Clinigen Group plc Clinigen to begin supplying Erwinase(R) in the UK (4604U)
April 06 2021 - 1:00AM
UK Regulatory
TIDMCLIN
RNS Number : 4604U
Clinigen Group plc
06 April 2021
6 April 2021
Clinigen to begin supplying Erwinase(R) in the UK
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Products and Services company, today announces that
it will be providing access to Erwinase (R) (L-asparaginase Erwinia
chrysanthemi) in the UK from the 6 April 2021. This is part of the
global exclusive licensing and distribution agreement with Porton
Biopharma ('PBL'), as previously announced on 16 April 2020.
Erwinase is approved in the UK as a component of a
chemotherapeutic regimen for the treatment of patients with acute
lymphoblastic leukaemia (ALL) who have developed hypersensitivity
to E. coli-derived asparaginase . Erwinase is manufactured by PBL
(PL 44403/0002) and Clinigen is responsible for marketing,
packaging, labelling, storage and distribution.
With the onboarding of Erwinase coming earlier than originally
anticipated this will bring forward an expected investment in
working capital in-line with our previous guidance of GBP10m -
GBP20m. Given the proximity to the year end and staggered roll out
across each territory this is not expected to have a material
impact on current year profit expectations.
Sam Herbert, Chief Operating Officer, Clinigen, said:
"Erwinase(R) is an important treatment option for healthcare
professionals in the UK and this represents a major milestone since
partnering with PBL. PBL has invested in enhancing its
manufacturing to increase Erwinase(R) capacity and our ongoing
focus is to ensure effective future supply in the UK and in other
international markets where patients need access. At Clinigen our
mission is to ensure the right medicines get to the right patients
at the right time and we see Erwinase(R) as a key part of that
mission."
Healthcare professionals can obtain ordering details about
Erwinase by calling the Clinigen customer service
team at +44 (0) 1932 824100 or emailing MedicineAccess@clinigengroup.com .
Patients seeking medical information should contact their
physician.
- Ends -
Contact details
Clinigen Group plc Tel: +44 (0) 1283 495010
Sam Herbert, Chief Operating Officer Investors@Clinigen.com
Numis Securities Limited - Nominated Adviser Tel: +44 (0) 20 7260
& Joint Broker 1000
James Black / Garry Levin / Freddie Barnfield Clinigen@Numis.com
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 / Tim Linacre / Rozi Morris
/ Phillip Marriage clinigen@instinctif.com
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products platform focused on providing
ethical access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time. The Group operates
from sites in North America, Europe, Africa and the Asia
Pacific.
Clinigen has more than 1,250 employees across five continents in
16 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 34 of the top 50 pharmaceutical companies; interacting
with over 5,000 hospitals across more than 115 countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About Erwinase (R) / Erwinaze (R)
Erwinase is indicated as a component of a chemotherapeutic
regimen for the treatment of patients with acute lymphoblastic
leukaemia (ALL) who have developed hypersensitivity to E.
coli-derived asparaginase. Erwinase is indicated in paediatric
patients from the age of 4 months and in adults.
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 leukemia (ALL) is a heterogenous hematologic
disease characterized by the proliferation of immature lymphoid
cells in the bone marrow, peripheral blood and other organs. Both
adults and children can get the illness, but it is most often
diagnosed in younger people. The incidence in the EU is thought to
be 1.28 per 1 000 000 individuals annually, with significant
age-related variations. Estimated new ALL cases in the US was
estimated to be 6150 in 2020 according to the SEER program.
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.
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