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Ann: Chair's Address and CEO Presentation, page-7

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    1. just a reminder
      16/9/20 from hottod

      Avecho

      The following information describing AVE’s TPM injectables products has been condensed from two presentations, which were released in December 2019 and June this year.

      TPM®/Daptomycin
      • Daptomycin is supplied as a lyophilized powder for reconstitution
      • TPM increases daptomycin solubility, allowing reconstitution in < 5 minutes to significantly increase workflow efficiency in the hospital
      • Daptomycin shelf-life stability increased to 24 hours at RT, and 72 hours in fridge.
      • Longer stability also enables larger, multi-use vials and provides commercial supply chain advantage

      TPM®/Propofol
      • TPM creates a transparent and thermodynamically stable microemulsion
      • No egg or soy based excipients, no risk of anaphylaxis, and reduced risk for bacterial growth
      • Clear formulation (better presentation) allows QC and confidence during infusion / mixture – less chance of product recall
      • Simple manufacture method; COGS projected to be cheaper than standard propofol emulsion
      • TPM® would significantly reduce the risk and expense of the supply chain for propofol
      • Could grow the overall propofol market, which has suffered from manufacturing issues and resulting product shortages

      TPM®/Vitamin K
      • TPM dissolves the Vitamin K in a stable, colloidal vesicle system
      • TPM formulations of Vitamin K developed which are: - free of problematic excipients (Cremaphor, Polysorbate 80, Lecithin) - stable for 2yrs - suitable for dosing paediatric (2mg/ml) and adult (10mg/ml) patients
      • There are no known allergens in the product, and no anticipated safety concerns.

      TPM®/Tacrolimus
      • TPM/Tacrolimus formulations made without Cremaphor (known adverse excipient)
      • TPM solubilizes tacrolimus during dilution prior to infusion

      TPM®/Melphalan
      • Melpahan is a water insoluble powdered (lyophilized) drug dissolved prior to use
      • There are no commercially available liquid formulations that would reduce handling prior to administration.
      • Liquid TPM/melphalan formulations successfully created

      TPM®/Clopidogrel
      • Clopidogrel is a powder given as an oral tablet for stroke.
      • An immediate, injectable alternative dosage format would be advantageous for stroke patients, but clopidogrel is insoluble at the typical pH range of IV injections (pH 3-10).
      • Liquid TPM/clopidogrel formulations suitable for injection successfully created

    Last edited by turps: 31/05/22
 
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