TIDMCLIN
RNS Number : 1721U
Clinigen Group plc
01 December 2021
1st December 2021
Clinigen Notes FDA Response to Porton Biopharma Limited's
Biologics License Application for Erwinaze(R)
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Services and Products company, announces today that
it has been informed by Porton Biopharma Limited ('PBL') that the
US Food and Drug Administration ('FDA') has issued a Complete
Response Letter ('CRL') regarding PBL's Biologics License
Application ('BLA') for Erwinaze(R) ( asparaginase Erwinia
chrysanthemi), an asparagine specific enzyme indicated as a
component of a multi-agent chemotherapeutic regimen for the
treatment of patients with acute lymphoblastic leukemia ('ALL') who
have developed hypersensitivity to E. coli-derived asparaginase,
which means the BLA cannot be approved in its current form.
As previously announced on 16 April 2020, Clinigen signed a
global licensing and distribution agreement with PBL to
commercialise and distribute Erwinaze(R)/Erwinase(R). Clinigen
currently supplies Erwinase(R) into more than 30 licensed and
unlicensed markets outside the US. The CRL does not impact these
markets.
PBL is in the process of reviewing the CRL and will provide
Clinigen with an update as soon as the discussions regarding the
response with the FDA have been completed.
Due to the recent negotiation of more favourable commercial
terms with PBL, cost savings linked to the delayed roll out of
Erwinaze(R) in the US and the continued strength of the pipeline
Clinigen maintains its FY22 guidance for EBITDA growth of 5% to
10%, and continues to expect strong, sustained growth in the years
thereafter in line with current market forecasts.
Sam Herbert, Group Chief Operating Officer, Clinigen, said:
"Although this is disappointing news for patients in the US, we
look forward to supporting our partner PBL to ensure that patients
in need outside the US are able to access Erwinase(R). To that end,
we continue to supply Erwinase(R) in ex-US markets."
- Ends -
Information within this announcement is deemed by Clinigen to
constitute inside information for the purposes of the UK version of
the Market Abuse Regulation (EU no. 596/2014)
Contact details
Clinigen Group plc Tel: +44 (0) 1283 495010
Sam Herbert, Group Chief Operating Officer Investors@Clinigengroup.com
& Head of Products Division
Rob Fox, VP Investor Relations and Corporate
Development
Numis Tel: +44 (0) 20 7260
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
Tel: +44 (0) 20 3709
Consilium Strategic Communications 5700
Mary-Jane Elliott / Matthew Cole / Jessica
Hodgson Clinigen@consilium-comms.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 1,000 employees across five continents in
14 countries, with supply and distribution hubs and operational
centers 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 120 countries.
For more information on Clinigen, please visit
http://www.clinigen.com .
About Erwinase
Erwinase (asparaginase Erwinia chrysanthemi) is an asparagine
specific enzyme indicated as a component of a multi-agent
chemotherapeutic regimen for the treatment of patients with acute
lymphoblastic leukemia ('ALL') who have developed hypersensitivity
to E. coli-derived asparaginase. Erwinase is indicated in pediatric
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 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.
Erwinia L-asparaginase is marketed under the name Erwinase
outside the United States by Porton Biopharma Limited, with
Clinigen as the exclusive licensed distributor.
About Acute Lymphoblastic Leukemia (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. In 2021, there are approximately 5,690
new cases of ALL (3,000 in males and 2,690 in females) in the U.S,
accounting for less than half of 1% of all cancers, according to
the American Cancer Society.
About Porton Biopharma Limited (PBL)
PBL is a biopharmaceutical development and manufacturing company
with approximately 400 staff. It was formed in April 2015 as a
spin-out company of Public Health England and has a sole
shareholder in 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, Dysport,
the UK's anthrax vaccine, and other medical treatments have been
developed at the site.
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