Hikma Advair Diskus ANDA delayed as FDA issues CRL

Shares of Jordan-based Hikma Pharmaceuticals (LSE: HIK) were down 8.2% at 1,795 pence mid-morning after it revealed receipt of a complete response letter (CRL) from the US Food and Drug Administration in relation to its Abbreviated New Drug Application (ANDA) for VR315, its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

The drug is delivered using UK-based Vectura Group’s (LSE: VEC) proprietary dry powder inhaler and formulation technology, with Vectura’s shares also falling by 9.3% to 131.60 pence on the news. Vectura is due to receive an $11 million milestone payment on approval of the ANDA plus a mid-teen percentage royalty on net sales of VR315 in the USA, which the company says it now does not expect to occur in 2017.

The FDA has categorized the CRL as ‘Major.’ Hikma and Vectura are in the process of reviewing the response and will provide an update on its application as soon as practicable once it has completed its review of the CRL and discussed this with the FDA. Based on the initial assessment, no material issues were raised regarding the substitutability of the proposed device, the companies said.