Ixico Regulatory News (IXI)

24 July 2017

IXICO plc

("IXICO" or the "Company")

Expansion of the commercial collaboration with Biogen and expert institutions

Further enhancement of IXICO's Assessa® PML platform to support pharmacovigilance reporting

IXICO plc (AIM: IXI), the digital technologies company serving neuroscience, announces an expansion of its pilot of the Assessa® PML platform which includes Biogen, a leading company in Multiple Sclerosis ("MS"), and expert reading institutions.

The Assessa® PML digital platform is being piloted in five EU countries as part of a collaborative agreement which was announced on 9 October 2015. The aim is to facilitate the remote transfer, management and storage of MRI scans to more reliably and effectively offer access to reading expertise for the detection of Progressive Multifocal Leukoencephalopathy ("PML"), a rare and potentially fatal disease that affects people living with MS. The pilot, which includes platform development and on-boarding of clinical sites participating in the pilot, has now been expanded to include pharmacovigilance reporting (monitoring the effects of medical drugs in order to identify and evaluate previously unreported adverse reactions).

The total contribution paid or to be paid to IXICO and its partners, associated with the scoping, development and pilot stages of this partnership, is in the order of £1.5m, of which £0.8m has been recognised from project inception to date. Subject to the timing of the work being performed, the fees payable to IXICO support the Company's confidence in delivering revenue growth in the financial year ending 30 September 2017. 

Giulio Cerroni, Chief Executive of IXICO, commented: "We are delighted to announce the expansion of this pilot involving clinical experts in specialist MS centres and Biogen. The Assessa® PML digital platform is intended to provide technology and speciality services to physicians involved in delivering care to people living with MS. PML can be potentially fatal and IXICO is proud to support those involved in its detection."

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About IXICO

IXICO is the digital technologies company serving neuroscience. Our mission is to transform the pursuit of improving brain health through the application of digital technologies to neuroscience. IXICO's specialist data analytics services are used by the global pharmaceutical industry to select participants for clinical trials, assess the safety and efficacy of new drugs in development and in post marketing surveillance. Our neurological disease focus includes Alzheimer's disease, Huntington's disease, Multiple Sclerosis, Parkinson's disease and our integrated digital platform encompasses the entire drug development lifecycle. It is a scalable and secure infrastructure for the capture and analysis of regulatory compliant clinical data to enable sponsors to make rapid, better informed decisions. IXICO is also collaborating with partners to develop new companion digital health products targeted at improving patient outcomes.

More information is available on www.IXICO.com

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world's oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies.

More information is available on www.biogen.com.

About Assessa® PML

Assessa®PML is a digital companion product to provide neurologists with second opinion reading services if there is a suspicion of PML. This digital platform is based on IXICO's existing Assessa® technology which has been further developed as part of a collaboration including IXICO, clinical experts in specialist centres in Europe , and with financial support from Biogen Inc., (NASDAQ: BIIB).

About PML

Progressive multifocal leukoencephalopathy ('PML') is a rare and potentially fatal brain infection, caused by the common John Cunningham virus, which can arise in persons whose immune system is weakened. PML has a typical mortality rate of 20-50 percent in the first few months following diagnosis but this does depend on speed of diagnosis, the severity of the underlying disease and treatment received. Those who survive PML can be left with severe neurological disabilities.

Some effective MS therapies that suppress a person's immune system have known increased risk of PML. If identified early from an MRI brain scan, PML can be treated by taking the patient off the drug concerned. However, symptoms of PML and disease pathology visible on MRI scans may be similar to those of a new MS lesion. Neuroradiology expertise for assessment of suspected PML is seldom available outside highly specialist centres.