Dermatology | Approved Drugs in UNITED STATES

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

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

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

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

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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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