LONDON (Alliance News) - Hikma Pharmaceuticals PLC and Vectura Group PLC Friday said the new drug application for their fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the Food & Drug Administration in the US.
The two FTSE 250-listed pharmaceutical companies are working together on the inhalation powder, which is a generic version of GlaxoSmithKline PLC's Advair Diskus, which is used to treat asthma and to maintain treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease.
Advair Diskus is delivered using Vectura's proprietary dry powder inhaler and formulation technology.
"We are very pleased to have achieved this important milestone in the development of generic Advair Diskus. With our partner, Vectura, our team has worked closely with the FDA to ensure the quality of the ANDA submission," said Said Darwazah, chairman and chief executive of Hikma.
"The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme ... We believe that the strong data package submitted will facilitate the approval of VR315 and gives us confidence that Hikma can be among the first companies to launch this product in the US," said James Ward-Lilley, chief executive of Vectura.
Importantly, Vectura said the milestone means it will receive a USD10.0 million payment, adding it will receive another USD11.0 million payment once it has received FDA approval and also receive a royalty payment on all sales in the US once launched.
Hikma did not mention any milestone payments in its own press release Friday.
By Joshua Warner; joshuawarner@alliancenews.com; @JoshAlliance
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