Nyxoah Provides General Corporate Update

Nyxoah Provides General Corporate Update

Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022

Mont-Saint-Guibert, Belgium – January 10, 2022, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided a general corporate update.

2021 Highlights

  • Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently 15 active and enrolling patient sites in the U.S., with implants expected to be completed in Q1 2022
  • Secured CE Mark MR conditional labeling for the Genio® system in January, ensuring that implanted patients can undergo full-body 1.5T and 3T MRI diagnostic scans
  • Raised $97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah’s second IPO after previously raising $100 million in the September 2020 Euronext Brussels IPO
  • Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate in September; engaged in sprint discussions with FDA regarding the IDE study for CCC patients in the U.S., which Nyxoah hopes to commence in the second half of 2022
  • Received expanded CE Mark indication to treat CCC patients in October, thus increasing Nyxoah’s total addressable market by at least 30% and thereby enabling patients not to have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure prior to Genio® implantation
  • Made strong commercial progress in Germany after obtaining a dedicated DRG code in January
  • Obtained DRG coding in Switzerland in March and secured first revenue in Spain; submitted reimbursement files in other key European markets
  • Entered exclusive licensing agreement with Vanderbilt University in February to develop next generation neurostimulation technologies, specifically a stimulator focused on the Ansa Cervicalis, which innervates the palatoglossus and/or the palatopharyngeus muscle; this collaboration has thus far resulted in initial prototyping discussions, and Nyxoah expects to make further progress on this project in 2022
  • Appointed Loic Moreau as Chief Financial Officer effective January 1, 2022, replacing Fabian Suarez, who is pursuing a new opportunity as CEO of a startup MedTech company
  • Announced the appointment of Rita Johnson-Mills to the Board of Directors in August

“2021 was a transformational year for Nyxoah as we achieved several important clinical, regulatory, commercial, and financial accomplishments and set ourselves up for continued progress in 2022 and beyond,” said Olivier Taelman, CEO of Nyxoah. “On the clinical front, we announced that our BETTER SLEEP clinical trial achieved a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post implantation for the entire cohort as well as for the subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC patients as well as by FDA in granting us Breakthrough Device Designation for the treatment of CCC patients in the U.S. We are also excited to partner with Dr. David Kent and his team at Vanderbilt University on the development of a next generation device that stimulates the Ansa Cervicalis, which Dr. Kent’s research suggests could be another effective way to treat OSA patients, and we look forward to advancing our work in creating a stimulator that leverages this novel approach.”

Mr. Taelman continued, “As we begin 2022, our primary clinical focus is on our DREAM U.S. IDE pivotal study in which patient enrollment and implants are well underway, and we still expect to complete our target of 134 implants by the end of Q1 2022. We continue to generate great enthusiasm from physicians and patients as we activate more sites and enroll more patients, and we are seeing implant rates accelerating as we move into the new year. We have also been encouraged by our sprint discussions with FDA regarding our IDE trial for CCC patients in the U.S., which we hope to commence in the second half of 2022. From a commercial standpoint, we have made tremendous progress in our key geographic markets, securing DRG codes in Germany and Switzerland, obtaining hospital reimbursement in Spain and awaiting reimbursement decisions in Belgium, the Netherlands, and the Nordic countries. Our commercial strategy centers on the concept of going deep as opposed to going wide; in other words, we want to focus our strategy on key Centers of Excellence with high levels of clinical expertise and patient care, large patient pools, and well-coordinated clinical and administrative infrastructures. This strategy, combined with our ability to treat CCC patients, has enabled us to gain meaningful market share in Germany, and we expect to exit 2022 as the market leader in that important country.”

Mr. Taelman concluded, “As proud and excited as we are of our significant accomplishments in 2021, we have our sights set much higher for 2022. Aiding our efforts is a strong balance sheet that we bolstered in July with close to $100 million raised in our Nasdaq IPO, less than one year after raising close to $100 million in our Euronext IPO in September 2020. This liquidity gives us ample flexibility to complete the DREAM study, conduct the ACCCESS study, invest further in our existing commercial operations, and begin to build out a U.S. commercial operation in anticipation of launch following FDA approval. We are extremely well positioned to execute on our clinical, regulatory, and commercial initiatives, and we look forward to providing further updates on our progress as the year unfolds.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements 
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

Gilmartin Group 
Vivian Cervantes
IR@nyxoah.com

 

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Clayfin and BRAC Bank win Most Impactful Digital Platform award from IBS Intelligence

Implementation at the Bangladeshi Bank produced 100% digital transaction growth and 36% manual to digital conversion

DUBAI, UAE, Jan. 10, 2022 /PRNewswire/ — Clayfin Technologies, a leading customer experience focused digital solutions provider for financial institutions, and BRAC Bank, have been awarded the ‘Best Digital Channel/Platform Implementation Award – Most Impactful Platform’ at IBSi Global FinTech Innovation Awards 2021.

The award has been given in recognition of the collaborative implementation of BRAC Bank’s new digital platform called ‘Astha’. Mobile Banking App ‘Astha’ comprises of a wide spectrum of digital services and engagement tools in retail banking. This is a prime example of digital infrastructure overhaul targeting superior customer experience, higher adoption rates and market impact. In less than a year of going live, Astha has made a significant impact adding 30% on digital customer growth, 100% in digital transaction volumes and 36% conversion from manual transactions to digital channel.

Recognizing the impactful solution implementation, Robin Amlôt, Managing Editor of IBS Intelligence, said, “I am thrilled to announce Clayfin Technologies along with BRAC Bank Limited as winners of the Most Impactful Project Award part of the Best Digital Channel/Platform Implementation category at the 3rd edition of the IBS Intelligence Global FinTech Innovation Awards 2021. The solution was highly impactful and resulted in an astounding 100% growth in digital transactions. Congratulations to the duo.”

On the occasion, Md. Sabbir Hossain, DMD and COO of BRAC Bank, said, “We are immensely honoured to have received this international award. The new Astha digital platform is part of our strategic digital system overhaul for delightful and convenient banking experience for the customers. Over a short period of time, the implementation of the app with the tagline ‘Bank Smart’ has helped us achieve a significant impact on our customer base. The award will help us launch more digital initiatives to take customer experience to newer heights.”

Rajesh BLN, CEO of Clayfin added, “We are proud and thankful to receive this award with BRAC Bank. Astha platform for BRAC Bank is functionally rich, intuitive, easy to use, safe and secure. For BRAC Bank, this is just the beginning of a journey. Through its digital initiatives, BRAC Bank will stay ahead of times, and will keep impacting the lives of more and more customers.”

About IBSi Global FinTech Innovation Awards 2021

IBS Intelligence is a pure-play Financial Technology focused research, advisory, and news analysis firm, with a 30-year track record and clients globally. The third edition IBSi Global FinTech Innovation Awards attracted global attention with over 190 participants from 48 countries.

About BRAC Bank

BRAC Bank Limited  traded as ‘BRACBANK‘ on Dhaka Stock Exchange has been one of the country’s fastest-growing banks in Bangladesh with a particular focus on the small and medium enterprise (SME) segment.

Taking inspiration from its parent organization BRAC, the largest NGO in the world, it focused on Small and Medium Enterprises. Based out of Dhaka, the bank offers SME Banking, Retail Banking, Wholesale Banking & Custodial Service, Treasury and Foreign Exchange & Related Services through 187 branches, 650 Agent Banking Outlets and digital channels. With more than 1.1 million customers, the bank has already proved to be the largest collateral-free SME financier in just 20 years of its operation in Bangladesh and continues to serve as a benchmark for governance, transparency and compliance in the banking sector.

About Clayfin

Clayfin is a leading provider of Digital Customer Experience solutions for Banks and Financial institutions. Clayfin works across geographies, and currently supports 80+ implementations across 30+ customers in APAC, Middle East and Africa.

Contact:

Mr. Jishith Gangadharan
jishith@clayfin.com
+91-8593931693

 

إبرام اتفاقية بين RedHill Biopharma وGaelan Medical لترخيص Talicia®‎ في الإمارات العربية المتحدة

ستدفع شركة Gaelan Medical مبلغ 2 مليون دولار مقدمًا لشركة RedHill بالإضافة إلى المعالم التنظيمية والمبيعات المحتملة وإتاوات متدرجة على صافي المبيعات، للحقوق الحصرية في الإمارات العربية المتحدة لشركة Talicia®‎

Talicia هو علاج معتمد من قبل إدارة الغذاء والدواء الأمريكية (FDA) في الولايات المتحدة لعلاج بكتيريا الملوية البوابية، وهي عدوى بكتيرية تؤثر على أكثر من 50 % من سكان العالم البالغين مما يمثل احتياجات كبيرة غير ملباة

RALEIGH, N.C. وتل أبيب، إسرائيل، 10 يناير 2022 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: أعلن RDHL) (“Redhill” أو “الشركة”)، وهي شركة تتخصص فب المنتجات الصيدلانية الحيوية، أنها دخلت في اتفاقية ترخيص حصرية مع Gaelan Medical Trade LLC (“Gaelan Medical”)، وهي شركة تابعة مملوكة بالكامل لمجموعة غسان عبود ( GAG)، في ما يتعلق بـ Talicia® (أوميبرازول ومغنيسيوم وأومكسيسيلين وريفابوتين، [1]، وهو علاج H. pylori في الإمارات العربية المتحدة.

RedHill Biopharma Logo (PRNewsfoto/RedHill Biopharma)

بموجب شروط الاتفاقية، ستتلقى RedHill دفعة مقدمة قدرها 2 مليون دولار وهي مؤهلة للحصول على مدفوعات إضافية بارزة بالإضافة إلى الإتاوات المتدرجة حتى منتصف سن المراهقة على صافي مبيعات Talicia في الإمارات العربية المتحدة. سوف تحصل شركة Gaelan Medical على الحقوق الحصرية لتسويق Talicia في الإمارات العربية المتحدة، بالإضافة إلى حق الشفعة لتسويق Talicia تجاريًا في منطقة مجلس التعاون الخليجي (المملكة العربية السعودية والكويت وقطر والبحرين وعمان) لفترة محددة مسبقًا.

وقال درور بن آشر، الرئيس التنفيذي لـ Redhill : “نحن سعداء بالشراكة مع Gaelen Medal للمساعدة في توفير Talicia لمرضى  H. pylori في الإمارات العربية المتحدة والأقاليم المحتملة الأخرى في المنطقة”. “هذه الشراكة مهمة بشكل خاص بالنظر إلى أن  الملوية البوابية، وهي مصدر قلق كبير للصحة العامة، تؤثر على ما يصل إلى 84% من السكان في المنطقة [2] وهي واحدة من أقوى عوامل الخطر لسرطان المعدة، مما أدى إلى الإقليمية الأخيرة إجماع اجتماع يدعو إلى عرض العلاج القذارة لجميع الأفراد المصابة بالملوية البوابية [3]. نحن نرى نموًا سريعًا لـ Talicia في الولايات المتحدة في ضوء معدلات الفشل المزعجة للعلاجات التي تعتمد على الكلارثروميسين ووعي الأطباء المتزايد للحاجة إلى علاج الملوية البوابية كخط علاجي أول. ونحن نواصل الاستكشاف مع الشركاء المحتملين زيادة الوصول إلى Talicia في المناطق خارج الولايات المتحدة.”

 وقال غسان عبود رئيس مجلس إدارة GAG “إنالملوية البوابية يمكن أن تسبب أضرارًا وخيمة ومكثفة في حال عدم القضاء عليها بشكل صحيح من أول مرة وهناك حاجة كبيرة لعلاج مثل Talicia في دولة الإمارات العربية المتحدة، حيث يصاب بالمرض 41% من السكان [4] ولديهم خيارات محدودة للعلاج.” “سيصبح Talicia أول منتج مجمع معتمد في دولة الإمارات مصمم خصيصًا لعلاج الملوية البوابية، ونحن متحمسون أن نكون شراكة مع RedHill ولاحتمال تحقيق إمكانات Talicia لمساعدة المرضى الذين يعانون من عدوى الملوية البوابية في الإمارات العربية المتحدة ومناطق أخرى.”

نبذة عن Talicia®  

Talicia® هو العلاج الوحيد الذي يستند إلى الريفابوتين المعتمد لعلاج عدوى الملوية البوابية ومصمم لمعالجة المقاومة العالية من البكتيريا الملوية البوابية التي تظهر مع المضادات الحيوية الأخرى. أدت المعدلات المرتفعة من مقاومة الملوية البوابية للكلارثروميسين إلى معدلات كبيرة من فشل العلاج مع العلاجات القائمة على كلاريتروميسين، وهي مصدر قلق قوي على الصحة العامة، كما أبرزت ACG وإدارة الغذاء والدواء الأمريكية (FDA) ومنظمة الصحة العالمية (WHO) في السنوات الأخيرة.

TALICIA®  عبارة عن كبسولة فموية جديدة، في جرعة ثابتة، بنسق الكل في واحد، مكونة كمزيج من اثنين من المضادات الحيوية (أموكسيسيلين وريفابوتين) ومثبط ضخ البروتون (PPI) (أوميبرازول). في نوفمبر 2019، تمت الموافقة على Talicia® من قبل إدارة الغذاء والدواء الأمريكية لعلاج عدوى الملوية البوابية عند البالغين. في دراسة المرحلة الثالثة المحورية، أظهر Talicia® القضاء على 84% من عدوى الملوية البوابية في مجموعة نية العلاج (ITT) مقابل 58% في مجموعة المقارنة النشطة (p <0.0001). تم اكتشاف مقاومة ضئيلة إلى صفرية للريفابوتين، وهو مكون رئيسي في Talicia®، في دراسة المرحلة الثالثة المحورية التي أجرتها RedHill. علاوة على ذلك، في تحليل البيانات من هذه الدراسة، لوحظ أن الأشخاص الذين تم تأكيد التزامهم [5] بعلاجهم لديهم معدلات استجابة بنسبة 90.3% في مجموعة Talicia® مقابل 64.7% في مجموعة المقارنة النشطة[6].

يعد Talicia® مؤهلاً للحصول على ما مجموعه ثماني سنوات من حصرية التداول في السوق الأمريكية بموجب تصنيفه ضمن منتجات الأمراض المعدية المؤهلة (QIDP) وتغطيه أيضا براءات الاختراع الأمريكية التي تمد حماية البراءات حتى عام 2034 مع براءات اختراع وتطبيقات إضافية معلقة، وحصوله عليها في مختلف المناطق في جميع أنحاء العالم.

نبذة عن الملوية البوابية

الملوية البوابية هي عدوى بكتيرية تصيب ما يقرب من 35%[7] من سكان الولايات المتحدة، مع علاج ما يقدر بمليوني مريض سنويًا[8]. في جميع أنحاء العالم، ثمة أكثر من 50% من السكان مصابين بالملوية البوابية، المصنفة من قبل منظمة الصحة العالمية كمسرطن من المجموعة 1. وهي تظل أقوى عامل خطر معروف للإصابة بسرطان المعدة[9] وعامل خطر رئيسي لمرض القرحة الهضمية[10] والأنسجة اللمفاوية المرتبطة بالغشاء المخاطي المعدي (MALT)[11]. يتم تشخيص إصابة أكثر من 27 ألف شخص أمريكي بسرطان المعدة سنويًا[12]. وقد أصبح القضاء على الملوية البوابية صعبًا بشكل متزايد، حيث فشلت العلاجات الحالية في حوالي 25-40% من المرضى الذين يبقون إيجابيي الإصابة بالملوية البوابية بسبب مقاومة عالية من الملوية البوابية للمضادات الحيوية – وخاصة كلاريثروميسين – التي لا يزال يستخدم عادة في العلاجات القياسية المجمعة[13].

نبذة عن Gaelan Medical

Gaelan Medical هي جزء من مجموعة غسان عبود، وهي مجموعة دولية شاركت في العديد من قطاعات الأعمال الرئيسية بما في ذلك الرعاية الصحية والسيارات والضيافة والعقارات والتجزئة والتموين والخدمات اللوجستية والتجارة والتجارة والتوزيع والإعلام لأكثر من عشرين عامًا. يقع المقر الرئيسي لشركة GAG في الإمارات العربية المتحدة، بالإضافة إلى مكاتب في أستراليا وبلجيكا والأردن وتركيا.

تؤمن مجموعة غسان عبود بأن الإنتاجية والابتكار والتحول تتطلب مشاركة مجتمعية وتضمن أن محفظتها الحصرية تعمل بطريقة واعية ومسؤولة تجعل الناس في المرتبة الأولى وراء رؤيتها “أن نكون في طليعة التميز”.

Gaelan Medical، شركة توزيع الرعاية الصحية ومنتجات التجميل التي تتخذ من الإمارات العربية المتحدة مقراً لها، تتبع مهمة الرعاية والعلاج، وهي مكرسة لدعم مقدمي الرعاية الصحية بحلول عالمية المستوى لخدمة المجتمعات بشكل أفضل في جميع أنحاء منطقة دول مجلس التعاون الخليجي. تلبي Gaelan Medical، بفضل فريق الإدارة ذي الخبرة، احتياجات الرعاية الصحية المتنوعة بما في ذلك: المستحضرات الصيدلانية، والمستهلكات الطبية، والمعدات الطبية، ومنتجات التجميل. إن مرونة الشركة وقدراتها المالية القوية لشركتها الأم GAG تجعلها الشريك المفضل والحل الشامل لاحتياجات المنطقة.

نبذة عن RedHill Biopharma 

. (Nasdaq: RDHL) RedHill Biopharma Ltdهي شركة تتخصص في المنتجات الصيدلانية الحيوية، وتركز بشكل أساسي على أمراض الجهاز الهضمي والمعدي. تروج RedHill لأدوية الجهاز الهضمي، Movantik® لعلاج الإمساك الناجم عن المواد الأفيونية عند البالغين[14]، وTalicia® لعلاج عدوى الملوية البوابية عند البالغين، وAemcolo® لعلاج إسهال المسافر عند البالغين[15]. تشمل برامج التطوير الرئيسية المرحلة السريرية الرئيسية في Redhill: (1) RHB-204، مع دراسة المرحلة 3 الجارية لمرض المتفطرات الرئوية غير السلية ( ( NTM ؛ (2) opaganib (ABC294640)، مثبط انتقائي SK2 شفوي من الدرجة الأولى في فئته يستهدف مؤشرات متعددة مع برنامج المرحلة 2/3 لدراسات COVID-19 والمرحلة 2 لسرطان البروستاتا وسرطان القنوات الصفراوية الجارية ؛ (3) RHB-107 (upamostat) ، مثبط إنزيم بروتياز سيرين عن طريق الفم في دراسة أمريكية للمرحلة 2/3 كعلاج لأعراض COVID-19، واستهداف العديد من السرطانات الأخرى وأمراض الجهاز الهضمي الالتهابية ؛ (4) RHB-104، مع نتائج إيجابية من دراسة المرحلة الأولى 3 لمرض كرون ؛ (5) RHB-102، مع نتائج إيجابية من دراسة المرحلة 3 لالتهاب المعدة والأمعاء الحاد والتهاب المعدة والنتائج الإيجابية من دراسة المرحلة 2 لـ IBS-D؛ (6) RHB106، تحضير معوي مغلف. يتوفر مزيد من المعلومات حول الشركة على www.redhillbio.com / https://twitter.com/RedHillBio.

حول Talicia®  (أوميبرازول مغنيسيوم وأموكسيسيلين وريفابوتين)

الدواعي والاستخدام

Talicia هو مزيج من ثلاثة أدوية من أوميبرازول، مثبط مضخة البروتون، أموكسيسيلين، مضاد للبكتيريا من فئة البنسلين، وريفابوتين، مضاد للبكتيريا ريفاميسين، محدد لعلاج عدوى الملوية البوابية عند البالغين.

للحد من تطور البكتيريا المقاومة للعقاقير والحفاظ على فعالية تاليسيا والأدوية الأخرى المضادة للبكتيريا، يجب استخدام تاليسيا فقط لعلاج أو منع العدوى التي ثبت أو يشتبه بشدة أنها تسببها البكتيريا.

معلومات مهمة للسلامة

يحتوي Talicia على أوميبرازول، مثبط مضخة البروتون (PPI)، أموكسيسيلين، مضاد للبكتيريا من فئة البنسلين وريفابوتين، مضاد للجراثيم ريفاميسين. يمنع استخدامه للمرضى الذين يعانون من فرط الحساسية لأي من هذه الأدوية، أو أي مكونات أخرى من المستحضر، أو أي بيتا لاكتام آخر أو أي ريفاميسين آخر.

يُمنع استعمال Talicia مع المرضى الذين يتلقون منتجات تحتوي على ريلبيفيرين.

يُمنع استعمال Talicia مع المرضى الذين يتلقون ديلافيردين أو فوريكونازول.

تم الإبلاغ عن تفاعلات فرط حساسية خطيرة ومميتة في بعض الأحيان مع أوميبرازول وأموكسيسيلين وريفابوتين.

تم الإبلاغ عن تفاعلات جانبية جلدية شديدة (على سبيل المثال متلازمة ستيفنز جونسون (SJS) وانحلال البشرة النخري السمي (TEN) مع ريفابوتين وأموكسيسيلين وأوميبرازول. بالإضافة إلى ذلك، تم الإبلاغ عن تفاعل دوائي مع فرط الحمضات والأعراض الجهازية (DRESS) مع ريفابوتين.

لوحظ التهاب الكلية المعوي الحاد في المرضى الذين يتناولون مثبطات مضخة البروتون والبنسلين.

تم الإبلاغ عن Clostridioides المرتبط بالإسهال العسير (CDAD) باستخدام جميع العوامل المضادة للبكتيريا تقريبًا وقد تتراوح من الإسهال الخفيف إلى التهاب القولون القاتل.

قد يسبب Talicia ضررًا للجنين. لا ينصح باستخدام Talicia أثناء الحمل. Talicia قد يقلل من فعالية وسائل منع الحمل الهرمونية. يوصى باستخدام طريقة إضافية غير هرمونية من وسائل منع الحمل عند تناول Talicia.

لا ينبغي استخدام Talicia في المرضى الذين يعانون من ضعف الكبد أو ضعف شديد في الكلى.

تم الإبلاغ عن الذئبة الحمامية الجلدية (CLE) والذئبة الحمامية الجهازية (SLE) في المرضى الذين يتناولون مثبطات مضخة البروتون. حدثت هذه الأحداث كبداية جديدة للمرض وكتفاقم لأمراض المناعة الذاتية الموجودة.

كانت ردود الفعل السلبية الأكثر شيوعا (≥1%) الإسهال، الصداع، الغثيان، آلام البطن، الكروماتوريا، الطفح الجلدي، العسر الهضمي، آلام البلعوم، القيء، والبيض المبيضات المفروج.

للإبلاغ عن ردود الفعل الضائرة، اتصل بشركة RedHill Biopharma INC على الرقم 1-833-ADRHILL (1-833-237-4455)  أو FDA على الرقم 1-800-FDA-1088 أو www.fda.gov/medwatch.

 تتوفر معلومات وصفية كاملة لـ Talicia على www.Talicia.com

ملاحظة: هذا البيان الصحفي، المقدم لأغراض التيسير على القراء، هو نسخة مترجمة من البيان الصحفي الرسمي الذي تنشره الشركة باللغة الإنجليزية. للحصول على بيان صحفي كامل باللغة الإنجليزية، بما في ذلك إخلاء المسؤولية عن البيانات التطلعية، يرجى زيارة: https://ir.redhillbio.com/press-releases

فئة: تجاري

بيانات الاتصال بالشركة:
Adi Frish
رئيس موظفي الشركات وتطوير الأعمال
Redhill Biopharma.
+972-54-6543-112
adi@redhillbio.com

للتواصل الإعلامي:
USA/UK: Amber Fennell, Consilium
783 658 7739 44 (0)+
fennell@consilium-comms.com

[1] يشار إلى Talicia® (أوميبرازول مغنيسيوم وأموكسيسيلين وريفابوتين) كبسولات متأخرة الإطلاق 10 مجم / 250 مجم / 12.5 مجم لعلاج عدوى هيليكوباكتر بيلوري (الملوية البوابية) عند البالغين. للحصول على معلومات كاملة وصفية www.Talicia.com.

[2] Hussein NR. Helicobacter pylori and gastric cancer in the Middle East: a new enigma? World J Gastroenterol. 2010;16(26):3226-3234. doi:10.3748/wjg.v16.i26.3226

Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, et al. Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis. Gastroenterology. 2017 Aug 1;153(2):420–9.

[3] Liou J, Malfertheiner P, Lee Y Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM), et al Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut 2020;69:2093-2112.

[4] Khoder G, Muhammad JS, Mahmoud I, Soliman SSM, Burucoa C. Prevalence of Helicobacter pylori and Its Associated Factors among Healthy Asymptomatic Residents in the United Arab Emirates. Pathogens. 2019؛ 8 (2): 44. تم النشر 2019 أبريل 1. DOI: 10.3390 / Pathogens8020044

[5] مُعرَّف على أنه مجموعة PK التي تضم هؤلاء الأشخاص في مجموعة ITT الذين أظهروا وجود أي مكون من مكونات الدواء التجريبي في الزيارة 3 (تقريبًا اليوم 13) أو تم رسم مستويات غير مكتشفة بعد> 250 ساعة من آخر جرعة.

[6] أظهرت دراسة المرحلة الثالثة المحورية مع Talicia® القضاء على 84% من عدوى الملوية البوابية مع Talicia® مقابل 58% في مجموعة المقارنة النشطة (تحليل ITT، p <0.0001).

[7] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.

[8] IQVIA Custom Study for RedHill Biopharma, 2019

[9] Lamb A et al. Role of the Helicobacter pyloriInduced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.

[10] NIH – Helicobacter pylori and Cancer, September 2013.

[11] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.

[12] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).

[13] Malfertheiner P. et al. Management of Helicobacter pylori infection – the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.

[14] تتوفر معلومات وصفية كاملة لـ Movantik® (naloxegol) على www.Movantik.com.

[15] تتوفر معلومات وصفية كاملة لـ (rifamycin) Aemcolo® على: www.Aemcolo.com.

الشعار – https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

Turkish forces arrest 5 PKK terror suspects in Istanbul

At least five PKK suspects were arrested in Istanbul in simultaneous counter-terror operations, according to Turkish security sources on Monday.

The anti-terrorism unit of Istanbul police launched the operations to arrest suspects who were accused of making fake passports for members of the PKK/KCK terror group, said a source who asked not to be named due to restrictions on speaking to the media.

Police teams also seized digital material along with organizational documents during the operations that took place on Dec. 31 and Jan. 5 in Istanbul.

In its more than 35-year terror campaign against Turkiye, the PKK – listed as a terrorist organization by Turkiye, the US and EU – has been responsible for the deaths of over 40,000 people, including women, children, and infants. The YPG is the PKK’s Syrian offshoot.

Source: Anadolu Agency

US, Russia begin security talks amid Ukraine tension

The talks started between US Deputy Secretary of State Wendy Sherman and Russian Deputy Foreign Minister Sergey Ryabkov at the US mission to the UN office in Geneva.

“The U.S. will listen to Russia’s concerns and share our own, but we have been clear we will not discuss European security without our Allies and partners,” Sherman said on Twitter.

The US has described talks as an “extraordinary meeting” of the two nuclear powers’ Strategic Stability Dialogue (SSD).

Both countries have said they will speak to the media after their meeting.

Among the issues expected to be discussed included Russian troops near Ukraine’s border, NATO’s eastward expansion, nuclear weapons control, cybercrime, and other bilateral matters.

Sherman and Ryabkov had also met on Sunday in Geneva to prepare for the meeting.

“The Deputy Secretary and Deputy Foreign Minister discussed the bilateral topics both sides would address during the extraordinary meeting of the Strategic Stability Dialogue (SSD) January 10,” said the US in a statement.

‘Commitment to diplomacy’

Sherman stressed the US commitment to diplomacy and “the international principles of sovereignty, territorial integrity, and the freedom of sovereign nations to choose their own alliances.”

“The United States will discuss certain bilateral issues with Russia at the SSD but will not discuss European security without our European Allies and partners,” said the statement.

Sherman said some subjects would only arise at the NATO-Russia Council meeting in Brussels on Jan. 12 and the Organization for Security and Co-operation in Europe (OSCE) Permanent Council meeting in Vienna the day after.

Russia had said it will seek firm legal guarantees for the non-expansion of NATO to the east and the non-deployment of weapons systems threatening Russia at the country’s borders.

Last month, Russian President Vladimir Putin called on NATO to start talks seeking to provide Moscow with reliable, legally binding, and long-term security guarantees.

The US also released the transcript of Secretary of State Antony Blinken’s appearance on “This Week with George Stephanopoulos,” which aired earlier on Sunday on ABC TV regarding Russia’s buildup of troops on the Ukrainian border in which America had offered two paths.

“One is through diplomacy and dialogue; the other is through deterrence and massive consequences for Russia if it renews its aggression against Ukraine,” said Blinken.

US President Joe Biden and Russian President Vladimir Putin had met in Geneva on June 16, and the two leaders decided to continue dialogue to resolve issues that could cause conflict.

Source: Anadolu Agency

After 2 decades, former British inmate recalls Guantanamo ordeal

A British citizen who was kept in custody and tortured at the infamous Guantanamo Bay detention center by the US government in the aftermath of the 9/11 terror attacks says he is still struggling for justice.

Speaking to Anadolu Agency on the 20th anniversary of the opening of the prison located in Guantanamo Bay, Cuba, Moazzam Begg, one of the directors of the London-based advocacy group CAGE, said: “We’ve been campaigning since the beginning against Guantanamo and also the Islamophobic policies that exist within the Western world.”

Begg, who was detained in Islamabad, Pakistan on Jan. 31, 2002, said he “tried to seek accountability” after his unjustified detention of two years at the International Criminal Court in The Hague and through the police by giving evidence about the role of British intelligence in torture, which is a crime.

He said that after giving evidence at a war crimes tribunal and meetings with ministers of the UK government, he “sat with people who have ordered … an inquiry into the role of the British in torture.”

“And every single step of the way, we find that the governments of the United States of America and all of its allies that were involved in torture are above the law,” Begg said.

“None of them are accountable for their role in the war crimes, in the war on terror.”

Begg said his attempt was a legal case “against those who were involved in torture.”

He said British police visited the US, Guantanamo, and Libya for investigations, but “every time they found that the governments of Britain, America, and elsewhere would not cooperate with the police investigation.”

“And so, that again, tells me that the government is above the law.”

Begg said there are still 39 prisoners who are in custody without indictment at the detention camp.

“American President George (W) Bush opened the place, but he also released … over 500 prisoners,” he said, adding that his successor Barack Obama failed to keep his promise to close the center and to prosecute those who were involved in torture.

Quoting former President Donald Trump as saying “I believe torture works,” Begg said: “Imagine if somebody of any other country said ‘I believe torture works, and I will torture prisoners,’ and then for somebody to say ‘I will torture American prisoners,’ what the world would think.”

Begg said US President Joe Biden has been in power for one year and has so far released one prisoner only.

“And that is a Moroccan prisoner called Abdul Latif Nasir.”

Bitter memories

Begg still remembers how he was detained and started his two-year-long journey of custody, torture, and rendition at the hands of the US government.

He said that on Jan. 31, 2002, “unidentified individuals who stormed into my house put a gun to my head, tied my hands behind my back, put a hood over my head, and carried me off into the back of a vehicle. There, I realized that these are CIA agents with the Pakistani ISI (Inter-Services Intelligence).”

“And they threatened to send me to Guantanamo. At first, they sent me to a series of secret detention sites, first in Pakistan and then into American custody, where they took me to Kandahar prison, then Bagram prison, where I stayed for about one year, and then eventually to Guantanamo, where I would remain for another two years, after which I was released without charge or trial.”

Torture and killings

Begg told Anadolu Agency that he “witnessed and endured many types of abuses myself, but the worst thing that I saw was a prisoner. He was brought to the front of me. His hands were tied to the top of the cage-like this, and he was suspended. He had, placed over his head, a sack and he was kicked repeatedly. And eventually, he was killed.”

“This is a death that the Americans have accepted. And the reason why they killed him was that they found it amusing that every time they kicked him on his leg, he said ‘Allah, Allah,’ so they kicked him so that he could say ‘Allah, Allah,’ and he did that. Over 100 times he was kicked on his leg.”

Remembering another beating to death of a separate prisoner after he tried to escape, Begg said they were “innocent prisoners, they were never charged with any crime.”

“So watching the abuse and the murder of these prisoners has been something that has remained with me all of this time.”

Worst memory

Begg said probably the worst thing that happened to him was in Bagram.

“I heard the sound of a woman screaming in the next cell, which they led me to believe was my wife being tortured,” he said.

“They brought pictures of my family, my children in front of me, while my hands were tied behind my back to my legs, and they said: ‘Well, where are your children? Where’s your wife? What do you think happens to them?

“Now, by Allah’s Mercy, (she) wasn’t my wife, but it was somebody else’s wife. It was somebody else’s daughter, it was somebody’s sister. They had a woman in that prison. I know that for a fact, and still I’m trying to discover who that woman was.”

An American project

“Well, let’s remember one thing. Guantanamo is an American project. It’s Republican. It’s Democrat. It’s Black. It’s white. It’s East Coast. It’s West Coast,” Begg said.

He explained his ordeal as he was detained in 2002.

“Two soldiers sat on top of me, one on my head, one on my back. They took out a knife and they slipped off my clothes with a knife and I could feel the cold steel against my skin. And then they dragged me in the mud, screaming and shouting, spitting in my face, spitting on my body, spitting on other prisoners, kicking me, punching me, bringing dogs, and then photographing me in this state, and then shaving my beard off, shaving my hair off, and then interrogating me naked, shivering in the cold.

“And (through) all of this, they were saying: ‘This is our right to do this.’ And I started to remind myself that America has a very brutal history against weaker nations, and I had to remind myself of history, that they may say one thing, but they do quite the other.”

‘Notorious site’

Rights group Amnesty International described the 20th anniversary of the opening of Guantanamo as “an anniversary that should never have been reached.”

“Since the Bush administration, there has been agreement among national security experts and across the political spectrum that the Guantanamo prison — a notorious site of torture and unjustifiable indefinite detention — should be closed,” Daphne Eviatar, Amnesty International USA’s director of Security with Human Rights, said in a statement.

“President Biden must uphold his commitment to close Guantanamo once and for all,” she said.

“The longer the prison remains in use, the longer it continues to undermine US credibility globally on human rights.”

Source: Anadolu Agency

NATO aims at agreeing on series of negotiations with Russia: Alliance chief

The NATO chief said on Monday that the military bloc aimed at agreeing with Russia on a series of negotiations as it was “not realistic” to expect all conflicts to be solved at once during this week’s talks with Moscow.

“It’s not realistic to expect that when we have finished meetings that are all scheduled (for this week), all problems will be solved,” NATO Secretary-General Jens Stoltenberg told reporters ahead of this week’s key diplomatic events between NATO allies and Russia.

“I really hope that there is a real will on both sides (…) to engage in the process that can prevent new armed conflicts in Europe. Therefore, we are aiming for an agreement on a way forward, a process, a series of meetings,” he added.

Stoltenberg spoke at a joint news conference with Ukrainian Deputy Prime Minister for European and Euro-Atlantic Integration Olga Stefanishyna before the extraordinary meeting of the NATO-Ukraine Commission.

Stefanishyna praised the allies’ decision on negotiating with Ukraine ahead of Wednesday’s NATO-Russia Council, calling it a “strong demonstration” of the principle that “nothing about Ukraine without Ukraine.”

“We will listen to Russia’s concerns, but any meaningful dialogue should also address our concerns about Russia’s actions, and it must take place in consultation with Ukraine as we are doing today,” Stoltenberg noted.

On Monday and Tuesday, US and Russian delegations led by US Deputy Secretary of State Wendy Sherman and Russian Deputy Foreign Minister Sergey Ryabkov are set to meet in Geneva.

The NATO-Russia Council will convene on Wednesday, for the first time since NATO suspended all practical cooperation with Moscow in 2014 because of Russia’s military intervention in Ukraine.

On Thursday, Russia will hold talks with Ukraine, Germany, and France as part of the so-called “Normandy format” to ensure the implementation of the Minsk peace agreements.

Last year was marked by high tensions between NATO and Russia over spying allegations and Russia’s continued military buildup in and around Ukraine.

Russia handed two draft agreements on European security guarantees to the US and NATO last month.

Source: Anadolu Agency

Honduran indigenous Lenca leader assassinated

An indigenous Lenca group leader was assassinated in western Honduras late Sunday, Spanish news agency EFE reported.

Pablo Isabel Hernandez was assassinated in the town of San Marcos de Caiquin, said Bertha Oliva, coordinator of the Committee of Relatives of the Disappeared in Honduras.

Oliva said they are shocked by Hernandez’s murder, who was a human rights defender and involved in education and environmental projects important to the Lenca community, a Mesoamerican indigenous people of southwestern Honduras and eastern El Salvador in Central America.

She said the Lenca leader had repeatedly claimed he was a target of threats, with his most recent complaint being filed on March 16 last year “for defending human rights, water, and land.”

Oliva urged Honduran authorities to investigate the tragic incident, and punish those guilty of his murder.

Source: Anadolu Agency

Germany has ‘moral’ duty to supply weapons to Ukraine: Envoy

Ukraine on Monday called on Germany to unblock arms sales to the country to deter Russia from a renewed attack.

Speaking to local media, Ukrainian Ambassador to Germany Andrij Melnyk warned that his country faces the real threat of an invasion from Russia.

“In order to prevent (Russian President Vladimir) Putin’s imminent attack … Kyiv expects massive military support from Germany,” he told the Funke media group.

Melnyk said Germany bears the same historical responsibility for Ukraine as it does for Israel, due to the crimes committed by the Nazis during World War II.

“We expect the German government to abandon this blocking attitude – which is morally absolutely reprehensible – and urgently provide the defensive weapons Ukraine needs,” he said.

Despite its strong political and economic support for Ukraine, Germany has so far opposed weapons sales to Ukraine, and also blocked arms supplies to the country via NATO’s procurement agency.

The Ukrainian government has repeatedly said the weapons to be purchased via NATO are exclusively defensive tools to protect the county from aggression.

A German government spokesperson said on Monday that Berlin remains committed to Ukraine’s sovereignty and territorial integrity, and will continue its efforts for a political solution to the conflict in eastern Ukraine.

“The federal government believes that the conflict there can only be resolved by diplomatic means and politically, not militarily,” deputy government spokesperson Christiane Hoffmann told a news conference in Berlin.

She said recent developments will be discussed this week during US-Russia talks in Geneva on Monday, followed by NATO-Russia Council on Wednesday, and a meeting of Organization for Security and Cooperation in Europe (OSCE) planned for Thursday.

Russia has recently amassed tens of thousands of troops near Ukraine’s eastern border, prompting fears that Kremlin could be planning another military offensive against its ex-Soviet neighbor.

NATO allies accuse Russia of trying to destabilize the country by providing military support to separatist forces in Ukraine’s eastern regions.

Source: Anadolu Agency