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    Rockwell Medical's Partner Drogsan Pharmaceuticals Submits Marketing Authorization Application in Turkey for Triferic AVNU

    Details:

    Triferic AVNU contains iron in the form of ferric pyrophosphate citrate. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin. It is indicated as an iron replacement product indicated for adult patients with HDD-CKD.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Nephrology Product Name: Triferic AVNU

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Drogsan Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 27, 2023

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    Rockwell Medical Receives Important Feedback from FDA on its IND Application for Phase 2 Trial of Ferric Pyrophosphate Citrate in Home Infusion

    Details:

    Company received feedback from USFDA regarding IND of Triferic (Ferric Pyrophosphate Citrate), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Hematology Product Name: Triferic

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 14, 2021

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    Rockwell Medical Study Demonstrates No Drug-drug Interaction Between Ferric Pyrophosphate Citrate and Unfractionated Heparin

    Details:

    TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease, Safety profile of drug is similar to placebo in controlled clinical trials in patients with end-stage kidney disease.


    Lead Product(s): Ferric Pyrophosphate Citrate,Heparin Sodium

    Therapeutic Area: Nephrology Product Name: Triferic

    Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 16, 2021

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    Rockwell Medical Submits Investigational New Drug Application with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia ...

    Details:

    Rockwell Medical is advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Hematology Product Name: Triferic

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 11, 2021

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    Rockwell Files Pre-IND Meeting Request with FDA for its Clinical Trial of FPC for Iron Deficiency Anemia in Patients Receiving Home Infusion

    Details:

    U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Hematology Product Name: Triferic

    Highest Development Status: Phase IIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 28, 2021

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    Rockwell Medical and Drogsan Pharmaceuticals Enter into Exclusive License Agreement for the Rights to Commercialize Triferic in Turkey

    Details:

    Under the terms of the license agreement, Drogsan will be the exclusive development and commercialization partner for Triferic (ferric pyrophosphate citrate injection) in Turkey and Rockwell Medical will supply the product to Drogsan.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Hematology Product Name: Triferic AVNU

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Drogsan Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 08, 2021

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    Rockwell Medical, Inc. Enters into Exclusive License and Supply Agreements with Sun Pharma for the Rights to Commercialize Triferic® in India

    Details:

    Under the terms of the agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic in India and Rockwell Medical will supply the product to Sun Pharma.


    Lead Product(s): Ferric Pyrophosphate Citrate

    Therapeutic Area: Hematology Product Name: Undisclosed

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 14, 2020

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