Abbott Statement on
Agreement With Brazilian Government for
Kaletra(R) (Lopinavir/Ritonavir)
SAO PAULO, Brazil, July 11
/PRNewswire-FirstCall/ -- Abbott
(NYSE: ABT) announced that it achieved its goals in
negotiating an
agreement with the government of Brazil regarding
Kaletra(R)
(lopinavir/ritonavir), the leading protease inhibitor.
The agreement
accomplishes Abbott's objectives of helping Brazil
expand patient
access to Kaletra while preserving the company's
intellectual
property rights, which Abbott was not willing to
negotiate.
Most importantly, the agreement allows the Brazilian
government to
expand the number of patients treated with Kaletra
without increasing
the government's annual cost for Kaletra. The agreement
doesn't
specify a per-capsule price. Instead, the price will be
dependent
upon the number of patients taking medication; it will
not be at the
low price quoted for local and generic manufacturers.
Financial
terms were not disclosed.
It is strong intellectual property protection that has
enabled the
discovery and development of the many HIV treatments
available for
patients today, and also ensures future advances to
address a virus
that continues to mutate and elude a cure. Abbott is
committed to
protecting its intellectual property so that innovation
flourishes
for the benefit of patients around the world.
Upon the expiration of the patent in 2015, Brazil will
be able to
locally manufacture Kaletra for HIV/AIDS patients in
Brazil,
following Abbott's transfer of technology.
Kaletra Safety
Information
KALETRA(R) (lopinavir/ritonavir)
is always used in combination with
other anti-HIV medicines to treat people with human
immunodeficiency
virus (HIV) infection. KALETRA should not be taken by
patients who
have had an allergic reaction to KALETRA or any of its
ingredients,
including lopinavir or ritonavir.
Taking certain medications with KALETRA could create the
potential
for serious side effects that could be life threatening.
KALETRA
should not be taken with astemizole, cisapride,
dihydroergotamine,
ergonovine, ergotamine, methylergonovine, midazolam,
pimozide,
terfenadine or triazolam.
In addition, KALETRA should not be taken with
fluticasone propionate,
rifampin, simvastatin, or products containing St. John's
Wort
(Hypericum perforatum). Particular caution should be
used when taking
KALETRA with sildenafil, tadalafil, or vardenafil.
Please consult
your local prescribing information for country specific
recommendations. Discuss all medicines, including those
without a
prescription and herbal preparations you are taking or
plan to take,
with your doctor or pharmacist.
Pancreatitis and liver problems, which can be fatal,
have been
reported. Patients should tell their doctor if they have
had liver
disease such as hepatitis. In patients taking protease
inhibitors,
increased bleeding (in patients with hemophilia) and
diabetes/high
blood sugar have occurred. Changes in body fat have been
seen in some
patients receiving antiretroviral therapy. Some patients
receiving
KALETRA have had large increases in triglycerides and
cholesterol.
Varying degrees of cross-resistance among protease
inhibitors have
been observed.
In KALETRA clinical trials, the most commonly reported
side effects
of moderate-to-severe intensity were abdominal pain,
abnormal bowel
movements, diarrhea, feeling weak or tired, headache,
nausea and
vomiting. Children taking KALETRA may sometimes get a
skin rash.
This is not a complete list of reported side effects.
KALETRA oral
solution contains alcohol.
KALETRA does not cure HIV infection or AIDS and does not
reduce the
risk of passing HIV to others. For more information,
including full
prescribing information, please visit http://www.kaletra.com
.
About Abbott
Abbott is a global, broad-based health care company
devoted to the
discovery, development, manufacture and marketing of
pharmaceuticals
and medical products, including nutritionals, devices
and
diagnostics. The company employs more than 60,000 people
and markets
its products in more than 130 countries.
Abbott's news releases and other information are
available on the
company's Web site at http://www.abbott.com .
FONTE Abbott Laboratories
11/07/2005
CONTATO: U.S. Media, Melissa Brotz, +1-847-935-3456, or
International Media, Brian Kyhos, +1-847-936-7988, both
of Abbott
Laboratories
Web site: http://www.abbott.com
http://www.kaletra.com
(ABT)
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469
E-MAILS: nelia_garcia@prnewswire.com.br
mary_dleon@prnewswire.com
PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: ABBOTT LABORATORIES
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