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    Paion "buy" (Seite 5804)

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      Avatar
      schrieb am 19.02.16 19:46:52
      Beitrag Nr. 65.367 ()
      Antwort auf Beitrag Nr.: 51.790.039 von Ahwas am 19.02.16 19:20:53Auf der Seite steht dieser Text - allerdings nichts neues:


      Remimazolam is a Phase 3 short-acting general anaesthetic/sedative that is being developed by PAION initially for use in minor medical interventions (procedural sedation)

      Situation Overview

      Remimazolam is an innovative short-acting general anaesthetic/sedative. Due to its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently

      marketed anaesthesia compounds. The rapid offset of Remimazolam effect is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam has potential

      in three indications: procedural sedation, general anaesthesia, ICU sedation. Paion expects to file for market approval for Remimazolam in the indication anaesthesia in the EU in the beginning of

      2016. In October 2015, the Company announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has informed PAION in writing that both the raw materials produced by PAION

      in Europe as well as the finished formulation fulfill the requirements for filing in Japan because the European and Japanese product are considered to be of equivalent quality and the differences are seen

      as having no direct impact on the pharmacokinetics of Remimazolam. This clarification was necessary for the filing dossier in Japan because PAION former partner Ono Pharmaceutical Co., Ltd. (Ono) is

      no longer available as a producer. In the case of a negative opinion, it would have been necessary to set up a new production process based on Ono manufacturing process, which would have led to a

      significant delay in the Japanese filing. As part of the validation campaigns of the manufacturing processes, PAION will collect more data to support the data package in Japan. These data are also

      required for the approval in the EU and U.S. A Japanese clinical research organization (CRO) is currently preparing the draft Dossier for the Pre-NDA meeting expected in early 2016. This meeting with the

      authority is a prerequisite for filing Remimazolam in Japan.


      Remimazolam is an innovative short-acting general anaesthetic/sedative. After intravenous administration Remimazolam rapidly induces the desired sedation. Importantly, this sedative effect quickly

      disappears. This rapid offset of the effect of the substance is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam is being developed as a

      sedative agent for day case procedures (procedural sedation) as well as for the induction and maintenance of anaesthesia. It could also be used as a sedative for patients in the Intensive Care Unit

      (ICU).


      The clinical studies performed with Remimazolam comprise two Phase I, three Phase II studies, and a Phase III study with single or multiple dose without an intervention or during endoscopy of the upper

      gastrointestinal tract or the colon.The generated data indicate a good tolerability of Remimazolam. A rapid onset and offset of the sedative effect was observed during the procedures. It was also shown

      that it is possible to achieve the same (safety) or better (efficacy) results with single or multiple dosing of Remimazolam as compared to single or multiple dosing of the gold standard Midazolam. The effect

      of Remimazolam can be reversed by the benzodiazepine antagonist Flumazenil. In May 2014, the company released results from an additional Phase II study showing Remimazolam was safe and

      effective during cardiac surgery and that it shares the fast-acting sedative profile of Propofol. In Europe, PAION has completed recruitment of a Phase II study, which was a randomised, Propofol and

      Sevoflurane (standard treatment) controlled Phase II study to evaluate the efficacy, safety and pharmacokinetics of Remimazolam during general anaesthesia in patients undergoing major cardiac surgery.

      After surgery, follow-up sedation in the recovery room or the intensive care unit (ICU) for up to 24 h took place. A total of 90 patients were treated. The primary efficacy endpoint as a general anaesthetic

      (defined as successful anaesthesia not requiring rescue therapy) was achieved in 98 % of patients in the two Remimazolam dose groups and 96 % in the Propofol/Sevoflurane group demonstrating an

      excellent efficacy rate across all treatment groups. As expected, the onset and offset of action profile was comparable between all treatment groups, showing that Remimazolam indeed shares the fast-

      acting sedative profile of Propofol. The safety profile was generally very good in all treatment groups. One of the key targets of this trial was to assess the cardiostability during cardiac surgery with

      Remimazolam when compared to Propofol/Sevoflurane, both of which are known to cause cardiac depression. The study evaluated a substantial number of parameters to analyse these effects.

      Remimazolam had already shown excellent cardiostability in the Ono Phase III study. During cardiac surgery, norepinephrine is routinely used to maintain blood pressure in the normal range and

      counteract pronounced blood pressure decreases. Norepinephrine and other adrenergic substances however are known to impair the microcirculation in vital organs thus exerting a negative short-, mid-

      and long-term effect. Therefore, lowering the norepinephrine dose is of high medical relevance. The amount of norepinephrine required to counteract the cardio-depressive effects (e. g. drop in blood

      pressure) is a direct measure of the cardio-depressive effects in each group: a higher amount of norepinephrine would be used to counteract higher cardiodepressive effects. The use of norepinephrine

      was 36.7 % lower in Remimazolam treated patients when compared to the Propofol/Sevoflurane group which can be regarded as a clinically meaningful differentiation. The study was designed to

      allow the comparison of data with the anaesthesia study conducted by Ono in Japan. In March 2015, PAION announced the initiation of a U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting

      sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy. The initiation of the Phase 3 trial in patients undergoing colonoscopies marks the start of PAION Phase 3 clinical program,

      which includes a second pivotal Phase 3 trial in patients undergoing bronchoscopies and a third smaller safety trial in high-risk patients undergoing colonoscopies. In parallel, PAION will conduct three

      Phase 1 studies.</p> <p>This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo and midazolam-controlled, U.S. multicenter study in 460 patients undergoing colonoscopies for

      diagnostic or therapeutic reasons. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary objective of this study is

      to investigate the short-term sedation, and hence the success of a colonoscopy compared to placebo and midazolam. The primary endpoint is the successful completion of the colonoscopy procedure

      with no requirement for alternative sedative. The completion of patient recruitment is expected before the end of 2015. June 2015, PAION announced the initiation of the second pivotal U.S. Phase

      3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy. This Phase 3 clinical trial is a prospective, double-blind, randomized,

      placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing bronchoscopies. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to

      achieve moderate sedation. The primary endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. The completion of patient recruitment is

      expected in 2016.</p> <p>In August 2015, PAION announced the initiation of an EU Phase III clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic in the indication general

      anesthesia. The now starting phase III study is a multi-national, multicenter, randomized, single-blind, propofol-controlled, confirmatory study in patients undergoing major cardiac surgery. The objective is

      to receive further data to evaluate efficacy, safety and pharmacokinetics of Remimazolam. The primary endpoint is successful anesthesia as measured by meeting a pre-defined level of sedation depth

      without the use of rescue medication. After end of surgery, patients will be transferred to the post anesthesia care unit (PACU) or the intensive care unit (ICU), with the option to continue Remimazolam

      treatment Seite 2 von 3 for up to 24 hours if required. A total of 530 patients will be treated in several European study centers. Results of the study are expected in 2016. The study is designed to provide

      further information about the cardiovascular tolerability profile of Remimazolam. Furthermore, it is expected that further insights on the predictable offset of effect as well as the easy control of sedation in

      the postoperative phase can be gained. Remimazolam will be evaluated against propofol during induction and maintenance of general anesthesia with respect to efficacy and tolerability. Data in the

      postoperative phase will also be obtained for further exploration of the ICU sedation indication. The study was designed such that the data can be combined with data collected in previous anesthesia

      studies, including data obtained from trials conducted in Japan. In December 2015, PAION announced the initiation of a smaller dedicated safety study of Remimazolam in ASA III/IV patients (American

      Society of Anesthesiologists classification III to IV) undergoing colonoscopy as part of the U.S. Phase III program. This trial will run alongside the two ongoing pivotal U.S. Phase III trials in colonoscopy

      and bronchoscopy. The trial is part of the development program, which PAION and the U.S. Food and Drug Administration (FDA) agreed upon for the filing of Remimazolam in the targeted indication

      procedural sedation Japan Clinical Program Ono Pharmaceutical has completed the Phase III programme of Remimazolam in anaesthesia as the lead indication for the Japanese market. As part of the

      Phase III programme, a Phase II/III study was conducted in Japan as a multi-centre randomised parallel-group study with Propofol as a control in surgery patients undergoing general anaesthesia in

      combination with analgesics. Remimazolam and Propofol were intravenously administered to 375 patients (two Remimazolam groups with induction doses of 6 mg/kg/h or 12 mg/kg/h and a dose of 1

      mg/kg/h for maintenance, 150 subjects per group), and 75 patients received a standard dose of Propofol, respectively, to compare the success rates of induction and maintenance of general anaesthesia

      and the safety profiles. All 375 patients achieved loss of consciousness and underwent successful intubation. As expected, the primary endpoint (efficacy) as a general anaesthetic was achieved by 100

      % of patients in all groups. No adverse events of concern were observed. The incidence rates of decrease in blood pressure were 35.3 %, 34.7 % and 60.0 % in the 6 mg/kg/h and 12 mg/kg/h

      Remimazolam and Propofol groups, respectively. In this study, Remimazolam showed a clinically meaningful advantage regarding cardiodepressive/hypotensive effects compared to Propofol. The

      incidence rate of cardiodepressive/hypotensive effects was significantly lower in each Remimazolam group as compared to the Propofol group (p = 0.0004 and p = 0.0003 for the 6 and 12 mg/kg/h doses

      vs. Propofol). The recruitment of the second study in the Phase III programme in more severely sick patients (American Society of Anesthesiologists classification III or higher) and the hepatic impairment

      study were completed. No unexpected adverse reactions were reported.



      In 2007 Ono was granted the rights to develop and market Remimazolam for the Japanese market. In this co-operation, data and information are continually shared so that each party benefits from the

      development progress of the other party. In November 2014, Paion announced that its Japanese development partner, Ono Pharmaceutical Co., Ltd. has informed PAION AG that they have to

      discontinue the project on strategic reasons considering issues in pharmacokinetic features, while no adverse events of concern were observed during clinical trials. Ono now has decided to stop

      its development activities and to return the icense. There will be no repayment for received milestone payments. Remimazolam is now available for licensing in Japan to other parties.
      In March 2012, an agreement was made with Yichang Humanwell Pharma, granting them an exclusive option to develop and market the drug in China.

      In 2013, the rights were partnered to R-Pharm in Russia. These license agreements were extended to Turkey in November 2013, and to the MENA (Middle East/North Africa) region in June

      2014. </p> <p>In July 2014, PAION granted Pendopharm an exclusive licence for the development and commercialization of Remimazolam in the territory of Canada. PAION has indicated interest

      in self-commercializing in Europe but partnering in all other territories. PAION is currently in discussions with potential licence partners to advance the development of Remimazolam, preferably for multiple

      indications, as quickly as possible as well as to prepare for subsequent commercialisation.
      Avatar
      schrieb am 19.02.16 19:46:49
      Beitrag Nr. 65.366 ()
      PS: wenn sich noch jemand von den "Guten" für den unsinnigen Grund des Studienabbruchs interessiert - der uns zwar beruhigen aber auch ärgern sollte - bitte BM an mich. Danke!
      Avatar
      schrieb am 19.02.16 19:37:32
      Beitrag Nr. 65.365 ()
      Sorry Jungs, sorry nach WOB und in die 993 Garage - BM zum Studienabbruch jetzt erst raus, bin auf der Autobahn :-)
      Avatar
      schrieb am 19.02.16 19:20:53
      Beitrag Nr. 65.364 ()
      Antwort auf Beitrag Nr.: 51.789.196 von luxinvest am 19.02.16 17:32:21
      Zitat von luxinvest: http://www.avarx.com/index.php/search/showOpportunityDetails…
      Sieht so aus als wäre Paion zwecks Partnerschaft nicht mehr verfügbar??


      Leider kann man da nicht viel lesen....man muss Premium user sein um alles zu sehen.

      Hilf uns doch mal auf die Sprünge! :cool:
      2 Antworten?Die Baumansicht ist in diesem Thread nicht möglich.
      Avatar
      schrieb am 19.02.16 19:11:33
      Beitrag Nr. 65.363 ()
      Antwort auf Beitrag Nr.: 51.789.598 von question-mark am 19.02.16 18:21:46
      Zitat von question-mark: genau so isses, wenn da irgendwas innerhalb weniger Tage gestrickt würde, hätte ich ein ganz schlechtes Gefühl, als einsteigender Partner muss man doch genau analysieren, was die PMDA gesagt hat und den Wert des deals kann man auch erst dann abschätzen.

      Und hey - das sind Japaner, wer mit denen schon gearbeitet hat, weiss, dass die alles tausenprozentig machen. Ich rechne eher mit ein paar Wochen - wenn es gut läuft ...


      Und genau das, das die Japaner eben so sehr genau arbeiten, macht diese gestrige News umso wertvoller. Könnte sein, das die PMDA mit ihrer "1000%igen Arbeit" den Weg hin zur Zula schon ein klein bisschen mit geebnet hat!

      Hier nochmals die News von Gestern:

      http://www.wallstreet-online.de/nachricht/8348443-dgap-news-…

      Trading Spotlight

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      Avatar
      schrieb am 19.02.16 18:29:37
      Beitrag Nr. 65.362 ()
      Lang genug Zeit hatte Paion und ein eventueller ja....
      Avatar
      schrieb am 19.02.16 18:26:14
      Beitrag Nr. 65.361 ()
      Antwort auf Beitrag Nr.: 51.789.568 von keinGeldmehr am 19.02.16 18:17:50ich gehe davon aus, das das schon alles lange vor dem meeting ausfürlich besprochen wurde.deshalb ist im moment alles möglich.
      Avatar
      schrieb am 19.02.16 18:23:24
      Beitrag Nr. 65.360 ()
      Antwort auf Beitrag Nr.: 51.782.479 von Investmaxx am 18.02.16 23:33:02
      Zitat von Investmaxx: Jetzt wird hier schon von Kursen 4-6€ geträumt hahaha
      Was soll jetzt noch kommen außer heiße Luft! Partner wird mal nicht so schnell gemeldet. Eine Kapitalerhöhung vielleicht ;-)
      Morgen gehts schnell wieder unter 2,00€


      Also Investmaxx du bist weder ein Guter Hellseher,noch stimmen deine Prognosen. Noch nicht mal im Ansatz bzw ein Glücks treffen kann man auch noch nicht mal dir zu gute kommen.Das einzige was kommt ist ??????

      Mist.Und der Mist ist noch schlauer als du es je werden wirst. Vergiss doch die Börse und spiel lieber mit Auto´s oder Barbies oder was weiss ich.Aber wenn du weiter hier versuchst Angst zu verbreiten ,und falsch information hier rein schreibst,werde ich dich Anzeigen wegen Falsch Beratung und Arglistige Täuschung.
      Avatar
      schrieb am 19.02.16 18:21:46
      Beitrag Nr. 65.359 ()
      Antwort auf Beitrag Nr.: 51.789.568 von keinGeldmehr am 19.02.16 18:17:50genau so isses, wenn da irgendwas innerhalb weniger Tage gestrickt würde, hätte ich ein ganz schlechtes Gefühl, als einsteigender Partner muss man doch genau analysieren, was die PMDA gesagt hat und den Wert des deals kann man auch erst dann abschätzen.

      Und hey - das sind Japaner, wer mit denen schon gearbeitet hat, weiss, dass die alles tausenprozentig machen. Ich rechne eher mit ein paar Wochen - wenn es gut läuft ...
      1 Antwort?Die Baumansicht ist in diesem Thread nicht möglich.
      Avatar
      schrieb am 19.02.16 18:17:50
      Beitrag Nr. 65.358 ()
      So schnell kann ich es mir mit ner Partnern in Japan nicht vorstellen. Falls es Interessenten mit einem annehmbaren Angebot gibt, wirds bestimmt noch ein paar Wochen dauern.
      Die neue Ausgangslage müssen beide Seiten erstmal begutachten.
      3 Antworten?Die Baumansicht ist in diesem Thread nicht möglich.
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