Product Stewardship and Environmental Impact at Alkermes

Originally published in Alkermes September 2023 Corporate Responsibility Report

Product Stewardship and Environmental Impact

Alkermes is committed to safe and sustainable research, development, manufacturing and commercialization of medicines. We implement this commitment by integrating EHSS risk management requirements throughout the lifecycle of each of our products. Our approach to product stewardship oversight and control includes:

• Generation of occupational and environmental toxicology data, which is iterated and augmented as each product progresses through its lifecycle;
• Development and application of appropriate occupational health, safety and environmental risk controls for each product based on scale, potency, task and other processing considerations;
• Utilization of protocols and risk assessments to support safe and responsible technology transfers within Alkermes or to external contract manufacturing organizations (CMOs), contract research organizations (CROs) or other third parties;
• Development of “green chemistry” processes designed to eliminate or reduce the use or generation of hazardous substances in the design and manufacture of future products; and
• Implementation of a global program for process hazard management with embedded controls as early as the candidate discovery stage and through full commercial-scale manufacturing of a product.

External Operations Risk Management

We have integrated certain EHSS risk management procedures and our formal RMS framework into our vendor management and governance processes. EHSS considerations and metrics are monitored and discussed as part of routine business review meetings with our external operations partners. This approach enables transparent conversations about EHSS risk and performance and provides a forum for Alkermes to communicate our expectations for responsible development and manufacture to our vendors.

To assess whether our vendors operate to Alkermes’ standards and encourage adherence to such standards, EHSS risk considerations and metrics are embedded into our vendor due diligence assessments, on-boarding procedures, technology transfers and routine business reviews.

We also incorporate EHSS-related provisions, as appropriate, into our service-level agreements related to our products.

Our vendor assessment tools, which we developed based on the Pharmaceutical Supply Chain Initiative’s ‘Pharmaceutical Industry Principles for Responsible Supply Chain Management’, evaluate key areas such as: EHSS management systems; performance and regulatory compliance; environmental sustainability; occupational health and safety systems; process safety management controls; physical security; human rights, labor and ethics policies; business continuity systems; and capability to safely handle Alkermes products.

We have conducted on-site audits or tabletop reviews to assess all external CMOs directly involved in the manufacture or packaging of proprietary Alkermes medicines, and use the information gained from these assessments to help us prioritize areas of focus for our ongoing risk management efforts.

Our Commitment to Sustainability in the Supply Chain

We are committed to minimizing the environmental and social impacts associated with our supply chain while ensuring the delivery of safe and effective pharmaceutical products to our patients. To support the achievement of a sustainable supply chain, we have engaged EcoVadis, an independent, globally recognized provider of sustainability ratings, to assess our suppliers and third-party service providers based on four key pillars: environment, labor and human rights, ethics and sustainable procurement. The goal of this engagement is to help us evaluate the ESG performance of our key suppliers, and foster transparency, accountability, and continuous improvement throughout our supply chain. In 2022, we established a global, cross-functional steering team to help guide evolution of our strategy for a sustainable procurement program. We plan to continue to engage with key suppliers in an effort to drive positive change and incorporate more sustainable practices into our supply chain. See page 22 for our efforts to advance our supplier diversity initiatives.

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