Pre-approval access policy to investigational or pre-approval products
BiomX Inc. (together with its subsidiaries, “BiomX”) is a clinical stage, microbiome company developing customized phage therapies to eradicate harmful bacteria in chronic diseases.
Occasionally a patient with a serious or life-threatening disease or condition may not have any effective currently available treatment option and may not be eligible for enrollment into any ongoing clinical trial, which is the first and most preferable path to receive investigational drugs. In such circumstances, patients may be provided access to investigational products pursuant to local regulations and mechanisms before regulatory approval. This potential pathway is known as “Pre-approval Access” or “Compassionate Use”. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is BiomX’s policy for evaluating and responding to requests for individual patient access to investigational products that are intended to treat serious diseases.
BiomX will consider granting pre-approval access to investigational or pre-approval products when all of the following criteria are met:
– An independent request has been received from the treating physician
– The patient to be treated has a serious or life-threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition
– The patient is ineligible for enrollment into or unable to access ongoing clinical trials
– Sufficient information exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated
– The investigational product is a pipeline product being developed by BiomX
– Sufficient information to inform appropriate use of the investigational medicine exists
– No concern exists that compassionate use of the investigational medicine might somehow compromise any related clinical trial or regulatory pathway
– BiomX has an adequate supply of the investigational product and providing the investigational product will not interfere with ongoing clinical trial(s) or with the overall development program
– The patient meets important medical criteria established by the medical experts working on the product development program
– Such access provisions as described above are allowed as per local laws and regulations. Request Procedure and Timing
A treating physician may submit questions or requests regarding BiomX’s Pre-approval Access Policy or clinical trials to the following: firstname.lastname@example.org
Each request will be reviewed fairly and promptly by qualified BiomX medical experts with every effort made to provide a response in a timely manner once all required medical information has been received from the treating physician. This timeline may be impacted by factors such as national and local requirements or government health authority feedback. Each request will be assessed in consideration of applicable local laws and regulations. BiomX may provide the product free of charge to patients in any pre-approval access programs initiated prior to obtaining first major approval. Any participant in BiomX’s pre-approval access program may be required to undertake certain standard obligations, regarding confidentiality and other customary matters. Once the product is approved by regulatory authorities and launched, a pre-approval access program cannot be used as a mechanism for provision of medicine to patients. The product may be made available through local mechanisms, such as a patient support program, as allowed by local laws.
As authorized by the 21st Century Cures Act, BiomX may revise this Pre-approval Access Policy at any time.