[Ip-health] Tufts University: Follow-On Drugs Improve Patient Safety and Help Reduce Costs

[Mike Palmedo]

http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=3D48

NEWS RELEASE

Follow-On Drugs Improve Patient Safety and Help Reduce Costs, According
to Tufts CSDD

Center for the Study of Drug Development
Tufts University
11/9/2004

BOSTON =96 Nov. 9, 2004 =96 Follow-on medicines, sometimes referred to as
me-too drugs, provide therapeutic advantages over existing treatments
and expand the opportunity to treat more patients with improved safety
and efficacy at lower cost, according to an analysis recently completed
by the Tufts Center for the Study of Drug Development.

The Tufts CSDD study also found that the first drug within a therapeutic
class to gain marketing approval in the U.S. by the Food and Drug
Administration (FDA) is not necessarily the best drug within that class.

=93Follow-on drugs result from a development race in which only one drug
can be the first approval in a new therapeutic class,=94 said Tufts CSDD
Director Kenneth I Kaitin. =93Far from being redundant, follow-on drugs
create therapeutic alternatives, which enable physicians to
individualize patient treatment.=94

He added that benefits of incremental innovation are similar to those
that occur in other healthcare product categories, such as diagnostics,
devices, vaccines, and in R&D for neglected diseases and rare illnesses.

Kaitin said follow-on drugs increase product availability from multiple
sources, creating competition that results in higher quality medicines
at lower cost. For example, he said, the current monthly cost of statins
launched in 2003 is 45 percent less than statins launched in the early
1990s, while the cost for ACE inhibitors (anti-hypertensives) launched
in the mid-1990s is 72 percent less compared to the early 1980s.

=93On average, one-third of all follow-on drugs in development receive a
priority rating from the FDA, which indicates that they constitute a
therapeutic advance over drugs already on the market,=94 said Kaitin.
=93This strongly suggests that the first products to reach the pharmacy
shelf may not be the safest or most efficacious.=94

The Tufts CSDD study also found that:

* Nearly all follow-on drugs for classes where the first-in-class drug
was approved in the 1990s were synthesized, had initial pharmacologic
testing, and were in clinical testing somewhere in the world before the
first-in-class drug was approved.

* Effective market exclusivity period for first-in-class drugs dropped
78%, from an average of 8.2 years in the 1970s to 1.8 years in 1995-98.

* A substantial number of late entering follow-on drugs had priority
ratings. For the classes with four or more follow-on drugs, 48% of the
follow-on drugs that had received a priority rating were the fourth or
later follow-on.