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  • 2,345 17 sep 2021 17:36
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ACPH - oktober mogelijke goedkeuring FDA voor Barhemsys

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  1. Fintech 13 25 september 2018 10:36
    Op 5 oktober zou de FDA zich uitspreken over de goedkeuring van de FDA voor Barhemsys.

    Een middel dat zou gebruikt worden om te misselijkheid bij operaties te verhelpen, simpel en kort uitgelegd. Een gigantische markt, weinig concurrentie en uitstekende fase 3 resultaten.

    Degroof Petercam geeft o.a. een koersdoel van 4.8 €.
    Edison investment research geeft zelfs een koersdoel van 10,9 €.

    De werkzame stof (hoofdbestanddeel) Barhemsys is reeds goedgekeurd onder een ander medicijn dat gebruikt wordt voor mensen met schizofrenie. De CEO zei bij de IPO in maart dit jaar dat hij de goedkeuring als een cadeau voor de aandeelhouders beschouwde, want hij is er gerust in. IPO was rond de 3.6 €, waar we nu terug rond schommelen.

    Zij hebben momenteel (slechts) 1 ander product in de pipeline, dat qua marktpotentieel nog veelbelovender zou zijn.

    Gezien de korte tijd t.e.m. eventuele goedkeuring heb ik enkele weken geleden op 3,... een eerste positie ingenomen. Lijkt me een zeer veelbelovend aandeel.
    Benieuwd naar andere meningen hier.
  2. Fintech 13 27 september 2018 18:23
    14 September 2018

    Positive BARHEMSYS™ Phase 3 Treatment Data Published in Anesthesia & Analgesia

    Cambridge, UK and Indianapolis, US – 14 September 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical trial with BARHEMSYS™ (intravenous amisulpride) have been published in the online edition of the leading peer-reviewed journal Anesthesia & Analgesia (Candiotti et al1). Positive headline results were first announced by the Company in August 2016.

    The pivotal Phase 3 trial met its primary endpoint, demonstrating that BARHEMSYS, at two doses tested (5 mg and 10 mg), was significantly superior to placebo at treating established post-operative nausea & vomiting (PONV) in patients at low-to-moderate risk of PONV who had not received any prior prophylaxis. BARHEMSYS at both doses also showed a safety profile similar to placebo.

    A New Drug Application (NDA) for BARHEMSYS, including data from this and three other positive Phase 3 trials, is currently under review by the US Food and Drug Administration (FDA), with a target date of 5 October 2018 to complete its review. The extensive clinical trial programme has investigated the safety and efficacy of BARHEMSYS in the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics.

    “PONV is a common complication of surgery affecting millions of patients who undergo general anaesthesia and represents an important challenge for physicians and patients. I am very encouraged by the results seen in this and other trials with BARHEMSYS, which could provide a valuable additional option for treating PONV,” said Professor Keith Candiotti MD, Professor of Anesthesiology and Interim Chair of the Anesthesiology faculty at the University of Miami’s Miller School of Medicine and chief investigator of the study.

    Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, added: “This is the fourth publication to come out of our rigorous, 3,300-patient BARHEMSYS clinical programme, which demonstrated efficacy in both the prophylaxis and treatment of PONV. BARHEMSYS is the first new agent in more than 20 years to be studied in prospective, randomised trials of the treatment of active PONV and we are therefore especially excited by the possibility of giving healthcare providers and patients another choice in that setting.”

    Note: The tradename BARHEMSYS™ has received conditional approval by the US FDA and has replaced the previously used BAREMSIS®.

    Summary of the trial and results

    The Phase 3 study ( identifier: NCT02449291) was a double-blind, randomised, placebo-controlled trial conducted at 21 sites in Europe and North America. It included 1,988 adult patients undergoing elective surgery under general anaesthesia who had a low-to-moderate risk of PONV based on the Apfel risk factor scoring system2. Patients who then suffered PONV were randomised equally to one of three single-dose, IV regimens: placebo or 5 mg or 10 mg amisulpride. A total of 560 patients were randomised to receive one of the study medications and were eligible for intent-to-treat analysis. The primary endpoint was complete response (CR), defined as no emesis in the period 30 minutes to 24 hours after study drug treatment and no use of rescue medication in the entire 24-hour period.

    The trial met its primary endpoint: CR occurred in 39/181 patients (21.5%) in the placebo group compared to 60/191 patients (31.4%; p=0.016) and 59/188 patients (31.4%; p=0.016) in the amisulpride 5 mg and 10 mg groups, respectively. One or more treatment-emergent adverse events were experienced by 39.8% of patients in the 5 mg group and 42.0% of the 10 mg group, compared to 53.0% of the placebo group. The only adverse events to occur in 5% or more of the patients in any group were flatulence, nausea occurring more than 24 hours after treatment, constipation and infusion site pain, all of which were similar between the groups.


    Candiotti KA, Kranke P, Bergese SD, et al. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg 2018; doi: 10.1213/ANE.0000000000003733 [epub ahead of print]Apfel, C.C., Läärä, E., Koivuranta, M., Greim, C.A., Roewer, N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology 1999, 91(3):693-700.


    BARHEMSYS comprises a low dose intravenous formulation of the marketed dopamine antagonist amisulpride, which Acacia Pharma has developed for the completely new, patent-protected uses of prevention and treatment of PONV.

    A New Drug Application (NDA) submission for BARHEMSYS, including data from four positive Phase 3 studies and more than 3,300 surgical patients and healthy volunteers, is currently under review by the US Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5 October 2018 to complete its review.

    The Company is seeking approval of BARHEMSYS for:
    Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis; andPrevention of PONV, either alone or in combination with an antiemetic of a different class.
  3. Fintech 13 28 september 2018 12:16

    Elvisfan schreef op 28 september 2018 11:05:

    En Elvisfan, wat denk je, goede tip tot nu toe? :-)
    Je hebt al 5% winst ongeveer hoop ik?

    Laat ons hopen dat het vuurwerk volgende week écht begint.

    Vraagje aan de andere volgers: waarom wordt het koersdoel van 10,9€ niet opgenomen door diverse beurssites (trivano, beursduivel, iex)?
  4. forum rang 6 Elvisfan 28 september 2018 13:21

    Fintech 13 schreef op 28 september 2018 12:16:


    En Elvisfan, wat denk je, goede tip tot nu toe? :-)
    Je hebt al 5% winst ongeveer hoop ik?

    Laat ons hopen dat het vuurwerk volgende week écht begint.

    Vraagje aan de andere volgers: waarom wordt het koersdoel van 10,9€ niet opgenomen door diverse beurssites (trivano, beursduivel, iex)?

    ik heb al winst jazeker, bedankt; ik heb vandaag en gisteren heel wat gelezen; die FDA approval komt haast zeker, ik verwacht volgende week naar vrijdag toe zeker nog een stijging en hoop dat het vrijdag ontploft en kermis is!
  5. forum rang 6 Elvisfan 28 september 2018 13:27

    Mopperaar schreef op 28 september 2018 12:27:

    Gisteren was de beurs al toe, nu is een.een beetje de vraag instappen bij +5%???

    Tegen sluiting nog eens kijken dan vlakt alles wat meer uit..

    idd, je kan nu beter wachten tot de late namiddag; hoogste koers was 3.90, neem van mij aan dat we die koers zeker zullen zien volgende week !!!
  6. forum rang 6 Elvisfan 28 september 2018 13:36
    Profile CEO Dr Julian Gilbert, heeft al heel wat waters doorzwommen ...

    Julian is Chief Executive Officer & Co-Founder of Acacia Pharma. He has more than 30 years of commercial and technical experience in the pharmaceutical industry gained at a number of companies including Chiroscience, Mundipharma, British Technology Group (BTG) and Smith Kline & French (now GlaxoSmithKline). Prior to co-founding Acacia Pharma, he was co-founder and commercial director of Arakis which was sold to Sosei in 2005 for £107 million. Arakis successfully developed a pipeline of clinical opportunities and out-licensed its lead project to Novartis (repurposed glycopyrronium for chronic obstructive pulmonary disease (COPD) - now branded Seebri® and Ultibro® Breezhalers®). Julian is one of the inventors on the new use glycopyrronium patent and led the commercialisation to Novartis. He also led the commercialisation of AD923 (sub-lingual fentanyl spray) for cancer breakthrough pain to Mundipharma. He has a degree in pharmacy and a PhD in pharmaceutics both from the University of Nottingham.
507 Posts
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