- HyBryte is been awarded innovation passport in the UK.
- Soligenix Inc. is planning to go ahead with PIM.
Soligenix Inc. is a late-stage biopharmaceutical company develops and commercializes products to treat rare ailments where there is an unmet medical need. Recently, it made an official announcement that under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP), its program HyBryte (hypericin) was awarded an “Innovation Passport” for the treatment of early stage Cutaneous T-cell lymphoma (CTCL) in adults.
ILAP was launched in UK at the start of 2021. It was meant to accelerate the development and access to promising medicines and facilitate patient access to new medicines. As a part of the UK’s plan to attract life sciences development in the post-Brexit era, the pathway features enhanced input, along with and interactions with the Medicines and Healthcare Products Regulatory Agency (MHRA). It also interacts with other stakeholders including the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). Innovative Licensing and Access Pathway Steering Group, comprises of representatives from MHRA, NICE, and SMC. This group decided to award the Innovation Passport to the HyBryte program.
First step in the ILAP process, the innovation passport designation triggers the MHRA and its other partner agencies to create a target development profile to chart out a roadmap regarding regulatory and development milestones with the goal of providing early patient access to the program receiving the Innovation Passport in the UK. Other benefits of ILAP include a 150-day accelerated assessment, a continuous benefit risk assessment, and rolling review.