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November/December
2006
BRIEFINGS
Genzyme will acquire AnorMed for $580 million,
emerging as the winner of the bidding war it waged
with Millennium Pharmaceuticals. What makes AnorMed
such an attractive target to both parties is its
proposed therapy for the transplantation of stem cells
into cancer patients, called Mozobil, which is
currently in Phase III clinical trials for multiple
myeloma and non-Hodgkin’s lymphoma.
A
coalition led by the last three secretaries of the
Health and Human Services Department is pushing for
more money for the FDA. The effort comprises industry,
consumer, and patient groups. The FDA’s budget has
lagged behind increases given to other public health
agencies, including the NIH and the CDC.
No
regulatory system exists in the US to approve
substitute versions of biotechnology drugs. Lawmakers
are acting: US Rep. Henry Waxman (D-California) plans
to introduce legislation in the current session of
Congress to create a regulatory framework to approve
generic biologic drugs; and US Sen. Orrin Hatch
(R-Utah) is working on draft legislation in the Senate
to create a system for testing and approving generic
biologic products.
Biotech
firms backed 51% or more by venture capital have been
denied SBIR grants since 2003, when the Small Business
Administration (SBA) ruled that such companies do not
qualify as small businesses. On July 27, a Senate
committee approved an amendment to legislation that
would reauthorize the SBA to exempt biotech companies
from the requirement that they be majority owned by
individuals to qualify for SBIR grants.
Pfizer’s
pick of Jeffrey B. Kindler as CEO could be considered
unusual, owing to his past experience as a lawyer with
no pharma background prior to joining Pfizer. However,
the changing climate of the pharma industry calls for
management of patent disputes, defense against
lawsuits, and the ability to work with increased
regulations from the FDA. This mix of legal and
regulatory issues may have tipped the scales in
Kindler’s favor.
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