Vectura Release: VR315 U.S. ANDA For Generic Advair Diskus Accepted For Filing By FDA And Milestone Payment
Chippenham, UK – 8 April 2016: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”), confirms that our partner on VR315 US, Hikma Pharmaceuticals PLC (through its wholly-owned subsidiary, West-Ward Pharmaceuticals) has confirmed its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The FDA provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, with a GDUFA goal date of 10 May, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura’s proprietary dry powder inhaler and formulation technology. The acceptance triggers a cash milestone payment to Vectura of $10 million.
Vectura is eligible to receive a further milestone payment of $11m upon approval by the FDA. In addition, Vectura will receive a royalty from all sales of VR315 in the US.
James Ward-Lilley CEO, commented:
“The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme. With our partner, Hikma, we have worked closely with FDA to ensure the quality of the ANDA submission. Our interactions with FDA have helped clarify the requirements for the development of a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus. 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. We look forward to working with our partner through the FDA approval process to bring this very important product for patients and which, upon successful launch, will be a major value driver for Vectura.”
ADVAIR and ADVAIR DISKUS are registered trademarks of Glaxo Group Limited.
The FDA provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, with a GDUFA goal date of 10 May, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura’s proprietary dry powder inhaler and formulation technology. The acceptance triggers a cash milestone payment to Vectura of $10 million.
Vectura is eligible to receive a further milestone payment of $11m upon approval by the FDA. In addition, Vectura will receive a royalty from all sales of VR315 in the US.
James Ward-Lilley CEO, commented:
“The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme. With our partner, Hikma, we have worked closely with FDA to ensure the quality of the ANDA submission. Our interactions with FDA have helped clarify the requirements for the development of a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus. 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. We look forward to working with our partner through the FDA approval process to bring this very important product for patients and which, upon successful launch, will be a major value driver for Vectura.”
ADVAIR and ADVAIR DISKUS are registered trademarks of Glaxo Group Limited.