FibroGen Licenses Oral HIF-PH Inhibitors, Including FG-2216 and FG-4592,
to Astellas for the Treatment of Anemia in Europe and Other Regions
FibroGen Positioned to Develop First Oral Anemia Therapy
for North America
South San Francisco, Calif. - April 28, 2006 - FibroGen, Inc. (FibroGen)
today announced it has completed an exclusive licensing agreement
with Astellas Pharma Inc. (Astellas) that provides Astellas rights to
certain FibroGen hypoxia-inducible factor (HIF) prolyl hydroxylase (PH)
inhibitors for development and marketing for the treatment of anemia
in Europe, Commonwealth of Independent States (CIS), Middle East, and
South Africa. These inhibitors include FG-2216 and FG-4592, currently in
human clinical trials. FibroGen retains rights in the rest of the world
except in Japan. The Japan rights were licensed previously to Astellas
(see FibroGen press release
September 24, 2004).
"We are very pleased to broaden our relationship with Astellas, a
highly recognized and capable global organization focused on ethical
pharmaceutical products generating approximately $8 billion per annum of
product sales," said Thomas B. Neff, Chief Executive Officer of FibroGen.
"Astellas has the skills, infrastructure, and experience to develop and
market oral therapies, which represents a significant asset in helping
us to realize the full potential of our HIF-anemia program and to meet
our goal of developing novel medicines that provide lower cost, broader
benefit, and improved access to anemia therapy."
Astellas has undertaken selected preclinical toxicology studies and
phase 1 clinical studies with FG-2216 in Japan and has had access to
FibroGen's phase 1 and 2 U.S. and European clinical trial data for
FG-2216 and FG-4592. Pursuant to the agreement, Astellas and FibroGen
will share in the leadership of the clinical programs for FG-2216 and
FG-4592 in both Europe and North America.
"Our confidence and enthusiasm are fortified by the high degree of
motivation that Astellas has shown to expand their involvement and
specific knowledge of FibroGen's HIF-anemia program through our Japanese
collaboration of the past two years," said Mr. Neff.
In Europe, sales of recombinant human erythropoietin (rHuEPO) products
for anemia of chronic kidney disease and chemotherapy-induced anemia
total approximately $3 billion per annum. Through this collaboration,
FibroGen is also positioned to address the larger, multi-million
patient market opportunities currently not penetrated and addressed
by rHuEPO products, including: chronic kidney disease (CKD) patients
who are not yet on dialysis (predialysis) and who are under the care
of primary care physicians, patients having cancer-related anemias,
patients with anemia associated with congestive heart failure (CHF),
age-related anemia patients, and patients with anemia of chronic disease
(ACD). ACD is also called anemia of inflammation and is often found in
patients with rheumatoid arthritis, inflammatory bowel disease, and Lupus.
In preclinical studies, FG-2216 and FG-4592 have been shown to suppress
the inhibitory effects of inflammatory cytokines on erythropoiesis,
a critical benefit for treating ACD.
"As a result of this agreement, we can focus our resources on completing
the development and commercializing oral anemia therapy in North America
where the majority of the anemia markets are not yet penetrated," said
Mr. Neff. "In addition, FibroGen retains opportunities in selected large
emerging market areas in Asia where chronic kidney disease, cancer, aging,
and chronic inflammatory disease cause very high rates of anemia in the
population. There exists a pressing unmet medical need in these markets
due to limited alternatives to transfusion and the prohibitively high
cost of the current anemia therapeutics, rHuEPO and intravenous iron. We
believe FibroGen's oral therapy is uniquely positioned to address the
medical need caused by anemia in these settings."
Under the agreement, Astellas will pay a licensing fee of $300 million to
FibroGen upon signing and will further pay development milestones totaling
$465 million and share in the costs of a transatlantic development program
and patent support. In the event the forecast for sales in Europe,
CIS, Middle East, and South Africa is achieved, this agreement offers
a potential financial result in excess of $2 billion dollars paid to
FibroGen during the 10 to 15 years after 2010. In addition, Astellas
will purchase $50 million of FibroGen shares.
Please see the Astellas press release (www.astellas.com)
for additional information regarding this collaboration.
About FG-2216 and FG-4592
FG-2216 and FG-4592 are investigational oral anemia therapies designed to
restore balance to the body's natural process of erythropoiesis
(production of oxygen-carrying red blood cells) through mechanisms
including: natural EPO production, suppression of the effects of
inflammation, down-regulation of the iron sequestration hormone hepcidin,
and an up-regulation of other iron genes, ensuring efficient mobilization
and utilization of the body's own iron stores. This contrasts with current
rHuEPO therapy, administered by subcutaneous or intravenous injection,
which in many cases requires concomitant intravenous iron therapy to
improve patient outcome.
About FibroGen
FibroGen, Inc., is a biotechnology-based drug discovery company using
its expertise in the fields of tissue fibrosis, connective tissue growth
factor (CTGF), and hypoxia-inducible factor (HIF) biology to discover,
develop, and commercialize novel therapeutics for fibrotic disorders,
diabetic complications, anemia, ischemic disease, cancer, and other areas
of unmet medical need. FibroGen also develops and produces recombinant
human collagens and gelatins using unique production technology that
provides the basis for FibroGens proprietary cosmetic dermal filler and
biomaterials supply business.
For more information about FibroGen, Inc., please visit
www.fibrogen.com.
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Contact:
Laura Hansen, Director of Corporate Communications
650-866-7828 or lhansen@fibrogen.com