[{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AMRYT Announces Positive Top Line Results from Pivotal Phase 3 \"ease\" Trial of Filsuvez\u00ae in Epidermolysis Bullosa","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Swixx BioPharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amryt and Swixx Sign Distribution Deal for Lojuxta","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces Positive Results from Phase 3 Trial of Filsuvez\u00ae in Epidermolysis Bullosa","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Medison Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amryt and Medison Pharma Sign Multi-Regional Distribution Agreements in Canada and Israel","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Medison Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amryt and Medison Pharma Sign Distribution Agreement for Myalepta\u00ae (metreleptin) in Canada","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Receives Reimbursement Approval from the French Ministry of Social Affairs and Health for Myalepta\u00ae (metreleptin)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Chiasma","pharmaFlowCategory":"D","amount":"$50.0 million","upfrontCash":"Undisclosed","newsHeadline":"Amryt Pharma to Acquire Chiasma, Inc. to Further Strengthen Global Leadership in Rare and Orphan Diseases","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Confirms NDA for Oleogel-S10 Will not Require an Advisory Committee Meeting","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces Oleogel-S10 EMA Regulatory Update","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces Successful Bioavailability Study for Mycapssa\u00ae (octreotide capsules)","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces Positive Interim Analysis Data From Open Label Phase of EASE Phase 3 Trial in EB","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Adopts Positive Opinion for Filsuvez for the Treatment of Dystrophic and Junctional EB","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt to Present Data from OPTIMAL and MPOWERED Phase 3 Trials Open Label Extension of Mycapssa\u00ae (oral octreotide) at ENDO 2022","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Filsuvez\u00ae for the treatment of Dystrophic and Junctional EB","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Presents New Analyses from the EASE Phase 3 Trial in Epidermolysis Bullosa at SPD 2022","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Receives Orphan Drug Designation from the FDA for Mycapssa (Oral Octreotide) for the Treatment of Carcinoid Syndrome","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Preclinical","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Preclinical"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt to Present Data from MPOWERED Phase 3 Trial of Mycapssa\u00ae (oral octreotide) at ENEA 2022","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces New Patent for Mycapssa\u00ae","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Adopts Positive Opinion for Mycapssa\u00ae for the Treatment of Acromegaly","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Receives Reimbursement Approval from the Dutch Ministry of Health for Myalepta\u00ae (metreleptin)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The British Journal of Dermatology Publishes Results from Amryt\u2019s EASE Phase 3 Trial in Epidermolysis Bullosa","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces New Patent for Mycapssa\u00ae","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Mycapssa\u00ae For the Treatment of Acromegaly","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"COMP Adopts Positive Opinion on Orphan Designation for Mycapssa\u00ae for the Treatment of Carcinoid Syndrome Associated with Neuroendocrine Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amryt Announces Positive Top Line Results from Phase 3 Pediatric Trial of Lomitapide in HoFH","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Chiesi Farmaceutici","pharmaFlowCategory":"D","amount":"$1,480.0 million","upfrontCash":"$1,250.0 million","newsHeadline":"Chiesi Farmaceutici S.p.A. to Acquire Amryt Pharma Plc","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Amryt Pharma","sponsor":"Chiesi Group","pharmaFlowCategory":"D","amount":"$1,480.0 million","upfrontCash":"$1,250.0 million","newsHeadline":"Chiesi Farmaceutici S.p.A. Completes Acquisition of Amryt Pharma Plc","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Amryt Pharma
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.
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 approved treatment.
Lojuxta (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolemia ("HoFH").
Mycapssa® (oral octreotide) is approved by the FDA and the EC for long-term maintenance treatment in acromegaly patients who have responded to and tolerated injectable treatment with octreotide or lanreotide (i.e. somatostatin analogs (SSAs)).
Mycapssa (octreotide) is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.
Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
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.
Myalepta (metreleptin) is approved in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired GL and in the EU as an adjunct to diet for the treatment of leptin deficiency.
91% of patients on Mycapssa® (octreotide) maintained IGF-1 response (95% CI 44-53), throughout the RCT, compared to 100% on iSRLs (95% CI 34-37). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month RCT phase.
Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.