Ibalizumab

TaiMed Biologics and AcedrA BioPharmaceuticals Partner to Commercialize Trogarzo® (Ibalizumab-uiyk) in the Middle East and North Africa Region

Retrieved on: 
Monday, March 18, 2024
HIV, Physician, Distribution, Patient, Ibalizumab, Marketing, Pharmaceutical industry

TAIPEI, Taiwan and RIYADH, Saudi Arabia, March 18, 2024 (GLOBE NEWSWIRE) -- Taimed Biologics (“TaiMed”), a publicly held Taiwanese biotechnology company, signed an Exclusive License and Distribution Agreement with AcedrA BioPharmaceuticals (“AcedrA”), a Saudi Arabia-based company operating in Middle East and North Africa region, to satisfy the unmet medical needs, under which AcedrA will register, promote and commercialize Trogarzo® (Ibalizumab-uiyk) in the MENA region.

Key Points: 
  • TAIPEI, Taiwan and RIYADH, Saudi Arabia, March 18, 2024 (GLOBE NEWSWIRE) -- Taimed Biologics (“TaiMed”), a publicly held Taiwanese biotechnology company, signed an Exclusive License and Distribution Agreement with AcedrA BioPharmaceuticals (“AcedrA”), a Saudi Arabia-based company operating in Middle East and North Africa region, to satisfy the unmet medical needs, under which AcedrA will register, promote and commercialize Trogarzo® (Ibalizumab-uiyk) in the MENA region.
  • “We are excited to broaden the reach of Trogarzo® to HIV patients in new countries.
  • AcedrA, then, by a wider array of distribution activities, will be responsible for regulatory, sales, marketing, medical, and distribution in the MENA region.
  • “We are committed to be a patient-centric company working closely with healthcare providers in the MENA region, and we will be pleased to partner with TaiMed strategically to improve patients' lives in the region.”

Theratechnologies’ Ibalizumab Demonstrates Cost-Effectiveness as an Addition to Routine Clinical Care in Heavily Treatment-Experienced People with HIV

Retrieved on: 
Thursday, October 19, 2023
Nexus, Markov, Pharmacy, OBR, Academy of Managed Care Pharmacy, Observation, Fungal infection, HIV, News, Acquisition, Nursing care plan, Journal, QALY, ART, Quality-adjusted life year, Database, Clinical trial, Abstract, HTE, Ibalizumab, Health, ICER, AMCP, SMR, EHR, Bronze medal, Bias, TSX, Health care, Pharmaceutical industry

The analysis, which was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 conference in Orlando, Fla., suggests that adding ibalizumab to routine clinical care may provide payers with a cost-effective treatment option that can substantially improve outcomes for HTE individuals with HIV.

Key Points: 
  • The analysis, which was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 conference in Orlando, Fla., suggests that adding ibalizumab to routine clinical care may provide payers with a cost-effective treatment option that can substantially improve outcomes for HTE individuals with HIV.
  • The analysis encompassed numerous costs, including those for treatment acquisition and administration, monitoring, adverse events, opportunistic infections, and terminal care.
  • Mortality assumptions and health-state utility values were based on disease-specific published literature and clinical trial data.
  • Over a lifetime horizon, the addition of ibalizumab to OBR increased the time patients’ HIV remained undetectable (less than 50 copies/ml) or suppressed (between 50 and 200 copies/ml).

TaiMed Announces Significant Progress in Clinical Trials for New HIV Treatment

Retrieved on: 
Monday, October 16, 2023
Clutch (eggs), USD, Injection, Maintenance, HIV, Drug, Clinical trial, Patient, Trial of the century, Pharmaceutical industry, Taime Downe, Ibalizumab

TAIPEI, Oct. 16, 2023 /PRNewswire/ -- TaiMed Biologics, an innovation-driven biotech company dedicated to serving unmet healthcare needs, has announced favorable results and the successful completion of the sentinel group in its phase 1b/2a clinical study evaluating its groundbreaking new treatment for HIV — Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy — initially unveiled at its investor conference on September 6. Following a professional assessment of dosing selection, the company has confirmed the dosages required for the future administration of the two-month combination therapy, thereby achieving its original goals for the sentinel group clinical trial.

Key Points: 
  • To ensure the success of future clinical trials, product positioning in the market, and expedite the overall clinical trial timeline, the company has promptly submitted a revised protocol to the U.S. FDA for the core group clinical trial.
  • Additionally, TaiMed is opening discussions with potential HIV pharmaceutical companies for licensing and co-development opportunities.
  • The sentinel group of the Phase 1/2a clinical study has confirmed TMB-365/380 as an ultra-long-acting new drug combination.
  • TaiMed plans to lead the way in this segment, serving patients and healthcare providers as a vital global leader in the realm of long-acting injections—and HIV treatment overall.

Theratechnologies’ Trogarzo® (Ibalizumab-uiyk) Shortens Time to HIV Undetectability and Extends Durability of Undetectability and Viral Suppression in a Matched Treatment Comparison

Retrieved on: 
Thursday, May 4, 2023
AIDS Healthcare Foundation, Database, University, Senior, HIV, VL, Clinical trial, Chapel Hill, ART, University of North Carolina academic-athletic scandal, Observation, Synthetic control method, AIDS, Ibalizumab, EHR, Data, Patient, Viral load, TSX, SMR, CD4, American Conference, Conference, Treatment, Disease, Vaccine, Pharmaceutical industry

The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison (MAIC) study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population, when randomization to a control arm would be impractical or unethical.

Key Points: 
  • The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison (MAIC) study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population, when randomization to a control arm would be impractical or unethical.
  • Despite ibalizumab trial participants having more severe disease at baseline than non-ibalizumab controls, ibalizumab was associated with superior virologic outcomes.
  • Additionally, the same significance emerged for maintaining viral suppression, which was 18 times lower for real-world non-ibalizumab regimens compared to ibalizumab.
  • For both durability analyses, confidence intervals were wide but statistically significant (SMR-weighted HR: 18.36; 95% CI: 2.48, 135.68).

Theratechnologies Reports Financial Results and Business Updates for the Fourth Quarter and Full Year Fiscal 2022

Retrieved on: 
Tuesday, February 28, 2023
Clinical trial, International Financial Reporting Standards, Term Asset-Backed Securities Loan Facility, Tranche, Conference call, MD, Policy, Classification, Loan, Intramuscular injection, Uncertainty, Acquisition, Research, FDA, Investment, International Accounting Standards Board, ATM, Growth, Exercise, Human, Bank statement, NASH, Government, Prescription, EDGAR, Fiscal, Conference, Association of International Accountants, International, Sale, COVID-19, Audit, Annual report, See, Video game, Pharmaceutical industry, Cryptocurrency, Retail, Bank, Security (finance), Risk management, Internet service provider, F8, Ibalizumab

For the fourth quarter of Fiscal 2022, sales of EGRIFTA SV® reached $14,458,000 compared to $12,753,000 in the fourth quarter of the prior year, representing an increase of 13.4%.

Key Points: 
  • For the fourth quarter of Fiscal 2022, sales of EGRIFTA SV® reached $14,458,000 compared to $12,753,000 in the fourth quarter of the prior year, representing an increase of 13.4%.
  • In the fourth quarter of Fiscal 2022, Trogarzo® sales amounted to $6,963,000 compared to $6,001,000 for the same quarter of 2021, representing an increase of 16.0%.
  • The Other asset was fully amortized during the first half of Fiscal 2022, and thus this charge was Nil in the fourth quarter of Fiscal 2022.
  • General and administrative expenses in the fourth quarter of Fiscal 2022 amounted to $3,956,000, compared to $3,537,000 reported in the same period of Fiscal 2021.

Theratechnologies’ Trogarzo® Approved by FDA for 30-Second Intravenous (IV) Push, Simplifying HIV Treatment for Heavily Treatment-Experienced Population

Retrieved on: 
Monday, October 3, 2022
Maintenance, ARV Super2, Forward-looking statement, GLOBE, NASDAQ, HIV-1, EDGAR, Subtypes of HIV, Dizziness, FDA, Allergy, SEDAR, Mission statement, MDR, ARV, Immune system, Breast milk, HIV, Infection, Power, Safety, Diarrhea, Immune reconstitution inflammatory syndrome, Program, Union, Patient, PK, Viral load, Vitamin, Rash, TSX, USP, Nausea, IV, Ibalizumab, Company, Pharmaceutical industry, Vaccine

The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment.

Key Points: 
  • The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment.
  • We are proud of our long-term commitment to bring much needed non-oral innovations to help shift the treatment paradigm for heavily treatment-experienced people living with HIV.
  • Results show that the safety and PK profile of Trogarzo administered via IV push are similar to that of IV infusion administration.
  • Do not receive Trogarzo if you have had an allergic reaction to Trogarzo or any of the ingredients in Trogarzo.

Theratechnologies Trogarzo® Data at AIDS 2022 Shows Potential for Improved Treatment Regimens

Retrieved on: 
Thursday, July 28, 2022
TSX, Dizziness, GLOBE, Diarrhea, International AIDS Society, Union, Research, HIV-1, Mission statement, Immune reconstitution inflammatory syndrome, Lenacapavir, ICAR, EDGAR, MDR, Immune system, Safety, NASDAQ, Antiviral Research, Kinetics, Conference, ARV, Albert Einstein College of Medicine, Rash, PK, SEDAR, FDA, Company, MD, Method, Patient, AIDS, Nausea, Etravirine, Poster, Vitamin, Forward-looking statement, International, Subtypes of HIV, Drug of last resort, Infection, HIV, Breast milk, Stanford University, Population, SC, OBR Open Building Research, Vaccine, Medical device, Pharmaceutical industry, Ibalizumab, Medicine

Additional data highlights synergistic activities between Trogarzo and dolutegravir, etravirine, tenofovir alafenamide and lenacapavir, a long-acting investigational antiretroviral therapy (ARV).

Key Points: 
  • Additional data highlights synergistic activities between Trogarzo and dolutegravir, etravirine, tenofovir alafenamide and lenacapavir, a long-acting investigational antiretroviral therapy (ARV).
  • The new data provide key understandings on the potential of Trogarzo (ibalizumab) to evolve treatment paradigms for heavily treatment-experienced HIV populations on complex regimens.
  • These data support the proof of concept that administration of Trogarzo via both IM and SC injection weekly or every two weeks are potential future improvements in convenience and accessibility.
  • We are proud to continue to investigate improving treatment for people living with HIV on complex treatment regimens.

Theratechnologies Announces Results From Two Posters Presented at ACTHIV 2021 Annual Meeting Highlighting Positive Patient Experience With Trogarzo®

Retrieved on: 
Thursday, May 20, 2021
Communication, Forward-looking statement, XC2, Ibalizumab

b'MONTREAL, May 20, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today reported on positive results presented in two separate posters in conjunction with ACTHIV 2021 virtual conference being held May 20-22, 2021.\nThe first poster1 included findings from a survey conducted among 30 Trogarzo\xc2\xae (ibalizumab-uiyk) patients to assess real-world patient experience and acceptance of IV administration.

Key Points: 
  • b'MONTREAL, May 20, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today reported on positive results presented in two separate posters in conjunction with ACTHIV 2021 virtual conference being held May 20-22, 2021.\nThe first poster1 included findings from a survey conducted among 30 Trogarzo\xc2\xae (ibalizumab-uiyk) patients to assess real-world patient experience and acceptance of IV administration.
  • The survey found that 100 percent of patients were either very satisfied or moderately satisfied with their experience with Trogarzo\xc2\xae (87 and 13 percent respectively).
  • You can identify forward-looking statements by terms such as "may", "will", "should", "could", \xe2\x80\x9cwould\xe2\x80\x9d, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them.
  • The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements.

Theratechnologies Announces Ibalizumab Inhibits HIV-2 In Vitro

Retrieved on: 
Monday, July 6, 2020
Antivirals, Ibalizumab, HIV/AIDS, System for Electronic Document Analysis and Retrieval, Contents, Articles, Health

MONTREAL, July 06, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that data presented at the 23rd International AIDS Conference virtual meeting, demonstrates that ibalizumab is active in vitro against group A and group B HIV-2.

Key Points: 
  • MONTREAL, July 06, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that data presented at the 23rd International AIDS Conference virtual meeting, demonstrates that ibalizumab is active in vitro against group A and group B HIV-2.
  • Based on results obtained in vitro, it is expected that ibalizumab could have some efficacy in patients infected with HIV-2.
  • HIV-2 multidrug resistance is on the rise in Europe and West Africa and there are limited therapeutic options, if any.
  • Further information about Theratechnologies is available on the Company's website at www.theratech.com , on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.

CytoDyn Receives BLA Acknowledgment Letter From the FDA

Retrieved on: 
Monday, June 8, 2020
Health, Drugs, Food and Drug Administration, United States Public Health Service, Fast track, Orphan drugs, Monoclonal antibodies, Breakthrough therapy, Ibalizumab, Teprotumumab

The Companys drug candidate, leronlimab, was previously granted Fast Track designation by the FDA and the BLA was granted rolling review.

Key Points: 
  • The Companys drug candidate, leronlimab, was previously granted Fast Track designation by the FDA and the BLA was granted rolling review.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA.
  • CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020.