Abbott Statement on Agreement With Brazilian Government for Kaletra(R) (Lopinavir/Ritonavir)
09 Luglio 2005 - 7:21AM
PR Newswire (US)
Abbott Statement on Agreement With Brazilian Government for
Kaletra(R) (Lopinavir/Ritonavir) SAO PAULO, Brazil, July 9
/PRNewswire/ -- Abbott announced today 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. The agreement does not specify a per-capsule price, and
will not be at the low price quoted for local and generic
manufacturers. The price of Kaletra will be dependent on the number
of patients treated. Abbott agreed to provide assistance to Brazil
to enable local manufacture of Kaletra for HIV/AIDS patients in
Brazil once the patent expires in 2015. Terms of this portion of
the agreement are under discussion. 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. 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/ . DATASOURCE: Abbott
CONTACT: Melissa Brotz, U.S. Media, +1-847-935-3456, or Brian
Kyhos, International Media, +1-847-936-7988 Web site:
http://www.abbott.com/ http://www.kaletra.com/ Company News
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