Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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[{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics To Present Data on Multiple Immunomodulation Approaches with KRYSTEXXA at the EULAR 2020","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen Finds Over 80% Of Patients with Spasticity And Cervical Dystonia Treated With Botulinum Toxin-A Experience Symptom Recurrence","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"May 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and New KRYSTEXXA\u00ae (pegloticase injection) Trials","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Enrolls in Horizon's FORWARD Trial to Evaluate Monthly Dosing of KRYSTEXXA and Methotrexate to Treat Uncontrolled Gout","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"University of Michigan","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data Published in Arthritis & Rheumatology Show Higher Response Rates of Horizon's KRYSTEXXA with the Immunomodulator Mycophenolate Mofetil","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MIRROR Randomized Controlled Trial Meets Primary Endpoint and Shows 71% of Patients Achieved a Complete Response Rate Using KRYSTEXXA\u00ae (Pegloticase Injection) with Methotrexate","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Being Presented at American College of Rheumatology Convergence 2021 Highlight Horizon\u2019s Commitment to Improving Outcomes for People Living with Uncontrolled Gout","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results from PROTECT Trial Evaluating KRYSTEXXA\u00ae (Pegloticase Injection) in Kidney Transplant Recipients with Uncontrolled Gout Presented as Part of American Society of Nephrology (ASN) Kidney Week","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"}]

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            Details:

            The results from the completed PROTECT trial (NCT04087720) demonstrated that Krystexxa (Pegloticase & Methotrexate) provide a substantial and sustained decrease in serum uric acid (sUA) for patients with uncontrolled gout who had received a kidney transplant.

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2021

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            The findings indicated that the use of KRYSTEXXA with an immunomodulator may improve persistence to therapy. Approx 90% of the evaluated population met the sUA treatment target and those who received immunomodulation after starting on KRYSTEXXA were less likely to discontinue.

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 01, 2021

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            Results show that 71% (71 of 100) of patients who were randomized to receive KRYSTEXXA with methotrexate compared to 40% (21 of 52) of patients who were randomized to receive KRYSTEXXA with placebo achieved the primary endpoint (p<0.001).

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 25, 2021

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            Details:

            The Reducing Immunogenicity of Pegloticase trial showed that 86% of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks vs 40% of patients (4 of 10) receiving KRYSTEXXA monotherapy.

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: University of Michigan

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2021

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            The current recommended dosing of KRYSTEXXA for adult patients is 8 mg given as intravenous infusions every two weeks, with each dose infused over at least two hours.

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 25, 2021

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            Details:

            The Company announced two new KRYSTEXXA development programs: KRYSTEXXA, with methotrexate monthly dosing trial and a KRYSTEXXA retreatment trial evaluating KRYSTEXXA, with methotrexate, in patients who have previously failed KRYSTEXXA.

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 11, 2021

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            Details:

            The real-world usage analysis illustrates that KRYSTEXXA is effectively employed and well-tolerated among dialysis patients. KRYSTEXXA® is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

            Lead Product(s): Pegloticase

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

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            Details:

            In the open-label trial, 79 percent of patients who received both KRYSTEXXA and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg/dL).

            Lead Product(s): Pegloticase,Methotrexate

            Therapeutic Area: Musculoskeletal Product Name: Krystexxa

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 16, 2020

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            Details:

            Data presentations demonstrate that KRYSTEXXA® (pegloticase injection) can be co-prescribed with three commonly used immunomodulators in rheumatology to potentially help more people with chronic gout refractory to conventional therapies.

            Lead Product(s): Pegloticase

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 03, 2020

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            80% of respondents experienced debilitating symptom recurrence, and revealed that a lack of long-lasting symptom control between injections has a profound impact on the personal and professional lives of patients.

            Lead Product(s): Botulinum toxin type A

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 23, 2020

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