11
Genzyme Biosurgery, Inc.
sion of Carticel in a couple of years
using a process called
autologous
chondrocyte graft (ACG) technology
licensed from Sentron Medical, re-
searchers intend to grow preformed
cartilage tissue on a two-dimensional
or flat surface. Genzyme wants to
convert the Carticel Service from an
open-knee procedure to a less-
invasive arthroscopic procedure or a
restoration product. In our opinion,
this would greatly enhance the accep-
tance of the product. Upon the suc-
cessful completion of preclinical stud-
ies using the ACG technology, Gen-
zyme Tissue Repair expects to file an
investigational new drug application
to initiate human clinical studies in
2001.
The former Genzyme Surgical
Products developed and marketed me-
chanical devices, biomaterials and
biotherapeutics for cardiothoracic and
other surgical markets, and this divi-
sion of Genzyme Biosurgery is devel-
oping biomaterials to prevent post-
surgical adhesions. The division's re-
search and development efforts are
focused on developing and commer-
cializing gene therapy, cell therapy
and other biosurgery products to ad-
dress cardiovascular diseases.
Seprafilm is Genzyme Surgical
Products' biomaterial for the preven-
tion of post-surgical adhesions. Bio-
materials are therapeutic products
with a physical component that can
act in part as a device with the meta-
bolic characteristics of a drug.
Adhesions are fibrous bands con-
associated with current therapies and
competitive products.
Widening U.S. acceptance of
Synvisc as a treatment for knee osteo-
arthritis has raised the product's visi-
bility as a possible treatment for hip
osteoarthritis. Using Synvisc in the
hip represents a large potential mar-
ket opportunity. Preliminary results
from a limited European trial show
that Synvisc provided effective and
sustained relief of pain in hip osteoar-
thritis patients. This small-scale trial
has set the stage for a larger study in
the U.S. If Synvisc's effectiveness as a
hip osteoarthritis treatment is proven
in a large, controlled trial, its revenue
potential could increase significantly.
In addition to the hips, Biomatrix
is also pursuing Synvisc in other ap-
plications, such as the shoulders. Gen-
zyme Biosurgery hopes to establish
numerous key distribution arrange-
ments so that sales of Synvisc can ex-
pand over the next several years, both
in the U.S. and abroad. But in order
for Synvisc to be successful, domestic
clinicians must be willing to adopt a
new approach to osteoarthritis ther-
apy. At the same time, the Biomatrix
division is researching to a wide vari-
ety of clinical applications of other
anti-adhesion products based upon its
hylan polymer technology.
Biomatrix also sells hylan prod-
ucts for cosmetic, ophthalmic, and
other uses. In addition, the division
comes with an active developmental
pipeline that should offer additional
revenue opportunities.
The former Genzyme Tissue Re-
pair developed and marketed products
for orthopedic injuries and severe
burns. The new division of Genzyme
Biosurgery has two products on the
market: Carticel, a cartilage replace-
ment product, and Epicel for the treat-
ment of severe burns. As a product
utilized primarily in younger patients
with knee defects, Carticel is comple-
mentary to Biomatrix's lead product,
Synvisc, which is used to treat osteo-
arthritis in older patients.
For the year's third quarter, Gen-
zyme Tissue Repair reported a net
loss of $5.6 million, or 19 cents per
share, higher than its estimated loss of
$4.1 million, or 14 cents per share-
primarily due to lower - than fore-
casted - product sales on Carticel and
Epicel. These results are reflective of
summer seasonality for this type of
elective surgery.
In July 2000, Genzyme Tissue
Repair submitted a 510K filing for
product approval for its Quick Tack.
The Quick Tack device is used in
place of sutures during the Carticel
implant procedure, which represents
the next step in the Carticel evolution.
Given the typical FDA review period
of 90 days for 510K filings, the ap-
proval is expected soon. Quick Tack
will replace the need for suturing the
periosteal flap over the defect and will
therefore, shorten the operative proce-
dure. Time saved represents an eco-
nomic benefit to surgeons.
The division hopes to complete
development of an arthroscopic ver-
BioTech Sage Report, January 2001
