[Ip-health] AIDS Update: DATA Report: G8 Countries Have Fallen Short on HIV/AIDS, Development Promises Made at 2005 Summit; Kaletra tablet (no need for refrig) approved

[Ann-Marie Sevcsik]

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Hadn't seen these posted yet but it may be my own oversight:

1. Global Challenges | G8 Countries Have Fallen Short on HIV/AIDS,
Development Promises Made at 2005 Summit, Report Says

[KaiserReports, Jul 03, 2006]

2. Abbott's Tablet Formulation Of Kaletra Receives Marketing Approval
>From European Commission: Abbott says approval will allow it to start
seeking approval for the drug in developing countries, where
refrigeration presents a stumbling block.




1. Global Challenges | G8 Countries Have Fallen Short on HIV/AIDS,
Development Promises Made at 2005 Summit, Report Says

[Jul 03, 2006]

      The Group of Eight industrialized nations has not fulfilled
pledges to provide antiretroviral drugs to Africa, expand trade and
increase aid, according to a progress report
<http://www.thedatareport.org/>  released on Thursday by DATA
<http://www.data.org/> , a debt relief and trade advocacy group
co-founded by Irish musicians Bono and Bob Geldof, Reuters
<http://today.reuters.com/news/newsArticle.aspx?type=worldNews&storyID=2
006-06-29T185751Z_01_N29411796_RTRUKOC_0_US-AFRICA-AID-BONO.xml&archived
=False>  reports (Wroughton, Reuters, 6/29). Leaders from the G8 in July
2005 agreed to an immediate doubling of aid to Africa to $50 billion
annually by 2010 in order to fight poverty and disease on the continent
(Dodds, AP/Yahoo! News
<http://news.yahoo.com/s/ap/20060630/ap_on_en_mu/people_geldof_2> ,
6/30). In the final communique, G8 leaders also agreed to cancel debt
for the world's poorest nations. The previous month, G8 finance
ministers had agreed to increase efforts to provide universal access to
HIV/AIDS treatment by 2010, as well as encourage research into vaccines
for HIV, tuberculosis and malaria (Kaiser Daily HIV/AIDS Report
<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=3
1256> , 7/8/05).

Report Details
"Overall, there is one cheer on debt, half a cheer on AIDS and boos and
wolf-whistles for what is happening on trade," Bono said Thursday after
the release of the DATA report. According to the report, G8 nations have
kept to their promises of canceling debt for 19 countries, mostly in
Africa. Debt relief in Cameroon, Mozambique, Tanzania, Uganda and Zambia
has led to funding increases in HIV/AIDS, education and health, the
report says. According to the report, not enough has been done to
increase access to antiretroviral drugs in Africa (Reuters, 6/29).
Although the number of people in Africa receiving antiretrovirals
increased from 100,000 in 2003 to 810,000 by the end of 2005, donors are
spending half the amount needed to reach G8 targets, the report said.
The report called for donors to increase bilateral and multilateral
funding, especially to the Global Fund To Fight AIDS, Tuberculosis and
Malaria <http://www.theglobalfund.org/en/> . The report warned that 1.4
million HIV-positive people in Africa in 2010 will lack access to
antiretrovirals if donors do not meet G8 targets (DATA release
<http://www.data.org/pdf/FINAL_DATA_REPORT_PR.pdf> , 6/29). Four million
HIV-positive people in Africa would receive antiretroviral drugs,
600,000 children would be saved from malaria and an additional 30
million children would go to school if G8 nations were to reach their
targets by 2010, according to the Guardian
<http://politics.guardian.co.uk/foreignaffairs/story/0,,1809430,00.html>
(Elliott, Guardian, 6/30). The report also says that G8 nations have
failed to reach a trade deal to open world markets to developing
countries (Reuters, 6/29). On the issue of trade, the "G8 are not just
off track, they've stepped backwards," the report says (DATA release,
6/29).

Country Assessments
According to the report, the U.S. has been the largest donor to HIV/AIDS
programs in Africa. The report praises France and the United Kingdom for
their contributions to the Global Fund. Contributions from Canada,
Germany, Italy and Japan have been slow, the report says. According to
the report, G8 nations collectively, with the exception of France, are
not on track to reach their target of doubling aid to Africa by 2010. To
reach the target, they would have to increase funding to Africa by $4
billion this year, according to the report (Reuters, 6/29). DATA plans
to publish a progress report annually until G8 nations fulfill their
pledges, the report says, adding that this year's progress report is
"not only a report card on 2005, but a road map forward to 2007 and
beyond to 2010" (DATA release, 6/29). This year's G8 summit is scheduled
to take place in St. Petersburg, Russia, from July 15 to July 17
(AP/Yahoo! News, 6/30).





Abbott's Tablet Formulation Of Kaletra Receives Marketing Approval From
European Commission

Monday, July 03, 2006; Posted: 06:03 AM

(RTTNews) - Early Monday, Abbott Park, Illinois-based health care
company Abbott Laboratories said that the company has received marketing
authorization from the European Commission for the tablet formulation of
Kaletra- lopinavir/ritonavir. The company noted that Kaletra was a new
version of the protease inhibitor for the treatment of HIV. The new
Kaletra tablet allows adult patients to take fewer pills with or without
food as part of their treatment regimen while maintaining the same
safety and efficacy, the company said. The company added that the new
formulation does not require refrigeration.

According to Abbott, the approved tablet formulation of Kaletra is
designed to offer patients new benefits not available with the current
soft capsules, enhancing the dosing convenience without compromising
efficacy.

Kaletra was developed using the proprietary Meltrex melt-extrusion
technology, a formulation process resulting in a stable, solid
dispersion of Kaletra, translating to fewer pills while maintaining the
same amount of lopinavir and ritonavir. The company noted that a single
Kaletra tablet would now be composed of 200 mg lopinavir and 50 mg
ritonavir, as compared to 133.3 mg lopinavir and 33.3 mg ritonavir in
the previously introduced soft capsule.

The company said the European Commission's approval of the tablet
formulation was based on data from pharmacokinetic studies. The Kaletra
tablet submission was filed as a line extension to the EMEA on May 19,
2005. Kaletra tablet was approved by the US Food and Drug
Administration, or FDA, on October 31, 2005.

The company said it has also filed for registration of the new tablet
formulation in countries in Africa, Asia and Latin America.

The approval had been expected following a positive opinion from a panel
of EU experts in April. U.S. regulators approved the new formulation
last October.

Kaletra is the biggest-selling of a class of HIV drugs known as protease
inhibitors. It was introduced in 2000. Adults taking Kaletra can now
take the pill with or without food and the number of daily pills is
reduced to four tablets from six a day.

Abbott said the European green light would allow it to start seeking
approval for the drug in developing countries, where refrigeration
presents a stumbling block.

The Kaletra tablet allows adult patients to take fewer pills with or
without food as part of their treatment regimen while maintaining the
same safety and efficacy.

In addition, the new formulation does not require refrigeration.



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