At Colonis Pharma Ltd, we are dedicated to developing treatment options that help improve clinical care and enhance the patient experience. How do we achieve this? Through our streamlined product development process. This process is generally much faster than the traditional drug development route, which involves patient recruitment and clinical trials.  

Step 1. Identify the unmet needs 

We start by identifying unmet needs of patients and healthcare professionals that a value-added medicine could meet: from different doses/dose regimens that fit certain patient populations better, to formulations that provide more convenient drug delivery. We identify these gaps through the following steps: 

• Review of the available global literature, leading to a deep understanding of the therapy area, patient demographics, and existing treatment pathways and protocols 

• Speaking with key opinion leaders (KOLs) and patient advocacy groups (PAG) to ensure that the outcomes of the literature review align with the real needs of patients and healthcare professionals 

By identifying the unmet needs, existing medicines can be repurposed in a meaningful way to create value-added medicines. 

Step 2. Develop the value-added medicine 

After the unmet need has been identified, the development of the value-added medicine begins. A key consideration during this stage is how to produce a stable formulation of the product. Following the development process, we submit an application to obtain the license for the value-added medicine.  

Step 3. Submit an application to the Medicines and Healthcare products Regulatory Agency (MHRA) 

The outcomes of the literature review and the discussions with KOLs and PAGs are combined to document the unmet need. This information then forms part of a comprehensive clinical overview document. 

The clinical overview also includes efficacy and safety data from existing reference products, dosage considerations, bioavailability, pharmacodynamics, pharmacokinetics (including in special patient populations), and a summary of the benefits and risks. The clinical overview is then submitted to the MHRA for evaluation – this is a crucial part of the regulatory review process for potential approval.  

Step 4. Commercialise the value-added medicine 

The approved, licensed value-added medicine is then distributed in its approved market – once the value-added medicine has been added to the relevant formulary, healthcare providers can start prescribing the product to meet their patients’ needs.  

Step 5. Collect feedback from different stakeholders 

A sales force may be involved in the launch of a value-added medicine, and their activities include gathering feedback from healthcare providers. So far, the feedback we’ve received on some of our value-added medicines includes: 

• The value-added medicine offers not only a more convenient formulation but also greater accuracy of dosing 

• The value-added medicine provides the convenience of fewer prescriptions for healthcare professionals to complete and dispense 

• The value-added medicine is a valuable add-on to existing therapies 

At their core, value-added medicines are created to improve patients’ outcomes by addressing their needs which may not be met with existing treatment options.  

Colonis Pharma Ltd is an independent entity under the Clinigen Group. 

December 2024 | GB-CPL-0-176 

© Colonis Pharma Limited 2024 

Registered in England & Wales No. 05486832. VAT Registration No. 862418028. Registered office: Colonis Pharma Ltd, 25 Bedford Square, Bloomsbury, London, WC1B 3HH.