Dermatology | Phase III Developments | UNITED STATES

Vanda Pharmaceuticals

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Vanda Reports results from the EPIONE study of Tradipitant in the treatment of Pruritus in Atopic Dermatitis

Lead Product(s): Tradipitant

Therapeutic Area: Dermatology

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 February 25, 2020

Details:

Tradipitant antipruritic effects not seen in moderate or severe Atopic Dermatitis and the study did not meet its primary endpoint.

Dermira

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Lilly Completes Acquisition of Dermira

Lead Product(s): Lebrikizumab

Therapeutic Area: Dermatology

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Eli Lilly and Company

Deal Size: $1,100.0 million Upfront Cash: $1,100.0 million

Deal Type: Acquisition February 20, 2020

Details:

The acquisition of Dermira also expands Lilly's portfolio of marketed dermatology medicines with the addition of QBREXZA® (glycopyrronium).

Incyte Corporation

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Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream for Atopic Dermatitis

Lead Product(s): Ruxolitinib

Therapeutic Area: Dermatology

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 February 19, 2020

Details:

Building on the previously-reported positive topline results from TRuE-AD2, the results of TRuE-AD1 also show that significantly more patients treated with ruxolitinib cream achieved the IGA-TS.

Arcutis Biotherapeutics

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Arcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psoriasis

Lead Product(s): Roflumilast

Therapeutic Area: Dermatology

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 February 13, 2020

Details:

Arcutis has enrolled the first patient in an open label extension study, DERMIS-OLE, evaluating topical roflumilast cream (ARQ-151) as a potential treatment for plaque psoriasis.

Elorac

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Elorac to Present Naloxone Lotion Phase III Study Update

Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Dermatology

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 February 10, 2020

Details:

The Phase III SPIRIT-2 trial is evaluating the safety and efficacy of naloxone lotion for relief of pruritus (itching) associated with Cutaneous T-Cell Lymphoma .

Corbus Pharmaceuticals

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Corbus Pharma Announces Proposed Public Offering of Common Stock

Lead Product(s): Lenabasum

Therapeutic Area: Dermatology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $40.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 06, 2020

Details:

Corbus intends to use the net proceeds to fund its continued development of lenabasum, CRB-4001 and its other preclinical compounds as well as for general corporate purposes.

Revance Therapeutics

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Revance Gest U.S. FDA Acceptance of BLA for DAXI

Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 06, 2020

Details:

Biologics License Application for DAXI in the treatment of moderate to severe glabellar lines has been accepted for review by the U.S. Food and Drug Administration (FDA).

Novan

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Novan Provides SB206 Program and Business Update

Lead Product(s): Berdazimer sodium

Therapeutic Area: Dermatology

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 February 06, 2020

Details:

Novan has been granted a Type C meeting with the U.S. FDA on April 1, 2020. Last subject completes last visit, Week 24 safety evaluation in company’s Phase 3 B-SIMPLE program with SB206.

AbbVie Inc

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RINVOQ™ Meets Primary and Key Secondary Endpoints

Lead Product(s): Upadacitinib

Therapeutic Area: Dermatology

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 February 05, 2020

Details:

In this large Phase 3 study, RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis.

Incyte Corporation

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Incyte's skin disease drug meets main goal in late-stage study

Lead Product(s): Ruxolitinib

Therapeutic Area: Dermatology

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 January 28, 2020

Details:

The study was testing the ruxolitinib cream in adolescent and adult patients aged 12 years and above.

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Product Type

Companies

Vanda Pharmaceuticals

Vanda Reports results from the EPIONE study of Tradipitant in the treatment of Pruritus in Atopic Dermatitis

Dermira

Lilly Completes Acquisition of Dermira

Incyte Corporation

Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream for Atopic Dermatitis

Arcutis Biotherapeutics

Arcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psoriasis

Elorac

Elorac to Present Naloxone Lotion Phase III Study Update

Corbus Pharmaceuticals

Corbus Pharma Announces Proposed Public Offering of Common Stock

Revance Therapeutics

Revance Gest U.S. FDA Acceptance of BLA for DAXI

Novan

Novan Provides SB206 Program and Business Update

AbbVie Inc

RINVOQ™ Meets Primary and Key Secondary Endpoints

Incyte Corporation

Incyte's skin disease drug meets main goal in late-stage study