MSF's response to Abbott

Open Letter To Abbott Laboratories from Doctors Without Borders/Médecins Sans Frontières (MSF)

Miles White
Chairman and CEO
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park, IL 60064-6189

Dear Mr. White,

I am writing to you to inform you of the order (Order Number 31556) placed today by Doctors Without Borders/Médecins Sans Frontières (MSF) for the new tablet form of lopinavir/ritonavir (LPV/r), marketed as Kaletra.

As you are well aware, the LPV/r tablet, approved by the US Food and Drug Administration in October 2005, has critical advantages for patients in developing countries, including: no dietary restrictions, lower pill burden, and no refrigeration requirement. In Abbott’s letter to MSF dated March 13, 2006, Abbott discussed the demands outlined in the enclosed letter signed by prominent HIV/AIDS researchers, practitioners, treatment advocates and people living with HIV/AIDS. However, Abbott failed to provide responses that address the immediate needs of our patients, and thousands of others, to access this drug. Therefore, MSF is asking Abbott to take concrete actions to make the new LPV/r accessible by placing this initial order (see attached).

In 2005, of the nearly 60,000 patients on antiretroviral treatment in MSF’s HIV/AIDS programs worldwide, approximately six percent of patients those on treatment for  years were on second-line regimens. In Khayelitsha, South Africa, in an MSF program that has access to viral load monitoring, 16% of patients needed a new drug combination after four years of treatment. These data underline the acute and growing need for access to second-line drugs. According to the new WHO guidelines, boosted protease inhibitors, such as LPV/r, represent the cornerstone of second-line therapy.

Access to the new heat-stable formulation of LPV/r is urgently needed for patients cared for by MSF and other people living with AIDS in developing countries, especially in hot climates where refrigeration is not readily available.

When we inquired about Abbott’s plans to market new LPV/r on December 21, 2005, Abbott replied that it would wait for European approval before initiating registration in developing countries, with the exception of South Africa where registration was supposed to be filed January 2006. In Abbott’s communication with MSF on March 13, 2006, Abbott did not provide a price or timeline for registeringthe new LPV/r formulation in developing countries, continuing to state that European approval was a prerequisite to registration. However, a Certificate of Pharmaceutical Product (CPP), which is required by some developing countries, could be issued by the US FDA as the product is sold in the US and could be exported from the US. Therefore, there is no barrier to file for registration. We urge you to act.

As you know, today Abbott has only made the new formulation of LPV/r available in the US at the Average Wholesale Price of $9687 per patient per year. For use in developing countries, MSF is prepared to pay no more than Abbott’s differential price for the softgel LPV/r formulation of $500 per patient per year for this essential medicine. We have consulted industry experts and understand that at commercial volumes, the melt-extrusion process that provides heat-stability is less expensive. MSF asks Abbott to do the following:

• Fulfill MSF’s order (Order Number 31556) at the price of no more than US$500 per year per patient within 30 days.


• Immediately begin the process of registering the new LPV/r formulation (200/50 mg tablets)in developing countries, both in eligible “Access” countries as well as in middle-income developing countries;


• Publish the lowest possible price for the new formulation of LPV/r in developing countries;


• Extend this low price to middle-income countries as other companies have done, so that patients and care-providers in these countries can access heat-stable LPV/r.

MSF’s initial order is for the following quantities in the following projects:

This order would allow MSF to provide the new LPV/r formulation to nearly 800 patients by the end of 2006. MSF will acquire the necessary authorizations to import an unregistered drug from the relevant authorities and has already begun this process in several of the countries listed above.

MSF requests that our order be delivered to MSF’s procurement center (MSF Logistique), a bonded pharmaceutical warehouse in Bordeaux, France so that we can ensure timely delivery to our projects in the above listed countries. MSF Logistique has been in operation since 1986 and has been a pharmaceutical establishment for wholesale distribution for humanitarian organizations since 1999. In addition, MSF Logistique is used by WHO to procure and manage global stocks of trypanomiasis drugs.

MSF recognizes the new formulation of LPV/r is needed by many care-providers in developing countries, and we urge you to set up an easy-to-use, temporary, distribution channel, until registration is complete so that patients outside of MSF projects can also access the new formulation of LPV/r.

If Abbott will not supply MSF with this order, MSF will have to adjust its procurement plans to avoid leaving patients untreated, and so we ask that Abbott inform MSF of its decision to supply MSF with the new tablet formulation of LPV/r within 5 business days. Please contact me at 212-679-6800 with anyquestions regarding the terms of this order.  I look forward to your response.

Sincerely,

Nicolas de Torrente
Executive Director
MSF-USA

encl: Copy of MSF order placed on March 15, 2006
Copy of letter dated March 15, 2006 from HIV/AIDS researchers, clinicians, treatment advocates

cc:
Heather Mason, Vice President, International Marketing, Abbott Laboratories
Robert Dintruff, Director, Global Cares Initiative, Abbott Laboratories
Rita Roy, Global Citizen Shop, Abbott Latoratories