Production & Manufacturing

Clinigen acquires global rights to Proleukin outside US

Published 18 July 2018

Clinigen Group has acquired the global rights to Proleukin (aldesleukin, recombinant interleukin-2) outside the United States from Novartis.

Financial details have not been disclosed.

Proleukin® is licensed in around 20 countries around the world and is primarily indicated for use in metastatic renal cell carcinoma, as well as for metastatic melanoma in certain markets.

In addition, Proleukin® is currently being investigated in clinical trials at varying dose levels and in combination with other licensed and developmental pharmaceutical products.

Clinigen will seek to revitalise sales of Proleukin® by working with Health Care Professionals to ensure its benefit to patients is well understood and by making the medicine available to those who need it through the Group’s global distribution network for both licensed and unlicensed supply. The Group is also investigating the opportunity to develop new dosage presentations and potential product combinations.

The acquisition of Proleukin® is a good fit with the Group’s current Commercial Medicines portfolio of products in the oncology and infectious disease therapy areas.

Clinigen,Group CEO Shaun Chilton said: “This acquisition strengthens our offering in Commercial Medicines and brings our specialty pharma product portfolio to six.

“It demonstrates our strategy of acquiring global rights to assets with the aim of revitalising and returning them back to the broadest possible access, whilst also supporting their use in new and emerging treatment regimens.” 

Clinigen chief business officer David Bryant said: “Proleukin is an important medicine that has demonstrated complete responses in some patients, with evidence of cancer free survival over 15 years. We believe that its use in emerging treatment regimens will continue to help people fight cancer for years to come.” 

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC). In certain markets Proleukin is also indicated for the treatment of adults with metastatic melanoma. Careful patient selection is mandatory prior to the administration of Proleukin. 

Evaluation of clinical studies to date reveals that patients with more favourable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity. Therefore, selection of patients for treatment should include assessment of performance status.

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.  

Source: Company Press Release