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            Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

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            Lead Product(s): Cyclosporin A

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 28, 2020

            Details:

            FDA has granted Fast Track designation to Liposomal Cyclosporine A for Inhalation (L‑CsA‑i), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome.

            Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

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            Lead Product(s): Cyclosporin A

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 20, 2020

            Details:

            Liposomal Cyclosporine A for Inhalation (L?CsA?i) is advancing in clinical studies for the treatment for bronchiolitis obliterans syndrome.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 04, 2020

            Details:

            Independent Data Safety Monitoring Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following completion of trial’s first interim analysis.

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            Lead Product(s): Treprostinil Sodium

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: LIQ861

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 28, 2020

            Details:

            The patent is expected to cover methods of treating patients with pulmonary hypertension through the inhalation of dry powder treprostinil.

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            Lead Product(s): Treprostinil Sodium

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2020

            Details:

            FDA accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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            Lead Product(s): Omalizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 26, 2020

            Details:

            If approved, Xolair will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-IgE antibody specifically designed to target and block IgE.

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            Lead Product(s): Dupilumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration June 11, 2020

            Details:

            Regeneron and Sanofi have commenced potentially registrational trials investigating Dupixent in a number of diseases driven in part by type 2 inflammation, including: COPD, Eosinophilic esophagitis, Prurigo nodularis, Chronic spontaneous urticaria and Bullous pemphigoid.

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            Lead Product(s): Indacaterol acetate,Glycopyrronium Bromide,Mometasone Furoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 05, 2020

            Details:

            Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.

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            Lead Product(s): Cefiderocol,Linezolid

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.

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            Lead Product(s): Tradipitant

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 20, 2020

            Details:

            Vanda is involved in the development of therapeutic solutions for COVID-19 and currently in Phase III studies with tradipitant for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

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