Outsourcing reformulation expertise
Reformulating an existing drug product can be a time- and cost-effective way of rejuvenating a product line while also making a therapeutic more patient-friendly. To find out more about how external expertise can help sponsor companies achieve success in reformulation strategies, BioPharm International spoke with Jan Jezek, chief scientific officer of Arecor, and Balasubramaniam Jagdish, assistant vice-president, Formulation Development, Bengaluru Site, Recipharm.
BioPharm: How might companies benefit from using a partner for reformulation tasks?
Jezek (Arecor): An innovative formulation technology company, such as Arecor, can use its expertise, know-how, and technology to develop novel formulations of therapeutic medicines with enhanced properties, enabled by the formulation, which would otherwise not be possible. These enhancements can improve treatment options and outcomes for patients. The technology can be applied to a variety of new products in development to maximize their benefit for patients. However, the reformulation technology can also be applied to existing marketed products as part of life cycle management.
Jagdish (Recipharm): Reformulations are often considered by big-brand pharmaceutical companies as a strategy for enhancing the lifecycle management of their patented product and to delay generic entry as far as possible. These companies often have many lead molecules to work upon, meaning it can be hard to find the capacity required for reformulation in-house. Working with a contract development and manufacturing organization (CDMO) partner can help them find that additional resource, enabling them to manage multiple reformulations simultaneously while freeing in-house capacity to focus on innovation.
For generic companies, reformulation gives them an advantage in terms of 505 b(2) filing. [FDA] 505 b2 approvals give additional exclusivity to a product. When applied to a reformulated drug, it can help to prevent generic entry until the expiry of the filing. As such, they keep development in-house, provided they have the internal capacity and infrastructure. However, if the generic company is reformulating to change excipient or manufacturing process, they may well prefer to outsource to a CDMO to provide the necessary expertise and infrastructure so they can concentrate on other projects.