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5346 Postings, 3847 Tage toni1111geht hier was

 
  
    #1
6
15.03.12 22:06
Die Biotechnologie-Firma MondoBiotech kämpft ums Überleben. Nun erhofft sich CEO Ruggero Gramatica Rettung aus Italien. Das im Kloster Stans eingemietete KMU steckt in Übernahmeverhandlungen mit Pierrel. Die Mailänder Firma befasst sich auf Kundenauftrag mit Dienstleistungen rund um die Entwicklung von Pharmazeutika. Zudem werden nördlich von Neapel, genauer in Capua, für Dritte Medikamente produziert.

Falls sich die beiden Seiten einigen können, soll MondoBiotech mit Pierrel Research International in Thalwil zusammengelegt werden. Beim Schweizer Ableger handelt es sich um jene Firma, die auf Kundenauftrag forscht. Doch Anfragen am Hauptsitz sind unerwünscht. Auf die Frage, wie viele Personen in Thalwil arbeiten, wurde der Telefonhörer aufgelegt.

Nach der Fusion hielte Pierrel die Mehrheit. Damit wäre Präsident Canio Mazzaro der neue starke Mann; er hält ein Viertel der Aktien an der Mailänder Firma. Woran die Italiener interessiert sind, ist nicht klar. MondoBiotech hat seit der Gründung 2001 primär heisse Luft und Riesenverluste produziert. Alleine im ersten Halbjahr 2011 ist ein Fehlbetrag von 54 Millionen angefallen. Jüngst wurde das Unternehmen stark redimensioniert, gegenwärtig stehen noch neun Namen auf der Gehaltsliste – davon fünf Manager. Der Aktienkurs ist seit dem IPO um sage und schreibe 99 Prozent abgestürzt.

Möglicherwiese will sich Pierrel einfach einen Aktienmantel umhängen, um so ohne Umwege den Sprung an die speziell bei italienischen Pharmaunternehmen beliebte Schweizer Börse zu schaffen. Die Firma könnte frischen Wind gebrauchen; ihre in Mailand kotierten Aktien haben seit 2007 über 80 Prozent an Wert eingebüsst, die Gesellschaft wird von der Börse noch mit 26 Millionen Euro bewertet. Über die letzten Jahre sind einige Dutzend Millionen an Verlusten angefallen.

Muss MondoBiotech in Stans die Lichter löschen, falls die Fusion platzt? «Die Firma ist in der Lage, ihr Kerngeschäft in diesem Jahr weiterzuführen», behauptet CEO Gramatica.

Am MondoBiotech-Hauptsitz im Kloster Stans arbeiten noch neun Personen – inklusive CEO Ruggero Gramatica.

http://www.bilanz.ch/unternehmen/mondobiotech-lichterloeschen

zur info ich bin noch nicht drinn  
1508 Postings ausgeblendet.
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5 Postings, 181 Tage fbo|229327453Geht es weiter abw?rts oder

 
  
    #1510
07.09.21 08:10

mal wieder anders herum .. wenn man das wüsste???

 

5 Postings, 181 Tage fbo|229327453Ups, es geht wieder deutlich abw?rts ....

 
  
    #1511
07.09.21 09:51

 Irgendwelche news warum?

 

2 Postings, 822 Tage Siebi2015News ...

 
  
    #1512
07.09.21 10:06
EQS-Adhoc: Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

 

760 Postings, 621 Tage IneosMitteilung Relief von Heute :-)

 
  
    #1514
08.09.21 11:59


PRESS RELEASE  
1

Relief Therapeutics to Participate in the H.C. Wainwright 23rd Annual Global
Investment Conference

Geneva, Switzerland, September 8, 2021 – RELIEF THERAPEUTICS Holding  AG (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, today announced that Jack Weinstein, Relief’s Chief Financial Officer and
Treasurer,  will  present  a  company  overview  at  the  H.C.  Wainwright  23rd  Annual  Global  Investment
Conference, being held virtually September 13-15, 2021.  

The on-demand presentation will be available beginning September 13, at 7:00am ET on the Relief website
at:  https://www.relieftherapeutics.com/news-and-events  and  will  be  archived  for  a  period  of  90  days
after the conference.

Management  will  also  host  one-on-one  meetings  during  the  event.  Institutional  investors  who  are
registered for the conference can log into www.hcwevents.com to request a meeting with the company.

ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the  U.S.  on  OTCQB  under  the  symbol  RLFTF.    For  more  information,  visit  www.relieftherapeutics.com.  
Follow us on LinkedIn.



PRESS RELEASE  
2

CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer  
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:  
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com



 

Clubmitglied, 483 Postings, 675 Tage Regi51@ Ineos du bist ein tiefgläubiger Mensch.

 
  
    #1515
08.09.21 17:21

760 Postings, 621 Tage IneosNächster Mitbewerber raus :-)

 
  
    #1516
09.09.21 08:09
Regie wie heisst es so schön ? Glaube und Hoffnung versetzen Berge !

https://ir.humanigen.com/English/news/...VID-19-Patients/default.aspx  

755 Postings, 1165 Tage User88Ich kann verstehen,

 
  
    #1517
09.09.21 20:00
daß die Mitbewerber aufgeben, die Konkurrenz ist einfach zu mächtig!

Aber was soll's, es ist ein zock!

 

760 Postings, 621 Tage IneosNeueste Meldung :-)

 
  
    #1518
10.09.21 01:13

 
Ad hoc announcement pursuant to Art. 53 LR  
1


Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research,
Launches PKU GOLIKE® KRUNCH in Germany and Italy

APR Expands PKU GOLIKE® Product Line with More Convenient, Chewable Tablet Option

Geneva, Switzerland, September 9, 2021 – RELIEF THERAPEUTICS Holding  AG (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma
Research SA (“APR”), has launched, through its affiliates in Germany and Italy, PKU GOLIKE® KRUNCH, a
convenient  chewable  tablet  for  the  dietary  management  of  phenylketonuria  (“PKU”),  a  rare,  recessive
metabolic genetic disorder affecting approximately 350,000 people globally.

“With PKU GOLIKE® KRUNCH, we are directly addressing a critical patient need with a much more flexible
and convenient option for the management of PKU. In particular, PKU GOLIKE® KRUNCH gives patients a
ready  to  chew  tablet  allowing  for  ‘on-the-go’ administration  of  protein  substitute.  This  new  option  is
intended to substantially improve adherence to therapy, which is extremely difficult to maintain for these
patients, leading to better outcome and quality of life,” stated Paolo Galfetti, Chief Executive Officer of
APR and President of Relief Europe. “As important, PKU GOLIKE® KRUNCH is the result of how flexible is
our patented Physiomimic Technology™, which allows to develop effective prolonged release, taste and
odor masked products. We are pleased to begin sales in Germany and Italy, two key markets within the
European Union, and in the coming months we plan to expand the distribution of PKU GOLIKE® KRUNCH
to additional countries in Europe.”

The  PKU  GOLIKE®  family  of  products  are  food  for  special  medical  purposes  (“FSMP”)  consisting  of  a
phenylalanine-free amino acid mix in granules. Engineered with the APR’s Physiomimic Technology™, PKU
GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures
a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and
aftertaste.  

“This newest launch by APR is a testament to the strength and adaptability of the Physiomimic Technology
and  is  a  key  addition  to  our  growing  line  of  marketed  products,” stated Raghuram  (Ram)  Selvaraju,
Chairman of the Board of Relief. “Moving forward, we plan to expand our existing commercial
infrastructure and refine marketing activities to accelerate the future growth of this product line. It is also
important to note that, since PKU GOLIKE® has been granted Orphan Drug Designation, we intend to  
 
Ad hoc announcement pursuant to Art. 53 LR  
2


assess the  pursuit of PKU GOLIKE® as a prescription product  for PKU in the U.S.,  where the  majority of
patients have no access to reimbursed medical foods.”

ABOUT PHENYLKETONURIA OR PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine,
leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive
levels  of  phenylalanine  in  the  blood  cause  accumulation  in  the  brain,  which  hampers  proper  brain
development  and  results  in  neurophysiological  dysfunction.  Treatment  of  PKU  is  lifelong,  requiring
patients  to  follow  a  strict  diet  that  severely  limits  phenylalanine  (and,  thus,  protein)  content.    This
necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent
protein deficiency and optimize metabolic control.  

ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the  U.S.  on  OTCQB  under  the  symbol  RLFTF.    For  more  information,  visit  www.relieftherapeutics.com.  
Follow us on LinkedIn.


CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer  
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:  
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com


 
Ad hoc announcement pursuant to Art. 53 LR  
3


Disclaimer:  This  communication  expressly  or  implicitly  contains  certain  forward-looking  statements
concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether APR can successfully market PKU GOLIKE® KRUNCH
in Germany, Italy and other European countries, (ii) whether PKU GOLIKE® KRUNCH will ever be approved
as  a  prescription  product  for  PKU,  and  (iii)  those  risks  discussed  in  RELIEF  THERAPEUTICS  Holding  AG's
filings with the SIX, which could cause the actual results, financial condition, performance or achievements
of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
AG is providing this communication as of this date and does not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.


.


 

760 Postings, 621 Tage IneosNoch mal in Deutsch ! :-)

 
  
    #1519
10.09.21 01:25
APR vermarktet ab heute PKU GOLIKE® KRUN in DE/IT, evtl. USA

Relief PR vom 09.09.2021/22:33 Uhr!

APR Applied Pharma Research, eine hundertprozentige Tochtergesellschaft von Relief Therapeutics, bringt PKU GOLIKE® KRUNCH in Deutschland und Italien auf den Markt

APR erweitert die PKU GOLIKE® Produktlinie mit einer bequemeren Kautablettenoption

Genf, Schweiz, 9. September 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"), ein biopharmazeutisches Unternehmen, das Patienten therapeutische Hilfe bei schweren Krankheiten mit hohem ungedecktem Bedarf bieten will, gab heute bekannt, dass seine hundertprozentige Tochtergesellschaft APR Applied Pharma Research SA ("APR") über ihre Tochtergesellschaften in Deutschland und Italien PKU GOLIKE® KRUNCH auf den Markt gebracht hat, eine praktische Kautablette für die diätetische Behandlung von Phenylketonurie ("PKU"), einer seltenen, rezessiven genetischen Stoffwechselstörung, von der weltweit etwa 350.000 Menschen betroffen sind.
"Mit PKU GOLIKE® KRUNCH adressieren wir direkt einen kritischen Patientenbedarf mit einer viel flexibleren und bequemeren Option für das Management von PKU.
Mit PKU GOLIKE® KRUNCH erhalten die Patienten eine Kautablette, mit der sie den Eiweißersatz auch unterwegs einnehmen können.
Diese neue Option soll die Therapietreue, die bei diesen Patienten extrem schwierig ist, erheblich verbessern und zu einem besseren Ergebnis und einer höheren Lebensqualität führen", erklärte Paolo Galfetti, Chief Executive Officer von APR und Präsident von Relief Europe.

"PKU GOLIKE® KRUNCH ist das Ergebnis der Flexibilität unserer patentierten Physiomimic Technology™, die es ermöglicht, wirksame Produkte mit verlängerter Wirkstofffreisetzung, Geschmacks- und Geruchsmaskierung zu entwickeln. Wir freuen uns, mit dem Verkauf in Deutschland und Italien, zwei Schlüsselmärkten innerhalb der Europäischen Union, zu beginnen, und planen, den Vertrieb von PKU GOLIKE® KRUNCH in den kommenden Monaten auf weitere Länder in Europa auszuweiten." Die Produkte der PKU GOLIKE®-Familie sind Lebensmittel für besondere medizinische Zwecke (FSMP"), die aus einer phenylalaninfreien Aminosäuremischung in Granulatform bestehen. PKU GOLIKE® wurde mit der Physiomimic Technology™ von APR entwickelt und ist das erste Aminosäureprodukt mit verlängerter Freisetzung, das sich durch eine spezielle Beschichtung auszeichnet, die eine bessere physiologische Absorption der Aminosäuren gewährleistet und gleichzeitig deren unangenehmen Geschmack, Geruch und Nachgeschmack maskiert. "Diese neueste Markteinführung von APR ist ein Beweis für die Stärke und Anpassungsfähigkeit der Physiomimic-Technologie und stellt eine wichtige Ergänzung unserer wachsenden Produktpalette dar", erklärte Raghuram (Ram) Selvaraju, Vorstandsvorsitzender von Relief. "Wir planen, unsere bestehende kommerzielle Infrastruktur auszubauen und die Marketingaktivitäten zu verfeinern, um das zukünftige Wachstum dieser Produktlinie zu beschleunigen. Da PKU GOLIKE® den Status eines Arzneimittels für seltene Krankheiten (Orphan Drug Designation) erhalten hat, werden wir prüfen, ob PKU GOLIKE® als verschreibungspflichtiges Produkt für PKU in den USA angeboten werden kann, wo die Mehrheit der Patienten keinen Zugang zu erstattungsfähigen medizinischen Nahrungsmitteln hat."

ÜBER PHENYLKETONURIE ODER PKU PKU ist eine seltene Erbkrankheit, die durch einen Defekt des Enzyms verursacht wird, das für den Abbau von Phenylalanin benötigt wird, was zu einer toxischen Anhäufung von Phenylalanin beim Verzehr von eiweiß- oder aspartamhaltigen Lebensmitteln führt. Ein zu hoher Phenylalaninspiegel im Blut führt zu einer Anhäufung im Gehirn, was die Entwicklung des Gehirns behindert und zu neurophysiologischen Störungen führt. Die Behandlung der PKU ist lebenslang und erfordert von den Patienten eine strenge Diät, die den Phenylalanin- (und damit auch den Eiweiß-) Gehalt stark einschränkt. Dies macht eine Supplementierung von Lebensmitteln auf Aminosäurebasis für besondere medizinische Zwecke (FSMP) erforderlich, um einen Eiweißmangel zu verhindern und die Stoffwechselkontrolle zu optimieren.

Ein Plan bringt Stabilität. Auf festem Boden lässt sich Erfolg aufbauen.
Es gibt nichts Gutes oder Schlechtes, nur das Denken macht es so.  

760 Postings, 621 Tage IneosPKU pro Person im Jahr ca. 10000 Euro :-)

 
  
    #1520
10.09.21 01:40
   

Improve our Future and Save Healthcare Dollars  

You can save American healthcare dollars and improve lives by
sponsoring   legislation   that   provides   the   medical   foods (formula and
modified low protein foods) needed   to   treat   patients   with   PKU   and  
other   inborn   errors   of metabolism.  

The  2008  Newborn  Screening  Saves  Lives  Act  guarantees  that  every
newborn in America is screened for PKU, but there are no federal
mandates to provide treatment.  

      A treated person with PKU lives a normal productive life. They work and pay taxes.
     Without treatment they are severely brain damaged, can’t work, and require costly care.
      The treatment is simple:  specially modified food and formula for the rest of their lives.
      The treatment is preventative care and cost effective chronic disease management.  
 
It costs $10,000 or less per year to provide the medical food and formula for a PKU patient.
It costs $200,000 or more per year to care for a brain damaged person with PKU. It is a 95% savings in medical expenses to treat a PKU patient with food and formula.
There are ~20,000 Americans with inborn errors of metabolism who need this treatment.


38 states have mandates to provide the food and formula for PKU, but many patients are
denied access to health insurance and treatment.  Most state mandates expire, at age 6 or 18, even though the diet is required for life.   As a result, patients can suffer brain damage
and cost the Health care system and tax payers an additional 1-2 Billion dollars per year.  
 
In states with treatment provisions, many self-insured plans deny treatment under ERISA.

   
More Information on Phenylketonuria (PKU)  

The costs of treating an individual with untreated PKU can be up to 13 times
the cost of providing proper treatment.  Therefore, screening for PKU and
maintaining lifelong care for affected individuals will result in a net gain to
taxpayers and a cost-savings to the government.  

What Is Phenylketonuria (PKU)?
   PKU is a metabolic disease in which the body
cannot process a part of protein called
phenylalanine. (1)
   If left untreated, PKU can lead to severe, progres-
sive mental retardation. (1)
   The reported incidence of PKU in the United
States ranges from 1 per 13,500 to 1 per 19,000
newborns. (2)

  In order to remain healthy, individuals with PKU
are limited to a highly restrictive low-protein diet
and must consume a liquid medical formula every
day for the rest of their lives. (3)

  Living with PKU is difficult. The specially manufac-
tured low-protein medical foods and medical for-
mula are extremely expensive.  The average fam-
ily cannot afford them without assistance. The
medically necessary formula and foods are often
not paid for by the state or insurance companies.
(4 & 5)
   The highly restrictive diet proves challenging for
many teens and adults.  There are many social
difficulties that come with managing PKU. (4 & 5)

  Women with PKU face a special dilemma in plan-
ning a pregnancy. Infants of mothers with high
phenylalanine levels exhibit mental retardation,
heart defects, and growth retardation. (6)
What is the impact of PKU?
  An estimated 20,000 people in the United States
have an inborn error of metabolism, such as PKU.
(7)
  5,000 of these individuals are not currently on a
low-protein diet.  (8)

  Studies show that individuals who discontinue diet
before age 10 will experience an average 12 point
drop in their IQ by adulthood.  Children and adults
who are off-diet also experience many other medi-
cal issues, including depression, impulse control
disorder, phobias, epilepsy, tremors, and pareses.
(9 &10)
  On average, it costs $15,000 per person per year
for treatment of PKU, including $5,000 for medical
visits and $10,000 for medical food and formula.
  Cost of care for an untreated PKU patient is ap-
proximately $200,000 per year for care in an in-
patient mental health facility (or at least $60,000/yr
for residential treatment).  (11)
1http://www.knowledgene.com/public/glossary_content.php3
2 http://www.ncbi.nim.nih.gov/books/bv.fcgi?rid=hstat4.section.20940
3 http://www.pku.com/AboutPKU/TheScienceOfPKU.aspx 4 http://www.mayoclinic.com/health/phenylketonuria/DS00514 5 http://www.mattdenn.com/category/news/
6 http://depts.washington.edupku/pro_info/mgmtGuide.html 7 http://www2.uthscsa.edu/nnsis 8 BioMarin
9 Koch et al.  “Phenylketonuria in adulthood: A collaborative study . ”   Jou r- nal of Inherited Metabolic Diseases  25 (2002): 338. 10 http://www.pkunews.org/adults/livesin.htm 11 Richard Koch, MD  
The costs of treating an individual with untreated PKU can be up to 13 times the
cost  of providing proper treatment.  Therefore, screening for PKU and maintaining
lifelong care for affected individuals will result in a net gain to taxpayers and a
cost-savings to the government.
 

760 Postings, 621 Tage Ineosneues Video Dr. Joey Johnson !!

 
  
    #1521
10.09.21 09:56

760 Postings, 621 Tage IneosPKU Golike Krun in DE/IT

 
  
    #1522
12.09.21 12:43
   Online Apotheke Startseite   PKU GOLIKE Krunch Creme Caramel Kautabletten, 10x30 Stück

PKU GOLIKE Krunch Creme Caramel Kautabletten 10x30 Stück
PKU GOLIKE Krunch Creme Caramel Kautabletten
Inhalt: 10x30 Stück
Anbieter: APR Applied Pharma Research Deutschland GmbH
Darreichungsform: Kautabletten
Grundpreis: 1 Stück 2,59 €
Art.-Nr. (PZN): 17280179
GTIN: 7640158093023

   775,64 €
   inkl. MwSt.
   versandkostenfrei!

   Verfügbar
   Versandfertig in
   7 Werktagen

und schon verfügbar !  :-)  

760 Postings, 621 Tage IneosBusiness NRXP :-)

 
  
    #1523
12.09.21 13:00

760 Postings, 621 Tage IneosDanke Paioneer :-)

 
  
    #1525
13.09.21 08:44
Hier noch mal in Deutsch :-) und als Adhoc
Relief Therapeutics gibt ein Update zu den regulatorischen Interaktionen im Vereinigten Königreich und in der Europäischen Union in Bezug auf den führenden Medikamentenkandidaten RLF-100 (Aviptadil)

Genf, Schweiz, 13. September 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief"), ein biopharmazeutisches Unternehmen, das Patienten therapeutische Linderung bei schweren Krankheiten mit hohem ungedecktem Bedarf verschaffen will, teilte heute mit, dass es von der britischen Arzneimittelbehörde MHRA (Medicines and Healthcare products Regulatory Agency) eine wissenschaftliche Beratung zu seinem führenden Prüfpräparat RLF-100TM (Aviptadil) für die Behandlung von Atemwegserkrankungen aufgrund von schwerem COVID-19 erhalten hat.
Der Leitfaden, der im Rahmen eines kürzlichen Treffens von Relief mit der MHRA erstellt wurde, enthielt Ratschläge zum geeigneten Weg für die Einreichung eines Antrags auf bedingte Marktzulassung (CMA)1 für die intravenöse Formulierung von RLF-100, vorbehaltlich der Bereitstellung aller Daten aus der Phase-2b/3-Studie in den USA, die von Reliefs Kooperationspartner, NeuroRx, Inc. ("NeuroRx")
Nach Ansicht der MHRA wäre eine CMA im Rahmen einer rollierenden Prüfung oder eines beschleunigten Prüfungsverfahrens ein geeigneter Weg, um einen raschen Zugang zu nützlichen Behandlungen für mit COVID-19 infizierte Patienten zu gewährleisten.
Eine rollierende Prüfung ermöglicht es der MHRA, mit der Prüfung der verschiedenen Abschnitte eines Antrags zu beginnen, sobald diese von Relief vervollständigt und der MHRA vorgelegt werden.
Relief teilte heute außerdem mit, dass es Gespräche mit der Europäischen Arzneimittelagentur (EMA) über den weiteren Zulassungsweg für RLF-100 in der Europäischen Union geführt hat.
Relief hat die EMA darüber informiert, dass es den Dialog mit der MHRA fortsetzen wird, sobald es wichtige Informationen über die Durchführung der Studie, die klinischen Daten und das Arzneimittel zusammengestellt hat.

Relief teilte außerdem mit, dass NeuroRx ihm bisher nicht alle Daten aus seiner US-Phase-2b/3-Studie zur Bewertung von intravenös verabreichtem Aviptadil für die Behandlung von Atemversagen bei schwerkranken Patienten mit COVID-19 zur Verfügung gestellt hat.

Es kann nicht garantiert werden, dass NeuroRx die erforderlichen Informationen zur Verfügung stellen wird.

1 Im Interesse der öffentlichen Gesundheit kann eine CMA für Arzneimittel auf der Grundlage weniger umfassender klinischer Daten als normalerweise erforderlich erteilt werden, wenn der Nutzen der sofortigen Verfügbarkeit des Arzneimittels das Risiko überwiegt, das sich aus der Tatsache ergibt, dass noch zusätzliche Daten erforderlich sind. Humanarzneimittel kommen in Frage, wenn sie für die Behandlung, Vorbeugung oder Diagnose von zu Invalidität führenden oder lebensbedrohenden Krankheiten bestimmt sind. Dazu gehören auch Arzneimittel für seltene Leiden. Ihre Verwendung ist auch für einen Notfall im Bereich der öffentlichen Gesundheit (z. B. eine Pandemie) vorgesehen.


 
Ad hoc announcement pursuant to Art. 53 LR  
1

Relief Therapeutics Provides Update on Regulatory Interactions in the United
Kingdom and European Union Relating to Lead Drug Candidate, RLF-100
(Aviptadil)
Geneva, Switzerland, September 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, reported today that it has received scientific advice from the Medicines
and  Healthcare  products  Regulatory  Agency  (MHRA)  in  the  United  Kingdom  (UK)  relating  to  its  lead
investigational  drug,  RLF-100TM  (aviptadil),  for  the  treatment  of  respiratory  deficiency  due  to  severe
COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the
MHRA,  included  advice  on  the  appropriate  pathway  for  submission  of  an  application  for  conditional
marketing  approval  (CMA)1  for  the  intravenous  formulation of  RLF-100,  subject  to  provision  of  all  data
from  the  U.S. Phase  2b/3 study  conducted  by  Relief’s  collaboration  partner,  NeuroRx,  Inc.  ("NeuroRx")
According  to  the  MHRA,  a  CMA  through  rolling  review  or  expedited  review  process  would  be  an
appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-
19.  A  rolling  review  allows  the  MHRA  to  start  review  of  various  sections  of  a  submission  as  they  are
completed by Relief and provided to the MHRA.  
Relief  also  reported  today  that  it  has  held  discussions  with  the  European  Medicines  Agency  (EMA)
pertaining to the regulatory path forward for RLF-100 in the European Union.  Relief has informed EMA
that it will proceed with further dialogue with the MHRA once it has compiled critical information related
to the study conduct, clinical data and the drug product.
Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3
study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically
ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.  



1  In  the  interest  of  public  health,  a  CMA  may  be  granted  for  medicines  on  less  comprehensive  clinical
data than normally required, where the benefit of immediate availability of the medicine outweighs the
risk inherent in the fact that additional data are still required. Medicines for human use are eligible if they
are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This
includes orphan medicines. Its use is also intended for a public health emergency (e.g., a pandemic).


 
Ad hoc announcement pursuant to Art. 53 LR  
2


ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and  use  in  human  patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the  U.S.  on  OTCQB  under  the  symbol  RLFTF.    For  more  information,  visit  www.relieftherapeutics.com.  
Follow us on LinkedIn.


CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer  
Mail: contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:  
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer:  This  communication  expressly  or  implicitly  contains  certain  forward-looking  statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its
Phase 2b/3 study, (ii) whether  aviptadil will ever be approved in the  UK or the EU for the  treatment of
respiratory failure in critically ill patients with COVID-19,  and (iii)  those  risks discussed in Relief's filings
with the SIX, which could cause the actual results, financial condition, performance or achievements of
RELIEF  THERAPEUTICS  Holding  SA  to  be  materially  different  from  any  future  results,  performance  or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and do not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.


 

760 Postings, 621 Tage IneosAPR stockt Personal auf :-)

 
  
    #1526
13.09.21 13:24
hier geht mehr : https://www.linkedin.com/feed/update/...activity:6843089836925063168/

Jetzt aktuell ist ja seitens Relief/Neurox die 3 Tägige Konferenz am laufen . Mal schauen was dabei
heraus kommt . :-)  

760 Postings, 621 Tage Ineosneues Video Dr. Joey Johnson :-)

 
  
    #1527
17.09.21 04:08

760 Postings, 621 Tage Ineosguter Artikel :-)

 
  
    #1528
17.09.21 14:17

760 Postings, 621 Tage Ineosmehr von Dr. Joey Johnson :-)

 
  
    #1529
17.09.21 14:24

760 Postings, 621 Tage IneosEndspurt Orderbook SIX :-)

 
  
    #1530
17.09.21 18:26
Detailinformationen
Timeserie
      Zeit     Preis      Vol.          §
      Zeit     Preis      Vol.          §
  17:33:50     0.147    22'477          §
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  17:31:36     0.147   146'147          §
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  17:31:36     0.147    13'466          §
  17:31:36     0.147    21'811          §
  17:31:36     0.147   458'922          §
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  17:31:36     0.147    86'887          §
  17:31:36     0.147    19'751          §
  17:31:36     0.147   173'670          §
  17:31:36     0.147   500'000          §
  17:31:36     0.147   356'939          §
  17:31:36     0.147     7'288          §
  17:31:36     0.147   127'464          §
  17:31:36     0.147    29'529          §
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  17:31:36     0.147    20'023          §
  17:31:36     0.147   178'322          §
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  17:31:36     0.147   146'321          §
  17:31:36     0.147   152'974          §
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  17:31:36     0.147   146'321          §
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  17:31:36     0.147       190          §
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  17:31:36     0.147    78'750          §
  17:31:36     0.147 1'471'491          §
  17:31:36     0.147    98'758          §
  17:31:36     0.147    25'000          §
  17:31:36     0.147   102'000          §
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  17:31:36     0.147     1'286          §
  17:31:36     0.147   420'388          §
  17:31:36     0.147   138'673          §
  17:31:36     0.147   206'039          §
  17:31:36     0.147    25'512          §
  17:31:36     0.147    71'060          §
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  17:31:36     0.147    68'028          §
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  17:31:36     0.147    40'060          §
  17:31:36     0.147    24'287          §
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  17:31:36     0.147   380'112          §
  17:31:36     0.147   158'024          §
  17:31:36     0.147   134'482          §
  17:31:36     0.147    24'527          §
  17:31:36     0.147       646          §
  17:31:36     0.147       288          §
  17:31:36     0.147    37'140          §
  17:31:36     0.147    19'295          §
  17:31:36     0.147    40'026          §
  17:31:36     0.147    44'818          §
  17:31:36     0.147    19'321          §
  17:31:36     0.147    43'907          §
  17:31:36     0.147   319'466          §
  17:31:36     0.147     5'026          §
  17:31:36     0.147    50'000          §
  17:31:36     0.147    98'925          §
  17:31:36     0.147        59          §
  17:31:36     0.147   287'000          §
  17:19:48     0.147     6'328          §
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  17:19:19     0.146     6'304          §
  17:18:58     0.146     4'000          §
  17:18:54     0.145     1'638          §
  17:18:54     0.145    14'328          §
  17:18:13     0.146    49'478§
Weniger anzeigen
 

131 Postings, 616 Tage stoam@Ineos

 
  
    #1531
18.09.21 11:11
Und was sagt uns das?  

Clubmitglied, 483 Postings, 675 Tage Regi51@stoam, Ineos zeichnet den Endspurt auf.

 
  
    #1532
18.09.21 18:19

760 Postings, 621 Tage Ineos28 September :-)

 
  
    #1533
18.09.21 21:24

760 Postings, 621 Tage IneosAd hoc :-)

 
  
    #1534
21.09.21 08:24

 
1


Ad hoc announcement pursuant to Art. 53 LR  
Relief  Therapeutics’  Wholly  Owned  Subsidiary,  APR  Applied  Pharma  Research,
Reports  Data  Published  in  the  Peer  Reviewed  Journal,  Nutrients,  Indicating
Additional Potential Benefits of Its Physiomimic™ Technology

• Data In Healthy Volunteers Suggests That APR’s Controlled Release Amino Acid Mix, PKU
GOLIKE®,  May  Be  Key  To  Reducing  Catabolic  Events  In  Patients  With  Phenylketonuria
(“PKU”), Improving Utilization Of Amino Acids And Quality Of Life  

Geneva, Switzerland, September 21, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma
Research  SA  (“APR”), reported data published in  the peer reviewed  journal, Nutrients, indicating
additional potential benefits of the company’s Physiomimic™ Technology to the management of patients
suffering from phenylketonuria (“PKU”).  

The paper, entitled, “Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute
for Phenylketonuria as a Single Dose in Healthy Volunteers,” provides a further evaluation of published
data  from  APR’s previously  reported,  randomized,  controlled,  single-dose  crossover  trial  in  healthy
volunteers which showed that a prolonged-release amino acid (AA) mixture, formulated with Physiomimic
Technology,  significantly  slowed  down  the  release  and  reduced  the  peak  plasma  concentrations  of
essential AAs compared with a free AA mixture. Authors of the current paper, including Anita MacDonald,
Ph.D. and Ania C. Muntau, M.D, renowned experts in the field of metabolic diseases, concluded that the
controlled release amino acid mix (PKU GOLIKE®), given its ability to prolong the release of AAs, appears
to be key to reducing catabolic events in patients with PKU, resulting in a more efficient utilization of AAs
for protein synthesis and, therefore, an improved quality of life.  

“The paper’s conclusions reaffirm our belief as to the benefits of our patented Physiomimic Technology,
the distinct advantages of our PKU GOLIKE® family of products, and the potential additional advantages
conferred by the product’s  unique  ability  to  prolong  the  release  of  AAs,” stated Paolo Galfetti, Chief
Executive Officer of APR and President of Relief Europe. “The  Physiomimic  Technology  allows  for  a
formulation of AAs which we believe leads to a physiological absorption profile more closely resembling
the absorption profile of natural proteins. Based on the results published in the paper, we plan to explore
 
2

additional  clinical  assessments  to  support  the  benefits  of  AAs  physiological  absorption  associated  with
PKU GOLIKE and the patented pharmaceutical Physiomimic Technology behind it.”

“The strong clinical results are a testament to the potential benefits of PKU GOLIKE® as compared to non-
prolonged  release  AA  supplementation,” stated Raghuram  (Ram)  Selvaraju,  Chairman  of  the  Board  of
Relief. “PKU GOLIKE® has been granted Orphan Drug Designation in the U.S. and further clinical studies
on  the  benefits  of  the  Physiomimic  Technology  will  help  as  we  pursue  PKU  GOLIKE®  as  a  prescription
product.  In  the  meantime,  we  will  focus  on  the  commercial  expansion  and  refinement  of  marketing
activities to facilitate the growth of this product line in Europe.”

About PKU GOLIKE
The  PKU  GOLIKE  family  of  products  are  food  for  special  medical  purposes  (FSMP)  consisting  of  a
phenylalanine-free  amino  acid  mix  in  granules.  Engineered  with  the  Company’s patented  Physiomimic
Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a
special coating that ensures a better physiological absorption of the amino acids, while also masking their
unpleasant taste, odor and aftertaste.  

About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine,
leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive
levels  of  phenylalanine  in  the  blood  cause  accumulation  in  the  brain,  which  hampers  proper  brain
development  and  results  in  neurophysiological  dysfunction.  Treatment  of  PKU  is  lifelong,  requiring
patients  to  follow  a  strict  diet  that  severely  limits  phenylalanine  (and,  thus,  protein)  content.    This
necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent
protein deficiency and optimize metabolic control.  

ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

 

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