AstraZeneca and FibroGen today announced that they have entered into a
strategic collaboration to develop and commercialize FG-4592, a
first-in-class oral compound in late stage development for the treatment
of anemia associated with chronic kidney disease (CKD) and end-stage
renal disease (ESRD).
This broad collaboration focuses on the US, China and all major markets
excluding Japan, Europe, the Commonwealth of Independent States, the
Middle East and South Africa, which are covered by an existing agreement
between FibroGen and Astellas Pharma Inc.
Buy Prilosec (Omeprazole) without prescription The AstraZeneca-FibroGen joint
effort will be focused on the development of FG-4592 to treat anemia in
CKD and ESRD, and may be extended to other anemia indications.
AstraZeneca will pay FibroGen committed upfront and subsequent
non-contingent payments totaling $350 million, as well as potential
future development related milestone payments of up to $465 million, and
potential future sales related milestone payments in addition to tiered
royalty payments on future sales on FG-4592 in the low 20 percent range.
Additional development milestones will be payable for any subsequent
indications which the companies choose to pursue.
Buy Viagra (Sildenafil Citrate) tabs online without prescription AstraZeneca will be
responsible for the US commercialization of FG-4592, with FibroGen
undertaking specified promotional activities in the ESRD segment in this
market. The companies will also co-commercialize FG-4592 in China where
FibroGen will be responsible for clinical trials, regulatory matters,
manufacturing and medical affairs, and AstraZeneca will oversee
promotional activities and commercial distribution.
FG-4592 is a small molecule inhibitor of hypoxia-inducible factor (HIF),
a protein that responds to oxygen changes in the cellular environment
and meets the body’s demands for oxygen by inducing erythropoiesis, the
process by which red blood cells are produced.
Buy Viagra Soft (Sildenafil Citrate) pills online without prescription FG-4592 has the potential
to address the considerable unmet medical need for an effective
treatment for anemia that offers the convenience of oral administration
and an improved safety profile as compared to current standards of care.
At present, treatment options involve a combination of injectable
erythropoiesis-stimulating agents (ESAs) and iron supplements. FG-4592
works through the body’s natural oxygen-sensing and response system to
help produce red blood cells.
Buy Vitamins online This can be compared to the body’s natural
response to conditions at high altitude, where oxygen levels are low,
which is to produce more red blood cells.
In Phase II clinical studies, FG-4592 met its primary objective of
demonstrating anemia correction in treatment-naïve CKD patients not on
dialysis as well as maintenance of hemoglobin levels and anemia
correction in patients on dialysis.
Buy Cyclogyl without prescription : Bristol-Myers Squibb Receives Positive Decision from National Institute of Health and Clinical Excellence (NICE) for YERVOY® (ipilimumab) FG-4592 has demonstrated this
efficacy combined with an acceptable safety profile in clinical trials,
and has been shown to achieve anemia correction in the absence of
intravenous iron supplementation.
The companies plan to undertake an extensive FG-4592 Phase III
development program for the US, and to initiate Phase III trials in
China, with anticipated regulatory filings in China in 2015 and in the
US in 2017.
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Our
collaboration with FibroGen on FG-4592 is an important addition to
AstraZeneca’s growing late-stage portfolio in cardiovascular and
metabolic disease, one of our core therapy areas.
All Best Rx : Buy drugs online We know from our
research into complications of renal disease that anemia continues to be
a challenge for patients with chronic kidney disease, due in part to the
inconvenience and complexity of existing injectable and intravenous
therapies and the safety concerns associated with them. The science
behind this compound is compelling. Through our collaboration with
FibroGen we aim to offer a first-in-class, convenient treatment option
for doctors and patients.”
Thomas B. Neff, Chief Executive Officer, FibroGen, said: “FG-4592 has
the potential to offer anemia patients an oral therapy that provides
coordinated erythropoiesis, that increases natural erythropoietin within
the normal physiological range, and that is effective without
intravenous iron supplementation and without an increased risk for
hypertension.
FDA Approved Rx : Online Pharmacy We are especially pleased that AstraZeneca will share our
commitment to making China the first-to-launch country for FG-4592 and
join our effort to bring important innovation in anemia therapy to CKD
and ESRD patients in the US and other countries. This agreement secures
proper development and commercialization resources for FG-4592, and
ensures US clinical trial efforts are fully funded.”
About chronic kidney disease and anemia
Diabetes, high blood pressure, and other conditions can cause
significant damage to the kidneys. If left untreated, those can result
in chronic kidney disease and progress to kidney failure. Such
deterioration can lead to patients needing a kidney transplant or being
placed on dialysis to remove excess fluid and toxins that build up in
the body.
Drugs Rx Guide : Buy drugs online The progression of CKD also increases the prevalence of
anemia, a condition associated with having fewer of the red blood cells
that carry oxygen through the body, and/or lower levels of hemoglobin,
the protein that enables red blood cells to carry oxygen. As hemoglobin
falls, the lower oxygen-carrying capacity of an anemic patients’ blood
results in various symptoms including fatigue, loss of energy,
breathlessness, and angina. Anemia in CKD patients has been associated
with increased hospitalization rates, increased mortality, and reduced
quality of life.
CKD is a worldwide critical healthcare problem that affects millions of
people and drives significant healthcare cost. In the US, prevalence of
CKD has increased dramatically in the past 20 years, from 10 percent of
the adult population (or approximately 20 million US adults) as stated
in the National Health and Nutrition Evaluation Survey (NHANES)
1988-1994, to 15 percent (or approximately 30 million adults) in NHANES
2003-2006. In 2009, total Medicare costs for CKD patients were $34
billion. China has an estimated 125 million CKD patients, or 5 times the
number of CKD patients in the US [Lancet April 2012].
About FG-4592
FG-4592 is an orally administered small molecule inhibitor of
hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in
development for the treatment of anemia in patients with chronic kidney
disease (CKD). HIF is a protein transcription factor that induces the
natural physiological response to conditions of low oxygen, “turning on”
erythropoiesis (the process by which red blood cells are produced) and
other protective pathways. FG-4592 has been shown to correct anemia and
maintain hemoglobin levels without the need for supplementation with
intravenous iron in CKD patients not yet receiving dialysis and in
end-stage renal disease patients receiving dialysis. An Independent Data
Monitoring Committee has found no signals or trends to date to suggest
that treatment with FG-4592 is associated with increased risk of
cardiovascular events, thrombosis, or increases in blood pressure
requiring initiation or intensification of antihypertensive medications.
Under a licensing agreement between FibroGen, Inc. and Astellas Pharma
Inc., Astellas is developing FG-4592 for the treatment of anemia in CKD
and ESRD patients in Europe, Japan, the Commonwealth of Independent
States, the Middle East, and South Africa.
About FibroGen
FibroGen, Inc., is a privately-held biotechnology company focused on the
discovery, development, and commercialization of therapeutic agents for
treatment of fibrosis, anemia, cancer, and other serious unmet medical
needs. FibroGen’s FG-3019 monoclonal antibody is in early-stage clinical
development for treatment of idiopathic pulmonary fibrosis and other
proliferative diseases, including pancreatic cancer and liver fibrosis,
and FG-4592 is a small molecule inhibitor of hypoxia-inducible factor
(HIF) prolyl hydroxylase currently in clinical development for the
treatment of anemia. FibroGen is also currently pursuing the use of
proprietary recombinant human type III collagens in synthetic corneas
for treatment of corneal blindness.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
