Discovery of the compound and animal research:

May 1, 2001. Harvard University press release. Five Creators of Revolutionary Cancer Therapy STI571 Win Thirteenth Annual Alpert Foundation Scientific Prize.

Dr. Matter, an early champion of kinase inhibitor research at Novartis, recruited Dr. Lydon to take on the effort of identifying Bcr-Abl inhibitors. Dr. Lydon, while working on this effort, began collaborating with Dr. Druker, whom he met years earlier when Druker was an oncology fellow studying kinases in the 1980s at the Dana Farber Cancer Institute, a Harvard Medical School teaching affiliate. They ultimately identified STI571, and in 1998, after curing mice, the drug was taken into clinical trials

First Human Trials

May 10, 2001. National Cancer Institute press release. Discoveries Leading to FDA Approval of STI571/Gleevec.

1998: STI571 was first tested in a small study in people to determine whether it is safe. Doctors noticed that with higher doses, patients had dramatic positive responses to the drug.

1999: The preliminary results of this early study showed that 31 out of 31 patients who received at least 300 milligrams daily had their blood counts return to normal. In nine of the 20 patients who were treated for five months or longer, no cells with the Philadelphia chromosome could be found.

April 5, 2001. New England Journal of Medicine. Efficacy and Safety of a Specific Inhibitor of the BCR-ABL Tyrosine Kinase in Chronic Myeloid Leukemia.

We conducted a phase 1, dose-escalating trial of STI571 (formerly known as CGP 57148B), a specific inhibitor of the BCR-ABL tyrosine kinase. STI571 was administered orally to 83 patients…

Conclusions: STI571 is well tolerated and has significant antileukemic activity in patients with CML in whom treatment with interferon alfa had failed.

In this dose-escalating pilot study, 58 patients were treated with STI571; 38 patients had myeloid blast crisis and 20 had ALL or lymphoid blast crisis…

Conclusions: The BCR-ABL tyrosine kinase inhibitor STI571 is well tolerated and has substantial activity in the blast crises of CML and in Ph-chromosome-positive ALL.

December 2, 2000. CML-Support press release. Glivec (STI571) Shows Promise In CML Treatment.

Chronic Phase Study:

A Phase II Study of STI571, A Tyrosine Kinase Inhibitor, in Patients with Resistant or Refractory Philadelphia Chromosome-Positive Chronic Myeloid Leukemia: Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Resta D, Capdeville R, Druker B. … 532 patients enrolled…

Accelerated Phase Study:

A Phase II Study of STI571 in Adult Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Accelerated Phase: Talpaz M, Silver RT, Druker B, Paquette R, Goldman JM, Reese SF, Capdeville R … includes 234 patients with CML in the accelerated phase…

Blast Crisis Phase Study

A Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis: Sawyers C, Hochhaus A, Feldman E, Goldman JM, Miller C, Ben-Am M, Capdeville R, Druker B. … includes 262 CML patients in the blast crisis phase…

Correspondence with Dr. Brian Drucker and Gloria Stone (from Novartis) regarding Gleevec R&D Funding

Subject: Re: Development of Gleevec
Date: Sat, 02 Feb 2002 09:15:10 -0800
From: "Brian Druker" -drukerb@ohsu.edu-
To: -mpalmedo@cptech.org-

Dear Mike,

During the years that Gleevec was developed, my lab was funded 50% by the National Cancer Institute (government), 30% by the Leukemia and Lymphoma Society (private sector), 10% by Novartis (pharmaceutical) and 10% by OHSU, my home institution.

Even though my lab was critical to the development of Gleevec, you should realize that a large part of the development of Gleevec occurred at Novartis.

Brian

Second email:

Subject: Funding
Date: Fri, 06 Sep 2002 07:44:01 -0700
From: "Brian Druker" -drukerb@ohsu.edu-
To: -mpalmedo@cptech.org-

Dear Mike,

I wanted to clarify a point about funding for Gleevec. The email I sent to you in February specifically covered funding in my laboratory during the preclinical testing of Gleevec. The data that I provided to Novartis was critical to their decision to proceed to clinical trials. However, Novartis was responsible for the bulk of the development costs. This includes all of the costs of formulation and production as well as all of the costs of clinical trials.

Sincerely,

Brian Druker, MD

In a subsequent email, Dr. Drucker refered me to Gloria Stone from Novartis, saying she would be a good person to talk to about the company's funding. Here is my email to her:

Subject: Gleevec R&D
Date: Mon, 23 Sep 2002 14:32:36 -0400
From: Mike Palmedo
Organization: CPTech
To: gloria.stone@pharma.novartis.com

Hi there.

My name is Mike Palmedo, and I was referred to you by Dr. Brian Drucker. I work for a nonprofit called the Consumer Project on Technology (http://www.cptech.org). One of the areas we work on is access to essential medicines, which leads us to research R&D costs of medicines.

I am writing to find out what data is available concerning Novartis' research spending for the development of Gleevec. It would be great if I could find out the number of trials funded by Novartis, the number of patients in each of these trials, and the duration of the trials, as well as any other useful information.

Thanks

Mike Palmedo
mpalmdo@cptech.org
T-202-387-8030
F-202-234-5176