SUMMERLIN, Nev., Sept. 22, 2021
/PRNewswire/ -- Secura Bio, Inc. (Secura Bio) -
(www.securabio.com), an integrated pharmaceutical company dedicated
to the worldwide development and commercialization of impactful
oncology therapies, today announced that it has entered into a
distribution agreement for COPIKTRA (duvelisib) with Clinigen Group
Plc (Clinigen) covering 39 countries in 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.
Clinigen is a global, specialist pharmaceutical services and
products company who partner with pharmaceutical and biotech
companies to provide ethical access to medicines for patients with
unmet medical needs.
COPIKTRA was granted marketing authorization by the European
Medicines Agency in May 2021 as
monotherapy for the treatment of 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. 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. The goal of therapy for patients with these cancers is
to improve overall survival and quality of life. COPIKTRA 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.
Secura Bio is currently working with the haematology community
and relevant authorities to ensure COPIKTRA is widely reimbursed
and commercially launched across Europe in the coming months.
"Partnering with Clinigen will enable COPIKTRA, an oncology
therapeutic with a novel mode of action, to be widely and rapidly
available to patients across Europe." said Joseph M. Limber, President
and CEO of Secura Bio. "Leveraging Clinigen's commercial
resources, supply and distribution infrastructure and regulatory
expertise will allow physicians and patients throughout
Europe to have access to another
valuable and beneficial option to combat the debilitating illnesses
of CLL and FL. We are excited to be working with Clinigen to
ensure successful market access, commercialization and supply of
Copiktra across the European geographies".
Sam Herbert, Chief Operating
Officer and Head of Products Division at Clinigen said
that "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."
Below is the full list of countries covered by the
agreement:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark,
Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The
Netherlands, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Albania, Andorra, Bosnia
Herzegovina, Iceland,
Kosovo, Liechtenstein, Monaco, Montenegro, Northern
Macedonia, Norway,
San Marino, Serbia, Switzerland
About Secura Bio, Inc.
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 Clinigen
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 COPIKTRA®(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 indicated in the United
States for the treatment of adult patients with relapsed or
refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) after at least two prior therapies and has accelerated
approval for refractory follicular lymphoma (FL) after at least two
prior systemic therapies. 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. Information about
duvelisib clinical trials can be found
on www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA
OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See
full prescribing information for complete boxed warning
- Fatal and/or serious infections occurred in 31% (4% fatal)
of COPIKTRA-treated patients. Monitor for signs and symptoms of
infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18%
(<1% fatal) of COPIKTRA-treated patients. Monitor for the
development of severe diarrhea or colitis. Withhold
COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5%
(<1% fatal) of COPIKTRA-treated patients. Withhold
COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1%
fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms
and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of
adult patients with:
- Relapsed or refractory chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) after at least two prior
therapies.
- Relapsed or refractory follicular lymphoma (FL) after at least
two prior systemic therapies. Accelerated approval based on overall
response rate; continued approval may be contingent upon
confirmatory trials.
WARNINGS AND PRECAUTIONS
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or
colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper
respiratory infection, pneumonia, musculoskeletal pain, and
anemia.
DRUG INTERACTIONS
- CYP3A inducers: Avoid co-administration with strong CYP3A
inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when
co-administered with strong or moderate CYP3A inhibitors. Reduce
COPIKTRA dose to 15 mg twice daily when co-administered with strong
CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when
co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
Please click here to see full Prescribing Information, including
Boxed WARNING, for COPIKTRA (duvelisib).
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of
non-Hodgkin lymphoma (NHL) that develops in mature white blood
cells called "T cells" and "natural killer (NK)
cells"1 which circulate in the bloodstream and the
lymphatic system. PTCL accounts for between 10-15% of all
non-Hodgkin lymphomas (NHLs) and generally affects people aged 60
years and older. Although there are many different subtypes of
peripheral T-cell lymphoma, they often present in a similar way,
with widespread, enlarged, painless lymph nodes in the neck, armpit
or groin. There are currently no well-established standards of
care for patients with relapsed or refractory disease.
To report Adverse Reactions, contact FDA at
1-800-FDA-1088 (1-800-332-1088)
or www.fda.gov/medwatch and Secura Bio at
1-800-9SECURA (1-844-973-2872).
Related Links
https://www.securabio.com
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