TIDMVEC
RNS Number : 8435T
Vectura Group plc
11 January 2017
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(R) and Seebri(R) and the first
approval using Vectura's handheld FOX(R) 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(R) ,
Ultibro(R) Breezhaler(R) , Seebri(R) Breezhaler(R) and the GSK
Ellipta(R) products (Breo(R) /Relvar(R) Ellipta(R) , Anoro(R)
Ellipta(R) and Incruse(R) Ellipta(R) ) 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(R) 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(R) 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 EUR1.5 million. The Group is also eligible to earn further total
potential milestones up to EUR46.5 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(R) 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(R) and Seebri(TM) Neohaler(R) 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(R) device which Bayer has branded
Breelib(R) . 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(R) 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(R) Diskus(R) 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(R) Diskus(R) ANDAs publicly filed and
accepted."
- Ends -
Enquiries
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 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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