Clinigen : acquires global rights to Proleukin®

RNS Reach

17 July 2018

Clinigen acquires global rights to Proleukin®
outside the United States

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, 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.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"This acquisition strengthens our offering in Commercial Medicinesand 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."

David Bryant, Chief Business Officer, Clinigen, 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."

The Group has also announced its year end trading update today- see separate press release.

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Contact details

Notes to Editors

About Proleukin® (aldesleukin)

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.

Experience in patients with ECOG PS >1 is extremely limited.

About metastatic renal cell carcinoma (metastatic RCC)

Renal cell carcinoma, also called kidney cancer, occurs when cancer cells form in the tubules of the kidney. Tubules are tiny tubes in your kidney that help filter waste products from your blood in order to make urine.

Smoking, hypertension, obesity, and hepatitis C all increase the risk of renal cell carcinoma. Renal cell carcinoma becomes metastatic renal cell carcinoma when it spreads beyond your kidney to your lymph system, bones, or other organs.

Aboutmetastatic melanoma

Melanoma is the rarest and most dangerous type of skin cancer. It begins in the melanocytes, which are the cells in your skin that produce melanin. Melanin is the pigment responsible for skin colour. Melanoma develops into growths on your skin, which often resemble moles. These growths or tumours may also come from existing moles. Melanomas can form on skin anywhere on your body, including inside the month or vagina.

Metastatic melanoma occurs when the cancer spreads from the tumour to other parts of your body. This is also known as stage 4 melanoma. Melanoma is the most likely of all skin cancers to become metastatic if not caught early.

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.

Clinical Trial Services

Clinigenis the global market leader in the specialist supply and management of quality-assured comparator medicines and services to clinical trials and Investigator Initiated Trials.

Unlicensed Medicines

Clinigen is the global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet medical need. The Group manages early access programmes to innovative new medicines and provides 'on demand' access globally to medicines which remain unlicensed at the point of care.

Commercial Medicines

Clinigen acquires global rights to niche hospital only and critical care products, revitalising these assets around the world and returning them back to sustained growth. It also provides access to licensed and branded generic medicines in the Africa and Asia Pacific region.

The Group also has an 'unlicensed to licensed' strategy, where it looks to take unlicensed medicines with commercial potential and licence them, helping to address unmet medical need and allowing the Group to capitalise on its market-leading positions.

For more information on Clinigen, please visitwww.clinigengroup.com