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Details:
KLISYRI (tirbanibulin) met key clinical criteria required for its inclusion with 49% of KLISYRI patients achieving complete clearance (100%) of lesions (9% for vehicle) and no patients withdrew from clinical trials due to adverse events.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
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 18, 2022
Details:
Under the terms of the licensing agreement, Hikma will be responsible for the registration and commercialisation of the product Finjuve, in certain MENA markets and Almirall will be responsible for product supply.
Lead Product(s): Finasteride
Therapeutic Area: Dermatology Product Name: Finjuve
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 01, 2021
Details:
Klisyri® (tirbanibulin) is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that we believe represents a significant step forward in the treatment of actinic keratosis (AK) of the face and scalp in adults.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Athenex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2021
Details:
Klisyri® (tirbanibulin) is a topical microtubule inhibitor indicated for the treatment of actinic keratosis (AK) of the face or scalp in adults and it acts through a selective antiproliferative mechanism of action.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
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 19, 2021
Details:
In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin versus 13% for vehicle-treated groups.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
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 21, 2021
Details:
Klisyri® is a novel, topical, first-in-class microtubule inhibitor that represents a significant step forward in the treatment of AK due to its short treatment protocol (once daily application for 5 days), and proven efficacy and safety profile.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
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 February 18, 2021
Details:
Klisyri® (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis (AK) on the face or scalp.
Lead Product(s): Tirbanibulin
Therapeutic Area: Dermatology Product Name: Klisyri
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Athenex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 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.
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
