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Idorsia Pharmaceuticals

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Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications

Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: VBP15

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Santhera Pharmaceuticals

Deal Size: $11.4 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 02, 2020

Details:

Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for all indications worldwide. Vamorolone is currently being investigated in the pivotal Phase 2b VISION-DMD study in patients with Duchenne muscular dystrophy (DMD).

EspeRare

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EspeRare Gets FDA Breakthrough Therapy Designation for ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia

Lead Product(s): ER-004

Therapeutic Area: Genetic Disease Product Name: ER-004

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

The Breakthrough Therapy Designation was granted following the promising results from three XLHED subjects who were treated by Professor Holm Schneider with a course of ER-004 intra-amniotic injections during the third trimester of pregnancy.

Santhera Pharmaceuticals

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Santhera Announces Completion of ReveraGen’s Long-Term Extension Study with Vamorolone in Duchenne Muscular Dystrophy

Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

Details:

Data from this VBP15-003 study in comparison to natural history study data demonstrated dose-dependent improvement in timed function tests. Vamorolone was reported to be safe and well tolerated up to the highest dose tested (6.0 mg/kg/day).

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Idorsia Pharmaceuticals

Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications

EspeRare

EspeRare Gets FDA Breakthrough Therapy Designation for ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia

Santhera Pharmaceuticals

Santhera Announces Completion of ReveraGen’s Long-Term Extension Study with Vamorolone in Duchenne Muscular Dystrophy