Idorsia and Simcere enter into a licensing agreement for daridorexant in China
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland & Nanjing, China – November 16 , 2022
Idorsia Ltd (SIX: IDIA, “Idorsia”), specialized in the discovery, development
and commercialization of small molecules to transform the horizon of
therapeutic options, and Simcere Pharmaceutical Group Ltd (2096.HK, “Simcere”),
an innovation and R&D-driven pharmaceutical company, announced today that they
have entered into an exclusive licensing agreement for Idorsia’s daridorexant
Jinsheng Ren, Chairman and CEO of Simcere commented :
'This licensing agreement represents an important and exciting step in
pursuing Simcere’s mission of providing today’s patients with medicines of the
future. There are over 200 million people in China who suffer from chronic
insomnia that may benefit from daridorexant. Patients are eager for a better
treatment option that improves quality of sleep and next day functioning.
Simcere has a proven track record of successfully developing and marketing
innovative Central Nervous System therapies in China. In collaboration with
Idorsia, we hope to bring another impactful medicine to millions of people.”
Under the agreement, Simcere will be granted an exclusive right to develop and
commercialize daridorexant in the Greater China region (Mainland China, Hong
Kong, and Macau), one of the world's largest pharmaceutical markets. Simcere
will be responsible for the funding and conducting of a local development
program with Chinese patients. Simcere successfully commercializes Sanbexin for
acute ischemic stroke and daridorexant will expand Simcere’s pipeline of
Central Nervous System (CNS) products in China.
According to the terms of the agreement, Idorsia will receive a US$ 30 million
upfront payment, and will be eligible to receive an additional milestone
payment of US$ 20 million upon regulatory approval by the National Medical
Products Administration, as well as commercial milestone payments and low
double-digit tiered royalties based upon future sales.
Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia commented:
“Daridorexant is on track to becoming a global success, helping the millions
of sufferers of insomnia around the world. Marketed as QUVIVIQ, we expect
daridorexant will soon be the leading branded insomnia medication in the US in
terms of new prescriptions. It is also the first dual orexin receptor
antagonist available to patients in Europe, and recent positive data in Japan
gives me confidence that we can make it available there too. We have been
convinced of Simcere’s shared enthusiasm for daridorexant, and I am confident
that they are the right partner to join us on our mission of bringing an
optimal treatment approach to patients with insomnia around the world by
developing and commercializing daridorexant in China.”
Idorsia’s research team has been working on the science of orexin and orexin
receptors since they were first described in 1998. The team’s initial work led
to the conclusion that antagonism of the orexin system was the key to
preserving a natural sleep architecture for patients with insomnia. With this
as the target, the team designed a dual antagonist with the goal of a rapid
onset of effect and a duration of action sufficient to cover the night but
short enough to avoid any negative next-morning residual activity at optimally
Daridorexant is a dual orexin receptor antagonist, which blocks the binding of
the wake-promoting neuropeptides orexins. Rather than inducing sleep through
broad inhibition of brain activity, daridorexant blocks only the activation of
orexin receptors. Consequently, daridorexant decreases the wake drive, allowing
sleep to occur, without altering the proportion of sleep stages. The results of
a Phase 3 clinical development program have been reported by Mignot, E., et al.
Safety and efficacy of daridorexant in patients with insomnia disorder: results
from two multicentre, randomised, double-blind, placebo-controlled, phase 3
trials, in The Lancet Neurology 2022;21:125–39.
Notes to the editor
Global regulatory status of daridorexant
In January 2022, QUVIVIQ (daridorexant) was approved by the US Food and Drug
Administration (FDA) and subsequently made commercially available in May 2022.
For more information about QUVIVIQ in the US, see the Full Prescribing
Information (PI and Medication Guide). In April 2022, marketing authorization
of QUVIVIQ was granted by the European Commission and subsequently by the
Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain via
the European Commission Decision Reliance Procedure. For more information about
QUVIVIQ in the EU, see the Summary of Product Characteristics . Launch
preparations are underway in the major European markets and QUVIVIQ was made
available in both Italy and Germany in November 2022. Daridorexant is currently
under review with Swissmedic and Health Canada.
About insomnia disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep,
causing clinically significant distress or impairment in important areas of
daytime functioning. This impact on sleep quantity or quality should be present
for at least three nights per week, lasts for at least three months, and occurs
despite an adequate opportunity to sleep.
Insomnia is a condition of overactive wake signaling and studies have shown
that areas of the brain associated with wakefulness remain more active during
sleep in patients with insomnia. It is a common problem with an estimated
prevalence in China of 15% of the adult population.
Insomnia as a disorder is quite different from a brief period of poor sleep,
and it can take its toll on both physical and mental health. It is a persistent
condition with a negative impact on daytime functioning. Idorsia’s research has
shown that poor quality sleep can affect many aspects of daily life, including
the ability to concentrate, mood, and energy levels.
The goal of treatments for insomnia is to improve sleep quality and quantity,
as well as daytime functioning, while avoiding adverse events and next-morning
residual effects. Current recommended treatment of insomnia includes sleep
hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.
About the orexin system
Wake and sleep signaling is regulated by intricate neural circuitry in the
brain. One key component of this process is the orexin system, which helps
promote wakefulness. There are two forms of orexin neuropeptides – small
protein-like molecules used by nerve cells (neurons) to communicate with each
other in the brain – orexin A and orexin B. Orexin promotes wakefulness through
its receptors OX1R and OX2R. Together, these neuropeptides and receptors make
up the orexin system. The orexin system stimulates targeted neurons in the wake
system – leading to the release of several chemicals (serotonin, histamine,
acetylcholine, norepinephrine) – to promote wakefulness. Under normal
circumstances, orexin levels rise throughout the day as wakefulness is promoted
and then fall at night. Overactivity of the wake system is an important driver
The daridorexant clinical development program
The Phase 3 registration program comprised two three-month studies, together
with a long-term double-blind extension study. The program enrolled a total of
1,854 patients with insomnia disorder. As insomnia often presents later in
life, and older adults are more susceptible to experience fragmented sleep,
early awakening and daytime sleepiness, around 40% of the recruited population
was at least 65 years of age.
The placebo-controlled studies investigated the effects of three doses of
daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning
parameters, objectively in a sleep lab by polysomnography and subjectively with
a daily patient diary at home. The impact of insomnia on patients’ daytime
functioning was measured daily using the sleepiness domain score from the
Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ © ) – a
patient-reported outcome (PRO) instrument developed and validated according to
the FDA Guidance for Industry.
More than 800 patients continued treatment in the 40-week extension study,
which measured the effect of all three doses vs. placebo, generating data for
long-term treatment of insomnia disorder.
Phase 3 data has been reported in The Lancet Neurology: The pivotal studies
demonstrated that daridorexant 50 mg significantly improved sleep onset, sleep
maintenance and self-reported total sleep time at months one and three compared
to placebo. The largest effect was observed with the highest dose (50 mg),
followed by 25 mg, while the 10 mg dose did not have a significant effect. In
all treatment groups the proportions of sleep stages were preserved, in
contrast to findings reported with benzodiazepine receptor agonists.
A major focus of the trials was to evaluate the impact of daridorexant on
daytime functioning in patients with insomnia disorder, as assessed by the
IDSIQ. IDSIQ is a patient-reported outcomes instrument specifically developed
and validated according to FDA guidelines, to measure daytime functioning in
patients with insomnia. The sleepiness domain score of the IDSIQ was evaluated
as a key secondary endpoint in both pivotal studies and comparisons to placebo
included type I error control for multiplicity. Daridorexant 50 mg demonstrated
highly statistically significant improvement in daytime sleepiness at month one
and month three. The sleepiness domain score was not significantly improved on
25 mg in either study at either timepoint.
The overall incidence of adverse events was comparable between treatment
groups. The most frequently reported adverse reactions were headache and
somnolence and, overall, the majority of adverse reactions were mild to
moderate in intensity. There was no evidence of dose-dependent increases in
adverse events across the dosing range. Further, no dependence, rebound
insomnia or evidence of abuse or withdrawal symptoms indicative of physical
dependence upon treatment discontinuation was observed in clinical studies.
Key literature Riemann, D., et al. Sleep. 2017;26(6):675-700. The Diagnostic
and Statistical Manual of Mental Disorders (5th ed.; DSM–5; American
Psychiatric Association, 2013). Wardle-Pinkston S., et al. Sleep Med Rev.
2019;48. Mignot, E., et al. Lancet Neurol. 2022;21:125–39. Muehlan, C., et al.
Expert Opin. Drug Metab. Toxicol. 2020;16(11):1063–1078. Muehlan, C., et al. J
Psychopharmacol. 2020;34(3):326-335. Buysse, D.J., et al. Drug Discov Today Dis
Models. 2011;8(4):129-137. Levenson, J.C., et al. Chest. 2015;147(4):1179-1192.
Boof, M.L., et al. Eur J Clin Pharmacol. 2019;75(2):195-205. Clifford, B.S., et
al. Trends Neurosci. 2001;24(12).726-31. Gotter, A.L., et al. BMC Neuroscience.
2013;14(1):14-19. Patel, D., et al. J Clin Sleep Med. 2018;14(06):1017–1024.
Hudgens, S., et al. Patient. 2020. doi:10.1007/s40271-020-00474-z.
Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven
pharmaceutical company. The company focuses on three therapeutic areas,
oncology, central nervous system and autoimmune diseases, with a
forward-looking vision toward disease areas that may have significant clinical
needs in the future, aiming to achieve the mission of 'providing today's
patients with medicines of the future.' Leveraging its R&D capability and
commercialization excellence, Simcere has built a market-leading product
portfolio in China. Its vigorous in-house R&D efforts and extensive R&D
collaborations have made it a strategic cooperation partner with world leading
innovative companies and research institutes.
For more information, please visit: http://en.simcere.com/
Media contact: firstname.lastname@example.org
Idorsia Ltd is reaching out for more – We have more ideas, we see more
opportunities and we want to help more patients. In order to achieve this, we
will develop Idorsia into a leading biopharmaceutical company, with a strong
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is
specialized in the discovery, development and commercialization of small
molecules to transform the horizon of therapeutic options. Idorsia has a broad
portfolio of innovative drugs in the pipeline, an experienced team of
professionals covering all disciplines from bench to bedside, state-of-the-art
facilities, and a strong balance sheet – the ideal constellation to translate
R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June
2017 and has over 1,200 highly qualified specialists dedicated to realizing our
For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
The above information contains certain 'forward-looking statements', relating
to the company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects', 'may',
'are expected to', 'will', 'will continue', 'should', 'would be', 'seeks',
'pending' or 'anticipates' or similar expressions, or by discussions of
strategy, plans or intentions. Such statements include descriptions of the
company's investment and research and development programs and anticipated
expenditures in connection therewith, descriptions of new products expected to
be introduced by the company and anticipated customer demand for such products
and products in the company's existing portfolio. Such statements reflect the
current views of the company with respect to future events and are subject to
certain risks, uncertainties and assumptions. Many factors could cause the
actual results, performance or achievements of the company to be materially
different from any future results, performances or achievements that may be
expressed or implied by such forward-looking statements. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those described herein
as anticipated, believed, estimated or expected.
Anhang Medienmitteilung PDF