Astellas Pharma Inc.
Rank 20 in 2016
Rises 1 place to 19th. Although it has made notable improvements, such as joining the TB Alliance, Astellas placed comparatively poorly in every Technical Area.
Falls 2 places to 20th. While some activities are guided by access-related goals, the company continues to lack an overall access-to-medicine strategy. Newly joined Access Accelerated.
Rises 5 places to 12th. One of only two companies who report having all components of an internal control framework looked for by the Index.
Rises 6 places to 11th, with strengthened R&D commitments, and a higher proportion of projects carried out in collaboration.
Holds 19th position for its continued lack of equitable pricing strategies for any of its marketed products for priority countries.
Falls 1 place to 14th, despite new engagement with Pat-INFOR-MED. It is affected negatively by a lack of transparency in remaining areas.
Falls 7 places to 17th, for failing to demonstrate initiatives which meet all good practice standards looked for by the Index.
Rises 3 places to 16th. Remains in last quartile. Does not have any structured donation programmes in place, nor does it disclose evidence of ad-hoc donations.
Develop a process to establish access plans for R&D projects during development. Astellas lacks a clear process for establishing access plans for R&D projects during development, instead it considers access on an ad hoc basis. It can improve in this area by publicly committing to develop access plans for R&D projects for diseases in scope with a clear timeline. It could consider the unique requirements for each of these projects. This includes developing access plans for projects such as its Phase III clinical candidate, gilteritinib, a potential oral treatment for leukaemia.
Develop access plans for key cancer products. Leuprorelin acetate (Eligard®) is a patented, first-line treatment on the 2017 WHO Model List of Essential Medicines (WHO EML) for the management of advanced prostate cancer. There is currently no evidence of any access plans for this product. The company could consider the application of, for example, equitable pricing strategies to support accessibility of this product.
Establish an overarching access strategy. Astellas can consolidate its access approaches into an overall strategy and clearly align it with its corporate strategy. The company could take this as an opportunity to incorporate its position on access to health into concrete objectives to improve access to medicine in low- and middle-income countries, and to expand access planning across their pipeline.
Strengthen processes to minimise the risk of non-compliance. Astellas can establish formal processes to ensure third-party compliance with the company's standards of anti-corruption and ethical marketing. Astellas can also provide non-sales based incentives for sales agents. Removing the emphasis on sales targets is recognised as a mechanism for reducing the impact of unethical marketing on, for example, rational prescribing.
Establish a clear and public post-trial access policy. Astellas' approach to post-trial access is broadly defined and carried out on a case-by-case basis. By developing a clear stance and protocol on post-trial access, and committing to register all new products in the countries where clinical trials for these products have taken place, it can expand access to medicine and ensure post-trial access for clinical trial participants.
Change since 2016
- Joined Access Accelerated with its Action on Fistula programme in Kenya. It has also committed to measure impact and share results publicly via Access Observatory.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
- Joined the Drugs for Neglected Diseases initiative's NTD Drug Discovery Booster to accelerate the development of early-stage projects for Chagas disease and leishmaniasis through compound library sharing.
- Joined the UN Shot@Life campaign in 2017 by supporting the measles campaign in Latin America.
Pipeline and Portfolio
for diseases and countries in scope
Comparatively small pipeline: 25 R&D projects (all medicines) for diseases in scope.
Clinical candidates: 19, including praziquantel for the treatment of schistosomiasis in children and ipragliflozin for type I diabetes mellitus.
Regulatory approvals: 3, including extended-release quetiapine for the treatment of bipolar affective disorder.
R&D focus: non-communicable diseases (cancer and diabetes mellitus).
Access provisions: for 4 projects, most commonly applied through access-oriented partnerships.
Comparatively small portfolio: 18 products (all medicines) for diseases in scope.
Portfolio focus: non-communicable diseases (hypertensive heart disease and epilepsy) and communicable diseases (viral hepatitis C).
Essential medicines: 44% of Astellas' medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 56% of Astellas' medicines have first-line indications for diseases in scope.
One business unit: Pharmaceuticals, with five main therapeutic areas (urology, oncology, immunology, nephrology, and neuroscience).
M&A news: 2016 acquisition of Ganymed Pharmaceuticals, specialising in oncology. 2017 acquisition Ogeda SA, a clinical-stage drug discovery company for women's health. 2018 acquisitions: of Universal Cells, with a pipeline focused on the development of stem cell technology; acquisition of Mitobridge, a start-up focused on discovering and developing small-molecule therapeutics that enhance mitochondrial function.
Presence in emerging markets: In 2018, Astellas reports sales in 39 countries in scope; six less than in the 2016 Index.
* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
** See Appendix IV for definition.