Biogen Statement About Commitment to Providing Global aducanumab Access to Patients Outside of the United States Through Two Early Access Pathways

At Biogen, our mission is to advance science in the development and approval of medications to benefit the greatest number of patients in a timely manner. Aducanumab is an Alzheimer’s disease treatment approved in the United States (U.S.) under the accelerated pathway based on reduction in amyloid beta plaques observed in patients treated with aducanumab. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Aducanumab is still under review in countries outside of the U.S. Making aducanumab broadly available to qualified patients through regulatory approval is one of our top priorities.

Biogen recognizes the high unmet medical need of Alzheimer’s patients in countries where aducanumab is not yet approved and as we work with regulatory authorities, we are committed to offering access programs for eligible patients, where permitted by local regulations. There are two potential early access pathways to aducanumab for appropriate patients outside of the U.S. (early access to aducanumab is not available in the United States as the product is commercially available): an Early Access Program (EAP) and a Charged Managed Access Program (CMAP) and we are working to assess the feasibility of the implementation of these programs on a country-by-country basis. All access programs are subject to local regulatory and health authority requirements.

The EAP program is for individuals with an unmet medical need in countries where aducanumab is not yet approved. The company provides aducanumab free of charge for patients who meet a defined eligibility criterion at eligible treatment centers/hospitals where patient treatment and management are provided by an appropriately trained specialist healthcare professional. Any additional costs, such as biomarker testing and infusion costs, are not covered by Biogen. The EAP is overseen by local regulatory authorities and the process varies by country. This program is anticipated to open in some countries starting in Q3 2021 and is expected to open in additional countries over the following months. 

The CMAP program is for individuals with an unmet medical need in countries where aducanumab is not yet approved. Aducanumab can be purchased and imported from other countries where commercial drug is available. Aducanumab has been approved under accelerated approval as ADUHELM™ (aducanumab-avwa) in the U.S. by the U.S. Food and Drug Administration. In the U.S., ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Under the CMAP, the specialist treating physician is responsible for patient management according to the U.S. Prescribing Information. When relevant, the CMAP may also need to be approved by local authorities. Neither the cost of the drug nor additional costs are covered by Biogen. 

In all circumstances, a patient’s physician is responsible for deciding if treatment with aducanumab is appropriate. For information regarding the availability, access, and timing of these programs, a patient’s treating physician can send an email to medicineaccess@clinigengroup.com. More information is also available on Biogen’s website at https://www.biogen.com/en_us/access-programs.html.

Please see full Prescribing Information including Medication Guide.

 

Biogen Safe Harbor Statement

This statement contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential clinical effects of aducanumab; the potential benefits, safety and efficacy of aducanumab; access to aducanumab, including through the EAP and CMAP programs; the identification and treatment of Alzheimer’s disease; potential regulatory approvals and the timing thereof; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of aducanumab; preparedness of healthcare providers to treat patients; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; the occurrence of adverse safety events, restrictions on use or product liability claims; risks of unexpected costs or delays or other unexpected hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; third party collaboration risks; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this statement. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.