Intech pharma - Pagina 3
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  1. #21
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    Dopo Novartis anche Merck; non male per una minuscola e semisconosciuta azienda biotech Israeliana.
    Ora aspettiamo l'estate per vedere se il test per la cura del Parkinson è andato bene.
    Speriamo che il rilascio in borsa sia veloce e non ritardato come il nostro brevetto.

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    Intec Pharma Granted European Patent


    May 20, 2019 at 7:00 AM EDT



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    Strengthens Protection for Accordion Pill Platform


    JERUSALEM, May 20, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that the European Patent Office has granted the Company European Patent No. 2997953 titled, "DELIVERY DEVICE FOR ORAL INTAKE OF AN AGENT," and covers Intec's gastro-retentive drug delivery device with perforated external film. The new European patent joins Intec Pharma's intellectual property of the IN-3 family of patents and provides coverage until 2027.

    "This new patent builds on our expanding global intellectual property estate to protect our Accordion Pill® (AP) technology and its variety of applications. Importantly, the new patent underscores Intec's continued innovation with respect to the Accordion platform technology and our commitment to expanding our patent protection to safeguard the AP platform for our biopharmaceutical products and products in development. This patent specifically protects our product development efforts for poorly soluble compounds, which utilize our perforated films as part of the innovative approach to enhanced drug delivery" said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

  3. #23
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    Secondo Voi la Pfizer si farà sfuggire l'occasione di stringere un'alleanza con la nostra piccola INTEC ?

  4. #24
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    Intec Pharma to Participate at June Investment Conferences


    May 28, 2019 at 7:00 AM EDT



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    JERUSALEM, May 28, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that Company management will participate at the following upcoming investment conferences in June.

    Jefferies Global Healthcare Conference

    Date: June 4-7, 2019
    Company Presentation: June 5, 2019 at 11:30 am (Eastern time)
    Location: The Grand Hyatt, New York City
    Presenter: Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma
    Format: Corporate presentation and One-on-One Investor Meetings

    JMP Securities Life Sciences Conference

    Date: June 19-20, 2019
    Company Presentation: June 20, 2019 at 9:00 am (Eastern time)
    Location: The St. Regis, New York City
    Presenter: Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma
    Format: Corporate presentation and One-on-One Investor Meetings

    Mr. Meckler's presentations will be webcast live and will be accessible through the Events section of Intec Pharma's website at Intec Pharma, where they will also be archived for a period of time.

    About Intec Pharma Ltd.

    Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company's Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage Phase 3 development for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with Novartis Pharmaceuticals and a research collaboration with Merck & Co.

  5. #25
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    Certo è che se questo sistema di rilascio ritardato funziona davvero, allora le possibili applicazioni son quasi infinite e si potranno quindi stringere accordi con tutto il mondo Pharma.
    Forse siamo di fronte a una possibile nuova stella del mondo farmaceutico ?

  6. #26
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    La prova del nove sul giusto funzionamento del rilascio ritardato/prolungato, lo avremo con il medicinale per la cura del Parkinson.
    Se va bene quello si spalancheranno immense praterie per la nostra Intec.
    Ancora pochi mesi e sapremo tutto.

  7. #27
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    Siamo sempre in attesa di buone nuove da parte di Intec; questo sistema di rilascio prolungato sembra davvero molto interessante e replicabile su moltissimi altri medicinali. Mi aspetto quindi delle belle soddisfazioni.

  8. #28
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    Intec Pharma Announces Results From Pharmacokinetic Study of AP-CD/LD 50/500 mg Dosed Three Times Daily Were Presented at the XXIV World Congress on Parkinson's Disease and Related Disorders


    June 19, 2019 at 7:00 AM EDT



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    JERUSALEM, June 19, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announced that results from a pharmacokinetics (PK) study of the Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) 50/500 mg dosed three times per day (TID) were highlighted yesterday in a poster presentation at the XXIV World Congress on Parkinson's Disease and Related Disorders taking place June 16-19, 2019 in Montreal, Canada.

    C. Warren Olanow, M.D., Professor and Chair Emeritus, Department of Neurology at Mount Sinai School of Medicine, New York, was the Senior Author of the Poster which is titled, "Pharmacokinetics of multiple doses of Accordion Pill Carbidopa/Levodopa in patients with Parkinson's disease." The poster can be accessed here.

    The presentation highlighted data collected during a cross-over PK study comparing AP-CD/LD 50/500 mg TID and standard immediate release (IR) CD/LD 37.5/150 mg 5x daily in patients with PD. PK samples were collected pre-dose and at 30-minute intervals post-dose over 16 hours and again at 24 hours post-dose.

    The primary endpoint of the study was the variability in plasma LD concentration in steady state (between four and 16 hours) as assessed by the LD fluctuation index [(Cmax-Cmin)/Cavg)]. The key secondary endpoint was the coefficient of variation (standard deviation of plasma LD concentrations divided by the average concentration). In addition, multiple sensitivity analyses were performed.

    The results showed that AP-CD/LD 50/500 mg TID met the study's primary endpoint of reducing plasma levodopa variability compared to standard IR-CD/LD when dosed five times per day (p=0.0048). Less variability was also observed for the coefficient of variation of plasma levodopa levels (key secondary endpoint; p=0.047). These results were supported by the findings of significant outcomes on each of the prespecified sensitivity analyses. AP-CD/LD was well tolerated with no serious adverse events.

    The study authors noted that motor complications are associated with variability in plasma levodopa concentration seen with IR levodopa, and concluded that the results of the present study "suggest that treatment with AP-CD/LD may reduce motor complications in patients with advanced PD as compared to standard IR-CD/LD treatment."

    "We are delighted to have these positive PK results presented by Dr. Olanow, a world-leading Parkinson's disease expert, at this prestigious medical meeting. These PK results are important as they confirm our expectations that AP-CD/LD 50/500 TID reduces levodopa variability in PD patients, which we expect will translate to a reduction in motor fluctuations in these patients," noted Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "We are eagerly awaiting the top-line results from our Phase 3 ACCORDANCE trial in the July/August time frame and these positive PK data support our belief that AP-CD/LD treatment could provide Parkinson's disease patients with a better baseline LD therapy to reduce motor complications."

  9. #29
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    Dunque a luglio/agosto avremo l'esito della fase clinica III; le premesse sono più che buone, ma non si può mai dire. Tra l'altro sarà poi la FDA a dare il giudizio finale.
    Anche se io punto di più sugli accordi con Novartis e Merck.

  10. #30
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    Intec Pharma Announces Results from Earlier Phase 2 Clinical Trial of Accordion Pill-Carbidopa/Levodopa in Advanced Parkinson's Disease Patients Published in Parkinsonism and Related Disorders


    June 25, 2019 at 7:00 AM EDT



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    Accordion Pill demonstrated more stable levodopa concentrations and significantly reduced OFF time in Parkinson's disease patients


    JERUSALEM, June 25, 2019 /PRNewswire/ --- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that results from an earlier Phase 2 clinical study of the Accordion Pill®-Carbidopa/Levodopa (AP-CD/LD) in Parkinson's disease (PD) patients were published in the peer-reviewed journal, Parkinsonism and Related Disorders. The article titled, "Pharmacokinetics and efficacy of a novel formulation of carbidopa-levodopa (Accordion Pill®) in Parkinson's disease" is now available online as an e-publication ahead of print. The article can be accessed here.

    The article reviews pharmacokinetic and efficacy data from the Company's phase 2, multicenter, open-label, two-way randomized crossover study that evaluated multiple dose strengths of the AP-CD/LD (50/250 mg, 50/375 mg or 50/500 mg) twice daily in one treatment period and an active comparator in the other treatment period. The article presents results from cohorts 1-4 out of the 6 cohorts of PD patients who participated in the study. Pharmacokinetics (PK) and efficacy were evaluated for AP-CD/LD compared with immediate release Carbidopa/Levodopa (IR-CD/LD). Treatment-emergent adverse events (TEAEs) and patient- and investigator-reported measures were also evaluated.

    The PK results showed that compared with IR-CD/LD, treatment with either AP-CD/LD dose demonstrated more stable LD plasma concentrations in both fluctuating and non-fluctuating PD patients, and significantly decreased the LD Cmax (57.1% and 66.8% decreases among fluctuating and non-fluctuating patients, respectively).

    According to the study's authors, "Overall, the PK profile of AP-CD/LD 50/375 is similar to the PK of intestinal CD/LD infusion and better than PK parameters reported for other orally administered LD products developed for extended dopaminergic effect."[1] [2]

    Treatment with either AP-CD/LD 50/375 dosed twice per day (Cohort 3) or AP-CD/LD 50/500 dosed twice per day (Cohort 4) significantly improved motor fluctuations compared with participants' current treatment. Cohort 3 significantly reduced mean daily OFF time by 44% (p< 0.001) and Cohort 4 significantly reduced mean daily OFF time by 45% (p< 0.001) compared with IR-CD/LD. In Cohorts 3 and 4, total ON time (ON state without dyskinesia), good ON time (ON state or ON with non-troublesome dyskinesia), the proportion of total ON time during waking hours, and the proportion of good ON time during waking hours significantly increased with both AP-CD/LD 50/375 and AP-CD/LD 50/500, while both bad times (OFF state and/or ON with troublesome dyskinesia) significantly decreased with both AP doses compared with IR-CD/LD.

    The results also showed that treatment with either AP-CD/LD 50/375 (Cohort 3) or AP-CD/LD 50/500 (Cohort 4) significantly improved both patient and investigator ratings on the Global Clinical Impression compared with current treatment (p< 0.01).

    TEAEs observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations. No new safety issues were observed throughout the study.

    "In addition to more consistent LD plasma concentrations with AP-CD/LD regardless of whether patients were experiencing motor fluctuations, this new delivery platform resulted in decreased OFF time compared with the IR form. Given the high correlation of clinical effect with LD pharmacokinetics, the efficacy of the AP-CD/LD 50/500 dose in Cohort 4 was not unexpected," concluded study author, Peter A. LeWitt, M.D., Departments of Neurology, Henry Ford Hospital and Wayne State University School of Medicine in Bloomington, Michigan. "Importantly, the substantially improved ON time for the AP versus IR was attained without an emergence of troublesome dyskinesia."

    "The valuable information gathered in this pilot study has informed and guided the further development of the AP for PD in an ongoing phase 3 multicenter, randomized, placebo-controlled study. In the phase 3 study, both 2x and 3x per day regimens of AP-50/400 and AP-50/500 mg doses are being tested. As these doses are the same or similar to those used in the pilot study reported here, similar stable LD and CD plasma levels within the therapeutic range necessary for PD symptom control are expected from the phase 3 study," added Dr. LeWitt, who is also the Principal Investigator of the global Phase 3 ACCORDANCE clinical study evaluating the AP in PD patients.

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