AbbVie Sees Solid Japan Outlook Despite 2020 Dip
Multi-Indication Pipeline
Executive Summary
AbbVie expects double-digit sales growth in Japan over the mid-term despite a decline last year, driven in large part by multi-indication plans for new products.
Although it saw sales fall last year, AbbVie Inc.’s Japanese subsidiary says it intends “to continue double-digit growth through 2025,” with hematologic oncology and immunology the main therapeutic focus areas.
The operation logged sales of JPY113.7bn ($1.04bn) in calendar 2020, a decrease of 9% from the previous year, hit in part, it said, by a shrinking market for hepatitis C. The subsidiary gave no product sales breakdown but markets Mavyret (glecaprevir/pibrentasvir) in this sector.
Japan nevertheless continued to be AbbVie’s second-largest single market outside the US and so a key part of its global business.
On the positive side, 2020 saw a number of line extensions including an expansion of indications for Humira (adalimumab), including the first approval worldwide for the blockbuster TNF inhibitor last November for pyoderma gangrenosum, a rare inflammatory skin disease.
The JAK inhibitor Rinvoq (upadacitinib) was launched in Japan in April 2020 for second-line rheumatoid arthritis (including prevention of structural joint damage) and contributed to growth despite the COVID-19 pandemic, country president James Feliciano told an online media briefing.
Continued expansion of indications and broad use data are expected to keep the now mature product weather biosimilar competition in Japan in some settings. The first such product, from Fujifilm Kyowa Kirin Biologics/Viatris Inc., hit the market in February this year, for eight indications including the mainstay rheumatoid arthritis one. (Also see "Viatris And FKB Introduce First Japanese Adalimumab Biosimilar" - Generics Bulletin, 15 Feb, 2021.)
Feliciano told the briefing he believes there should be no "forced switching" to the biosimilar if disease is well controlled.
Despite the business challenges around the pandemic, the company highlighted its average annual growth rate of around 10% in Japan since the operation was formed 2013, and sees a strong local pipeline as driving the expected mid-term growth.
Key Pipeline Assets
Rinvoq was filed in June 2020 for psoriatic arthritis not adequately responsive to conventional therapies and also last October for moderate to severe atopic dermatitis. Maviret meanwhile is awaiting approval for pediatric chronic hepatitis C (ages 3-11) following a submission this April, development head Koichi Nishijo told the briefing.
In oncology. a key pillar will be the Bcl-2 inhibitor Venclexta (venetoclax), approved in Japan in March this year for the additional indication of acute myeloid leukemia, following on from its initial approval in the country in 2019 for relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
More than 15 line extensions for immunology and four additional indications are planned for the drug, with multiple myeloma and myelodysplastic syndrome among those now in Phase III in Japan.
Five additional molecules are under local development for hematological tumors and 14 for solid tumors. Reflecting AbbVie’s global pipeline, "the number in development in Japan increased by 282% last year compared to 2016 [11 versus 42], while the number of global clinical studies including Japan increased by 155% [29 vs 74]," Nishijo noted.
This has in multiple cases led to parallel or even Japan-first clinical development timelines, particularly in oncology, he noted. One (non-cancer) example highlighted was the antibody-drug conjugate ABBV-3373/154 for rheumatoid arthritis, for which the Japanese subsidiary has been a pioneer.
Policy Concerns
Feliciano, who heads the Japan committee of US industry association PhRMA, also touched on a number of policy issues in Japan. "If the environment deteriorates further, this will force difficult choices over what projects to advance locally," he said. This "is creating tension within the company."
He pointed to Rinvoq in particular, for which AbbVie is running a very broad program in Japan and has spent "millions and millions of dollars" on local clinical trials. However, the relatively new product is now not eligible for the price maintenance premium (which maintains initial reimbursement prices) and could be subject to annual price cuts. "This just doesn't make sense," he declared.
PhRMA, along with other research industry groups in Japan, recently set out their views on changes to Japan's national reimbursement pricing system and other healthcare-related policies. (Also see "Research Industry Presents United Front On Japan Reforms" - Pink Sheet, 20 May, 2021.)
(Modified on 4 June to add further statements on policy-related issues.)