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Details:
Edurant (rilpivirine) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Lead Product(s): Rilpivirine,Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Edurant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2024
Details:
Cabenuva is a combination of cabotegravir which inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for HIV replication and rilpivirine which inhibits HIV-1 reverse transcriptase.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2024
Details:
Apretude (cabotegravir) is an integrase strand transfer inhibitor, long acting injection, which is being evaluated for the treatment of HIV-1 infection.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Apretude
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2024
Details:
Vocabria (cabotegravir injection) is an integrase strand transfer inhibitor and used in combination with the Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2023
Details:
Apretude (cabotegravir) long-acting for PrEP is an integrase strand transfer inhibitor (INSTI), which is indicated for the treatment of sexually acquired HIV-1 infection.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Apretude
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
CAB LA (cabotegravir) long-acting for PrEP is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: CAB LA
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2023
Details:
Through the agreement, the selected generic manufacturers, Aurobindo, Cipla and Viatris, will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to required regulatory approvals being obtained.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabotegravir-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Medicines Patent Pool
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 30, 2023
Details:
Cabenuva is a combination of cabotegravir which inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for HIV replication and rilpivirine which inhibits HIV-1 reverse transcriptase.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
Vocabria (cabotegravir injection), used in combination with rilpivirine injection is a complete long-acting regimen dosed monthly or every 2-months, for the treatment of HIV-1 in adults.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
Vocabria/Rekambys (cabotegravir, rilpivirine; marketed as Cabenuva in the US) administered every two months in Europe for the treatment of Long Acting HIV.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP, the first long-acting HIV prevention medicine, in 90 countries, subject to regulatory approvals being obtained.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabotegravir LA-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Medicines Patent Pool
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 28, 2022
Details:
Cabotegravir LA for PrEP continued to be well-tolerated throughout the study, with no new safety concerns identified during the 12-month unblinded period. Cabotegravir LA for PrEP is currently approved in the U.S. as Apretude.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Apretude
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
CABENUVA is the first and only complete long-acting HIV-1 treatment regimen, and the first to be made available for eligible adolescents, building on Janssen’s ongoing commitment to fighting HIV and improving HIV treatment options for young people living with HIV.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
US FDA approval of updated label streamlines the initiation process for the cabenuva is first and only complete long-acting HIV treatment by allowing people to start directly with injections.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
US FDA approval for Cabenuva (cabotegravir, rilpivirine), integrase strand transfer inhibitor, updated label streamlines the initiation process for the first and only complete long-acting HIV treatment by allowing people to start directly with injections.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
U.S.FDA approval is based on FLAIR week 124 results, which showed there were similar outcomes regarding maintenance of virologic suppression, safety, tolerability and pharmacokinetics in people starting Cabenuva (cabotegravir and rilpivirine) injections.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
Cabenuva (cabotegravir, rilpivirine) maintain viral suppression is now approved for administration as few as six times a year for virologically suppressed adults living with HIV without prior treatment failure or resistance.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
CABENUVA is comprised of two separate injectable medicines, rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences, and ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single dose vial.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
Cabenuva comprised of, rilpivirine extended-release injectable suspension, and cabotegravir extended-release injectable suspension, offers virologically suppressed adults living with HIV an injectable treatment option administered as few as six times a year.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
ViiV Healthcare’s cabotegravir in combination with Janssen Pharmaceutical's rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio that is centred on delivering innovative medicines for the HIV community.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women use in HIV prevention.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
The companies are planning to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: $215.0 million Upfront Cash: $40.0 million
Deal Type: Collaboration June 22, 2021
Details:
ATLAS-2M met its primary endpoint at Week 48, demonstrating that the efficacy of long-acting cabotegravir and rilpivirine dosed every 2-months (every eight weeks) was non-inferior to monthly dosing (every four weeks).
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2021
Details:
ATLAS-2M 96-week findings for investigational long-acting cabotegravir and rilpivirine administered every 2-months for the treatment of HIV-1 in virologically suppressed adults as well as an analysis of renal and bone outcomes from ATLAS and ATLAS-2M.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
The sNDA seeks to expand Cabenuva’s label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known resistance to cabotegravir or rilpivirine.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2021
Details:
Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
The breakthrough therapy designation is based on efficacy and safety results from HPTN 083, a phase IIb/III clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg for HIV prevention.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Interim analysis from HPTN 084 study shows long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills in preventing HIV acquisition in women.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute of Allergy and Infectious Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Interim data presented at IDWeek 2020 showed the majority of patient participants continue to find once-monthly injectable cabotegravir plus rilpivirine to be acceptable for treating their HIV and appropriate for their daily lives .
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Twelve-month findings from the POLAR study showed continued durable viral suppression with no incidence of virologic failure among participants who switched to long-acting injectable cabotegravir and rilpivirine from oral regimen.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Regimen is based on co-administration of REKAMBYS® (rilpivirine injection) and ViiV Healthcare’s VOCABRIA® (cabotegravir injection) once every month or once every 2- months to treat HIV-1.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
Final data analysis from HPTN 083 study at AIDS 2020 shows investigational, long-acting injectable cabotegravir administered every two months is 66% more effective than daily pills in preventing HIV-1 acquisition.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
ViiV Healthcare announced positive initial findings from the CUSTOMIZE trial, which aims to identify successful methods of implementing the investigational once-monthly, long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV-1 into clinical practice.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 04, 2020
Details:
Comapany to present the final efficacy analysis from the global HPTN 083 study evaluating cabotegravir for HIV prevention.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
Interim analysis of the HIV Prevention Trials Network (HPTN) 083 study showed that ViiV's cabotegravir is 69% more effective at preventing HIV acquisition than daily oral PrEP with emtricitabine/tenofovir disoproxil (FTC/TDF).
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
The study showed that CAB LA lowered HIV incidence among cisgender men and transgender women who have sex with men.
Lead Product(s): Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Findings from the ATLAS-2M phase III study showed that the administration of injectable cabotegravir and rilpivirine every two months was as effective and safe as once-monthly administration.
Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2020
Details:
The Phase 2 trial will also test whether the combination could prevent HIV from rebounding to detectable levels in people who previously kept the virus suppressed with daily antiretroviral therapy.
Lead Product(s): VRC07-523LS,Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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