Dermatology | Approved Drugs | Pipeline Prospector

Sanofi

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FRANCE France

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Perrigo Acquires Market-Leading OTC Self-Care Brands In Eastern Europe From Sanofi

Lead Product(s): Azeloglycine

Therapeutic Area: Dermatology Product Name: Iwostin

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Perrigo Company plc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition August 11, 2020

Details:

Perrigo will acquire three Eastern European OTC skincare and hair loss treatment brands (Emolium®, Iwostin® and Loxon®) from Sanofi.

Sanofi

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FRANCE France

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Sanofi's DUPIXENT Receives Positive Recommendation from INESSS for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents

Lead Product(s): Dupilumab

Therapeutic Area: Dermatology Product Name: Dupixent

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2020

Details:

Recommendation was supported by multiple clinical trials that demonstrated superiority of Dupixent® over placebo in improving disease extent and severity, skin clearance and itch intensity, as well as health-related quality of life.

Cassiopea

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ITALY Italy

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Cassiopea Receives FDA Approval for Winlevi® (clascoterone Cream 1%)

Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

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 27, 2020

Details:

In pivotal clinical trials, WINLEVI demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema.

Revance Therapeutics

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United States

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Revance Positioned to Launch Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers

Lead Product(s): Hyaluronic Acid,Lidocaine

Therapeutic Area: Dermatology Product Name: RHA

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:

Company’s field force is established and will begin introducing its prestige aesthetics portfolio, including the RHA® Collection of dermal fillers, resilient hyaluronic acid, and the HintMD financial technology (fintech) platform, in the United States (U.S.) in September.

EPI Health

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United States

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MC2 Therapeutics Announces Collaboration with EPI Health on Commercialization of Newly Approved Psoriasis Drug, WYNZORA® Cream, in the US

Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Product Name: Wynzora

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: MC2 Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 24, 2020

Details:

Collaboration accelerates a Q1 2021 comprehensive launch of MC2’s WYNZORA® Cream to patients with plaque psoriasis in the US. WYNZORA® Cream is the first drug based on PADTM Technology – providing innovative solutions to unmet needs in chronic inflammatory conditions.

Novartis Pharmaceuticals Corporation

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Switzerland

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Novartis Cosentyx® Receives EU Approval for First-Line Systemic Treatment in Pediatric Psoriasis

Lead Product(s): Secukinumab

Therapeutic Area: Dermatology Product Name: Cosentyx

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile.

Janssen Pharmaceutical

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United States

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U.S. Food and Drug Administration Approves STELARA for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Lead Product(s): Ustekinumab

Therapeutic Area: Dermatology Product Name: Stelara

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 30, 2020

Details:

STELARA is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for pediatric psoriasis use, providing a new proven treatment for children (6-11 years of age) who have had few available options.

Sera Labs

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United States

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CURE Pharmaceutical to Acquire Sera Labs in a $20 Million Transaction

Lead Product(s): Cannabidiol

Therapeutic Area: Dermatology Product Name: Seratopical

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: CURE Pharmaceutical

Deal Size: $20.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition July 28, 2020

Details:

Acquisition of Sera Labs will add to CURE a growing brand portfolio and monetization platform that fits remarkably well with CURE’s development capabilities, products, and existing market verticals.

MC2 Therapeutics

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United Kingdom

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MC2 Therapeutics Announces FDA Approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis

Lead Product(s): Calcipotriol,Betamethasone

Therapeutic Area: Dermatology Product Name: Wynzora

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 22, 2020

Details:

The FDA approval is based on the results of the US Phase 3 clinical trial1 against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate.

Almirall

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SPAIN Spain

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Almirall Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets

Lead Product(s): Sarecycline

Therapeutic Area: Dermatology Product Name: Seysara

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 18, 2020

Details:

FDA approved an important update to the Seysara® label stating that P. acnes strains displayed a low propensity for the development of resistance to sarecycline. This information is included in the Microbiology Section (12.4) of the prescribing information.

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Approved

Product Type

Companies

Sanofi

Perrigo Acquires Market-Leading OTC Self-Care Brands In Eastern Europe From Sanofi

Sanofi

Sanofi's DUPIXENT Receives Positive Recommendation from INESSS for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents

Cassiopea

Cassiopea Receives FDA Approval for Winlevi® (clascoterone Cream 1%)

Revance Therapeutics

Revance Positioned to Launch Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers

EPI Health

MC2 Therapeutics Announces Collaboration with EPI Health on Commercialization of Newly Approved Psoriasis Drug, WYNZORA® Cream, in the US

Novartis Pharmaceuticals Corporation

Novartis Cosentyx® Receives EU Approval for First-Line Systemic Treatment in Pediatric Psoriasis

Janssen Pharmaceutical

U.S. Food and Drug Administration Approves STELARA for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Sera Labs

CURE Pharmaceutical to Acquire Sera Labs in a $20 Million Transaction

MC2 Therapeutics

MC2 Therapeutics Announces FDA Approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis

Almirall

Almirall Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets