|Eli Lilly CEO John Lechleiter|
More than a decade after launching an ambitious technology transfer program to help China, India, Russia and South Africa produce two drugs to treat multidrug-resistant tuberculosis, Eli Lilly ($LLY) has published a how-to paper about the program to which it has committed more than $160 million. The bottom line of its white paper is that the undertaking was harder than expected, and while it did not fully achieve all of its goals, it was worth doing.
"We thought bigger," Lilly CEO John Lechleiter said about the program. "With a lot of Lilly people contributing their time and talents and working with multiple partners, it's been an extraordinary story and an extraordinary accomplishment."
Lilly said the transfer to 7 manufacturers of the technology to produce Lilly's TB medicines capreomycin and cycloserine came after a dramatic global rise in MDR-TB cases in the late 1990s and early 2000s. Lilly had been producing "nominal quantities" of the two drugs, which were effective against MDR-TB. It doubled production and subsidized the cost of the drugs but realized that demand would quickly outstrip its ability to supply it. After consulting experts, it was decided that helping companies in the regions most affected to produce the meds, was a better long-term solution. It would increase capacity and should lower costs to patients. It invested $70 million initially, but later more than doubled that as the effort demanded.
The company soon realized it was going to be more difficult than first envisioned. A single approach was not possible. There were distinctive differences in each market that would need to be accounted for. It also learned that the U.S. approach to making meds, in terms of quality and efficiency, would often need to be taught,. It didn't always exist in emerging markets.
And so, over the course of the program, Lilly found there were a number of steps that would be required to be successful. Among them were the need to:
- Commit the time and expertise of multiple staff members over the lifetime of the project.
- Provide on-site technical and quality assistance.
- Pay for plant upgrades in some cases or buy the kind of equipment that would reduce costs over time.
- Help manufacturers to improve their efficiency so they could invest in the staff and facilities that were needed.
- And use contract manufacturers to expand supply of capreomycin during technology transfer.
In the end, Lilly said the program pretty much achieved its goals, except for lowering the cost of manufacturing and the price to patients in all cases. That was hampered by the fact that many patients were not being diagnosed and treated, and so while the numbers of people with MDR-TB did grow significantly, demand for the drugs did not.
Lilly said it discovered that a technology transfer on the scale that it undertook is not going to be successful on its own. "It will take a multi-pronged, focused effort by governments, public health advocacy groups, manufacturers, and others, working together, to effect these changes," the company said.
- here's the announcement
- find the white paper here