Secura Bio Announces European Distribution Agreement for COPIKTRA® with Clinigen Healthcare Limited

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Sep 22, 2021, 09:00 ET

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).