Vectura Group plc Portfolio Update - VR315 US (5729U)
April 08 2016 - 2:00AM
UK Regulatory
TIDMVEC TIDMHIK
RNS Number : 5729U
Vectura Group plc
08 April 2016
Vectura Group plc
VR315 US
ANDA for Generic Advair Diskus(R) accepted for filing by FDA and
milestone payment
Chippenham, UK - 8 April 2016: Vectura Group plc (LSE: VEC;
"Vectura" or "the Company"), confirms that our partner on VR315 US,
Hikma Pharmaceuticals PLC (through its wholly-owned subsidiary,
West-Ward Pharmaceuticals) has confirmed its abbreviated new drug
application (ANDA) for fluticasone propionate and salmeterol
inhalation powder has been accepted for filing by the U.S. Food and
Drug Administration (FDA).
The FDA provided Hikma, through its wholly-owned subsidiary,
West-Ward Pharmaceuticals, with a GDUFA goal date of 10 May, 2017.
This product is the generic version of GlaxoSmithKline's Advair
Diskus(R) , which is indicated for the treatment of asthma and the
maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive pulmonary
disease (COPD) and is delivered using Vectura's proprietary dry
powder inhaler and formulation technology. The acceptance triggers
a cash milestone payment to Vectura of $10 million.
Vectura is eligible to receive a further milestone payment of
$11m upon approval by the FDA. In addition, Vectura will receive a
royalty from all sales of VR315 in the US.
James Ward-Lilley CEO, commented:
"The FDA acceptance of the ANDA filing is an important
regulatory step for our VR315 programme. With our partner, Hikma,
we have worked closely with FDA to ensure the quality of the ANDA
submission. Our interactions with FDA have helped clarify the
requirements for the development of a robust, patient friendly,
(AB-rated) substitutable generic product for Advair Diskus. We
believe that the strong data package submitted will facilitate the
approval of VR315 and gives us confidence that Hikma can be among
the first companies to launch this product in the US. We look
forward to working with our partner through the FDA approval
process to bring this very important product for patients and
which, upon successful launch, will be a major value driver for
Vectura."
ADVAIR and ADVAIR DISKUS are registered trademarks of Glaxo
Group Limited.
-Ends-
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
This product is the generic version of GlaxoSmithKline's Advair
Diskus(R) , which is indicated for the treatment of asthma and the
maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive pulmonary
disease (COPD) and is delivered using Vectura's proprietary dry
powder inhaler and formulation technology.
About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational group
focused on developing, manufacturing and marketing a broad range of
both branded and non-branded generic and in-licensed products.
Hikma operates through three businesses: "Injectables", "Branded"
and "Generics", based principally in the United States, the Middle
East and North Africa (MENA) and Europe. In 2015, Hikma achieved
revenues of $1,440 million and profit attributable to shareholders
of $252 million.
About Vectura
Vectura is a leading independent inhaled device, formulation,
development and specialist commercial
business focusing on the development of pharmaceutical therapies
for the treatment of airways diseases.
Vectura was established in 1997 to identify and develop
opportunities in drug formulation and delivery.
Vectura was listed on the London Stock Exchange in 2007 and is a
member of the FTSE 250 index. Vectura's main locations are in
Chippenham and Cambridge, in the UK, and Munich, in Germany.
Vectura's strong revenue growth is driven by an increasing
amount and range of royalties from marketed products and
significant milestone achievements. Vectura's diversified and
rapidly growing revenue base from the development and
commercialisation of its partnered products underpins the cash flow
to develop its pipeline and maintain investment in technology.
Vectura has established development collaborations, joint
ventures and licence agreements with several global pharmaceutical
and biotechnology companies, including Hikma (through its
wholly-owned subsidiary, West-Ward Pharmaceuticals), Novartis,
Sandoz, Baxter, GSK, UCB, Ablynx, Grifols, Janssen and Tianjin
KingYork Group Company. Vectura has committed pipeline programmes
combining novel and known treatments and is eligible for potential
future milestone payments of more than GBP90 million through to the
financial year 2022. Unique proprietary DPI and smart nebulisation
technologies provide Vectura with a base for further collaboration
agreements with new and existing partners.
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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