New development and licence agreement for a US inhaled generic (VR2081)

June 28, 2017 at 5:25 PM

Chippenham, UK – 28 June 2017: Vectura Group plc (LSE: VEC) (“Vectura”, “the Group”), an industry-leading device and formulation business for inhaled airways products, today announces that through its subsidiary, Jagotec AG (collectively, “Vectura”, “the Group”), it has signed an exclusive development and licence agreement with Sandoz AG (“Sandoz”), a global leader in generic pharmaceuticals and a division of the Novartis Group, for the development of a generic of an existing major inhaled combination therapy for asthma and COPD in the US (VR2081) delivered using a pressurised metered dose inhaler (“pMDI”).

Under the terms of this agreement, Vectura is responsible for the development of the formulation and manufacture of clinical batches for use in pilot clinical studies whilst Sandoz is responsible for the clinical development, manufacture and commercialisation of VR2081. 

Vectura will receive an initial payment of $5 million from Sandoz and is eligible to receive up to a further $5 million upon achievement of pre-determined development milestones. The Group is also eligible to receive a double digit percentage royalty on net sales in line with our other generic development programmes. The total R&D cost borne by Vectura is expected to be below $20 million up to regulatory filing and subsequent launch, which is anticipated in the early to mid-2020’s. It is expected that the $5 million initial milestone will be recognised in revenues across 2017 and 2018 but will be offset by a modest increase in R&D spend in those years. The overall R&D guidance range of £65 million - £75 million for each of 2017 and 2018 remains unchanged. 

The global respiratory market, worth over $40 billion[1] in 2015, is expected to continue to grow, with current estimates predicting low single digit percentage growth annually up to 2025[1]. Within this, the dynamics of the classes of products are forecast to change significantly with further generic penetration of core classes such as ICS/LABA and LAMA expected to gain momentum. The generics market is growing and accounts for over 80% of all US prescriptions and in 2015 was estimated to be worth c. $80 billion[2].

James Ward-Lilley, Chief Executive Officer, commented:

"This agreement, extending our existing strong relationship with Sandoz, further reinforces Vectura’s compelling position as a leader in the development of inhaled novel and generic products leveraging our suite of formulation and device platforms and proven development capabilities. Following the merger of Vectura and Skyepharma last summer we announced that we were prioritising three to five generic projects utilising the Group’s newly combined pMDI and DPI device platforms. This programme represents the first partnered collaboration of this series of projects and offers substantial potential for future value creation."  

This announcement includes inside information

 - ENDS -

 For more enquiries, please contact

Vectura Group plc

+44 (0)1249 667700

Andrew Derodra – Chief Financial Officer
Fleur Wood –  Director, Communications
Elizabeth Knowles – Director, Investor Relations and Analysis

 

Consilium Strategic Communications

+44 (0)20 3709 5700

Mary-Jane Elliott / Sue Stuart / Jessica Hodgson

 vectura@consilium-comms.com

About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.  

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, and Tianjin KingYork. 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] Source: Global Data 2016, market defined as Asthma, COPD,  Allergic Rhinitis, IPF, CF, ARDS and RSV

[2 ] Generic Drug Access & Savings Report 2017 (US Market) – AAM/QuintilesIMS

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