TIDMCLIN
Clinigen Group plc
22 September 2021
22(nd) September 2021
Clinigen signs European agreement with Secura Bio for the
exclusive supply and distribution of COPIKTRA(R)
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Services and Products company, announces it has
signed an exclusive agreement with Secura Bio, Inc ('Secura Bio')
for the supply and distribution of COPIKTRA(R) in most of
Europe.
COPIKTRA(R) was granted marketing authorization by the European
Medicines Agency in May 2021 as monotherapy for the treatment of
adults with relapsed or refractory Chronic Lymphocytic Leukemia
(CLL) in patients who have received at least two prior therapies
and for the treatment of Follicular Lymphoma (FL) that is
refractory to at least two prior systemic therapies. The goal of
therapy for patients with these cancers is to improve overall
survival and quality of life. COPIKTRA(R) is a dual inhibitor of
PI3K-delta and gamma pathways, which are involved in the
proliferation of malignant cells and are thought to play a role in
the formation and maintenance of the supportive tumor
microenvironment.
PRIMO, a Phase 2 study, also seeks to evaluate COPIKTRA(R) for
patients with relapsed or refractory peripheral T-cell
lymphoma.
Under the terms of the agreement Clinigen will market, supply
and distribute COPIKTRA(R) into 39 countries across Europe
including Austria, Belgium, Croatia, Czech Republic, Denmark,
Finland, France, Greece, Hungary, Ireland, Italy, The Netherlands,
Poland, Portugal, Spain, Sweden and Switzerland. Secura Bio will
promote and distribute COPIKTRA directly in Germany and the United
Kingdom.
Sam Herbert, Chief Operating Officer and Head of Products
Division, Clinigen, said:
"Clinigen is very pleased to be partnering with Secura Bio. This
new and exclusive agreement will help address a significant unmet
need for patients with B-cell blood cancers across Europe. This
agreement underlines Clinigen's strength in partnering with
pharmaceutical companies and leveraging our significant commercial
knowledge and infrastructure to ensure the right medicine gets to
the right patients at the right time ."
Joseph M. Limber, President and Chief Executive Officer, Secura
Bio, said:
"Partnering with Clinigen will enable COPIKTRA, an oncology
treatment with a novel mode of action, to be widely and rapidly
available to patients across Europe. Leveraging Clinigen's
commercial resources, supply and distribution infrastructure and
regulatory expertise will allow physicians and patients throughout
Europe to gain access to a valuable option to combat the
debilitating illnesses of CLL and FL. We are excited to have
Clinigen to ensure successful market access, commercialization and
supply of COPIKTRA in Europe."
- Ends -
Contact details
Clinigen Group plc +44 (0) 1283 495010
Sam Herbert, Group Chief Operating Officer investors@clinigengroup.com
Rob Fox, VP Investor Relations and Corporate
Development
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Tel: +44 (0) 20 3709 5700
Hodgson Clinigen@consilium-comms.com
Secura Bio, Inc
Mark Spring, Chief Financial Officer Tel: +1 (702) 465-4196
mspring@securabio.com
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products company 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
centres of excellence in key long-term growth regions. The Group
works with 34 of the top 50 pharmaceutical companies; interacting
with over 20,000 healthcare professionals across more than 120
countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma
(FL)
CLL and FL are slow-growing incurable blood cancers that can
lead to life-threatening complications such as anemia, serious
infections, and bone marrow failure requiring treatment
About Secura Bio
Secura Bio is an integrated, commercial-stage pharmaceutical
company dedicated to the worldwide development and
commercialization of impactful oncology therapies for physicians
and their patients. For more information on Secura Bio, please
visit www.securabio.com .
About COPIKTRA(R)(duvelisib )
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first United States FDA approved dual inhibitor of
PI3K-delta and PI3K-gamma, two enzymes known to help support the
growth and survival of malignant cells. PI3K signaling may lead to
the proliferation of malignant cells and is thought to play a role
in the formation and maintenance of a supportive tumor
microenvironment. COPIKTRA is also being developed for the
treatment of peripheral T-cell lymphoma (PTCL), for which it has
received Fast Track status in the United States and is being
investigated in combination with other agents through
investigator-sponsored studies.
For more information on COPIKTRA, please visit www.COPIKTRA.com
. For more information on COPIKTRA EU Product Information, please
visit https://www.ema.europa.eu/en/medicines/human/EPAR/copiktra .
For information about duvelisib clinical trials can be found on
www.clinicaltrials.gov.
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