Co-Formulate strengthens relationship with Proveca to develop multiple paediatric formulations

Co-Formulate Limited, a division of Quotient Clinical, a leading provider of early stage drug development services, has announced that they have been contracted by Proveca Ltd. to perform paediatric formulation development work on several additional off-patent compounds.

This agreement follows Co-Formulate’s successful development of an age-appropriate, taste-masked formulation of Proveca’s first paediatric medicine, Sialanar, in line with regulatory requirements. Proveca recently announced a positive EMA opinion for the Sialanar glycopyrronium bromide oral solution, and subsequent approval of an EU-wide Paediatric Use Marketing Authorization (PUMA). Co-Formulate contributed to the authoring of the drug product sections of the Paediatric Investigation Plan (PIP) and PUMA.

Proveca is a specialist pharmaceutical company engaged in the development of paediatric medicines. Co-Formulate is applying its expertise in formulation development, allied with its capabilities in analytical and stability testing, and scale-up and regulatory support to develop a range of alternative formulations for children of different age groups across a range of dose formats.

Huw Jones, Director and Founder of Co-Formulate Ltd., said "We are delighted to extend our agreement with Proveca, following the success of Sialanar, and look forward to working on the new compounds. Following the acquisition of Co-Formulate by Quotient Clinical in December 2015, the company is now able to offer customers end-to-end services covering formulation development, taste masking, clinical pharmacokinetic and taste assessments, and GMP clinical trial manufacturing and global supply, all under the umbrella of a single organisation."

Simon Bryson, Director and Co-Founder of Proveca Ltd., commented "We were very pleased with the outcome of the Sialanar formulation project, and are now delighted to be working with Co-Formulate on a range of further products."