Veloxis Pharmaceuticals

    [td_text_with_title custom_title=”Company description”]Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. Veloxis’ unique, patented delivery technology, MeltDose®, is designed to enhance the absorption and bioavailability of select orally administered drugs. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.[/td_text_with_title]
    Drugs

    Envarsus

    Envarsus® XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients. In all of the clinical trials, Envarsus® XR dosed once daily demonstrated significantly higher bioavailability [...]
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    [td_text_with_title custom_title=”Latest post”]

    Envarsus gets FDA Approval

    Veloxis Announces U.S. FDA Approval of Envarsus® XR for Treatment of Kidney Transplant Patients   Envarsus® XR is Indicated for Patients Converted from Tacrolimus Immediate-release Formulations  –   Envarsus® XR is Expected to be Available for Patients and Physicians in 4Q2015 Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus […]

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    U.S. District Court Rules in favour of FDA – still blocked

    Stocks in Veloxis is down almost 10% on news that a U.S. District Court ruled that Envarsus® XR is blocked in de novo setting Veloxis. “Today’s court ruling has provided the needed clarity on the initial label indication for Envarsus XR in the U.S.,” said William Polvino, M.D., president and chief executive officer of Veloxis. […]

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    Veloxis årsrapport 2014

    Veloxis årsrapport 2014 Året 2014 var et meget begivenhedsrigt år for Veloxis. Selskabet gennemgik en overgang fra et udviklingsselskab til nu at være i en kommerciel fase. Veloxis transplantation lægemiddel Envarsus® blev lanceret i Europa med første salg i Tyskland gennem partneren Chiesi Farmaceutici SpA. Veloxis vil fortsatte med at rulle produktet ud i hele […]

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    [/td_text_with_title][td_text_with_title custom_title=”From Wikipedia”]

    Veloxis Pharmaceuticals A/S, formerly LifeCycle Pharma A/S, develops improved versions of difficult-to-formulate drugs with its proprietary drug formulation technology, called MeltDose®. Veloxis is focused on building a clinical and market-stage pharmaceutical business around its late-stage transplant immunosuppression product candidate LCP-Tacro. The company was founded in 2002 as a spin-off from H. Lundbeck A/S. Veloxis is headquartered in Horsholm, Denmark, with an office in Cary, North Carolina [1]

    MeltDose Technology Platform

    MeltDose works by incorporating a drug substance with low water solubility into a "meltable" vehicle.[2] It is then sprayed on an inert particulate carrier using fluid bed equipment.

    The melt is solidified when deposed on a particle carrier, and thus captures the active drug in a solid dispersion either as a solid solution or in a nano-crystalline state. The particle size is then increased by controlling and optimizing the product temperature and feed rate of the melt.

    The granulate can be directly compressed into tablets without additional processing steps besides blending with a lubricant. In addition, the technology allows for customization of the release profile.

    Once in tablet form, the dissolution profile and the particle size of drugs manufactured using MeltDose® technology remain stable allowing for a long shelf-life.

    Product Pipeline[3]

    • LCP-Tacro (tacrolimus) is a once-daily dosage version of tacrolimus for prevention of rejection in organ transplant patients in two Phase 3 clinical trials in kidney transplant patients. The first study in stable transplant patients showed that LCP-Tacro was non-inferior in efficacy and safety compared to twice-daily tacrolimus (Prograf®) [ESOT REF]. The second Phase 3 clinical trial in de novo patients is ongoing.[4] A Phase 3b clinical trial evaluating whether patients experiencing symptomatic tremor on twice-daily tacrolimus demonstrate improvement in their tremors when switched to LCP-Tacro was published in 2017, and demonstrated that LCP-Tacro resulted in improvements on a number of patient-reported outcomes.[5]
    • FENOGLIDE (fenofibrate) for dyslipidemia, marketed in the U.S. by Santarus, Inc.[6]


    References

    1. ^ "Home - Veloxis - Transplant Patients"..mw-parser-output cite.citation{font-style:inherit}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation .cs1-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/6/65/Lock-green.svg/9px-Lock-green.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .citation .cs1-lock-limited a,.mw-parser-output .citation .cs1-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Lock-gray-alt-2.svg/9px-Lock-gray-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .citation .cs1-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/a/aa/Lock-red-alt-2.svg/9px-Lock-red-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration{color:#555}.mw-parser-output .cs1-subscription span,.mw-parser-output .cs1-registration span{border-bottom:1px dotted;cursor:help}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/4/4c/Wikisource-logo.svg/12px-Wikisource-logo.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output code.cs1-code{color:inherit;background:inherit;border:inherit;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;font-size:100%}.mw-parser-output .cs1-visible-error{font-size:100%}.mw-parser-output .cs1-maint{display:none;color:#33aa33;margin-left:0.3em}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration,.mw-parser-output .cs1-format{font-size:95%}.mw-parser-output .cs1-kern-left,.mw-parser-output .cs1-kern-wl-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right,.mw-parser-output .cs1-kern-wl-right{padding-right:0.2em}
    2. ^ Van Arnum P. Formulation Development Forum: Controlled Agglomeration for Poorly Soluble Drugs. Pharmaceutical Technology 35(7).
    3. ^ "Home - Veloxis - Transplant Patients".
    4. ^ Clinicaltrials.gov identifier: NCT01187953
    5. ^ Langone A, Steinberg SM, Gedaly R, et al. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015;29(9):796-805. https://onlinelibrary.wiley.com/doi/full/10.1111/ctr.12581
    6. ^ "Home | Salix Pharmaceuticals".
    source: https://en.wikipedia.org/wiki/Veloxis_Pharmaceuticals[/td_text_with_title]