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Find Approved Immunology Drugs in Clinical Development

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            Lead Product(s): Infliximab

            Therapeutic Area: Immunology Product Name: Remsima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 28, 2020

            Details:

            The positive CHMP opinion recommends expanding the marketing authorisation for the subcutaneous (SC) formulation of Remsima® for use in an additional five indications, including for the treatment of inflammatory bowel disease (IBD) and ankylosing spondylitis.

            Entero Healthcare Solutions

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            Lead Product(s): Mycophenolate Mofetil

            Therapeutic Area: Immunology Product Name: Cellcept

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 18, 2020

            Details:

            Entero will be responsible for promotion, marketing and distribution of Roche Pharma’s key nephrology drugs viz., Mycophenolate Mofetil (Cellcept), Valganciclovir (Valcyte), Epoetin Beta (NeoRecormon), and Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in India.

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            Lead Product(s): Canakinumab

            Therapeutic Area: Immunology Product Name: Ilaris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 16, 2020

            Details:

            The U.S. Food and Drug Administration approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD).

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership June 08, 2020

            Details:

            For the emergency drug epinephrine from TEVA, Schreiner MediPharm developed an Autoinjector-Label with special protection against abrasion.

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            Lead Product(s): Upadacitinib

            Therapeutic Area: Immunology Product Name: Rinvoq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 06, 2020

            Details:

            In SELECT-CHOICE, RINVOQ™ (upadacitinib) met both the primary and key secondary endpoints compared to ORENCIA® (abatacept) on change from baseline in DAS28-CRP at week 12 in patients with rheumatoid arthritis and inadequate response to biologic DMARDs.

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            Lead Product(s): Upadacitinib,Methotrexate

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2020

            Details:

            Long-term results from the SELECT-COMPARE and SELECT MONOTHERAPY studies showed that RINVOQ™ (upadacitinib, 15 mg) continued to improve signs and symptoms in patients with rheumatoid arthritis through 72 and 84 weeks, respectively.

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            Lead Product(s): Infliximab

            Therapeutic Area: Immunology Product Name: Remsima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2020

            Details:

            1-year data from a randomised controlled trial in patients with rheumatoid arthritis (RA) show no impact of body mass index (BMI) on clinical response to subcutaneous infliximab (Remsima® SC / CT-P13 SC).

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            Lead Product(s): Ixekizumab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved ASAS40 response criteria compared to placebo.

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            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Fresenius Kabi AG

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 28, 2020

            Details:

            Medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional therapy option to the rheumatologists and dermatologists they work with.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sandoz Inc

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Termination May 11, 2020

            Details:

            Adamis and Sandoz have reached an agreement allowing for the mutually agreed return to Adamis of SYMJEPI products' marketing, promotion and distribution rights and the termination of the deal.

            PharmaCompass