Importantly there is significant opportunity for directly substitutable generics and branded ‘super-generics’ (i.e novel versions of generics), as over 75% of current products will go off-patent within the next five years. The industry also expects price erosion in the respiratory market to be significantly less than classically observed with other types of products when generics are introduced. Forecasts suggest that generic prices could be remain as high as 80% of the Originator brand.
The regulatory environment in Europe is conducive to accelerated development of generic, orally inhaled products, with the opportunity for regulatory approval by in vitro equivalence alone (i.e. without the need for clinical trials). In the US, the Food & Drug Administration is reviewing its criteria for demonstrating bioequivalence, which while still expected to be challenging, is aimed at facilitating the entry of new generic products.
However, because of the technical and manufacturing complexities in meeting quality standards set for approval of generics on the basis of in vitro equivalence alone, Prosonix believes it is unlikely that approval can be achieved without novel particle engineering technologies, such as those developed by Prosonix. The Company therefore expects competition to be limited.
Further important opportunities exist for Prosonix in emerging markets where the combination of unique engineered particles in simple, low cost, and possibly disposable devices could revolutionise the delivery of long-term respiratory therapy.
*Pulmonary Drug Delivery Systems: Technologies and Global Markets