Proveca Ltd is a pharmaceutical company specialising in identifying, developing and licensing off-patent medicines with unmet priority health care needs, with a focus on the paediatric market. By developing the necessary formulations and clinical data required to obtain a Paediatric Use Marketing Authorisation (PUMA) these drugs will benefit from a period of 10 years' market protection (8 years of data and market protection plus 2 further years of market protection). In addition, where appropriate, Orphan Drug status (Orphan Drug) will be sought which affords a period of 10 years' market exclusivity to run concurrently.
Value will be realised through commercialisation of the licensed medicine or an outright sale of the licence to a larger pharmaceutical company.
Proveca has a strong pipeline of relevant, optimal candidates identified from its methodology, research and analysis process. Several products have been taken through scientific advice with the European Medicines Agency (EMA), 2 Paediatric Investigation Plans (PIPs) have been granted to date and several others are in process. Proveca will aim to identify a sufficient number of candidates and undertake the research work required to achieve PIP approval on one to two drugs per annum.
Most drug development has traditionally been focused on adults with little or no clinical evaluation undertaken in children; hence licences for paediatric use are not common and therefore present a large unmet medical need. Although many medicines are administered to children, the majority are not licensed for use in children and are not in an age-appropriate format.
In 2007, the European Regulators initiated a number of developments aimed at providing incentives to companies to license existing off-patent authorised products for use in children. The most significant of these was the PUMA licensing process. This type of marketing authorisation covers the indication and appropriate formulation for the paediatric population. The development requirements of the medicine for use in children are set out in an agreed PIP.