Dermatology | Approved Drugs | Pipeline Prospector

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.

Sun Pharmaceutical Industries Limited

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INDIA India

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Hikma and Sun Pharma enter into exclusive licensing agreement for ILUMYA™ for the Middle East and North Africa region

Lead Product(s): Tildrakizumab

Therapeutic Area: Dermatology Product Name: Ilumya

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Hikma Pharmaceuticals PLC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 15, 2020

Details:

Under the terms of the licensing agreement, Hikma will be responsible for the registration and commercialisation of ILUMYA™ in all MENA markets and Sun Pharma will be responsible for product supply.

AbbVie Inc

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United States

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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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United States

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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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United States

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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.

Samsung Biologics

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Korea, Republic Of

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GSK Partners with Samsung Biologics to Secure Additional Manufacturing Capacity for Innovative Biopharmaceutical Portfolio

Lead Product(s): Belimumab

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: GlaxoSmithKline

Deal Size: $231.0 million Upfront Cash: Undisclosed

Deal Type: Agreement May 21, 2020

Details:

Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK’s future needs and will supplement GSK’s existing manufacturing network.

Alembic Limited

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INDIA India

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Alembic Pharmaceuticals Announces Its Joint Venture, Aleor Dermaceuticals Receives USFDA Approval for Clobetasol Propionate Shampoo, 0.05%

Lead Product(s): Clobetasol Propionate

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 20, 2020

Details:

The approved ANDA is therapeutically equivalent to the reference listed drug product, Clobex Shampoo, of Galderma Laboratories, Clobetasol Propionate Shampoo is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.

Amgen Inc

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United States

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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.

Foamix Pharmaceuticals

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ISRAEL Israel

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Menlo Therapeutics and Cutia Therapeutics ink License Agreement for AMZEEQ™ and Approved Topical Minocycline Products in Greater China

Lead Product(s): Minocycline

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Cutia Therapeutics

Deal Size: $11.0 million Upfront Cash: $10.0 million

Deal Type: Licensing Agreement April 23, 2020

Details:

Cutia will have an exclusive license to obtain regulatory approval and sell AMZEEQ. Foamix is to supply Cutia with the finished licensed products for clinical and commercial use.

Biofrontera

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United States

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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.

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Product Type

Companies

Almirall

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

Sun Pharmaceutical Industries Limited

Hikma and Sun Pharma enter into exclusive licensing agreement for ILUMYA™ for the Middle East and North Africa region

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

Samsung Biologics

GSK Partners with Samsung Biologics to Secure Additional Manufacturing Capacity for Innovative Biopharmaceutical Portfolio

Alembic Limited

Alembic Pharmaceuticals Announces Its Joint Venture, Aleor Dermaceuticals Receives USFDA Approval for Clobetasol Propionate Shampoo, 0.05%

Amgen Inc

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

Foamix Pharmaceuticals

Menlo Therapeutics and Cutia Therapeutics ink License Agreement for AMZEEQ™ and Approved Topical Minocycline Products in Greater China

Biofrontera

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