Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Chiesi Group
Deal Size : $1,480.0 million
Deal Type : Acquisition
Chiesi Farmaceutici S.p.A. Completes Acquisition of Amryt Pharma Plc
Details : The acquisition expands chiesi’s rare disease medicine portfolio by adding Amryt's pipeline including, Filsuvez (oleogel-S10), a topical therapeutic gel, is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : $1,250.0 million
December 04, 2023
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Chiesi Group
Deal Size : $1,480.0 million
Deal Type : Acquisition
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Chiesi Group
Deal Size : $1,480.0 million
Deal Type : Acquisition
Chiesi Farmaceutici S.p.A. to Acquire Amryt Pharma Plc
Details : Filsuvez (oleogel-S10), a topical therapeutic gel, is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approv...
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : $1,250.0 million
August 01, 2023
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Chiesi Group
Deal Size : $1,480.0 million
Deal Type : Acquisition
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Filsuvez (Oleogel-S10) is a herbal medicinal product which contains birch triterpenes from birch bark. This sterile gel is being developed to speed up healing of skin wounds in adults and children with severe subtypes of epidermolysis bullosa.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 25, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amryt Presents New Analyses from the EASE Phase 3 Trial in Epidermolysis Bullosa at SPD 2022
Details : Key highlights include efficacy of Oleogel-S10 (filsuvez) on accelerated wound healing, data on procedural pain and dressing change frequency, and a 12-month interim analysis of the open-label phase, in patients with Dystrophic Epidermolysis Bullosa.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 07, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Filsuvez® for the treatment of Dystrophic and Junctional EB
Details : Filsuvez (Birch Bark Dry Extract) /Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 23, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Adopts Positive Opinion for Filsuvez for the Treatment of Dystrophic and Junctional EB
Details : The CHMP positive opinion for Filsuvez is supported by Phase 3 data from EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amryt Announces Positive Interim Analysis Data From Open Label Phase of EASE Phase 3 Trial in EB
Details : The trial met its primary endpoint in the double-blind phase (DBP; 90 days); target wounds treated with Oleogel-S10 reached first complete wound closure by Day 45 more frequently than wounds treated with control gel, with statistical significance (p=0.01...
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 26, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA
Details : The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. Filsuvez® has been selected as the brand...
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 28, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amryt Announces Oleogel-S10 EMA Regulatory Update
Details : Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children an...
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 28, 2022
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Confirms NDA for Oleogel-S10 Will not Require an Advisory Committee Meeting
Details : Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults.
Product Name : Filsuvez
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 06, 2021
Lead Product(s) : Episalvan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable