Clinigen and United Therapeutics Initiate Managed Access Program for UNITUXIN (Dinutuximab)

BURTON ON TRENT, U.K. - Nov. 4, 2015 - PRLog -- Clinigen Group plc’s (AIM: CLIN, ‘Clinigen’ or the ‘Group’) Idis Managed Access (MA) division and United Therapeutics Corporation (‘United Therapeutics’), a biotechnology company focused on the development and commercialization of products for chronic and life-threatening conditions, have initiated a Managed Access program for UNITUXIN™ (dinutuximab) injection.

The program, which will be managed by Idis MA, will enable individual adolescents and children as young as 12 months old with high risk neuroblastoma to receive UNITUXIN™ (dinutuximab) injection in specific countries where the drug has not yet been commercialized.

Neuroblastoma is the most common extracranial solid cancer in childhood and has the highest incidence in infancy, with approximately 1,500 patients in the European Union diagnosed each year, of whom 50% are classed as high risk.

UNITUXIN™ (dinutuximab) injection was granted Marketing Authorization by the European Commission in August 2015 for the treatment of high risk neuroblastoma in patients from 12 months to 17 years. These patients had previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). On 10 March 2015 UNITUXIN™ (dinutuximab) injection became the first therapy to be approved by the US Food and Drug Administration (FDA) for this indication.

Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group said: “Neuroblastoma is a devastating disease which seriously endangers young lives and where there are few treatment options available. As partners to United Therapeutics, we can leverage our global distribution network and regulatory expertise to deliver UNITUXIN™ injection to the physicians on behalf of their young patients wherever and whenever it is needed, fast.”

Dr. Jay Watson, Pharm.D., Executive Vice President of Strategic Operations & Logistics for United Therapeutics, said:  “We are very excited to partner with Idis Managed Access to help in the global distribution of UNITUXIN™ as a means to expand access for this important treatment in patients with neuroblastoma, prior to formal marketing authorization approval in those countries.”

Access to UNITUXIN™ (dinutuximab) injection will be provided by Idis MA following a physician request for individual patients who meet the established eligibility criteria. Healthcare professionals can obtain details about the Managed Access program by calling +44 (0)1932 824 123 or via email at global@idispharma.com

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About UNITUXIN™ (dinutuximab) injection
Unituxin (dinutuximab) is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain kappa. Unituxin reacts specifically with the ganglioside GD2, which is highly expressed on the surface of the neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.

On 10 March 2015, Unituxin, in combination with GM-CSF, IL-2 and RA, became the first therapy to be approved by the US Food and Drug Administration for the treatment of paediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent multimodality therapy.

Unituxin carries a Boxed Warning alerting patients and health care professionals that Unituxin irritates nerve cells, causing severe pain that requires treatment with intravenous narcotics and can also cause nerve damage and life-threatening infusion reactions, including upper airway swelling, difficulty breathing, and low blood pressure, during or shortly following completion of the infusion. Unituxin may also cause other serious side effects including infections, eye problems, electrolyte abnormalities and bone marrow suppression. Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf

About Clinigen Group
Clinigen Group is a global pharmaceutical and services company with a unique combination of businesses dedicated to delivering the right drug to the right patient at the right time.

The Group consists of four synergistic businesses that provide medicines to patients with unmet medical need; through Clinigen Clinical Trial Services we manage the supply of commercial medicines for clinical trials, through Idis Managed Access we run early access programs for our own and other companies’ portfolios, our Idis Global Access team works directly with healthcare providers to enable ethical compliant access to unlicensed medicines, and through Clinigen Specialty Pharmaceuticals, we market our own portfolio of niche commercial products.

Clinigen is the global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need. In October 2015, Clinigen acquired Link Healthcare, further strengthening our international distribution network in the AAA region – Asia, Africa and Australasia.

For more information, please visit www.clinigengroup.com