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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.
Lead Product(s): Oleogel-S10
Therapeutic Area: Rare Diseases and Disorders Product Name: Filsuvez
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Chiesi Group
Deal Size: $1,480.0 million Upfront Cash: $1,250.0 million
Deal Type: Acquisition April 12, 2023
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 approved treatment.
Lead Product(s): Oleogel-S10
Therapeutic Area: Rare Diseases and Disorders Product Name: Filsuvez
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Chiesi Farmaceutici
Deal Size: $1,480.0 million Upfront Cash: $1,250.0 million
Deal Type: Acquisition January 08, 2023
Details:
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").
Lead Product(s): Lomitapide
Therapeutic Area: Genetic Disease Product Name: Lojuxta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
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)).
Lead Product(s): Octreotide Acetate
Therapeutic Area: Oncology Product Name: Mycapssa
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
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.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
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.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
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.
Lead Product(s): Oleogel-S10
Therapeutic Area: Rare Diseases and Disorders Product Name: Filsuvez
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
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.
Lead Product(s): Metreleptin
Therapeutic Area: Genetic Disease Product Name: Myalepta
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2022
Details:
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.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
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.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
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