Japan, April 28 , 2006-Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) announced that Astellas and FibroGen, Inc. ("FibroGen" headquarters: South San Francisco, CA; chairman, founder and CEO: Thomas B. Neff) have concluded the licensing agreement of FibroGenfs investigational oral therapies for anemia FG-2216, FG-4592 (development codes) and other compounds with similar mechanisms of action for exclusive development and marketing in Europe, Commonwealth of Independent States (CIS), Middle East, and South Africa.
FG-2216 and FG-4592 are oral anemia therapies that inhibit prolyl hydroxylase (PH), an enzyme that mediates the degradation of hypoxia-inducible factor (HIF), which is critical for the production of endogenous erythropoietin (EPO) and other genes to enable complete erythropoiesis. At present, recombinant human EPO (rHuEPO) administered by subcutaneous or intravenous injection is the mainstay of treatment for anemia. FG-2216 and FG-4592 are expected to meet unmet medical needs as the worldfs first low-molecular-weight oral drug for the treatment of anemia. The current market for rHuEPO in 5 major European countries (Germany, France, Italy, United Kingdom and Spain) is estimated to US$ 2.5 billion, and the market is expected to continue to grow.
In Europe, FG-2216 is in the stage of exploratory clinical trials directed by FibroGen for the indication of renal anemia and chemotherapy-induced anemia. Its efficacy for treating renal anemia in rHuEPO naive patients has already been confirmed. Upon signing the agreement, Astellas will join the various clinical studies underway in the U.S. and Europe with FibroGen. As one of these joint development efforts, FibroGen and Astellas plan to start Phase IIb clinical trials for renal anemia in the first half of the fiscal year ending March 2007. Further, both companies plan to conduct joint development of FG-2216 for oncology indications such as chemotherapy-induced anemia and cancer-related anemia. Astellas expects that the peak annual sales of FG-2216 will reach 80 to 100 billion yen in Europe. Astellas believes FG-2216 will contribute to the substantial expansion of the company's European business since the infrastructure it has established in Europe in the fields of urology and renal transplantation can be fully utilized for the successful marketing of FG-2216.
Under the agreement, Astellas will pay a upfront fees of US$ 300 million to FibroGen upon signing of the agreement and will further pay development milestones totaling US$ 465 million and share in the costs of a transatlantic development program. The products shall be supplied to Astellas by FibroGen. In addition, Astellas will purchase shares to be newly issued by FibroGen for US$ 50 million.
Astellas signed a definitive agreement for the exclusive rights to develop and market FG-2216 in Japan in June 2005 and is now conducting Phase I clinical trials targeting renal anemia associated with chronic renal insufficiency at the pre-dialysis and dialysis stage.
Anemia is seen in patients with renal insufficiency, and its main cause is thought to be the deficiency of the hematopoietic factor erythropoietin (EPO). Mainly produced in the kidneys, EPO acts on the bone marrow and produces erythrocytes by promoting their differentiation and growth. Patients with renal insufficiency show anemia due to the shortage of EPO as impairment of renal function progresses. In Europe, about 220,000 patients with chronic renal insufficiency on dialysis therapy are thought to receive rHuEPO to deal with anemic symptoms. Through this collaboration, Astellas and FibroGen are also positioned to address the larger opportunities currently not penetrated by rHuEPO products including: chronic kidney disease (CKD) patients who are not yet on dialysis (predialysis), congestive heart failure (CHF) and anemia of aging. Anemia associated with anti-cancer chemotherapy is characterized by relative decreases in erythropoiesis due to bone marrow ablation and/or renal toxicity caused by the use of some chemotherapeutic agents to treat cancer. In Europe, it is estimated that approximately 430,000 cancer patients under chemotherapy receive rHuEPO.