Hikma Pharmaceuticals Plc Hikma announces agreement with Vectura
November 08 2018 - 4:44AM
RNS Non-Regulatory
TIDMHIK
Hikma Pharmaceuticals Plc
08 November 2018
London, 8 November 2018 - Hikma Pharmaceuticals PLC (Hikma,
Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1
Moody's / BB+ S&P, both stable) today announces that it has
signed an agreement with Vectura Group plc (Vectura) for the global
development and commercialisation of generic versions of GSK's
Ellipta(R) portfolio, utilising Vectura's proprietary
Open-Inhale-Close dry powder inhaler device.
Siggi Olafsson, Chief Executive Officer of Hikma, said: "The
generic respiratory market is a key area of pipeline focus for
Hikma. This agreement leverages the investment we have made and the
experience we have gained through our generic Advair Diskus(R)
programme. By strengthening and expanding our partnership with
Vectura, we will develop a pipeline of complex respiratory products
that will enable us to deliver sustainable long-term growth."
A significant opportunity to bring complex respiratory products
to market
Following interactions with the US FDA, Vectura and Hikma
believe the Open-Inhale-Close dry powder inhaler device has the
potential to be developed as an AB-rated substitutable drug-device
combination for generic versions of the GSK Ellipta(R) portfolio.
This presents a significant opportunity, with net sales for
Ellipta(R) products in the US projected to be $4 billion by 2024
and approximately $5.5 billion globally(1) .
The Open-Inhale-Close dry powder inhaler programme includes the
development of AB-rated substitutable generics of up to five GSK
respiratory medicines. Hikma and Vectura have agreed to develop and
commercialise at least three of the portfolio products. A
substitutable generic version of Breo(R) Ellipta(R) (fluticasone
furoate and vilanterol trifenatate) will be prioritised for the
first wave of development. Pharmaceutical and device development
work has progressed in parallel with partnering discussions. The
new device is an evolution of Vectura's lever-operated multi-dose
(LOMI) device and builds on Vectura and Hikma's shared experience
with the generic Advair Diskus(R) programme, enabling accelerated
development under this new agreement.
Financial considerations
Upon signing, Hikma will make an upfront payment of $15 million
to Vectura. Vectura will be responsible for, and fund, initial
device and formulation development. Hikma will be responsible for
clinical development, regulatory submission and commercialisation.
Upon transfer of the first product to Hikma's manufacturing
facility to enable clinical manufacturing, Hikma will make a $5
million milestone payment to Vectura. Thereafter, Hikma will make
milestone payments of up to $75 million at various stages of
development, including the delivery of pharmacokinetic clinical
trials, pivotal clinical trials, ANDA submissions and FDA
approvals. On approval, Hikma will pay a share of distributable net
profit of up to a mid-teen percentage for each portfolio product.
Hikma will also pay sales milestones on the achievement of certain
cumulative net sales targets. Vectura will contribute up to $70
million towards Hikma's development activities for the portfolio.
Vectura's contribution to the development costs will be deferred
and made through a reduced profit share mechanism following
commercial launch of the first product.
(1) Global Data, October 2018
-- ENDS -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
FTI Consulting
Ben Atwell/Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
40 years, we've been creating high-quality medicines and making
them accessible to the people who need them. We're a global company
with a local presence across the United States (US), the Middle
East and North Africa (MENA) and Europe, and we use our unique
insight and expertise to transform cutting-edge science into
innovative solutions that transform people's lives. We're committed
to our customers, and the people they care for, and by thinking
creatively and acting practically, we provide them with a broad
range of branded and non-branded generic medicines. Together, our
8,500 colleagues are helping to shape a healthier world that
enriches all our communities. We are a leading licensing partner in
the MENA region, and through our venture capital arm, are helping
bring innovative health technologies to people around the world.
For more information, please visit www.hikma.com.
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
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END
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