Astellas Pharma Inc.

Stock Exchange: XTKS • Ticker: 4503 • HQ: Tokyo, Japan • Employees: 17,113 (FY2014)

Ranking by technical area
Ranking by strategic pillar

Performance

Astellas falls two places to 20th, despite improving in certain areas. In R&D, it commits to maintaining its investment in R&D overall at over 17% of net sales, and has clear targets to develop products for neglected tropical diseases. Its approach to intellectual property has improved, with a pledge not to file for or enforce IP rights in select Least Developed Countries and low-income countries. It is one of the biggest risers in capacity building, focusing on Asia. It has yet to implement an equitable pricing strategy for a disease in scope, and has no relevant registration targets. Its transparency around marketing and lobbying is low, and it was found to have acted unethically twice. It has set objectives relating to access to medicine, but they do not clearly link to an overall access strategy. Astellas does not donate products for diseases in scope.

Change since 2014

Still lacks a clearly defined access strategy and its stakeholder engagement activities are still conducted on an ad hoc basis.

Exhibits weaker performance in compliance than in 2014. It was found to have breached the UK PMCPA code twice: for providing false information and for failing to provide accurate information.

Its R&D strategy for 2015-2017 includes multiple targets to develop products for the diseases of poverty, and to maintain the ratio of its total R&D investment at more than 17% of net sales.

Improves its accountability for its sales agents’ pricing practices, by providing pricing guidelines.

Still has no set targets for filing for the registration of new products in countries in scope.

Publicly commits not to file for or enforce patents in select Least Developed Countries or low-income countries.

Has improved in building local capacity in supply chain management and in health-related areas beyond the production and distribution of medicines, including building healthworker capacity in Kenya.

Opportunities

Put access plans in place for pipeline projects. Astellas can make specific access plans for each R&D project for high-burden diseases: e.g., its medicines in phase I for asthma, kidney diseases and schizophrenia. This can include committing, during late stages of clinical development, to registering successful innovations in countries where they are needed.

Build lasting improvements in local R&D capacity. Astellas can draw on its existing R&D activities in countries in scope to build local research capacity: e.g., through institution-level partnerships with local public research organisations. This will help address local skills gaps in a systemic and sustainable way.

Transfer knowledge of equitable pricing strategies. Astellas can transfer its experience of equitable pricing to products for diseases in scope. This could include existing products, as well as products emerging from its pipeline.

Expand Changing Tomorrow Together programme. Astellas can expand this stakeholder engagement programme to low- and middle-income countries where it has operations. This could lead to a structured approach to stakeholder engagement.

Join efforts to combat antimicrobial resistance. Astellas has nine antibiotics on the WHO EML that are used in clinical practice and are important for low-resource settings. It can increase access to these medicines, while ensuring their responsible use. It can join global efforts to address antimicrobial resistance, for example by signing the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance.

Leverage R&D expertise in product adaptation for more diseases. Through partnerships, Astellas can apply its expertise in adapting existing products to meet specific needs (as exhibited in its schistosomiasis partnership) to more disease areas.

Sales and operations

Astellas is active in five therapeutic areas: urology, oncology, immunology, nephrology, and neuroscience. The company aims to expand its portfolio with products for muscle diseases and opthamology. The company has sales in 45 countries in scope. At the end of 2015, Astellas sold its dermatology business to LEO Pharma for USD 727 mn.

Early 2016, the company acquired the regenerative ophthalmology biotech Ocata Therapeutics for a similar amount.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Astellas has a small portfolio of 15 medicines for relevant diseases and a small pipeline of eight R&D projects that address the needs of people in countries in scope.

Astellas’ portfolio is mainly focused on infectious diseases, and includes seven broad-spectrum antibiotics registered for the treatment of multiple diseases in scope. In Q1 2016, Astellas gained marketing authorization (FDA) for isavuconazonium sulfate (Cresembra®), an azole antifungal to be used in conditions associated with HIV/AIDS.

Products per disease category

Astellas’ portfolio contains 15 medicines, targeting infectious diseases, asthma, diabetes, schizophrenia and hypertensive heart disease.

Its relevant pipeline is mainly clustered in clinical development, with projects targeting lower respiratory infections, schistosomiasis, schizophrenia, chronic kidney disease, severe asthma and diabetic nephropathy. Astellas has two R&D projects that target high-priority product gaps with low commercial incentive: for Chagas disease and schistosomiasis. Both of these projects are being conducted in partnership. Astellas’ investigative medicines for schizophrenia, chronic kidney disease and severe asthma moved from pre-clinical into clinical development since the last Index.

Pipeline projects

Astellas is collaborating on drugs for Chagas disease, and (via the Pediatric Praziquantel Consortium with Merck KGaA) for schistosomiasis. The latter includes plans for access, e.g., via manufacturing in endemic countries.

First-line treatments and essential medicines

60% of Astellas’ medicines are listed on the WHO EML and/or as first-line treatments. This includes nilvadipine (Nivadil®), doxycycline and benzylpenicillin.

Pipeline by stage of development
– Innovative medicines and vaccines

Astellas’ pipeline is highly focused on innovative projects. Alongside several medicines, it is developing an H5N1 avian influenza vaccine (in phase II) and a seasonal influenza vaccine (in phase III).

Pipeline by stage of development
– Adaptive medicines and vaccines

Astellas, via the Pediatric Praziquantel Consortium with Merck KGaA, is co-developing a new formulation for in children under six. Features include a less bitter taste, making the pill easier for children to take.

Please refer to the pdf of the report card (that can be downloaded here) for information on Astellas’ performance per technical area.

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