Dermatology | Approved Drugs in UNITED STATES

Janssen Pharmaceutical

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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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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.

AbbVie Inc

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AbbVie Presents New Late-Breaking Data Showing SKYRIZI Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® at 52 Weeks

Lead Product(s): Risankizumab-rzaa

Therapeutic Area: Dermatology Product Name: Skyrizi

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 June 12, 2020

Details:

New head-to-head data from the IMMerge Phase 3b open-label study show SKYRIZI demonstrated superiority to COSENTYX at week 52, with 66 percent of SKYRIZI patients achieving completely clear skin (PASI 100) versus 40 percent of COSENTYX patients.

Eli Lilly

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Lilly Highlights the Evolution of Its Dermatology Portfolio at Annual American Academy of Dermatology Meeting (AAD)

Lead Product(s): Ixekizumab

Therapeutic Area: Dermatology Product Name: Taltz

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 June 12, 2020

Details:

Highlights of the data being presented at this year's AAD meeting include additional results from BREEZE-AD1 and BREEZE-AD2, Lilly's Phase 3 trials that are part of the baricitinib development program to support global submissions for baricitinib as a treatment for AD.

Menlo Therapeutics

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Menlo Therapeutics Announces Covered Status for AMZEEQ® (minocycline) topical foam, 4%, on Additional Commercial Formulary

Lead Product(s): Minocycline

Therapeutic Area: Dermatology 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 May 27, 2020

Details:

AMZEEQ® (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients, has been added to the prescription drug formulary of one of the largest payors in the U.S. AMZEEQ.

Amgen Inc

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Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis

Lead Product(s): Apremilast

Therapeutic Area: Dermatology 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 May 06, 2020

Details:

Oral Otezla 30 mg twice daily achieved a statistically significant improvement, compared with placebo in mild-to-moderate Psoriasis.

Biofrontera

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Biofrontera AG Enters Into Exclusive License Agreement with Maruho Co., Ltd.

Lead Product(s): Aminolevulinic Acid

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Maruho Co, Ltd

Deal Size: Undisclosed Upfront Cash: $6.4 million

Deal Type: Licensing Agreement April 20, 2020

Details:

Maruho will obtain exclusive development and commercialization rights including the right to sublicense for Ameluz® in Asia, Australia, New Zealand.

Paratek Pharmaceuticals

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Paratek Announces License Grant to Almirall for SEYSARA® (sarecycline) for Greater China Region

Lead Product(s): Sarecycline

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Almirall

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement February 24, 2020

Details:

Almirall plans to develop sarecycline for acne in China, with a potential submission to the China National Medical Products Administration in 2023.

Certara

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Certara Partners with Galderma in Advancing Modeling and Simulation Technology to Attain FDA Approval of AKLIEF® Topical Acne Cream

Lead Product(s): Trifarotene

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Galderma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership January 08, 2020

Details:

Certara's Simcyp population-based Simulator was used to support Galderma’s successful U.S. FDA new drug application for AKLIEF (trifarotene) Cream, 0.005% for the topical treatment of acne.

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Find Approved Dermatology Drugs in Clinical Development in UNITED STATES

United States

Product Type

Companies

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

AbbVie Inc

AbbVie Presents New Late-Breaking Data Showing SKYRIZI Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® at 52 Weeks

Eli Lilly

Lilly Highlights the Evolution of Its Dermatology Portfolio at Annual American Academy of Dermatology Meeting (AAD)

Menlo Therapeutics

Menlo Therapeutics Announces Covered Status for AMZEEQ® (minocycline) topical foam, 4%, on Additional Commercial Formulary

Amgen Inc

Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis

Biofrontera

Biofrontera AG Enters Into Exclusive License Agreement with Maruho Co., Ltd.

Paratek Pharmaceuticals

Paratek Announces License Grant to Almirall for SEYSARA® (sarecycline) for Greater China Region

Certara

Certara Partners with Galderma in Advancing Modeling and Simulation Technology to Attain FDA Approval of AKLIEF® Topical Acne Cream