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Secura Bio Announces European Distribution Agreement For COPIKTRA With Clinigen Healthcare Limited

Secura Bio, Inc. an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, 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.

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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.

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“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

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