Global Insight Perspective | |
Significance | Astellas is making good on its promises during the merger of Yamanouchi and Fujisawa to supplement its existing pipeline, which was relatively weak on big ticket candidates, with licensing activities. |
Implications | In addition to building the actual size of Astellas' pipeline, the eight new candidates which the company has acquired in recent months have added favourable diversity into highly specialised markets, both in Japan and abroad. |
Outlook | From a position of weakness, Astellas has transformed its R&D department into one of the most robust pipelines in the Japanese industry, and it has utilised its large cash flow for licensing activities- this is relatively unusual amongst Japanese drug firms, which are notoriously conservative, and Astellas' business model will win it many overseas friends. |
Astellas Builds its Fibre
Astellas Pharma (Japan) and FibroGen (U.S.) have concluded the licensing agreement for investigational oral anaemia therapies FG-2216, FG-4592 and other compounds with similar mechanisms of action. The deal builds on an existing partnership between FibroGen and pre-merger Yamanouchi, and it has now acquired exclusive development and marketing rights in Europe, the Commonwealth of Independent States (CIS), the Middle East, and South Africa.
Astellas will pay an upfront fees of US$ 300 million to FibroGen upon signing of the agreement and will further pay development milestones totalling US$465 million and share in the costs of a transatlantic development programme. The products will be supplied to Astellas by FibroGen. In addition, Astellas will purchase shares to be newly issued by FibroGen for US$50 million.
FG-2216 and FG-4592 are oral anaemia therapies that inhibit prolyl hydroxylase (PH), an enzyme that mediates the degradation of hypoxia-inducible factor (HIF), which is thought to be critical for the production of endogenous erythropoietin (EPO) and other genes to enable complete erythropoiesis. At present, recombinant human EPO (rHuEPO), administered by subcutaneous or intravenous injection, is the mainstay of treatment for anaemia, and FG-2216 and FG-4592's primary benefit will lie in their value as the first low-molecular-weight oral drug for the treatment of anaemia.
FibroGen and Astellas plan to start Phase IIb clinical trials for FG-2216 for renal anaemia in the first half of the fiscal year (FY) 2006/07, and the companies plan to conduct joint development of FG-2216 for oncology indications such as chemotherapy-induced anaemia and cancer-related anaemia. Astellas expects that the peak annual sales of FG-2216 will reach ¥80-100 billion in Europe. Astellas is already conducting Phase I clinical trials for the drug in Japan , targeting renal anaemia associated with chronic renal insufficiency at the pre-dialysis and dialysis stage.
Astellas: Newly In-Licensed Drugs | ||||
Drug | Company | Indication | Stage | Size of Deal (US$ mil.) |
FG-4592 | Fibrogen | Anaemia | I | 765 |
FG-2216 | Fibrogen | Anaemia | I | |
ILY-101 | Ilypsa | Hyperphosphataemia | I | 92 |
Degarelix | Ferring | Prostate Cancer | I | n/a |
XP-13512 | Xenoport | Pain | III | 60 |
Garenoxacin | Toyama | Quinolone antibiotic | III | n/a |
Telavancin | Theravance | Glycopeptide anti-infective | III | 241 |
Amevive (alefacept) | Biogen Idec | Psoriasis | Marketed | 60 |
Source: Company releases, Global Insight | ||||
Outlook and Implications
Unlike many other players in the Japanese drug industry, Astellas has recognised the relative weakness of local, in-house pipelines. Although Japanese companies in the past were able to maintain such small pipelines due to the willingness of foreign pharma to license Japanese rights of their marketed drugs to domestic players, this is no longer the case. Astellas is thus building up its expertise in a variety of R&D areas, and Global Insight feels that its pipeline strength following the FibroGen deal now renders it a more attractive proposition than Takeda, the industry leader. Daiichi-Sankyo remains in the midst of a slow-burning merger, and is an entirely different animal to the outward-looking, dynamic Astellas.
The FibroGen deal provides the greatest number of synergies in the licensing arrangements that Astellas has signed in recent months, and its potential investment of US$765 million is a major gamble, considering the early stage of research for the candidates. Clearly, several of Astellas' new pipeline targets will fail due to the vagaries of the pharma industry, but it has several relatively low-risk prospects to offset the more specialised candidates in oncology, urology and dermatology which it has recently acquired. The FibroGen deal brings Astellas' potential spend to around US$1.5-1.8 billion in recent months - financial details of two deals have not been disclosed, and the others amount to around US$1.22 billion.