CRED ERP 25

Case Study 2

TOPRA CRED EU Procedures

TOPRA CRED EU PROCEDURES

Case Study 2

Introduction

Your company, TOPRAPharm Ltd, is developing a product for labour induction called Inductomor. Inductomor is a prostaglandin (PG).

TOPRAPharm is based in Italy and has no international affiliates. TOPRAPharm is a company of 49 sta ff with an annual turnover of €10 M. You are responsible for developing the regulatory strategy and for filing the submission for this product in Europe.

Relevant information relating to Inductomor

The drug substance (DS) in Inductomor is also used in a nationally registered product which is used in a different indication. This product is called Cartotect and is marketed by an entirely separate company. Cartotect has been on the market as a nationally registered product in various EU member states for over 10 years.

Cartotect is registered nationally in various EU member states for aiding in the regeneration of cartilage following orthopaedic surgery at high doses administered orally.

In clinical use of Cartotect, it was discovered that as a side effect, Cartotect produces uterine contractions in women.

Clinicians subsequently began using low doses of Cartotect off-licence for labour induction.

Clinicians found that lower doses could be used for labour induction when administered vaginally.

Many clinical papers on the off-licence use of Cartotect in labour induction have since been published attesting to its efficacy, but pointing out the need for a formulation containing a dose more suitable for labour induction and for vaginal administration. TOPRAPharm has recognised the unmet clinical need for a properly formulated pharmaceutical form of this PG for labour induction and intends to develop a licence application for use in labour induction.

TOPRAPharm has therefore developed a formulation of the PG at a dose specifically for labour induction to be administered vaginally.

There is a market for Inductomor across the EU.

1