12
ecting tissue surfaces that are nor-
mally separate. Adhesion formation is
a normal and exceedingly common
consequence of surgery, resulting
from the built-in cellular repair re-
sponse following a tissue injury like a
surgical incision or suture placement.
Adhesions can lead to serious compli-
cations, including small bowel ob-
struction, female infertility, chronic
pain, and can complicate future op-
erations.
Medical products companies have
pursued a variety of approaches to
addressing the problem of adhesion
formation, such as the use of anti-
inflammatory agents and antithrom-
botics. Genzyme's Seprafilm Biore-
sorbable Membrane is a hyaluronic-
acid based product, placed by the sur-
geon at the end of a surgery directly
onto tissue surfaces just before clo-
sure. The product acts as a temporary
barrier, keeping tissue surfaces sepa-
rated during the initial postoperative
days, when adhesions form. The prod-
uct gradually hydrates into a gel and
is resorbed by the body within seven
days. Seprafilm was approved with
the indication to reduce the incidence,
extent and severity of postsurgical
adhesion formation in the abdominal
and pelvic cavity.
Another novel product that Gen-
zyme Surgical Products has on the
market is FocalSeal, a surgical sealant
distributed and co-promoted by a
company called Focal. FocalSeal is a
light-activated sealant approved for
pulmonary (lung), cardiothoracic and
gastrointestinal surgery in North
America. FocalSeal is a syrup-like
"glue" made from a synthetic polyeth-
ylene glycol (PEG) polymer. The
product can be used to seal tissue
leaks which can occur along suture or
staple seams. The product is targeted
at pulmonary surgeries at risk for lung
leakage. This clinical problem, called
pneumothorax, can develop when air
leaks out of the lungs but accumulates
within a closed chest, compromising
breathing. The standard treatment for
pneumothorax and a routine preven-
tive measure following chest surgery
is the placement of chest drainage
tubes, which allow for the decompres-
sion of air leaks.
Genzyme Surgical Products is
also developing a new gene-based
therapeutic designed to induce angio-
genesis (collateral blood vessel forma-
tion) in ischemic tissue, so that the
product can treat heart tissue injured
following ischemic injury such as a
heart attack.
The mechanism underlying the
product is that the delivery of the
naturally occurring hypoxia inducible
factor (Hif-1) to heart muscle tissue
through gene therapy may provide a
potent local stimulus for an angio-
genic response. Hif-1 has been shown
to turn on the expression of many pro-
teins, including vascular endothelial
growth factor (VEGF), a primary in-
ducer of angiogenesis. The product is
also being developed for peripheral
vascular disease.
The big question with the merger
of these three companies into Gen-
zyme Biosurgery is: will this new
entity be able to compete effectively in
the rapidly emerging market for bio-
technology products that can improve
or replace surgery?
BSR views the for-
mation of Genzyme Biosurgery fa-
vorably, as the three subdivisions pro-
vide significant leverage and infra-
structure for the company as part of a
major corporation (Genzyme Corp.)
focused on biomaterials and bio-
therapeutics for surgical and medical
procedures. Genzyme Biosurgery will
have at least 22 of its own products on
the market and an additional 10 in the
pipeline. The newly combined entity
will gain major collaborations from
Biomatrix with Wyeth-Ayerst, Novar-
tis, Boehringer Ingelheim and Bayer.
With the creation of Genzyme
Biosurgery under Genzyme's roof, this
new company should be able to pio-
neer and create a platform for the de-
velopment of new and exciting new
therapies for many years to come. As
a result,
BSR will add Genzyme Bio-
surgery to our BioPortfolio in antici-
pation that the company will have the
potential to fulfill its mission.
*****
BioTech Sage Report, January 2001
