VR315 US completes clinical study

January 08, 2016 at 7:00 AM

Chippenham, UK – 8 January 2016: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), announces the completion of a clinical trial for VR315 in the US. VR315 is a generic, inhaled combination therapy (fluticasone/salmeterol) for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.

Vectura can also confirm that its partner for this programme and VR506 US, is Roxane Laboratories, Inc. a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT, and a member of the Boehringer Ingelheim group of companies. VR506 is a generic, inhaled monotheraphy (corticosteroid) for asthma delivered using Vectura's proprietary dry powder inhaler and formulation technology.

In August 2011, Vectura signed a licence agreement with Roxane Laboratories, Roxane Laboratories, Inc. is a subsidiary of Boehringer Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies, for the development, manufacturing and commercialisation of VR315 in the US. To date, Vectura has announced development milestones under this agreement totalling $12m.

Vectura is eligible to receive a further $23m upon achievement of future pre-determined development milestones on VR315. These milestones, together with the initial payment of $10m in August 2011, total $45m. In addition, Vectura will receive a royalty from all sales of VR315 in the US.

To date, Vectura has previously received an initial cash milestone payment on VR506 of $4 million and a further $8 million could be received upon achievement of pre-determined development milestones. In addition, Vectura will receive a royalty from all sales of VR506 in the US.

James Ward-Lilley CEO, commented:

"This announcement marks an important step in the progression to market for our VR315 programme. With the completion of this important clinical trial and details of the study and partner disclosed we now look forward to submission of the file, positioning VR315 competitively in what will be a major value opportunity."

 

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Enquiries

Vectura Group plc

+44 (0)1249 667700


Karl Keegan, Chief Corporate Development Officer

Fleur Wood, Director – Investor Relations and Corporate Communications

 

 

 

Citigate Dewe Rogerson

+44 (0)20 7638 9571

David Dible / Mark Swallow


About VR315

VR315 is a generic, inhaled combination (fluticasone/salmeterol) therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.

Full details of the completed trial are available on www.clinicaltrials.gov.

About Roxane Laboratories, Inc.

Roxane Laboratories is located in Columbus, Ohio, in a modern 500,000-square-foot manufacturing and laboratory facility that spans 70 acres and employs more than 1,400 people. Roxane markets more than 80 medications in nearly 250 package sizes, focusing on an expanding line of Generic pharmaceutical products, including bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, – potent compounds and CII narcotics.

Roxane Laboratories, Inc. is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT, and a member of the Boehringer Ingelheim group of companies. For more information, please visit www.roxane.com.

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.

 

[1] Decision Resources 2014

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