TIDMCLIN
RNS Number : 8095J
Clinigen Group plc
16 April 2020
16 April 2020
Clinigen signs exclusive global licensing and distribution
agreement with
Porton Biopharma to commercialise Erwinase(R) / Erwinaze (R)
Group provides trading update on COVID-19
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the
global pharmaceutical and services company, has signed an exclusive
licensing and distribution agreement with Porton Biopharma Limited
('PBL') to commercialise Erwinase (R) / Erwinaze (R) ('Erwinase')
and is issuing a trading update regarding COVID-19.
Global licensing and distribution agreement with Porton
Biopharma for Erwinase(R)/ Erwinaze (R)
Erwinase is approved for patients with Acute Lymphoblastic
Leukaemia (ALL) who have developed hypersensitivity to E.
coli-derived asparaginase in 19 countries, including the US, Europe
and Japan.
Clinigen will look to expand the market opportunity for Erwinase
by driving awareness of the product's availability, ensuring
uninterrupted patient access, launching in select new countries and
increasing the global supply of the product into unlicensed markets
utilising its global infrastructure through a global access
program.
Erwinase will be the Group's third biologic and fits well within
Clinigen's existing haematology and oncology product portfolio and
customer base. It further strengthens and leverages Clinigen's
newly established commercial infrastructure in both the EU and
higher value US market where it currently owns the rights to
Proleukin (R) , Foscavir(R), Ethyol(R) and Totect(R).
In the year to 31 December 2019, net sales of Erwinase were
$177m. Whilst the agreement will start on 1 January 2021, it is
anticipated that net sales for Clinigen will begin in the second
half of 2021 as the product is transitioned from PBL's current
licensing partner. PBL will maintain the trademarks and manufacture
the product, whilst Clinigen will be responsible for product
marketing, packaging, labelling, storage and distribution of the
product.
Clinigen will pay PBL GBP5m upfront in cash consideration plus
future sales-based milestone payments of up to GBP20m, alongside
tiered royalty payments based upon worldwide net sales of Erwinase.
Upon onboarding the product, Clinigen expects a modest amount of
working capital investment (GBP10m-GBP20m across FY21/22) to
support the product which can be funded through its current debt
facilities.
Trading update regarding COVID-19
Clinigen has implemented a range of measures to prioritize
keeping its employees safe, including extensive home working,
whilst ensuring it can support hospitals and their patients during
these times.
The Group has been working closely with its pharmaceutical
clients as well as its hospital customers to ensure that the supply
of critical medicines to patients on a global basis continues
uninterrupted.
Trading for the year to 30 June 2020 continues to be in line
with the Board's expectations and the business had a strong first
nine months of the year with organic gross profit growth of over
10% to the end of March 2020.
To date the Group has experienced only marginal disruption from
COVID-19 which is a testament to the strength of its global
diversified platform and its partners in the industry.
The cash generation delivered in the first three months of the
second half has proceeded in line with the Board's expectations as
the Group has made material strides in alleviating issues related
to the ERP system.
The fundamental positive cash generation characteristic of
Clinigen remains unchanged with significant levels of liquidity
available to the Group from its GBP430m debt facility. Clinigen
expects to keep well within its 3.0x net debt / EBTIDA covenant
limit throughout FY20 before reducing this leverage ratio to below
2.0x during FY21.
Shaun Chilton, Group Chief Executive Officer, Clinigen,
said:
"This licensing agreement fits with our strategy to partner with
pharmaceutical companies to expand and extend the lifecycle of
their products by utilising our global platform and expertise in
the supply and distribution of both unlicensed and licensed
medicines.
"As part of our portfolio in oncology and haematology, Erwinase
strengthens our commercial offering in key markets and will be a
priority product for the Group. The agreement will ensure
healthcare professionals have the broadest possible access to this
important treatment for their patients.
"As the COVID-19 situation continues to evolve, our priority
remains the safety of our employees and our clients. We have also
performed well during these challenging times. Our unique business
has the international reach and capability to continue to offer a
meaningful contribution to helping our customers and partners at a
time when they need us the most."
- Ends -
Information within this announcement is deemed by the Company to
constitute inside information under the Market Abuse Regulations
(EU) No. 596/2014.
Contact details
Clinigen Group plc Tel: +44 (0) 1283 495010
Shaun Chilton, Chief Executive Officer
Nick Keher, Chief Financial Officer
Matt Parrish, Head of Investor Relations
Numis Securities Limited - Nominated Adviser Tel: +44 (0) 20 7260 1000
& Joint Broker
James Black / Freddie Barnfield
RBC Capital Markets - Joint Broker Tel: +44 (0) 20 7653 4000
Marcus Jackson / Elliot Thomas
Instinctif Partners Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell / Phillip Marriage Email: clinigen@instinctif.com
Notes to Editors
About Erwinase(R) / Erwinaze(R)
Erwinase is indicated for the treatment of Acute Lymphoblastic
Leukaemia (ALL), a type of cancer that particularly affects
children. Erwinase is an asparaginase enzyme derived from the
bacterium Erwinia chrysanthemi that is used as part of the
treatment protocols in conjunction with radiotherapy or
chemotherapy.
Asparagine is an amino acid that is essential for cell growth;
it is produced by most but not all cells. Mutated cancer cells in
ALL rely on asparagine circulating in the blood for growth.
L-asparaginases are a group of enzymes that lower circulating
asparagine levels in the blood, thereby depriving the mutated cells
of asparagine and inhibiting their growth.
There are several different types of L-asparaginase available on
the market, each derived from a different bacterium. Patients
receiving treatment with L-asparaginase derived from Escherichia
coli (E. coli), who develop hypersensitivity to that form of the
enzyme, may be able to continue treatment with Erwinase as the
enzymes are immunologically distinct. Antibodies targeting E. coli
derived L-Asparaginase have been shown not to cross-react with
Erwinase.
About Acute Lymphoblastic Leukaemia (ALL)
Acute lymphoblastic leukaemia (ALL) is a type of blood cancer
that starts from young white blood cells called lymphocytes in the
bone marrow. Both adults and children can get the illness, but it
is most often diagnosed in younger people. There are approximately
5,000 new cases each year in the US and 4,000 in Europe. The
disease is the most common childhood cancer and is responsible for
more than 80 percent of childhood leukaemia cases.
About Porton Biopharma Limited (PBL)
PBL is a biopharmaceutical development and manufacturing
company. It was formed in April 2015 as a spin-out company of
Public Health England, part of the Department of Health and Social
Care. PBL is based at Porton Down, Wiltshire, which has a long
history of pharmaceutical development and manufacturing. Erwinase,
the UK's anthrax vaccine, Dysport and other medical treatments have
been developed at the site by the forerunners to PBL. PBL has
approximately 350 staff and has a sole shareholder in the
Department of Health and Social Care.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and
services company with a unique combination of businesses focused on
providing ethical access to medicines. Its mission is to deliver
the right medicine to the right patient at the right time through
three areas of global medicine supply; clinical trial, unlicensed
and licensed medicines. The Group has sites in North America,
Europe, Africa and Asia Pacific.
Clinigen now has over 1,100 employees across five continents in
14 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 22 of the top 25 pharmaceutical companies; interacting
with over 15,000 registered users across over 100 countries,
shipping approximately 6.4 million units in the year.
For more information on Clinigen, please visit
www.clinigengroup.com .
Cautionary statement
This announcement contains certain projections and other
forward-looking statements with respect to the financial condition,
results of operations, businesses and prospects of Clinigen Group
plc. These statements are based on current expectations and involve
risk and uncertainty because they relate to events and depend upon
circumstances that may or may not occur in the future. There are a
number of factors which could cause actual results or developments
to differ materially from those expressed or implied by these
forward-looking statements. Any of the assumptions underlying these
forward-looking statements could prove inaccurate or incorrect and
therefore any results contemplated in the forward-looking
statements may not actually be achieved. Recipients are cautioned
not to place undue reliance on any forward-looking statements
contained herein. Except as required by law, Clinigen undertakes no
obligation to update or revise (publicly or otherwise) any
forward-looking statement, whether as a result of new information,
future events or other circumstances.
The information contained in this statement has not been audited
and may be subject to further review.
This information is provided by RNS, the news service of the
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END
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