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.”