[Ip-health] Merck Wants To Develop Follow-On Biologics

[Sarah Rimmington]

Merck Wants To Develop Follow-On Biologics
http://www.pharmalot.com/2008/12/merck-wants-to-develop-follow-on-biologics=
/
By Ed Silverman // December 9th, 2008 // 10:11 am

The drugmaker is hosting its annual R&D briefing for Wall Street
analysts and fund managers, where surprises are usually not on display.
This time, however, Merck execs are saying they want to establish a new
unit to make generic biotechs, which some calls biogenerics, biosimilars
or follow-on biologics, although there are subtle differences between
these terms.

In any event, the basis for the effort is Merck=92s acquistion of GlycoFi,
a biotech bought two years ago for its proprietary glyco-engineering
technology. The move represents what Merck execs are caling a
=93significant=94 opportunity since so patents on so many big-selling
biologies are scheduled to expire through 2017. Merck=92s first follow-on
biologic is for anemia, with plans to in 2012, and another five
candidates are hoped to be in late-stage development by then (see Merck
statement available at
http://www.merck.com/newsroom/press_releases/financial/2008_1209.html).

=93We believe we can become the leading provider of high quality,
competitively priced follow-on biologics,=94 Merck ceo Dick Clark says.
The arrival of the Obama administration and renewed enthusiasm on
Capitol Hill for legislation that could create an easier path for
generic biotech medicines may help Merck=92s cause.

Of course, the possibility that Congress will finally give the FDA a
green light to create a so-called pathway for developing follow-on
biologics is more likely, since President-elect Barack Obama made a
point of saying he supports such a move as a way to lower health care
costs (back story: http://www.pharmalot.com/2008/09/obama-mccain-agree-
on-one-thing-generics/). For now, though, Merck chief scientist Peter
Kim says his strategy assumes it will not be possible anytime soon to
pursue biosimilars.

Separately, Merck plans to push for expanded use of its Isentress AIDS
med and the Gardasil vaccine next year. In particular, the drugmaker
will seek FDA approval to market the Gardasil HPV vaccine for women up
to 45 years old and=85men.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/