FibroGen, Inc. has completed an exclusive licensing agreement with Astellas Pharma Inc. that provides Astellas rights to certain FibroGen hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitors for development and marketing for the treatment of anaemia 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.

"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," Thomas B. Neff, Chief Executive Officer of FibroGen said adding, "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-anaemia program and to meet our goal of developing novel medicines that provide lower cost, broader benefit, and improved access to anaemia therapy."

Under the agreement, Astellas will pay a licensing fee of $300 million to FibroGen upon signing and will further pay development milestones totalling $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.

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 US 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, according to the company release.

In Europe, sales of recombinant human erythropoietin (rHuEPO) products for anaemia of chronic kidney disease and chemotherapy-induced anaemia 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 anaemias, patients with anaemia associated with congestive heart failure (CHF), age-related anaemia patients, and patients with anaemia of chronic disease (ACD). ACD is also called anaemia 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 anaemia therapy in North America where the majority of the anaemia markets are not yet penetrated," said 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 anaemia 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 anaemia therapeutics, rHuEPO and intravenous iron. We believe FibroGen's oral therapy is uniquely positioned to address the medical need caused by anaemia in these settings," he added.