Access to Investigational Drugs

Eisai’s General Approach to Access to Investigational Drugs

At Eisai, we are committed to developing safe and effective drugs for the health and well-being of people worldwide as embodied by our human health care (hhc) mission. We conduct clinical trials on drugs to make sure that we have the scientific evidence needed for a government health authority to approve them. Because we give first thought to patients and their families, the information collected through clinical trials is important because it helps Eisai and health authorities confirm the safety and efficacy of our investigational drugs. Through this process, drugs are approved and then made available for physicians to prescribe for patients who may need them.

Before an investigational drug is approved, some patients can gain access to that drug by enrolling in a clinical trial. If a patient(s) does not qualify for a clinical trial, Eisai believes that, in certain circumstances, it may be consistent with our hhc mission to provide access to an investigational or commercially unavailable drug through an individual or group program outside the context of a clinical trial. (This type of access is sometimes known colloquially as “compassionate use,” “expanded access,” or “named patient,” depending on the type of program.)

For more information on expanded access programs sponsored by Eisai, please visit https://clinicaltrials.gov and search under “Eisai expanded access.”

Eisai’s Criteria for Patient Eligibility

Under limited circumstances, Eisai may consider providing investigational drugs to patients through an individual or group program where the following criteria are met:

Disease/Treatment

The patient has a disease or condition that is “serious” or “immediately life-threatening,” and there is no comparable or satisfactory alternative treatment available to the patient. Also, the patient must not be eligible for and must not have access to a current Eisai clinical trial.

Risk/Benefit

Eisai determines that the potential benefits of treatment with the investigational drug outweigh the potential risks to the patient. This assessment takes into consideration the condition of the patient and the sufficiency of safety and efficacy data for the investigational drug. The potential risks must be reasonable given the disease or condition to be treated.

Drug Development

Providing the investigational drug will not interfere with the initiation, conduct, or completion of Eisai’s clinical trials or development of the drug. Also, the drug requested is not available in the patient’s country.

Legal, Regulatory and Other Requirements

Providing the investigational drug complies with applicable local legal and regulatory requirements. This includes any necessary reviews and approvals by health authorities and institutional review boards/ethics committees, as well as use of the drug under the supervision of a licensed physician.

Eisai reviews applications for access to investigational drugs that meet these criteria. Access to Eisai’s investigational drugs under an individual or group program is only available through the patient’s physician.

How to Contact Eisai About Access to Investigational Drugs

Patients interested in Eisai’s investigational drugs must work through their treating physicians to see if they are eligible to enroll in an Eisai clinical trial or receive the drug through an individual or group program. For more information about eligibility for access to investigational drugs, physicians should call or e-mail Eisai Medical Information at the number or e-mail address below.

Email: esi_medinfo@eisai.com

Toll free: 1-888-274-2378

Eisai anticipates acknowledging receipt of requests made to Eisai Medical Information within two (2) business days.

If you have a patient who cannot afford a drug that is commercially available, the patient will not be eligible for access to the drug under the process described above. However, please contact the applicable Eisai Patient Assistance Program (PAP) to determine if your patient is eligible for patient assistance in accordance with the terms, conditions and criteria of that PAP. Information on Eisai’s reimbursement and patient assistance programs can be found at www.eisaireimbursement.com.

Please note that neither this Web site, nor Eisai’s policies and procedures, are intended to provide, nor should be construed as providing, automatic access to the Company’s products.