Vectura Group plc: Pre-close update
January 11 2017 - 7:05AM
Vectura Group plc
Pre-close update
Significant business development progress with
year-end revenues in line with expectations
Chippenham, UK - 11 January
2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an
industry-leading device and formulation business for inhaled
airways disease, today announces an unaudited pre-close update
ahead of its results for the nine months ended 31 December 2016,
due in March.
Following the step-change in financial
performance announced in the interim results in November, further
significant progress was made in December with the announcement of
a global pMDI triple programme with Mundipharma, confirmation of
the US commercialisation for Ultibro® and Seebri® and the first
approval using Vectura's handheld FOX® smart nebuliser as part of a
referenced labelled product.
Trading
Revenues for 2016 are anticipated to be in line
with the Board's expectations with positive momentum from the seven
key recently-launched inhaled products including flutiform®,
Ultibro® Breezhaler®, Seebri® Breezhaler® and the GSK
Ellipta® products (Breo®/Relvar® Ellipta®,
Anoro® Ellipta® and Incruse® Ellipta® )
providing a strong base of recurring revenue. The continued
weakness of sterling against the Group's main trading currencies,
in particular the US dollar and Euro, has also benefited reported
results. Volumes in the flutiform® supply chain have been at record
levels and good progress is being made with the
previously-announced capital expenditure initiatives to expand
capacity. Ultibro continues to benefit from strong data from the
FLAME study as well as the results of the CRYSTAL study showing
improved lung function and COPD symptoms after direct switch from
previous treatment.
In addition, on 6 January 2017 Pacira
Pharmaceuticals, Inc. reported preliminary unaudited net sales of
EXPAREL® in Q4 2016 were $71.4 million, compared to $67.2 million
for Q4 2015. The Group earns a three percent. share of net sales
(on a cash received basis) and is also eligible for a sales
milestone of $32 million when worldwide annual net sales of the
product reach $500 million (on a cash received basis).
Pipeline progress
On 23 December a global development and licence
agreement was signed with Mundipharma International
Corporation Limited and a US independent associated
company ("Mundipharma") for the VR2076 pressurised Metered
Dose Inhaler ("pMDI") ICS/LABA/LAMA triple programme. Following
successful completion of feasibility work, which Vectura was
responsible for, Mundipharma confirmed the exercise of its
option to develop and commercialise VR2076 initially in
asthma. This exercise triggered a payment to Vectura of €1.5
million. The Group is also eligible to earn further total potential
milestones up to €46.5 million linked to development, regulatory
and launch progress of the programme as well as royalties on any
future net sales of the product. The first regulatory filings of
VR2076 are planned in the EU for late 2022/early 2023. This
agreement extends our successful collaboration with Mundipharma on
flutiform® and, along with the Novartis QVM149 DPI programme,
increases the Group's exposure to the important emerging triple
combination class.
On 21 December Novartis signed a licensing
agreement with Sunovion Pharmaceuticals Inc., a strong established
respiratory business with an existing COPD portfolio, to
commercialise Utibron(TM) Neohaler® and Seebri(TM) Neohaler® in the
US. The Group expects these products to be launched in H1 2017 and
will receive royalties on any future net sales, making a further
contribution to the substantial existing recurring and growing
royalty stream we currently receive from Novartis.
On 22 December Bayer AG ("Bayer"), our partner
on VR876, confirmed completion of the EU regulatory procedure that
allows an alternative nebulised delivery (method of administration)
for its currently marketed product Ventavis (iloprost) using
Vectura's handheld smart nebuliser FOX® device which Bayer has
branded Breelib®. The positive regulatory action on this programme
with Bayer is particularly significant as it represents the first
regulatory approval and progression to commercialisation of
Vectura's FOX® smart nebuliser as part of a referenced labelled
product. Although the financial value for the Group from this
programme will be relatively modest, given the small patient
population, this external platform validation coincides with
sustained interest from multiple potential collaborators seeking to
leverage the FOX's unique drug device technology. We look forward
to concluding a number of these new partnerships in 2017.
James Ward-Lilley, Chief Executive Officer,
commented:"Vectura starts 2017 in a strong position with
significant progress made with the pipeline and sustained growth
momentum in recurring revenues driven by the seven recently
launched inhaled products.
We look ahead now to reporting our 2016
preliminary results in March, further pipeline news flow and
leveraging Vectura's proven device and formulation capabilities
through additional business development opportunities. An important
part of our news flow for 2017 remains VR315, our generic
Advair® Diskus® programme partnered with Hikma. This
programme remains under FDA regulatory review and we continue to
work closely with our partner through this process. VR315 has a
GDUFA goal date of 10 May 2017 and is one of only two generic
Advair® Diskus® ANDAs publicly filed and accepted."
- Ends -
Enquiries
Vectura Group plc |
+44 (0)1249 667700 |
Andrew Derodra - Chief Financial OfficerFleur Wood -
Director CommunicationsElizabeth 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 inhaled airways
disease focused business with proprietary formulation and devices
across DPI, pMDI and "smart" nebulisation platforms. With our
extensive range of technologies, capabilities and collaborations,
we believe we can become a leader in the development of inhalation
products, increasing our ability to help patients suffering from
respiratory diseases. In June 2016 Vectura completed a merger
with Skyepharma PLC.
Vectura has seven 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, 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.
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