Abstract
Introduction
Small-molecule pharmaceutical manufacturers have had a rough year: 2007 saw
the abrupt ending of the development of many highly anticipated blockbuster
compounds. Now, many small-molecule companies are left with an aging portfolio
of blockbuster products that are about to lose patent-protection-and a
new-product pipeline that is insuffi ciently stocked with late-stage products
to make up for lost blockbuster revenues. For at least the near-term, biotech
companies now have the advantage in the blockbuster market: there is little-if
any-threat to these companies' best-selling products from generics competition
upon patent expiry.
Get the Answers You Need to Shape Your Strategy
- Each year from 1996 to 2006, with only one exception, Pfi zer or
GlaxoSmithKline led all pharmaceutical companies in the number of blockbusters
marketed. However, both smaller and midsize pharmaceutical and biotech
companies also marketed products that attained $1 billion in sales during that
time period. What implications does the rise of smaller and midsize
companies hold for the blockbuster arena-and for the pharmaceutical industry
as a whole?
- Although many Big Pharma companies will be losing patent protection on
many of their blockbuster drugs in the upcoming years, one Big Pharma company
is poised to make a splash in the blockbuster arena. Which company is this?
What two drugs is this company developing that will likely achieve blockbuster
status?
- Barring unexpected delays in development, Merck' s Isentress is expected to
be the fi rst integrase inhibitor to reach the HIV market and thereby become a
new blockbuster drug for Merck. Why might subsequent drugs in this class
have a particularly diffi cult time breaking into the HIV market after
Isentress has established a signifi cant presence?
- As with sales of small-molecule blockbusters, sales of biologics
blockbusters are susceptible to both equivalent (generics) products and to "me
too" drugs. Evidence is building, however, that suggests biologics
blockbusters will ultimately have more staying power than small-molecule
blockbusters. What factors may ultimately determine the longevity of
biologics blockbusters?
Scope
- Retrospective: trends during the past 11 years (1996-2006) in the
number of blockbusters, the companies producing blockbusters, and the
therapeutic areas blockbuster drugs have addressed.
- Recently failed, highly anticipated blockbuster candidates:
potential blockbuster compounds that were abruptly discontinued or withdrawn
by Sanofi -Aventis, Pfi zer, and Neurochem.
- Upcoming patent effects on current blockbusters: patent expiry
dates in each of the seven major markets for 2006' s best-selling prescription
drugs in the world; the late-stage product pipelines of select Big Pharma
companies in relation to the upcoming loss of patent protection for their
blockbuster drugs.
- Emerging blockbusters: potential $1 billion compounds in late-stage
development in each of five different therapeutic areas (metabolic diseases,
cardiovascular disease, oncology, infectious diseases, psychiatric disorders).
- Outlook and conclusion: the post-Vioxx world; the looming threat of
generics; the outlook for biologics blockbusters.
- Expert commentaries: detailed examinations by industry experts of
three vital blockbuster issues: the threat of biosimilars to the sales of
biologics blockbusters, Big Pharma' s aggressive pursuit of biologics licensing
and acquisition agreements (written by Spectrum Program Manager Barbara
Bolten, M.S., M.B.A., and the disaster with Pfi zer' s Exubera (written by
Decision Resources Senior Analyst Donny Wong, Ph.D.).
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