[Ip-health] Biotech still a sales star,,Global revenue up 12.5%, outstripping mainstream

[Sarah Rimmington]

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Biotech still a sales star
Global revenue up 12.5%, outstripping mainstream
Wednesday, June 18, 2008
BY ROBERT COHEN
STAR-LEDGER WASHINGTON BUREAU


WASHINGTON -- Global sales for biologic medicines, including therapies
for cancer, auto-immune disorders, diabetes and rheumatoid arthritis,
rose 12.5 percent last year, to reach $75 billion, according to a report
by IMS Health.

The market research firm said the revenue growth in biologics was nearly
double the rate of traditional pharmaceuticals, which increased only 6.4
percent worldwide in 2007.

"The biotech market has expanded dramatically during the past five
years, consistently exceeding overall pharmaceutical market growth two-
to threefold," said Murray Aitken, a senior vice president of IMS.

"Recent innovations, the continued expansion of approved indications for
existing products, and the gradual uptake of biotech products outside
the U.S. have fueled that growth, and improved the quality of life for
millions of patients across a growing number of disease areas," he said.

IMS said that 22 biotech products generated sales exceeding $1 billion
in 2007, compared with just six products in 2002.

Despite the success, IMS said the biotech industry's rate of growth last
year was not as high as 2006, when sales jumped 18.2 percent. And while
the industry will continue to prosper and has many innovative medicines
in the pipeline, IMS said, the growth rate may level off during the next
five years.

"After 20 years of what some would call a charmed life, biotech is now
facing a new reality," said Aitken.

Among the issues facing the industry, he said: Loss of patent protection
and competition from so-called biosimilars; insurers and other payers
showing reluctance to fund innovative drugs without "compelling value
propositions"; and safety concerns for some therapies.

Biologic pharmaceuticals are produced through highly complex processes
from genetically engineered cell cultures, rather than synthesized
chemically like traditional medicines. Oncology therapies, auto-immune
agents, anti-diabetic agents and pure vaccines represented the majority
of the market and growth last year.

Unlike traditional pharmaceuticals, there is no generic competition for
biotechnology drugs in the United States that in some cases cost
patients tens of thousands of dollars a year. Europe, however, recently
instituted a system to bring lower-cost biologics, sometimes called
biosimilars, to patients.

Last year, Congress took up legislation to create a Food and Drug
Administration approval process for generic biologic pharmaceuticals,
but the debate reached an impasse. The legislative battle is expected to
resume in 2009, with the biotech and generic drug industries clashing
over several issues, including the length of time the innovator
companies may retain exclusive patent rights to their products.

In addition to the congressional battle, the industry has faced a number
of FDA questions regarding the safety of some of its products, including
anemia drugs marketed by Amgen and Johnson & Johnson. The anemia drugs
still account for billions of dollars in sales, but have lost ground
because of reimbursement reductions instituted by Medicare and Medicaid.

The United States remains the largest market for biotech medicines,
representing 56 percent of total sales last year. IMS said five major
European countries account for 24 percent of the market.

Currently, the top drugs in terms of 2007 sales include Enbrel, a $5.2
billion rheumatoid arthritis medicine from Amgen and Wyeth; Aranep, a
$4.4 billion Amgen anemia drug; Remicade, a $4.2 billion Crohn's Disease
drug sold by Johnson & Johnson and Schering-Plough; and
Mabthera/Rituxan, a $3.7 billion Roche cancer drug.

IMS said the biotech industry has a strong research and development
pipeline, with six products that are expected to be launched by the end
of 2009 that will potentially reach $1 billion in sales. The market
research firm said these include innovative treatments for respiratory
virus, melanoma and osteoporosis.

Robert Cohen may be reached at rcohen@starledger.com.


=A9 2008  The Star Ledger
=A9 2008 NJ.com All Rights Reserved.

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