Sleep

Pfizer Inc

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United States

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CAMBODIA PHAR-MED 2020

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Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for...

Lead Product(s): Reboxetine

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Axsome Therapeutics

Deal Size: $331.0 million Upfront Cash: $3.0 million

Deal Type: Licensing Agreement January 13, 2020

Details:

Agreement accelerates ongoing clinical development of AXS-12 (reboxetine) in narcolepsy which expands Axsome’s pipeline with new Phase 3-stage esreboxetine product candidate for fibromyalgia

Adare Pharmaceuticals

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Adare Pharmaceuticals and NLS Pharmaceutics Collaborate to Develop Mazindol Controlled Release (CR) for the Treatment of ADHD and Narcolepsy

Lead Product(s): Mazindol

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: NLS Pharmaceutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration January 13, 2020

Details:

NLS Pharmaceutics entered a collaboration to develop mazindol (MZD) CR product candidates for the treatment of narcolepsy and ADHD utilizing Adare’s proprietary modified release technologies.

Avadel Pharmaceuticals

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IRELAND Ireland

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Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218

Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep Product Name: FT218

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2020

Details:

Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218.

Eisai

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JAPAN Japan

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Eisai to Launch In-House Developed New Anti-insomnia Drug in Japan

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).

Idorsia Pharmaceuticals

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Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results

Lead Product(s): Daridorexant

Therapeutic Area: Sleep Product Name: ACT-541468

Highest Development Status: Phase III 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:

The study confirms the findings of the first pivotal study, demonstrating efficacy of treatment with daridorexant on objective and subjective sleep parameters and showed positive effects on daytime functioning, with patients reporting no morning sleepiness and other symptoms.

Minerva Neurosciences

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CAMBODIA PHAR-MED 2020

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Minerva Neurosciences Exercises Right to Opt Out of Agreement With Janssen for Seltorexant (MIN-202)

Lead Product(s): Seltorexant

Therapeutic Area: Sleep Product Name: MIN-202

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Janssen Pharmaceutica

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 01, 2020

Details:

Minerva Neuroscienceshas exercised its right to opt out of its agreement with Janssen Pharmaceutica future development of seltorexant. As a result, Minerva will now collect a royalty on worldwide sales of seltorexant in all indications.

Eisai

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JAPAN Japan

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Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia

Lead Product(s): Lemborexant

Therapeutic Area: Sleep Product Name: Undisclosed

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 June 01, 2020

Details:

In clinical studies, DAYVIGO helped some people with insomnia fall asleep faster and stay asleep longer compared to placebo. The effects of DAYVIGO at first use were generally consistent with later timepoints.

Umecrine Cognition

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SWEDEN Sweden

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Karolinska Development’s Portfolio Company Umecrine Cognition Presents Positive Additional Results From A Phase 2a Study Of Golexanolone

Lead Product(s): Golexanolone

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 08, 2020

Details:

Analyses of data for additional efficacy endpoints reveal that treatment with the golexanolone exerts a significant effect on brain signaling with a positive effect on excessive daytime sleepiness.

Sosei Group Corporation

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JAPAN Japan

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CAMBODIA PHAR-MED 2020

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Sosei Heptares Announces Scientific Progress with Orexin Agonist Program in Conjunction With Spin-off Companies Orexia and Inexia

Lead Product(s): Undisclosed

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Discovery Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

Sosei Heptares solves structure of the agonist bound orexin OX2 receptor and identifies small molecule binding site using unique StaR® technology and structure-based approach.

Avadel Pharmaceuticals

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IRELAND Ireland

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Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218

Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

The primary analysis of FT218 demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all three co-primary endpoints compared to placebo .

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Pfizer Inc

Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for...

Adare Pharmaceuticals

Adare Pharmaceuticals and NLS Pharmaceutics Collaborate to Develop Mazindol Controlled Release (CR) for the Treatment of ADHD and Narcolepsy

Avadel Pharmaceuticals

Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218

Eisai

Eisai to Launch In-House Developed New Anti-insomnia Drug in Japan

Idorsia Pharmaceuticals

Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results

Minerva Neurosciences

Minerva Neurosciences Exercises Right to Opt Out of Agreement With Janssen for Seltorexant (MIN-202)

Eisai

Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia

Umecrine Cognition

Karolinska Development’s Portfolio Company Umecrine Cognition Presents Positive Additional Results From A Phase 2a Study Of Golexanolone

Sosei Group Corporation

Sosei Heptares Announces Scientific Progress with Orexin Agonist Program in Conjunction With Spin-off Companies Orexia and Inexia

Avadel Pharmaceuticals

Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218