Named Patient Access

In cases where a clinical trial is not an option, Fennec may elect to provide physician-requested named patient access to its investigational medicines in countries where Fennec intends to submit an application for marketing authorization of the requested product. Once the product is approved in a country, the named patient program is no longer available in that country. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking named patient access to unapproved medicines. Fennec will consider requests for access to its investigational medicines, as permitted by applicable law, in very specific circumstances, when all of the following criteria are met:

• The patient has a serious or immediately life threatening disease for which no alternative therapies are currently available.
• The named patient access program is authorized for the requested indication.
• There is adequate clinical evidence of a positive benefit-risk ratio for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
• Providing investigational medicine through named patient access will not compromise clinical trials or the regulatory pathway.

Physicians seeking named patient access to a Fennec investigational product on behalf of their patient should submit an inquiry to [email protected]. Fennec will promptly acknowledge receipt of requests from treating physicians, generally within 24 to 48 hours of receiving the request for information. Physicians will then be directed to submit required documentation to Fennec.

Medical professionals at Fennec who are familiar with the data collected on the investigational drug will evaluate the request based on the scientific evidence available at the time of the request. Fennec will strive to respond to the treating physician immediately after the receipt of required medical documentation. If Fennec supports the request for investigational medicine, final approval from regulatory bodies then follows.

Physicians who receive a Fennec investigational medicine for their patients through the named patient access program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property.

This policy is subject to change. Fennec will revisit the policy periodically and amend it as appropriate.