Clinigen Signs Exclusive Supply & Distribution Agreement with Lukare for Elliotts B® Solution
Published: Jun 14, 2018
Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical and services company, has signed an exclusive agreement with Lukare Medical (‘Lukare’) to manage the supply and distribution of Elliotts B® Solution.
Under the terms of this supply and distribution agreement with Lukare, Clinigen will provide physicians and pharmacists with access to Elliotts B® Solution on an unlicensed, on-demand basis for patients around the world, excluding the US and Canada.
Marketing authorisation is granted in the United States, but Elliotts B® Solution is currently unavailable to meet patient needs elsewhere in the world.
Elliotts B® Solution (buffered intrathecal electrolyte/dextrose injection) is a diluent for methotrexate sodium, a chemotherapeutic drug and immune system suppressant, and cytarabine, a chemotherapeutic drug. These products require intrathecal administration (into the cerebrospinal fluid) for the prevention or treatment of meningeal leukaemia or lymphocytic lymphoma.
Julie Gosper, Head of Global Access, Clinigen, said: “We look forward to working with Lukare Medical to make Elliotts B® Solution available on an unlicensed basis outside the US and Canada. This partnership demonstrates our ongoing commitment to supply the right medicine to the right patient at the right time, to improve the quality of people’s lives around the world.”
Edwin Hernandez, CEO, Lukare Medical, said: “We are pleased to form this partnership with Clinigen. This relationship will greatly enhance our ability to make Elliotts B® Solution available to other regions of the world. We are confident many patients and researchers will benefit from the opportunity to use Elliotts B® Solution.”
About Elliotts B® Solution
Elliotts B® Solution (buffered intrathecal electrolyte/dextrose injection) is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
The efficacy of Elliotts B® Solution as a diluent for the intrathecal administration of chemotherapeutics is based on its ability to act as a buffer and to raise the pH of chemotherapeutics at acid pH (e.g. cytarabine) and to lower the pH of chemotherapeutics at basic pH (e.g. methotrexate). In addition, data demonstrate that methotrexate, cytarabine, and hydrocortisone sodium succinate are stable in Elliotts B® Solution for at least 10 hours at 25 degrees C. No precipitation was observed.
Elliotts B® Solution is comparable in pH, electrolyte composition, glucose content, and osmalarity to cerebrospinal fluid.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. Clinigen acquired Quantum Pharma in November 2017.
About Lukare Medical
Lukare Medical, LLC is dedicated to ensuring the commercial viability of small market products that offer the highest value for patients with rare medical needs.
Clinigen Group plc
Shaun Chilton, Group Chief Executive Officer
Julie Gosper, Head of Global Access
+44 (0) 1283 495010
Melanie Toyne-Sewell / Alex Shaw
+44 (0) 20 7457 2020