Barcelona, Spain, February 9, 2012 - Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to distribution, today announces that it has completed phase I clinical trials of Lorediplon in insomnia. The trials demonstrated the orally available compound has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem.
The pharmacodynamic effects of a single oral administration of Lorediplon (at 1mg, 5mg and 10mg doses), zolpidem (10mg) and placebo, were assessed in 34 healthy adult subjects employing a phase advanced model of insomnia, in which subjects retire to bed five hours earlier than normal and are required to stay there until early morning. In this model Lorediplon demonstrated dose related clinical benefits in measured sleep parameters that were either comparable to or exceeded zolpidem, in terms of the duration and quality of sleep that subjects achieved. Lorediplon was safe and well tolerated, with no residual effects observed up to 14 hours after dosing.
In addition, Lorediplon has proven safe and well tolerated in the 129 subjects involved in all Phase I clinical studies.
"Insomnia remains a common sleep disorder that has both a significant impact on an individual's quality of life and broader impact on society, in terms of reduced productivity and associated healthcare costs," says Antonio Guglietta, R&D director at Ferrer. "Lorediplon is the first product to enter clinical trials from our CNS discovery program, the aim of which is to deliver differentiated products targeting underserved needs in insomnia and related sleep disorders. Having demonstrated the clinical benefits, safety and tolerability of Lorediplon, we are actively seeking partners to further the worldwide clinical development and commercialisation of Lorediplon."
The emerging clinical and preclinical profile of orally available Lorediplon supports further development as a potential best-in-class non-benzodiazapine (BZD) treatment for sleep insomnia, both in terms of efficacy (improved sleep maintenance and quality), tolerability and the absence of next-day residual effects associated with other treatments in this class.
Lorediplon is the subject of a number of granted and pending patents and is available for further development and commercialisation worldwide from Ferrer.
Insomnia is a common sleep disorder characterized by difficulty in the initiation and/or maintenance of sleep, or abnormalities in the duration or restorative quality of sleep. While the prevalence of insomnia varies, it has been estimated that transient insomnia lasting less than two weeks affects up to 80 per cent of the population on a yearly basis, while chronic insomnia affects 15 per cent of the population. Sleep maintenance insomnia, or the inability to stay asleep throughout the night, is significantly more prevalent than sleep onset insomnia.
Insomnia is often accompanied or caused by other comorbid conditions and is associated with significant night-time and daytime symptoms, including tiredness, difficulty concentrating and irritability as well as increased healthcare utilization and reduced work productivity, lower quality of life, and impairments of memory, mood and cognitive function.
Currently, the major hypnotic drugs on the market are gamma-Amino Butyric Acid A (GABAA) receptor modulators. They potentiate GABA, the main inhibitory neurotransmitter in the brain, and facilitate sleep onset and sometimes total sleep time but their use is associated with changes in sleep architecture, decrease in psychomotor and cognitive functioning, dependency, withdrawal effects, increased incidence of falls and apnea.
Lorediplon is a novel, longer acting non-BZD hypnotic drug that modulates the GABAA receptor. More specifically, it is very potent at the alpha1-subunit which is considered to be the most relevant target of the GABAA receptor for the treatment of insomnia. Compared to other non-BZD receptor agonists (such as zolpidem), Lorediplon has demonstrated in preclinical and clinical studies a potent hypnotic profile and extended systemic half-life, properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. Moreover, Lorediplon has demonstrated a good preclinical and clinical safety and tolerability profile, including the absence of next-day residual effects and other side-effects associated with other treatments in this class. The favourable risk/benefit profile of Lorediplon supports the further development of the drug for the treatment of unmet needs in sleep maintenance insomnia.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. It is present in more than 90 countries, with 23 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors, key areas for contributing to people's health and quality of life. Since the beginning, Ferrer has been committed to the research and development of innovative medicinal products in its six R&D centres (four in Spain) and to a solid industrial structure, with thirteen manufacturing centres (seven in Spain). This research and manufacturing capacity covers the pharmaceutical, diagnostics, vaccines, fine chemical, food and feed sectors. In recent years, it has concentrated on diversifying across the whole healthcare spectrum, including prescription drugs, hospital products, molecular diagnostics, OTC and self-care. This diversification goes hand in hand with the setting-up and consolidation of strategic alliances. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics.
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