Pfizer agrees price cut in Clinton deal
pharmafile | August 7, 2009 | News story | Research and Development, Sales and Marketing | HIV, Pfizer, generics
Former US President Bill Clinton has brokered major new deals with Pfizer and Mylan to cut the price of tuberculosis and HIV treatments in developing countries.
The agreement forged by the Clinton Foundation represents the first time a second-line regimen of four ARVs will be available for an annual cost of less than $500.
The agreement with Pfizer is also the first deal struck with any major pharma company, and is part of a comprehensive package aimed at helping millions of HIV patients with limited access to treatment.
The agreement is aimed at patients whose disease has progressed despite first-line treatment and now requires second-line treatment. It also addresses the huge problem of patients who have co-infection of TB and HIV.
The World Health Organisation recently revised its estimates, and now says there are at least 1.4 million cases of HIV-positive TB – or nearly 15% of the total incident cases, double previous estimates.
Treating TB and HIV in developing countries is complicated by numerous problems, including a drug interaction between standard TB medicines and protease inhibitors – which are the mainstay of second-line HIV treatment.
Pfizer's rifabutin is important because it does not interact with protease inhibitors, allowing patients to receive the full dose of these drugs, but rifabutin's price has been too high for developing countries.
Now Pfizer has agreed a 60% price cut, bring the drug's cost to $1 per dose for patients taking second-line HIV/AIDS medications.
Rifabutin is already off-patent, and generics companies Lupin of India and Med Shine Pharma of China already produce rival versions, but Pfizer's new price will under cut these competitors.
Mylan cuts price of antiretroviral drugs
Meanwhile, Mylan and its subsidiary Matrix are to make a price cut on its antiretroviral drugs that represents a 28% reduction on the current lowest price. All four drugs – atazanavir (ATV), ritonavir (RTV), tenofovir (TDF), and lamivudine (3TC) – are needed for once-daily treatment of patients who have developed resistance to standard first-line antiretrovirals.
The four drugs will be available in three pills, with tenofovir and lamivudine combined into a single pill. The new Clinton deal means these pills will be available immediately as separate products for a total of less than $475 annually.
Matrix will develop a single "second-line-in-a-box" dosing regimen – at $425 annually starting in 2010 to make it easier for patients to take the medicines.
The new products and prices will be available to members of the Clinton Foundation's Procurement Consortium across Africa, Asia, Latin America and the Caribbean. TDF+3TC is FDA approved, and ATV and RTV are pending approval by the World Health Organisation (WHO).
"Thanks to the work of my Foundation's HIV/AIDS Initiative, two million people living with HIV/AIDS are now able to access lifesaving treatment," President Clinton said.
"But their continued survival depends on uninterrupted access to medicines and quality and affordable health care throughout their entire life. Today's announcement will help ensure we can sustain treatment over a lifetime and better treat patients with both HIV and TB, two key steps in turning the tide of the global HIV/AIDS pandemic."
Mylan chairman and chief executive Robert J. Coury said his company was proud to continue it commitment to providing affordable HIV medicines.
As well as producing the 'second-line-in-a-box', to reduce the number of pills patients need to take and improve patient compliance, another important part of the deal is the development of a heat-stable version of ritonavir.
The existing ritonavir formulation required continuous refrigeration, a major problem in developing countries with limited infrastructure that the new version will overcome.
Jeffrey Kindler, chairman and chief executive of Pfizer, said the new deal with the Clinton foundation was one of several it was pursuing "to find new ways to connect people to the medicines they need".
He said: "We are working on innovative solutions to bring health care to customers who have often been neglected in the past and do this in a socially responsible, sustainable, and commercially viable way."
Prices and aggregating demand
The Clinton Foundation says the new products and prices would enable cumulative cost savings of $400 million over the next five years, if they are fully implemented.
Only 3% of patients on treatment in low-income and sub-Saharan African countries are taking second-line ARVs today, but these patients account for nearly 20% of total ARV expenditures because of the high cost of second-line drugs compared to first-line drugs.
The Foundation says these percentages will grow steadily in the coming years as increasing numbers of HIV/AIDS patients experience first-line treatment failure.
There were between 200,000 and 250,000 second-line patients across the developing world at the end of 2008, and this number is expected to double over the next three years.
Another important coordinating body in the deal is UNITAID. First established in 2006, it is an international drug purchase organisation set up by Brazil, France, Chile, Norway and the UK.
UNITAID facilitated the new deal through its Second-Line Project, which aims to address fundamental problems for suppliers of drugs as well as governments and patients. UNITAID funding for the project created a reliable market for key second-line medicines by increasing and aggregating demand across 25 countries.
The aim is to increase the predictability of demand and consequently encourage suppliers to pursue accelerated R&D on new products and allow them to offer lower prices by achieving economies of scale and reducing production risks.
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