[Ip-health] FDA extends Bayer's CIPRO monopoly 6 months

[James Love]

Because Bayer has undertaken some modest tests on pediatric patients,
the FDA has extended the CIPRO monopoly until June 9, 2004.  The cost to
consumers to extend the monopoly will far far exceed Bayer's investment
in pediatric trials.  It would have been far far cheaper to simply
require Bayer or the generic entrants to finance the trials on pediatric
patients, while allowing faster introduction of generic ciprofloxcin.

	Jamie


http://www.adage.com/news.cms?newsId=39447

FDA EXTENDS CIPRO'S EXCLUSIVE MARKETING WINDOW
Six Months Added in Return for Pediatric Trials
December 19, 2003
QwikFIND ID: AAP24Q
By Rich Thomaselli

DETROIT (AdAge.com) -- The Food and Drug Administration has given Bayer
HealthCare AG an additional six months of market exclusivity for its
antibiotic Cipro, according to the pharmaceutical company.

Because Bayer conducted pediatric clinical trials on Cipro at the FDA's
request, the government agency approved the additional six-month window
of exclusivity. No unauthorized generic versions of Cipro
(ciprofloxacin) can be approved to enter the market prior to June 9, 2004.

Anthrax antidote
The FDA originally approved Cipro in 1987 for a broad range of
infections, including lower respiratory tract, urinary tract, skin and
skin structure, bone and joint infections and infectious diarrhea. The
drug came to prominence two years ago as an antidote to anthrax, at the
height of the terrorism scare in the country following the Sept. 11 attacks.

There is no consumer advertising for the product. The extra six months
will allow Bayer to switch consumers to Cipro XR, an extended-release
version of the antibiotic. Omnicom Group's Lyons Lavey Nickel Swift, New
York, handles the account for Cipro XR, which was just approved by the
FDA in October.

Clinical studies
According to the terms of the Best Pharmaceuticals for Children Act of
2002, the FDA may grant a drug additional marketing exclusivity if a
company conducts clinical studies in pediatric groups at the written
request of the FDA. This provision is designed to encourage further
investigation into the unmet medical needs of children.




--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040