ViiV and Janssen To Collaborate on Long-Acting Injectable HIV Treatment

ViiV Healthcare and Janssen have announced a plan to work together on the development of long-acting injectable HIV treatment using ViiV's investigational integrase inhibitor cabotegravir and an injected formulation of Janssen's currently available oral NNRTI rilpivirine (Edurant).

Long-acting drugs could offer an attractive option for people with HIV facing lifelong antiretroviral therapy. The advantages of sustained release drugs include greater convenience and potentially better adherence, but the drawback is that a long-acting drug cannot easily be removed from the body once administered, so it is especially important to establish safety in advance.

As reported recently in Lancet Infectious Diseases, injectable cabotegravir and rilpivirine administered once every 4 or 8 weeks maintained HIV suppression in people with undetectable viral load as well as a standard oral antiretroviral regimen and appeared safe and well-tolerated in the Phase 2b LATTE 2 trial.

The long-acting formulations of cabotegravir and rilpivirine are also being studied for pre-exposure prophylaxis, or PrEP. In animal studies, monthly cabotegravir injections protected macaque monkeys against infection with an HIV-like virus delivered via rectal or vaginal exposure.

Below is an edited excerpt from a ViiV press release describing the collaboration.

ViiV Healthcare to Progress Collaboration with Janssen to Develop the First Long-acting, Two Drug Injectable Regimen for Treatment of HIV

London, UK -- January 7, 2016 -- ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today formalized its collaboration with Janssen Sciences Ireland UC (Janssen) for the phase III investigation and commercialization of the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV-1 infection. The long-acting formulations of cabotegravir (CAB LA) and rilpivirine (RPV LA) are being investigated as an injectable maintenance treatment for patients who have achieved viral suppression. 

"As a company committed to innovation in the field of HIV, this agreement with Janssen will enable us to progress the development of the first long-acting, injectable two drug regimen," said Dominique Limet, CEO, ViiV Healthcare. "If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three drug therapy."

While HIV is now considered a chronic manageable condition for most individuals, there are remaining treatment challenges that continue to impact the lives of people living with HIV, which may include tolerability, safety, dosing schedules, drug interactions and adherence. ViiV Healthcare is committed to investigating new treatment options that may help to address some of these challenges with the aim of providing healthcare professionals with alternative treatment options for appropriate patients.

As part of this agreement and as announced at the GSK R&D day (3 November 2015), the two companies expect to start a phase III program to evaluate the efficacy, safety and tolerability of the long-acting, two drug injectable regimen in mid-2016.

This is the second development agreement with Janssen. In June 2014 both companies entered into an agreement to develop and commercialize a single-tablet combining ViiV Healthcare’s integrase strand transfer inhibitor (INSTI), dolutegravir (Tivicay) and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (Edurant).  A phase III clinical trial program to evaluate the safety and efficacy of both medicines as maintenance treatment of HIV-1 infection began in May 2015. These agreements build on ViiV Healthcare’s strategy to collaborate with other companies, institutions and not-for-profit organizations to contribute to the understanding and management of HIV.

About cabotegravir 

Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir (Tivicay). Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a long-acting nanosuspension formulation for intramuscular (IM) injection.

About rilpivirine

Rilpivirine (Edurant) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV‑1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load <100,000 HIV RNA copies/mL.

Rilpivirine was developed by Janssen. Rilpivirine is approved in US and EU as EDURANT as a single agent tablet dosed at 25 mg taken once a day and is always taken with a meal. The overall safety profile of rilpivirine is based on phase III clinical studies. Rilpivirine is also available in the United States (US) and the European Union as part of a once daily fixed dose antiretroviral combination with Gilead Sciences Inc’s tenofovir disoproxil fumarate and emtricitabine. This combination, is known as Complera (US) or Eviplera. The most common side effects of Edurant include: depression, headache, trouble sleeping (insomnia) and rash.

About dolutegravir

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 90 countries across North America, Europe, Asia, Australia, Africa and Latin America.

See full press release for Important Information about Tivicay (dolutegravir)and Important Safety Information for Tivicay (dolutegravir). Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi (TYO: 4507) joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. For more information visit http://www.janssen.com.

1/20/16

Source

ViiV Healthcare. ViiV Healthcare to progress collaboration with Janssen to develop the first long-acting, two drug injectable regimen for treatment of HIV. Press release. January 7, 2016.