28th Jul 2015 07:00
Vectura Group plc
Announces successful pre-IND meeting with the US FDA regarding VR647
Chippenham, UK - 28 July 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), which specialises in the development of products for the treatment of airways-related diseases, announces that on 10 June 2015, it held a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of VR647.
VR647
VR647 is a budesonide inhalation suspension co-packaged with a Smart Card for use in the breath-actuated AKITA® JET nebuliser, wholly owned by the Company. The proposed indication is a maintenance treatment and prophylactic therapy of asthma in children. The Company is seeking to improve the nebulised delivery of budesonide.
Following this meeting the Company can confirm that the FDA has agreed with our intent to rely on the 505(b)(2) pathway for the development programme with the aim of filing a New Drug Application (NDA). The development plan requires a small number of clinical studies that are within our previously guided R&D spend and offers a significant product development opportunity for the Company. Filing of VR647 is anticipated in 2H 2019.
Dr Trevor Phillips, Interim CEO, commented:
"We are pleased with the outcome of the meeting with the FDA. The FDA's feedback has provided clear direction for the remaining studies required for the NDA and we believe we are well positioned to successfully transition this programme into development."
-Ends-
Enquiries
Vectura Group plc | +44 (0)1249 667700 |
Trevor Phillips, Interim CEO | |
Karl Keegan, Chief Corporate Development Officer | |
Citigate Dewe Rogerson | +44 (0)20 7638 9571 |
David Dible / Malcolm Robertson |
About Vectura
Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth $44 billion worldwide.1
Vectura now has eight products marketed by partners with growing global royalty streams and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura currently has disclosed development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols, Janssen Biotech and Tianjin KingYork Group Company.
Vectura develops products for airways diseases and owns formulation and inhalation technologies that are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy.
For further information, please visit Vectura's website at www.vectura.com.
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
________________
Related Shares:
VEC.L