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Pfizer to roll out Maraviroc in July; South Africa availability
  Thursday, June 7, 2007 at 07:47 EDT
JOHANNESBURG - Pharmaceutical giant Pfizer Inc said Wednesday that it would launch a new HIV-AIDS drug, Maraviroc, in July after tests were conducted successfully in the United States. April 24 the FDA review panel voted unanimously to recommend accelerated approval of Maraviroc.
"A new HIV-AIDS medicine is coming out in July after tests being carried out in the United States by the FDA (Food and Drug Administration)," the head of the firm in South Africa, Richard Paulson said at a briefing to journalists.
The new drug, which will be taken orally, is set to be formally approved by the FDA on June 20, a spokesman for the company said.
Maraviroc, brand name Celsentri, received a good safety report at the FDA hearing recently where Pfizer and the FDA scientists presented safety and efficacy data for review by the FDA Antiviral Advisory Committee.
South Africa: Pfizer Seeks Licence for New Aids Drug
Business Day (Johannesburg)
7 June 2007
PHARMACEUTICAL company Pfizer said yesterday it had applied for fast-track approval of its experimental oral anti-retroviral drug, maraviroc, from the Medicines Control Council.
This is the first new oral class of HIV medicine available in more than 10 years, and it takes a different approach to reducing HIV.
Maraviroc works outside white blood cells, stopping the virus before it enters uninfected cells rather than fighting the virus inside the cells.
Pfizer said it had moved with urgency in the research and development of maraviroc, characterising the clinical profile and submitting the data to regulatory authorities as quickly as possible.
CEO Richard Paulson told the Johannesburg Press Club yesterday that the drug would be available in the US next month.
He said the medicine would also be available in SA on a named-patient basis, supported by a motivation from the treating physician to the Medicines Control Council.
"Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS and those at risk around the world," he said.
"We also acknowledge that the prevention, management and treatment of HIV/AIDS is top national priority. "
The pharmaceutical company is also building a plant to manufacture generic drugs.
The company has said the project, launched this year, was healthy for competition.
It said that innovative drugs would help reduce costs and drive economic growth locally. The company would provide medication 40%-50% cheaper to SA to help lessen the burden of health care.
The pharmaceutical company also donated R1m to the Soweto Hospice in 2005 to build a bigger facility to care for terminally ill patients, and has medically related tertiary scholarships for black South Africans that have produced 12 graduates as doctors, dentists or pharmacists.
The company has a mentoring programme which was launched by the health ministry in 2000.
It has spent more than R40m on the programme for patient education and health care.
"Our message is that every employee is working for a healthier world," Paulson said.
Pfizer is the third -biggest manufacturer and distributor of prescription medication in SA, with sales close to R1bn.
Pfizer said it expected the registration of the new anti- retroviral drug for SA will be filed in the fourth quarter of this year.
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