Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Otezla-Generic (apremilast) is an inhibitor of phosphodiesterase 4 (PDE4). It is indicated for the treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers.
Product Name : Otezla-Generic
Product Type : HPAPI
Upfront Cash : Inapplicable
December 01, 2022
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amgen Wins Patent Appeal on Otezla® (apremilast)
Details : Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP), indicated for the treatment of plaque psoriasis in adults.
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
April 19, 2023
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amgen Announces Positive New Data At EADV 2022 For Otezla® (Apremilast)
Details : 16-week data demonstrated clinically meaningful and statistically significant improvement in genital psoriasis, with twice many patients achieving primary endpoint of clear (0) or almost clear (1) sPGA-G scale receiving Otezla (apremilast) when compared ...
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
September 08, 2022
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Presentations will cover a range of clinical data for Otezla® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis.
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
August 30, 2022
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amgen Announces New Otezla (Apremilast) Data at AAD Congress 2022
Details : New data further reinforces clinical benefit of Otezla (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 in mild to moderate plaque psoriasis and in patients with palmoplantar pustulosis.
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
March 25, 2022
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The adverse events observed in the trial were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea, headache, nausea and nasopharyngitis.
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
December 20, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Cadila gets US FDA Marketing Approval for Apremilast Tablets
Details : Zydus Pharmaceuticals (USA) Inc. has received final approval from the US Food and Drug Administration (FDA) to market apremilast tablets in the strengths of 10 mg, 20 mg, 30 mg tablets are indicated for treatment of adult patients with plaque psoriasis.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
September 24, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Otezla® (apremilast) has potential to be first and only approved oral therapy for the mild-to-moderate patient population. Acceptance based on data from Phase 3 ADVANCE Study, demonstrating clinically meaningful improvements through week 32.
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
May 05, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Immunology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Shilpa Medicare Gets Tentative American Health Regulator Nod for Apremilast Tablets
Details : The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
March 05, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compa...
Product Name : Otezla
Product Type : HPAPI
Upfront Cash : Inapplicable
February 22, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable