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De concurrentie van Ruconest

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Omlaag ↓

DeZwarteRidder 2 december 2016 18:38

Mogelijk zeer gevaarlijke concurrent voor Pharming:
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BioCryst Pharmaceuticals, Inc. (BioCryst) is a biotechnology company. The Company designs, optimizes and develops small molecule drugs that block enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases. The Company uses X-ray crystallography, computer modeling of molecular structures and chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the enzymes that control cellular biology. Its drug candidates include RAPIVAB, RAPIACTA, PERAMIFLU, Avoralstat, BCX7353, other second generation hereditary angioedema (HAE) compounds, BCX4430 and Forodesine. Its product RAPIVAB contains peramivir. Peramivir is an intravenous neuraminidase inhibitor approved in various countries for the treatment of patients with influenza, in the United States as RAPIVAB. RAPIVAB is used for the treatment of acute uncomplicated influenza. Its BCX4430 is a broad-spectrum antiviral (BSAV) research program.

[verwijderd] 2 december 2016 18:45

About RUCONEST®

Under the Biologics Price Competition and Innovation Act of 2009, RUCONEST was granted Market exclusivity in the USA until July 2026

DeZwarteRidder 2 december 2016 18:46

quote:
lower schreef op 2 december 2016 18:45:
About RUCONEST®
Under the Biologics Price Competition and Innovation Act of 2009, RUCONEST was granted Market exclusivity in the USA until July 2026

Is totaal niet van belang!

[verwijderd] 2 december 2016 18:47

Dit is het laatste goede vergelijk wat ik kan vinden uit 2015

Hereditary Angioedema (HAE) Drug Utilization and Spend: a Medical and Pharmacy Integrated Analysis
cdn.app.compendium.com/uploads/user/2...

[verwijderd] 2 december 2016 18:53

Study: Drug costs for hereditary angioedema tripled in 2 years
April 15, 2015
formularyjournal.modernmedicine.com/f...

A Cost-Effectiveness Comparison of Icatibant and C1-Esterase Inhibitor Concentrate for the Symptomatic Treatment of Acute Attacks of Types I and II Hereditary Angioedema in the UK Setting
www.rtihs.org/sites/default/files/Pea...

DeZwarteRidder 2 december 2016 18:58

Next generation kallikrein inhibitors for HAE
BCX7353 and other 2nd Gen kallikrein inhibitors

BioCryst’s goals for its second-generation kallikrein inhibitor program are to develop and launch a revolutionary treatment for hereditary angioedema patients, consisting of an oral, once-a-day drug that could restore the normal phenotype of kallikrein inhibition – resulting in elimination of angioedema attacks in patients with confirmed Hereditary Angioedema.

In October 2015, BioCryst announced that it’s randomized, placebo-controlled, Phase 1 clinical trial of orally-administered BCX7353 in healthy volunteers successfully met all of its objectives. BCX7353 was generally safe and well tolerated at all doses up to 500 mg once-daily for 7 days and 350 mg once-daily for 14 days in healthy volunteers, with dose-related drug exposure and a half-life supporting a once-daily dosing regimen.

There were no serious adverse events (AEs) and most AEs were mild. No dose-limiting toxicity was identified. The safety, tolerability, drug exposure and on-target plasma kallikrein inhibition results strongly support advancing the development program into a Phase 2 study in hereditary angioedema (HAE) patients.

On August 11th, 2016, BioCryst announced that it dosed the first subject in the APeX-1 clinical trial of BCX7353 for the oral treatment of hereditary angioedema (HAE). APeX-1 is a two part, Phase 2, randomized, double-blind, placebo-controlled dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of BCX7353 as a preventative treatment to eliminate or reduce the frequency of angioedema attacks in HAE patients. Up to approximately 50 eligible subjects with HAE will be enrolled in the study.

In part 1 of APeX-1, subjects with HAE will be randomized in a 1:1 ratio to receive an oral dose of either 350 mg of BCX7353 once daily or placebo once daily for four weeks. An interim analysis will be conducted after the first 24 subjects have completed treatment through study day 28. If a robust treatment effect is observed at the interim analysis, Part 2 of the study will be initiated. In the event the treatment effect is not well characterized with 24 subjects, a total of up to approximately 36 subjects will be enrolled in part 1. The sample size in Part 1 is being kept flexible to cover a range of response options that would achieve 90% power with an alpha of 0.05, based on reduction of attack rate of at least 70% on BCX7353, placebo response rate of approximately 30%, and standard deviation of approximately 0.45 attacks per week.

To characterize dose-response in part 2 of APeX-1, 14 additional subjects with HAE will be randomized to 250mg of BCX7353 once daily (n=6), 125mg of BCX7353 once daily (n=6) or placebo (n=2).

The primary efficacy endpoint of APeX-1 is the number of angioedema attacks; attack rate per week, counts of attacks, proportion of subjects with no attacks, and number of attack-free days will be analyzed. Efficacy analyses will be conducted for HAE attacks reported over the entire dosing interval (Days 1 through 28) and during the dosing period in which plasma concentrations of BCX7353 should be at steady-state conditions (Days 8 through 28). Secondary efficacy endpoints include severity and duration of angioedema attacks, and measures of health-related quality of life. Safety will be characterized through evaluation of adverse events and laboratory testing. Pharmacokinetics and pharmacodynamic effects will be assessed through measurement of plasma drug levels and kallikrein inhibition.

Additional details regarding the APeX-1 trial design are available at www.clinicaltrials.gov

[verwijderd] 2 december 2016 19:02

ISPOR 20th Annual International Meeting
Philadelphia, PA, USA
May, 2015
A Cost Efficiency Model for Comparing On-demand Treatment Costs in Hereditary Angioedema
www.ispor.org/research_pdfs/49/pdffil...

Tabel 3!!! Minder vials nodig van Ruconest!!!

RESULTS:
Formulas were developed that allow insertion of local acquisition csts for any of the HAE products, according to the quantity of vials or syringes required for initial dosing. A weighted percentage of the cost of the initial dose was added to determine the total cost, factoring in the anticipated need for re-dosing. For products having more than one published re-dosing frequency, the lowest reported frequency was used as a conservative approach. Specific cost estimation formulas address three theoretical patient weight categories: < 40 kg (to reflect small adults or pediatric patients), a standard 75 kg adult, and obese patients weighing between 100-125 kg.
CONCLUSIONS:
While therapy choices in HAE should be primarily driven by clinical factors and patient preferences, cost of treatment can be an important consideration if multiple options are considered equally appropriate. The formulas presented provide a simple, objective means of quickly comparing direct product costs for treating an HAE attack using local pricing figures

Link naar de site waar bovenstaande verwijzing staat.https://www.ispor.org/ScientificPresentationsDatabase/Presentation/54742

[verwijderd] 2 december 2016 19:17

Cost-utility analysis of Ruconest® (conestat alfa) compared to Berinert® P (human C1 esterase inhibitor) in the treatment of acute, life-threatening angioedema attacks in patients with hereditary angioedema

Results: The incremental cost-utility ratios (ICURs) for the evaluated interventions compared with placebo were as follows: EUR 15,226 per QALY (Ruconest®) and EUR 27,786 per QALY (Berinert® P). The probability of cost-utility (ICUR< EUR 24,279 per QALY) assessed for Ruconest® administered in the case of acute angioedema attack was 61% and
41% for Berinert® P.
Conclusions: The administration of Ruconest® in acute life-threatening angioedema attacks is economically justified from the Polish healthcare payer’s perspective, results in lower costs and is characterized by higher cost-utility probability compared with Berinert® P.

Bijlage:

DeZwarteRidder 2 december 2016 19:47

quote:
lower schreef op 2 december 2016 19:17:
Cost-utility analysis of Ruconest® (conestat alfa) compared to Berinert® P (human C1 esterase inhibitor) in the treatment of acute, life-threatening angioedema attacks in patients with hereditary angioedema

Results: The incremental cost-utility ratios (ICURs) for the evaluated interventions compared with placebo were as follows: EUR 15,226 per QALY (Ruconest®) and EUR 27,786 per QALY (Berinert® P). The probability of cost-utility (ICUR< EUR 24,279 per QALY) assessed for Ruconest® administered in the case of acute angioedema attack was 61% and
41% for Berinert® P.
Conclusions: The administration of Ruconest® in acute life-threatening angioedema attacks is economically justified from the Polish healthcare payer’s perspective, results in lower costs and is characterized by higher cost-utility probability compared with Berinert® P.

Maak je niet druk voor niks: Berinert gaat z'n prijs verlagen, net zo als in Nederland gebeurt is.

antop 2 december 2016 19:56

Waar maak jij je druk om DZR... Vandaag sluiten we groen en dat op rode beursdag en bovendien bovenstaande post van lower....is upper????

[verwijderd] 2 december 2016 20:03

Die bange ridder is nog steeds de ongekroonde koning van de onzin...

Gewoon links laten liggen ( of rechts) dan krijgt ie geen aandacht meer, en druipt ie vanzelf af...

pafrans 2 december 2016 20:13

quote:
IlI schreef op 2 december 2016 20:03:
Die bange ridder is nog steeds de ongekroonde koning van de onzin...

Gewoon links laten liggen ( of rechts) dan krijgt ie geen aandacht meer, en druipt ie vanzelf af...

Niet de bange ridder, maar De Zwakke Ridder" Dan klopt de afkorting weer.

DeZwarteRidder 2 december 2016 20:16

quote:
pafrans schreef op 2 december 2016 20:13:
Die bange ridder is nog steeds de ongekroonde koning van de onzin...
Gewoon links laten liggen ( of rechts) dan krijgt ie geen aandacht meer, en druipt ie vanzelf af...
Niet de bange ridder, maar De Zwakke Ridder" Dan klopt de afkorting weer.

Zit ma ook in de aandelen....???

DeZwarteRidder 2 december 2016 20:52

quote:
IlI schreef op 2 december 2016 20:03:
Die bange ridder is nog steeds de ongekroonde koning van de onzin...
Gewoon links laten liggen ( of rechts) dan krijgt ie geen aandacht meer, en druipt ie vanzelf af...

Bijlage:

[verwijderd] 2 december 2016 20:55

Mooi dat Up moment en gesteund want wat we eerder zagen dat de koers down gezet werd gebeurde dat nu niet.
Stel dit weekend positief nieuws dan wordt het een leuke 5 Dec.

Las ik toch in het frommel stukje van DZR dat Valeant het initiatief nam tot verkoop rechten.
Snap nu wel waarom DZR niet op een gesprekje durfde.
Als je zulke onwaarheden om populair te zijn schrijft wat ben je dan aan het doen?

Jammer want er waren zat redenen te bedenken om te twijfelen, echter nu niet meer.
Pharming gaf geen nieuws simpel omdat dat niet kon.
Echter het knallen zoals grote Rob meldt komt heel dicht bij.

Ruud..

[verwijderd] 2 december 2016 21:01

quote:
lower schreef op 2 december 2016 19:18:
Cost-utility analysis of Ruconest® (conestat alfa) compared to Berinert® P (human C1 esterase inhibitor) in the treatment of acute, life-threatening angioedema attacks in patients with hereditary angioedema

Results: The incremental cost-utility ratios (ICURs) for the evaluated interventions compared with placebo were as follows: EUR 15,226 per QALY (Ruconest®) and EUR 27,786 per QALY (Berinert® P). The probability of cost-utility (ICUR< EUR 24,279 per QALY) assessed for Ruconest® administered in the case of acute angioedema attack was 61% and
41% for Berinert® P.
Conclusions: The administration of Ruconest® in acute life-threatening angioedema attacks is economically justified from the Polish healthcare payer’s perspective, results in lower costs and is characterized by higher cost-utility probability compared with Berinert® P.

extract:
Additionally, the positive decision about financing of Ruconest
® (conestat alfa) within the therapeutic health program
in the assessed medical indication has other advantages.
Introduction of the therapeutic health program would assure
permanent access (in the case of a direct life threat
caused by an acute angioedema attack) to effective treatment
options for patients with HAE. According to Polish and
international guidelines, Ruconest® (conestat alfa) should
be administered whenever there is a significant therapeutic
indication

DeZwarteRidder 2 december 2016 21:03

quote:
Declan schreef op 2 december 2016 20:55:
Las ik toch in het frommel stukje van DZR dat Valeant het initiatief nam tot verkoop rechten.
Ruud..

Geheel verzonnen...!!

De Vries heeft daarover slechts een vage suggestie gedaan in een interview.

[verwijderd] 2 december 2016 21:14

quote:
DeZwarteRidder schreef op 2 december 2016 21:03:
[...]
Geheel verzonnen...!!

De Vries heeft daarover slechts een suggestie gedaan.

Ruud alshij slaapt (of wakker is)

Bijlage:

[verwijderd] 2 december 2016 21:16

quote:
DeZwarteRidder schreef op 2 december 2016 21:03:
[...]
Geheel verzonnen...!!

De Vries heeft daarover slechts een suggestie gedaan.

Goed zo want stel je voor dan zou de Vries op de BAVA gelogen hebben.
En dat zou erg geweest zijn..

Blij dat je deze dwaling inziet.
Complimenten voor je eerlijkheid.

Ruud..

[verwijderd] 2 december 2016 21:20

quote:
DeZwarteRidder schreef op 2 december 2016 21:03:
[...]
Geheel verzonnen...!!

De Vries heeft daarover slechts een vage suggestie gedaan in een interview.

Geen Zin Meer In Jou Leugens
youtu.be/ZrofIzDaX6U

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