Clinigen and Galen enter exclusive Global Access agreement for chemotherapy drug DaunoXom
OREANDA-NEWS. Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Idis Global Access (GA) division has signed an exclusive supply agreement with Galen Ltd ('Galen'), a privately owned pharmaceutical sales and marketing company.
Under the terms of the supply agreement, Idis GA will provide Galen's chemotherapy drug DaunoXome® to Healthcare Professionals on an on-demand basis in 20 European countries, Australia, New Zealand and Hong Kong, where it is unlicensed at the point of care. Galen has retained the rights to supply DaunoXome in the UK and selected countries outside Europe.
DaunoXome (daunorubicin citrate - 2 mg/ml-concentrate for solution for Infusion) is a sterile pyrogen-free, preservative-free product in a single use vial for intravenous infusion. It has Medicines and Healthcare products Regulatory Agency (MHRA) approval to treat AIDS-related Kaposi's sarcoma, a rare type of cancer that develops from the cells that line lymph or blood vessels and affects the skin and organs such as the lungs, liver and digestive tract.
About DaunoXome
DaunoXome is a liposomal preparation of daunorubicin formulated to maximize the selectivity of daunorubicin for solid tumors in situ. While in the circulation, the DaunoXome formulation helps to protect the entrapped daunorubicin from chemical and enzymatic degradation, minimises protein binding, and generally decreases uptake by normal (non-reticuloendothelial system) tissues. The specific mechanism by which DaunoXome is able to deliver daunorubicin to solid tumors in situ is not known. However, it is believed to be a function of increased permeability of the tumor neovasculature to some particles in the size range of DaunoXome. In animal studies, daunorubicin has been shown to accumulate in tumors to a greater extent when administered as DaunoXome than when administered as daunorubicin. Once within the tumor environment, daunorubicin is released over time enabling it to exert its antineoplastic activity.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.
The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.
Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.
The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).
Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.
About Galen
Galen is a privately owned, specialty pharmaceutical company headquartered in Craigavon (Northern Ireland). The organisation markets products throughout the UK, Ireland, Europe and the US in therapy areas such as gastroenterology, female health and pain management. Galen is also focused on oncology and plans to continue expanding its portfolio with selected specialty products on an international basis. Through organic growth and acquisitions, Galen has product sales in 23 countries.
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