particularly focused on children.
Q:
What are your major challenges?
MCHUGH: One of the biggest challenges is the need to make
second- and third-line antiretroviral drugs more accessible
and affordable to treatment-experienced HIV/AIDS patients
whose existing regimens fail. As part of our Global Access
Program, in 2007 we signed a royalty-free, non-exclusive
license agreement with Aspen, Africa’s largest pharmaceutical
manufacturer. Aspen has four manufacturing sites in
South Africa and one in India. Under the agreement, Aspen
registers, packages and distributes the protease inhibitor
PREZISTA™ (darunavir) in Sub-Saharan Africa. Tibotec
selected Aspen because of that company’s extensive African
distribution network and pioneering endeavors in enhancing
access to AIDS treatment in resource-constrained settings.
Aspen and Tibotec share responsibility for ensuring prompt
and affordable access to patients in the Sub-Saharan region.
There will be a single product, distributed by Aspen and sold
to the patient at a price that is not to exceed $3 per day —
the lowest price in the world. In essence, Aspen is Tibotec’s
local partner in expediting pre-approval access, registration,
and the development of sustainable supply chains to meet
patients’ needs in more than 20 countries.
PROFILES IN COMMITMENT
Julie McHugh
Company Group Chairman
Virology
Is there a degree to which the lower cost of
Q: local labor for a company like Aspen helps
bridge the gap between higher material prices and
lower retail prices?
MCHUGH: Yes, that’s exactly the idea. A company like Aspen is a
generic manufacturer with a different cost structure than ours.
For example, it is not an innovator company, so it has no cost
associated with research, and its per-unit cost can be significantly
lower. We’re also in early discussions with other “enabled
partners” in other parts of the world. These companies are in
relatively low-cost labor markets like China and India. We are
exploring the possibility of partnering with them to reduce
the cost of goods and pass those savings along in the form of
broader access for patients.
Have there been any noteworthy developments
Q: in the Global Access Program, which was rolled
out in 2006?
MCHUGH: Perhaps the greatest challenge, and indeed achievement,
of the Global Access Program to date has been the need
to make regulatory submissions in least developed countries
that may often have weak national regulatory systems and
bodies. However, we have made 20 submissions to date
in Sub-Saharan African nations and other least developed
countries and the program is continuing. Essentially, with the
Global Access Program, we challenge ourselves to work with
local governments on access and pricing for PREZISTA™ that
both ensures that patients who need it have access and reflects
the value it brings to the treatment of HIV. We will shortly
expand the program beyond PREZISTA™ to our second HIV
drug, INTELENCE™, which was approved in its first market,
the U.S. in January 2008.
In a longer-range development, we just filed for a new
indication for PREZISTA™ use in people with HIV who are
starting treatment for the first time. We fully expect that it
will be used not only in treating resistance but will become
the frontline protease inhibitor of choice as well. In the
process, we will extend the public-private partnerships that
provide patients in the developing world with affordable
access to the drug.
Q:
What about infectious diseases other than HIV/AIDS?
MCHUGH: We are particularly interested in tuberculosis (TB)
and are actively seeking out collaborations with public-private
drug development partnerships (PDPs) to bring to market
the first new TB compound in nearly forty years — which was
discovered by Johnson & Johnson scientists. We aim to marry
the expertise and creativity of the pharmaceutical industry
with the public health know-how of PDPs and international
agencies. The goal is to create a new model of drug development
that prioritizes the health needs of developing countries.
We know we can’t solve all the world’s health problems on
our own, but we are working hard to do our part. �
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