Press Release

FibroGen Announces Positive Results From First Clinical Trial of
Recombinant Human Gelatin
Results support use of recombinant gelatin as a vaccine and biologic
stabilizer
South San Francisco, Calif. - July 21, 2003 - FibroGen, Inc.,
today announced positive results from the first clinical safety study
of recombinant human gelatin, finding the study material safe and well
tolerated at all doses tested. The data support the use of FibroGen's
proprietary 8.5 kD gelatin fragment as a safe and fully characterized
alternative to animal- and plasma-derived proteins currently used
as stabilizing components in formulations of vaccines and biological
therapeutics.
Products containing animal- or plasma-derived proteins, such as
gelatin and albumin, respectively, have the potential to induce harmful
inflammatory or immune responses in humans and pose risk of contamination
with potentially life-threatening pathogens, such as viruses or prions.
In addition, the current process of making gelatin by denaturing collagen
(a protein extracted from the skin, bones, and tissues of animal
carcasses) yields a highly variable material that is not easily traced
to its source once incorporated into consumer products.
"FibroGen's recombinant gelatin stabilizer is expected to provide safer
delivery and improved performance of vaccines and biologics," said James
W. Polarek, Ph.D., Vice President, Collagen and Gelatin Development. "Our
recombinant gelatin is produced in a yeast system, eliminating the
risk of contamination with transmissible pathogens that is associated
with proteins derived from animal tissues or human plasma. FibroGen's
proprietary technology also enables the consistent production of highly
purified and fully characterized recombinant gelatin fragments that can
be tailored for specific customer applications."
The safety of FibroGen's 8.5 kD recombinant gelatin fragment was
examined in human volunteers at doses similar to, or significantly
greater than, the dosage of animal-derived gelatin found in marketed
vaccines. Healthy volunteers received a total of three doses of either
1 mg, 15 mg, or 60 mg of recombinant gelatin administered
intramuscularly at two-week intervals. The subjects were followed for 56
days after administration of the last dose, and no adverse events related
to the study material were reported in any of the three dose groups. Serum
was analyzed by ELISA for antibody production against recombinant gelatin
or potential yeast host cell contaminants. No significant changes in
antibody titers against recombinant gelatin or yeast-derived mannan and
protein were seen over the course of the study. Finally, no significant
changes related to study material were observed for the standard serum
chemistry parameters measured over the course of the study.
"FibroGen is working closely with several leading vaccine companies
in the evaluation of our recombinant gelatins as stabilizers for
new vaccine products and replacements in existing vaccines," said
Thomas B. Neff, Chief Executive Officer. "We believe the successful
demonstration of tolerability in this clinical safety study will support
our commercialization process. Our next objective is to complete a Master
File with the U.S. Food and Drug Administration, which will facilitate the
registration of products that incorporate our recombinant gelatins."
About FibroGen's Recombinant Human Gelatin
FibroGen's recombinant human gelatins are engineered from specific
segments of human collagen genes. No animal- or human-derived materials
are used in the entire production process. FibroGen's proprietary
technology enables the production of discrete, reproducible batches of
gelatin fragments having specific molecular weights (e.g., 8.5 kD,
25 kD, 50 kD), providing customers with the ability to select
a product optimized for specific applications. For example, FibroGen's
recombinant gelatin fragments can be used as excipients that are
completely reproducible, traceable, and characterizable. The development
of yeast production strains with high productivity, coupled with highly
efficient purification processes, enables competitive production costs.
About FibroGen, Inc.
FibroGen, Inc., is a privately held biopharmaceutical company focused
on the discovery, development, and commercialization of therapeutics and
biomaterials to address unmet needs in the medical, pharmaceutical, and
consumer markets. FibroGen's therapeutic target areas include fibrosis,
anemia, and ischemia, and the Company develops and manufactures
recombinant human collagen and gelatin biomaterials. FibroGen is
headquartered in South San Francisco, California, with additional
operations at FibroGen Europe Corp., the Company's subsidiary located
in Helsinki, Finland.
For more information about FibroGen, Inc., please visit
www.fibrogen.com.