Hikma Pharmaceuticals (HIK) has been dealt another blow after US regulators said it had to conduct a further clinical study into its generic version of GlaxoSmithKline’s (GSK) Advair asthma treatment.
The news has triggered a 1.8% decline in Hikma’s share price to 882p. Vectura (VEC) fell 7.2% to 75.4p as it is responsible for the dry powder technology for Hikma’s generic treatment. In contrast, Glaxo’s shares nudged up 0.6% to £13.44.
Hikma has worked with the US Food and Drug Administration (also known as the FDA) since the regulator delayed its VR315 treatment in May. It had previously disputed the FDA’s demand to conduct a new clinical endpoint study.
Other companies trying to launch generic versions of Glaxo’s treatment have also experienced delays including Mylan and Novartis.
In a bid to accelerate progress, Hikma now expects to start patient enrolment in the next few weeks and anticipates new clinical data will be submitted ‘as early as possible in 2019.’
Mylan hopes to launch its Wixela Inhub generic in the US by June, which is relevant to UK investors as its partner is London-listed Consort Medical (CSRT).
Panmure Gordon analyst Dr Julie Simmonds expects the earliest of approval of Hikma’s VR315 treatment will be in 2020.
She says the first generic product in the market usually gains the largest market share.
‘The generic Advair market is substantial, we estimate worth over $800m in total, and in a drug/device combination, the device will also have an influence over market share,’ comments Simmonds.
