Global Insight Perspective | |
Significance | The fast-track approval from South Africa's Medicines Controls Council (MCC) is almost certain to be granted. Regarding the drug's U.S. launch, a formal endorsement approval by the U.S. FDA is expected on 20 June, with the resultant launch tentatively set for early July. |
Implications | The pricing strategy for the drug in South Africa will be closely watched as generic firms have already flooded the African market. Pfizer hopes to sell the drug at 40-50% discount in South Africa. |
Outlook | Approval of Maraviroc represents the onset of a new class of AIDS drugs, and despite the concerns flagged up on safety by the FDA before the expert panel's positive recommendations, Pfizer is expected to start marketing the drug in South Africa before the end of 2007. |
New AIDS Drug
The South African subsidiary of U.S. drug giant Pfizer has sought for a speedy approval of its new HIV/AIDS treatment, Maraviroc. Business Day reports that the company has applied for fast-track approval from the Medicines Control Council (MCC) for the experimental oral drug. The source quoted CEO Richard Paulson as stating that Pfizer is making the drug available on a ”named-patient basis” in South Africa. The company has also signalled the setting up of a facility for generic drugs production and expects registration of Maraviroc to be completed soon after. The drug will be priced at a 40-50% discount on the South African market, Paulson said.
The drug is touted as the first potential drug in a new class of AIDS drugs targeting the CCR5 receptor. The drug, to be marketed as Celsentri, belongs to the entry inhibitor class, which works by preventing the virus from entering T-cells. Thus, their delivery mechanism is different from antiretrovirals already available on the market, including protease inhibitors, nucleoside reverse transcriptase inhibitors, and non-nucleoside reverse transcriptase inhibitors. So far, Pfizer has been able to gain a positive recommendation from the expert panel in April, in favour of approving the treatment for use in combination with other antiretrovirals. The company has conducted the pivotal MOTIVATE trials for the drug.
U.S. Market Launch
In the report, Paulson provided a timeframe for the drug's launch in the United States. Pfizer expects a favourable FDA approval by 20 June and will introduce Maraviroc in July, the senior company executive reiterated. However, the experimental drug has evoked some concerns from the FDA on the entire class of drugs, with agency reviewers noting a modest increase in liver problems. Other concerns include AIDS Health Foundation's contention of irresponsible marketing campaigns involving the company's erectile dysfunction drug Viagra (sildenafil), which the organisation claims increases the spread of sexually transmitted diseases (source: Agence France-Presse—AFP). The drug will be part of a set of new drugs scheduled for launch this year. Paulson said that the company's focus is to introduce four new drugs each year.
Outlook and Implications
The Maraviroc application will most certainly be approved on a fast-track basis by the MCC, with a potential registration and launch in late 2007 or early 2008. The pricing strategy adopted by Pfizer will come under scrutiny and will depend upon the response from generic firms that have previously clamoured over each other to offer antiretroviral generic alternatives at a fraction of the price in the region. The approval will generate speculation of whether Pfizer will take the route of out-licensing the drug to local manufacturers, as has been the norm in the past two years for AIDS drugs. However, the experimental drug being the first in its class, and the U.S. drug major’s establishment of a facility in the country may also prompt it to test the market before making any out-licensing decisions. The South African government has earmarked a US$1.89-billion, five-year AIDS strategy, which includes extending the treatment coverage to 80% of the country’s 5.5 million affected patients.
The launch in the U.S. market will mark the first in this class of drugs. The FDA has approved one other entry inhibitor—Fuzeon, which targets the gp41 protein on the virus—but Maraviroc differs as it essentially targets the CCR5 protein. The AIDS drugs market is expected to increase to over US$10 billion in the next decade, as new drugs from Merck & Co, Pfizer, Johnson & Johnson (J&J), and Gilead Sciences (all U.S.) are prepared for launch.
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