A US based biotechnology company approached BAP Pharma to enquire about providing life-saving early access to a promising treatment that was undergoing phase II trials.
A number of critically ill patients, based in the United Kingdom, were currently receiving treatment with a standard therapeutic but had exhibited poor clinical outcomes.
An emergency ‘Medicines and Healthcare products Regulatory Agency’ (MHRA) application was submitted to allow importation of the needed unlicensed medicine to the United Kingdom for the patients.
BAP Pharma was able to fast-track the importation of the medicine from the United States compliantly and safely deliver them to the hospitals within the expected treatment timeline.
The MHRA granted the emergency approval for the unlicensed medicine supply to all of the patients, and one patient was able to receive the treatment immediately, resulting in lifesaving outcomes.
Due to the exceptional service received, the US biotechnology company decided to extend the BAP Pharma program to include additional patients within the European Union through a Compassionate Use Program.
BAP Pharma were able to provide a tailored access solution for the patients, which included importing an unlicensed medicine, ensuring the required treatment was provided in a timely manner.