Vectura Provides Status Update on Hikma’s ANDA for Generic Advair Diskus VR315 (US)


Vectura Group plc, an industry-leading inhalation CDMO, recently confirmed the announcement made by its partner Hikma Pharmaceuticals PLC, which has received a minor complete response letter (CRL) from the US FDA in relation to its abbreviated new drug application (ANDA) for its US generic version of GlaxoSmithKline’s Advair Diskus VR315 (US).

Hikma is working closely with the FDA to quickly address the small number of questions raised in the minor CRL. Once answered, Hikma can expect to receive a response from the FDA within 90 days. Both Hikma and Vectura are committed to bringing this important product to the US market and remain confident in the submission.

Hikma has stated that it now expects to receive approval for its generic Advair Diskus in early 2021. Approval of VR315 (US) will trigger milestones to Vectura of $11m, with a mid-teen percentage royalty on net sales of the product. Aside from VR315 (US), all other Vectura guidance for 2020 remains unchanged.

 Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.

Vectura has 11 key inhaled and 11 non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Its partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork. For more information, visit www.vectura.com.