Astellas Pharma Inc. (Tokyo:4503) President and CEO Kenji Yasukawa, who took the reigns in April, unveiled his 2018 strategic plan for the company Tuesday, including a restructuring of R&D and Japan operations. The pharma anticipates a decline in its FY19 core operating profit due to loss of exclusivity for key products and aims to generate mid- to long-term growth in core operating profit beginning in FY2020.
Astellas' top priority under the plan is investing in business growth. The three-pronged strategy emphasizes approvals and expanded labels for key marketed and late-stage products, introduces focus areas for early stage R&D and creates a new Rx+ business for additional revenues.
The pharma will restructure all operations in Japan, including R&D and sales and marketing, and discontinue several Japan units.
Astellas said additional approvals for prostate cancer therapy Xtandi enzalutamide to treat earlier stages of prostate cancer could yield peak sales of ¥400-¥500 billion ($3.6-$4.5 billion). It expects peak sales of Xtandi plus four key late-stage assets, including gilteritinib (ASP2215), to reach about ¥1 trillion ($9 billion) in the next 10 years. Astellas plans to seek approval for gilteritinib, a small molecule AXL receptor tyrosine kinase (AXL; UFO) and FMS-like tyrosine kinase 3 (FLT3; CD135) inhibitor, to treat several acute myelogenous leukemia (AML) indications.
Astellas also highlighted fezolinetant (ESN364), an agonist of neurokinin 3 receptor (TACR3; NK3R), which it gained last year via its acquisition of Ogeda S.A. for EUR500 million ($533.3 million) up front and up to EUR300 million ($320 million) in milestones. The candidate is in Phase II testing to treat menopause-related vasomotor symptoms (see BioCentury, April 7, 2017).
Yasukawa said on a conference call that the company adopted eight focus areas for early stage research, including cell therapy with a pilot in ophthalmic diseases, immuno-oncology therapies to treat tumors with inadequate response to PD-1/PD-L1 inhibitors and fast skeletal muscle troponin activator reldesemtiv (CK-2127107). The pharma is developing reldesemtiv with Cytokinetics Inc. (NASDAQ:CYTK) to treat several indications, including spinal muscular atrophy (SMA).
Astellas' new Rx+ business will include programs to develop digital devices or diagnostic tools based on the pharma's current technology and IP.
Yasukawa presented plans to "reinforce" the company's presence in the Japan market through steady launches of new products and expanded labels of gastrointestinal drug Linzess linaclotide and diabetes drug Suglat ipragliflozin. With those combined approvals, it expects Japanese sales to exceed ¥100 billion ($897.9 million) in the early 2020s. Astellas has exclusive Japanese rights to Linzess from Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) under a 2009 deal.
As part of its Japanese restructuring, Astellas will discontinue activities in its Research Technologies Co. Ltd., Marketing and Sales Support Co. Ltd. and Learning Institute Co. Ltd., except for its green-supply supporting operations, by the end of its FY18, which ends March 31, 2019.
It also plans to divest its Analytical Science Laboratories Co. Ltd. to Eurofins Scientific S.E. (Euronext:ERF) close in FY18. Yasukawa officially took over as president and CEO on April 1 but was named to the position in January. He was previously chief strategy and chief commercial officer.
Astellas shares rights to Xtandi with Pfizer Inc. (NYSE:PFE).