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Lead Product(s): Ramelteon
Therapeutic Area: Sleep Product Name: Rozerem
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
Upsher-Smith’s product is AB-rated to the branded product, ROZEREM® (ramelteon) tablets.* Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
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Lead Product(s): Pitolisant
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Citrine Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 28, 2020
Details:
The partnership provides Citrine with exclusive rights to develop, register, market, and manufacture Wakix® (pitolisant) in China for the treatment of narcolepsy and obstructive sleep apnea.
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Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Xywav demonstrated highly statistically significant differences in median change in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo.
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Lead Product(s): Pitolisant
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy .
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Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
All patients were treated with Xywav during the open-label titration period and clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) were observed.
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Lead Product(s): Melatonin,Chamomile
Therapeutic Area: Sleep Product Name: Kinderlyte Sleep
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
Kinderlyte's Herbal Sleep Supplement is a doctor-formulated, drug-free sleep aid that uses a proprietary blend of melatonin and calming botanicals such as chamomile, passionflower, and lemon balm to support sleep.
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Lead Product(s): Lemborexant
Therapeutic Area: Sleep Product Name: Dayvigo
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
Details:
The main presentations from Eisai at this conference include presentations relating to the SUNRISE 2 Phase III clinical trial conducted globally, including sites in Japan.
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Lead Product(s): Zolpidem Tartrate
Therapeutic Area: Sleep Product Name: Zolpimist
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and will be able to be commercialized and supplied within Australia.
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Lead Product(s): Pitolisant
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 27, 2020
Details:
The company expects to initiate a Phase 3 trial for EDS and cataplexy in pediatric patients in the 2H21. It also plans to start Phase 2 trials for EDS and other key symptoms in patients with Prader-Willi Syndrome and in adult patients with myotonic dystrophy in the 1H21.
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Lead Product(s): Lemborexant
Therapeutic Area: Sleep Product Name: Dayvigo
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R).
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