Astellas Pharma Inc. and FibroGen, Inc. have concluded the licensing agreement of FibroGen's investigational oral therapies for anaemia 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 anaemia 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 anaemia. FG-2216 and FG-4592 are expected to meet unmet medical needs as the world's first low-molecular-weight oral drug for the treatment of anaemia. 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.
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.
In Europe, FG-2216 is in the stage of exploratory clinical trials directed by FibroGen for the indication of renal anaemia and chemotherapy-induced anaemia. Its efficacy for treating renal anaemia in rHuEPO naive patients has already been confirmed. Upon signing the agreement, Astellas will join the various clinical studies underway in the US and Europe with FibroGen. As one of these joint development efforts, FibroGen and Astellas plan to start Phase IIb clinical trials for renal anaemia 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 anaemia and cancer-related anaemia. 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.
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 anaemia associated with chronic renal insufficiency at the pre-dialysis and dialysis stage.