Aciclovir

EQS-News: AiCuris Announces Strategic Shift to Focus Development and Commercialization of Anti-infectives for Immunocompromised Patients

Retrieved on: 
Thursday, July 6, 2023
MSD, HSV, Letermovir, Aciclovir, EAP, Therapy, Cytomegalovirus, Diabetes, Infection, ADV, Eye, Cancer, Breakthrough therapy, Research, DSM-IV codes, RNA, Life expectancy, HSCT, US, EKC, Radiation, AIDS, Patient, System Infected: Backdoor VBS Dunihi, CMV, Nightfall and Other Stories, CFO, Pritelivir, Merck, BKV, Merck & Co., Immunodeficiency, BK virus, Market Access Program, BK, Vaccine, Fine chemical, Pharmaceutical industry

AiCuris to continue its transition into a fully integrated biopharmaceutical company leveraging its research, clinical development, and commercialization expertise.

Key Points: 
  • AiCuris to continue its transition into a fully integrated biopharmaceutical company leveraging its research, clinical development, and commercialization expertise.
  • With AiCuris’ enhanced focus on development and commercialization of anti-infectives for immunocompromised individuals, the Company will discontinue research activities outside of this strategic scope.
  • Larry Edwards, CEO of AiCuris Anti-infective Cures AG, said: “Immunocompromised patients develop severe, partially life-threatening disease from infections that are typically well controlled in immune competent individuals.
  • Highly prevalent latent virus infections such as CMV, HSV and BKV can cause severe complications in immunocompromised patients for example, after transplantations.

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Tuesday, June 6, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, MSD, Cytomegalovirus, Neutropenia, Male, Pimozide, Aciclovir, IV, AE, Culture, Alkaloid, Simvastatin, Aes, Myopathy, Valganciclovir, MRK, HSCT, Immunotherapy, Merck & Co., Hypertension, Incidence, Ergotism, Diarrhea, Drug, Patient, Leukopenia, Blood, CMV, Kidney, Ciclosporin, ALT, Transplant, Rhabdomyolysis, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, NYSE, Food, Safety, Disease, Medical device, Vaccine, Pharmaceutical industry, Merck

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Key Points: 
  • PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
  • Increased pimozide concentrations due to concomitant administration of PREVYMIS may lead to QT prolongation and torsades de pointes.
  • Study drug was initiated between Day 0 and Day 7 post-kidney transplant and continued through Week 28 (~200 days) post-transplant.
  • The most common primary reasons for transplant were congenital cystic kidney disease (17%), hypertension (16%), and diabetes/diabetic nephropathy (14%).

Global Genital Herpes Treatment Market Outlook Report 2022-2027 Featuring Key Vendors - GlaxoSmithKline, Glenmark Pharmaceuticals, Viatris, Novartis, Teva Pharmaceuticals, & Bausch Health Companies - ResearchAndMarkets.com

Retrieved on: 
Friday, August 5, 2022
Infectious Diseases, Pharmaceutical, Health, People, FDA, LGBT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Woman, Ageing, Valaciclovir, Pharmacy, Retail, Risk, MSM, Famciclovir, Recurrence, Sex organ, Food, Simplex, Population, NE, Geography, GSK, Incidence, IND, Man, HSV, Patient, HSV-2, Company, Genital herpes, Vaccine, STD, OTC, Infection, Awareness, Immunodeficiency, Sanofi, Herpes labialis, WHO, Technology, Herpes simplex virus, HIV, Factor X, Sex, STI, Vertically transmitted infection, Investigational New Drug, Pharmaceutical industry, Birth control, Aciclovir, Aciclovir, Pritelivir, Moderna

The "Genital Herpes Treatment Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Genital Herpes Treatment Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • The global genital herpes treatment market is segmented based on drug type, distribution channel, virus type, route of administration, and geography.
  • HSV-2 is the leading virus type segment as HSV-2 is the leading cause of genital herpes.
  • North America is the major revenue contributor to the global genital herpes treatment market, with a share of more than 40%.

Navamedic ASA - Exclusive agreement with Vectans Pharma for the unique cold sore treatment product Sitavig®

Retrieved on: 
Thursday, August 4, 2022
Sores, Pachydactylus labialis, CEO, Population, Lip, Sale, Herpes labialis, Mouth, Marketing, Patient, Aciclovir, Nordic, Acquisition, Partnership, OTC, Herpes simplex virus, Ownership, Pharmaceutical industry, Vaccine

This entitles Navamedic to the ownership of the marketing authorizations for the product in these regions.

Key Points: 
  • This entitles Navamedic to the ownership of the marketing authorizations for the product in these regions.
  • It is a key element of our value creation strategy to secure and increase value creation through ownership of products and exclusive marketing rights," says Kathrine Gamborg Andreassen, CEO of Navamedic ASA.
  • Cold sores - also called fever blisters - is a common and recurring condition that affects about 20 - 40% of the population.
  • Sitavig (acyclovir) is a 50mg Muco-Adhesive Buccal tablet that represents a breakthrough in the treatment of cold sores.

Information Update - Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity

Retrieved on: 
Thursday, July 28, 2022
NDMA, Tablet, Cancer, Shingles, Vegetable, Genital herpes, Recurrence, Patient, Nitrosamine, Dairy, Communication, Risk, Air pollution, Aciclovir, Drinking water, Dietary supplement

This means that long-term exposure to a level above what is considered acceptable may increase the risk of cancer.

Key Points: 
  • This means that long-term exposure to a level above what is considered acceptable may increase the risk of cancer.
  • There is no immediate risk in continuing to take the recalled medication, since the increased risk of cancer typically involves long-term exposure to the nitrosamine impurity above the acceptable level.
  • This is an update to a communication on a previous recall.
  • Please see the full advisory for more information, including more on the risk and what patients should do.

Advisory - Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity

Retrieved on: 
Thursday, April 28, 2022
Shingles, Drinking water, Vegetable, Canada, Pharmacy, Tablet, Patient, Genital herpes, Health Canada, Cancer, Ciba-Geigy Canada Ltd v Apotex Inc, Aciclovir, NDMA, Dairy, Nitrosamine, Recurrence, Risk, Air pollution, Health, Dietary supplement

Issue:Certain lots are being recalled due to the presence of a nitrosamine impurity above the acceptable level.

Key Points: 
  • Issue:Certain lots are being recalled due to the presence of a nitrosamine impurity above the acceptable level.
  • Apotex Inc. is recalling certain lots of Apo-Acyclovir (acyclovir) tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above the acceptable level.
  • There is no immediate risk in continuing to take the recalled medication, since the increased risk of cancer typically involves long-term exposure to the nitrosamine impurity above the acceptable level.
  • Should any additional recalls be deemed necessary, Health Canada will update the table and inform Canadians.

DGAP-News: AiCuris starts its first pivotal clinical phase 3 trial with pritelivir for the treatment of HSV infections in immunocompromised subjects based on efficacy and safety data from a phase 2 trial

Retrieved on: 
Thursday, July 8, 2021
Chemical compounds, Purines, Organic compounds, Foscarnet, Aciclovir, Chemistry, pritelivir, HSV, AiCuris Anti-infective Cures AG, PRITELIVIR, HSV, AICURIS ANTI-INFECTIVE CURES AG

The PRIOH-1 multi-center open label trial is designed to evaluate the efficacy and safety of orally administered pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.

Key Points: 
  • The PRIOH-1 multi-center open label trial is designed to evaluate the efficacy and safety of orally administered pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.
  • Efficacy was also seen in patients who in addition showed resistance or intolerance to foscarnet and had very limited treatment options.
  • In none of the patients, treatment with pritelivir was prematurely discontinued due to adverse events during the trial.
  • Based on the results from the recent US clinical phase 2 trial, AiCuris has started a pivotal phase 3 trial as a basis for NDA submission.

DGAP-News: AiCuris received approval from BfArM to initiate Compassionate Use Program for Pritelivir in Germany

Retrieved on: 
Wednesday, December 2, 2020
Medical specialties, Sexually transmitted diseases and infections, Viral diseases, Purines, Virology, Clinical medicine, Aciclovir, Herpes simplex, Expanded access, Pritelivir, HSV, Compassionate Use Program (CPU), AiCuris Anti-infective Cures GmbH

"Especially in immunocompromised patients, HSV can lead to serious complications," said Dr. Holger Zimmermann, CEO of AiCuris.

Key Points: 
  • "Especially in immunocompromised patients, HSV can lead to serious complications," said Dr. Holger Zimmermann, CEO of AiCuris.
  • At the same time, the data collected in this program will help to bring the drug to patients as quickly as possible and support the planned approval of pritelivir."
  • The Compassionate Use Program in Germany is part of an Early Access Program (EAP) which is operated by myTomorrows, a Netherlands-based HealthTech company facilitating access to medicines in development and real-world data collection.
  • The EAP for treatment of acyclovir-resistant mucocutaneous HSV infections provides immunocompromised patients in different countries worldwide with pre-approval access to pritelivir.

DGAP-News: AiCuris was Granted Breakthrough Therapy Designation by U.S. FDA for Pritelivir for the Treatment of HSV Infections in Immunocompromised Patients

Retrieved on: 
Friday, June 5, 2020
Viruses, RTT, Infectious diseases, Medical specialties, Sexually transmitted diseases and infections, Viral diseases, Purines, Herpes, Foscarnet, Aciclovir, Herpes simplex, Breakthrough therapy, Breakthrough Therapy Designation, Pritelivir, HSV, AiCuris Anti-infective Cures GmbH

AiCuris was Granted Breakthrough Therapy Designation by U.S. FDA for Pritelivir for the Treatment of HSV Infections in Immunocompromised Patients

Key Points: 
  • AiCuris was Granted Breakthrough Therapy Designation by U.S. FDA for Pritelivir for the Treatment of HSV Infections in Immunocompromised Patients
    The issuer is solely responsible for the content of this announcement.
  • AiCuris was Granted Breakthrough Therapy Designation by U.S. FDA for Pritelivir for the Treatment of HSV Infections in Immunocompromised Patients
    Wuppertal, June 05, 2020 - AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced that the Company has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for oral pritelivir, AiCuris' lead candidate for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised adults.
  • foscarnet, a virostatic agent which is used mainly for the treatment of HSV resistant to other antiviral drugs.
  • With the Breakthrough Therapy designation, AiCuris reached an important milestone and is now looking for a partner for the further development of pritelivir.

Genital Herpes Treatment Drugs: Global Market Insights & Projections, 2016 to 2026

Retrieved on: 
Thursday, May 2, 2019
RTT, Sexually transmitted diseases and infections, Infectious diseases, Medical specialties, Virology, Herpes, Viral diseases, Purines, Herpes simplex, Genital herpes, Aciclovir, Sexually transmitted infection

DUBLIN, May 2, 2019 /PRNewswire/ -- The "Global Genital Herpes Treatment Drugs Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2018 To 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 2, 2019 /PRNewswire/ -- The "Global Genital Herpes Treatment Drugs Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2018 To 2026" report has been added to ResearchAndMarkets.com's offering.
  • The global genital herpes treatment drugs market is expected to expand at a CAGR of 4.9% from 2018 to 2026.
  • Acyclovir is presently dominating the drug class for the genital herpes treatment drugs market.
  • The rising prevalence of sexually transmitted disease and effective treatment guidelines drive the genital herpes treatment drugs market growth in North America.