10 June 2014

The Chiesi Group and UCL (University College London) are collaborating to test a novel melatonin formulation as a brain protective medicine for babies who suffer birth asphyxia.

The collaboration is supported by UCL Business PLC (UCLB), UCL’s wholly owned technology transfer company, who have granted Chiesi access to specific research knowledge developed by Professor Nicola Robertson, a renowned expert in the field of neonatal neuroscience and neuroprotection and Professor Xavier Golay an expert in the field of physiological MRI and image-based biomarkers.

Chiesi will be responsible for the development of a melatonin formulation suitable for neonatal use and for the subsequent full development of the product including the clinical trial program, while UCL, as part of this collaboration, will be entitled to receive royalties on future sales in addition to other undisclosed payments.

Birth asphyxia is a very serious clinical condition caused by temporary but abrupt interruption of the constant blood flow to the brain around the time of birth. In Europe, US and Australia the incidence of birth asphyxia is 2-3 cases per 1000 births at term; in mid and low resource settings the incidence can be 5-20 times more common. Globally, birth asphyxia is the fifth leading cause of child deaths and there is a significant burden of disability as children mature. In 2010, birth asphyxia was the cause of 2.4% of the Global Burden of Disease and 6.1 million years of life with disability.

Despite excellent maternity services and the significant improvement in birth asphyxia outcomes following the introduction of therapeutic hypothermia, around 40% of infants still have an abnormal neurodevelopmental outcome. Melatonin is a natural hormone mainly secreted at night, which in pharmacological doses can add to hypothermia to protect the baby brain from damage. Consequences of birth asphyxia include devastating disabilities such as cerebral palsy, cognitive, hearing, language and speech impairments, epilepsy and delay in development. These have serious effects on the individual, the family, society and the economy. The clinical need for novel, safe and effective therapies to optimise brain protection following birth asphyxia is therefore paramount.

Speaking about the collaboration, Professor Nicola Robertson, Professor of Perinatal Neuroscience at UCL, said: “We are very excited about the collaboration. Even though therapeutic hypothermia is used in many hospitals, cooling is only partially effective and other medicines are desperately needed to optimally treat birth asphyxia”.

Dr Chris Williams, Senior Business Manager at UCLB said: “This is an excellent partnership for both parties, combining the world class translational research strengths of Professors Robertson and Golay, along with their colleagues at UCL with the significant development and commercialisation capabilities of the Chiesi Group, to progress this important therapy to market”.

Dr Paolo Chiesi, Vice President and Director of Research & Development for the Chiesi Group said:“Our company has a strong track record in the field of neonatology and we are very proud and pleased to contribute to the healthcare of this vulnerable and important patient population. We are currently leveraging our established product developments and emerging pipeline to expand our work into additional areas of high unmet medical need for neonates. In this regard, we look forward to executing on the promise of this exciting partnership with UCL which we recognise as a centre of excellence in the field”.

For enquiries or to arrange an interview with one of the spokespeople quoted, please contact:

UCL Business PLC – Emma Alam, Marketing and Communications Manager, +44 (0)20 7679 9798 / e.alam@uclb.com
UCL – Henry Rummins, Media Relations Manager, +44 (0)20 7679 9063 / h.rummins@ucl.ac.uk
Chiesi Group – Valentina Biagini, Group Communication Manager, v.biagini@chiesi.com

About UCL Business PLC
UCL Business PLC (UCLB) is a leading technology transfer company that supports and commercialises research and innovations arising from UCL, one of the UK’s top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from laboratory to market. UCLB supports UCL’s Grand Challenges of increasing UCL’s positive impact on and contribution to Global Health, Sustainable Cities, Intercultural Interaction and Human Wellbeing.

For further information, please visit: www.uclb.com or follow us on Twitter @UCL_Business

About Chiesi Farmaceutici S.p.A
Chiesi Farmaceutici is a research-focused international group, with more than 75 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics and specialist medicine areas. In 2013, Chiesi achieved sales of over 1.2 billion Euros, constituting double digit growth over 2012. Its R&D centres in Parma (Italy), Paris (France), Rockville (USA), Chippenham (UK) and the R&D team of the newly-acquired Danish company Zymenex, integrate their efforts to advance Chiesi’s pre-clinical, clinical and registration programs. The Chiesi Group employs approximately 3900 people, 480 of which are dedicated to R&D activities.

For more information, please visit: www.chiesi.com