Doctors Without Borders welcomed th...

Doctors Without Borders welcomed the arrival of the novel tablet formulation of Abbott Laboratories' AIDS medicine Kaletra in Nigeria last month

The organization strives Abbott isn't moving quickly enough to make the unsalable article more widely available in countries where it is pressingly needed.

The drug's arrival in Nigeria followed its availability in southward Africa, Cameroon and Kenya, the cluster said. But the medicine is merely available for use at Doctors Without Borders clinics, not over those countries, said Kate Evans, U coordinator for Doctors Without Borders' Access to Essential Medicines campaign.

It's "a vast concern," she said. "Patients in our shoot forwards can benefit, but not patients receiving care from other providers in those same countries."

Abbott's Kaletra is the principally prescribed drug in its class in the world. The medicine is a next to the first line therapy, meaning it is used when standard put drugs intos cease working.

Abbott landed U regulatory approval of the strange formulation in October.

The recently made known form of the drug has explanation advantages, including not requiring refrigeration, not having to be taken with nutriment and requiring patients to take fewer pills. Adult patients can take four tablets a day, down from six capsules.

Abbott is moving as quickly as possible to make the medicine available, said Abbott spokeswoman Jennifer Smoter Abbott has filed for registration of the just discovered drug in Asia, Latin America, and 11 countries in Africa, including southerly Africa, which represents about half of the Kaletra used in Africa today, she said.

Doctors Without Borders has ordered a six-month yield of the medicine, and rely upons to be able to come up to face to face the demand for about 800 patients.

Sub-Saharan Africa is domicile to 64 percent of the bulk of mankind living with HIV.

Abbott last month said it received regulatory approval in Europe to market the remedy something it said it required before it could solicit registration to market the physic in Africa.

if it were not that Evans said that step wasn't required for all African countries and countries in Latin America. Abbott could have chosen a speedier passage to make the drug available in Africa month sooner by dint of submitting registration documents directly in those countries, she said.

Abbott also could have sought a certificate of pharmaceutical consequence last year from the U diet and Drug Administration when the recent formulation was approved, and that also would have enabled the company to bring the unsalable article to market more quickly in Africa, she said.

"We want Abbott to accelerate the registration process" she said.

"In those countries that do require a certificate of pharmaceutical product" she said, "they should realize this document from wherever it's available the soonest That may be the European Union. That may be the FDA. They could have started that proces month and month ago."

Smoter said the certificate of pharmaceutical produce has to come from the native land of origin, and noted the tablets are manufactured in Germany. She said that given the fact that the consequence isn't manufactured in the U the vast majority of African countries want the certificate to approach from Europe.

"We full intend to register in all of the countries where Kaletra is available today," she said.

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Deerfield-based Baxter International said it received regulatory approval in Canada to market Advate, used to treat the life-blood clotting deficiency disease hemophilia.

Advate, which generated more than $600 million in incomes for Baxter last year, is approved for use in the United States, Australia and 14 European countries.

e-mail: fknowles@suntimes.com

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