Earlier this week, Lilly and GE Healthcare announced a collaboration to develop a treatment for Alzheimer's Disease. The plan is to utilize GE's extensive imaging expertise to develop techniques for earlier diagnosis of Alzheimer's, which could then be treated by a drug developed by Lilly. Quote:
Fairfield-based GE will develop contrasting agents, which are injected into patients to help Lilly scientists evaluate therapies to treat Alzheimer's. GE will have access to Lilly's extensive molecular libraries to search for compounds that would be promising for use in targeted diagnostic imaging agents for Alzheimer's disease.
Lilly, based in Indianapolis, will then have access to any diagnostic agents developed by GE to use from the early research phase through clinical trials.
Scientists at both companies can accelerate their progress by sharing molecular libraries, research findings and other resources, GE officials said.
GE's health care business is developing targeted molecular diagnostics for a variety of neurological diseases, including Parkinson's disease and Alzheimer's disease. GE is planning to expand its activities with pharmaceutical partners to research other diseases.
This touches on a second area of interest of mine, which is the co-development of diagnostics and therapeutics. Diagnostics and therapeutics are usually (exclusively?) developed separately, and often by different companies. Pharma companies tend to use well-established markers of disease for their clinical trials and for marketing, as this makes it easier for them and for their prescribers. Plus, diagnostics tend to be low volume, low margin products (at least from a pharma perspective). However, the lack of good diagnostics tools and techniques has hampered drug development in some areas, Alzheimer's being one of them.
In theory, a company can identify a novel marker of disease in animal studies, then develop a human version of a diagnostic test. Concurrently, the company can use this marker for the development of a drug to treat the disease. Upon approval, a simple diagnostic tool can drive earlier treatment of disease. The company potentially captures revenue from the diagnostic (initial use and monitoring) and the drug itself. Even if the drug is discontinued, the patient may remain "captured" through continued use of the diagnostic.
The catch, of course, is the drug which is co-developed may have to be extraordinarily safe if it is to be used in a pre-disease state. There is also the potential issue of reimbursement. Will an insurer cover the use of a drug which is being prescribed for a patient with positive diagnostic results, but no symptoms of a disease? What will this do to the R&D budget, especially for a small company?
Note that in the Lilly/GE example, there is a sharing of risk and reward. No company needs to undertake co-development on their own.
Fortunately, the FDA has recognized the need (and potential) for co-development. They recently released a draft concept paper on Drug-Diagnostic Co-Development: pharmacoconceptfn.pdf They recognize the emergence of imaging, pharmacogenomics, and other approaches which can be used in order to treat disease earlier.
I think this is a terrific philosophy which cuts across a number of major therapeutic areas and indications. Cancer, Alzheimer's, Parkinson's, Diabetes...and on and on.
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