[Ip-health] Bayh Dole Rights, Size of Clinical Trials, 2004 Approvals

[Mike Palmedo]

http://www.cptech.org/blogs/drugdevelopment/2006/07/bayh-dole-rights-size-o=
f-clinical.html

Bayh Dole Rights, Size of Clinical Trials, 2004 Approvals

July 10, 2006
Mike Palmedo

CPTech has looked at the patents for New Molecular Entities (NMEs) that
came to the market in 2004.

Excluding antibiotics, which do not have Bayh-Dole listings in their
patents, the FDA approved 19 NMEs in 2004. Nine of these received
priority status for approval, meaning they were found to have
significant therapeutic gain over existing medicines. The remaining 10
NMEs were given standard approvals.

For the products for which data was available, I looked up the number of
patients cited by the FDA in approving the medicines. (I had to exclude
three of the priority NMEs approved in 2004 for which the label did not
include the number of patients) The average (mean) number of patients in
the clinical trials on which the FDA approvals were based was 1073 for
priority drugs and 1840 for standard drugs. The median numbers of
patients in these clinical trials were 1290 for the priority drugs and
2058 for the standard drugs. These figures are considerably lower than
the average size of clinical trials used by DiMasi in his often-cited
research on the cost of drug development =96 5,303 patients.

The Orange Book lists 45 patents on the 19 NMEs. Three of these patents
include clauses citing government funding and subsequent Bayh-Dole
rights to use or license the patent. These three patents cover two of
the nine drugs which received priority approval =96 two patents for Clolar
(a leukemia drug sold by Genzyme) and one for Lyrica (a diabetes drug
sold by Pfizer).

A spreadsheet with the drugs, patents, and size of trials is online here:
http://www.cptech.org/ip/health/rnd/2004nmes-07102006.xls

[Posted by Mike Palmedo to Drug Development (with access) at 7/10/2006
03:59:00 PM]