Janssen Generic ARV Licensing

Partnership objective

To facilitate and ensure sustainable and affordable access to generic versions of Janssen’s HIV medicines within the licensing territory.

The HIV Medicines Access & Partnerships Program has prioritized registration efforts in those countries with greatest HIV burden and economic vulnerability. The HIV Medicines Access & Partnerships Program has prioritized registration efforts in those countries with greatest HIV burden and economic vulnerability. Copyright Johnson & Johnson

What are the health needs and challenges?

Providing people living with HIV/AIDS (PLWHA) with first-line HIV medicines is currently a top public health priority for countries with high HIV burdens. According to the World Health Organization (WHO), the availability of HIV medicines is expanding at a rapid rate, especially in sub-Saharan Africa (SSA). Janssen Pharmaceutical Companies of Johnson & Johnson is committed to helping PLWHA through effective and sustainable access to our HIV medicines. As a key element of the new Janssen Global Public Health group, global HIV Medicines Access & Partnerships Program is working to fulfill PLWHA needs in resource-limited settings (RLS).

HIV treatment is a life-long commitment for patients and Janssen access efforts for HIV recognize that commitment for the long-term. Direct agreements with generic manufacturers allow sharing of technical skills and experience as well as ensure not only the availability of generic versions of Janssen’s medicines, but also their safety and quality. Generic manufacturers play an important role in support of a strategy to reduce costs and maintain the affordability of these medicines.

Description of partnership activities and how they address needs and challenges

Janssen R&D Ireland (formerly Tibotec Pharmaceuticals) granted multiple non-exclusive licenses to Hetero Drugs, Emcure Pharmaceuticals, Strides ArcoLab and Matrix Laboratories of India, and Aspen Pharmacare of South Africa to manufacture, market and distribute generic versions of its non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC 278), subject to its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults. The Indian companies have rights to market the product in 112 lower-middle-income countries (LMICs). Aspen has rights to market the product in SSA, including South Africa. These agreements offer licensees the technical information and knowledge (“tech transfer”) to manufacture the active pharmaceutical ingredients (API) and finished product. They also enable the development of appropriate fixed-dose combinations (FDCs) of rilpivirine with other HIV medicines within the licensing territories. The generic manufacturers will be responsible for timely regulatory filing for generic rilpivirine and for seeking pre-qualification from the World Health Organization (WHO) and FDA ANDA generic drug approvals.

How challenges are addressed by the partnership activities

A comprehensive multi-country branded registration effort is necessary to ensure timely availability of both branded and generic medicines. The HIV Medicines Access & Partnerships Program has prioritized registration efforts in those countries with greatest HIV burden and economic vulnerability. EDURANT™ received its first regulatory approvals in the United States and Europe in 2011. This is an important first step, as many resource-limited countries require EMA and/or FDA approval documentation to submit local regulatory dossiers. Regulatory filings for branded EDURANT™ are ongoing worldwide, including in RLS. In December 2013, EDURANT™ was approved in South Africa—its first regulatory approval in SSA.

After a drug receives regulatory approval, ongoing clinical research continues to provide invaluable insights on the most effective use of new medicines. Janssen supports or conducts clinical research on the appropriate and safe use of our approved HIV medicines in RLS. Janssen is currently supporting the Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF) study, which will help further determine the appropriate clinical positioning of rilpivirine in RLS. Patients with higher viral loads (VL >100,000 copies/mL) are less likely to achieve viral suppression with rilpivirine, which is a concern in RLS where viral load testing, especially prior to treatment initiation, is not often available. SALIF will explore rilpivirine as a potential “switch” option once a viral load of <50 copies/mL is reached. This study is an important first step in efforts to ensure the safe and appropriate use of rilpivirine in resource-limited settings. SALIF is a multicenter, multi-country, open-label study that will take place at 28 sites in six countries in sub-Saharan Africa (Ghana, Uganda, Kenya, Senegal, Cameroon, and South Africa) and two countries in Asia-Pacific (Thailand and Vietnam). Patient recruitment is underway.

Janssen also regularly seeks input on local treatment barriers, research, guidelines and clinical practice from treatment experts and advocates with wide-ranging expertise across treatment, education, public and private sectors in RLS.       

Lessons learned

Licensing agreements with generic partners to facilitate and ensure sustainable access to generic versions of Janssen’s HIV medicines are an important part of Janssen’s HIV Medicines Access & Partnerships Program. Key considerations of Janssen’s current HIV portfolio – including potential partner interest and the expected clinical demand – have driven the Company’s licensing strategy and influenced the timing of when licenses are issued and the number of licensees for each product.

Although rilpivirine is not yet included in WHO’s treatment guidelines for first- or second-line treatment and currently there is limited clinical demand, Janssen licensed the compound prior to approval in the US and Europe because of its potentially high public health impact. This early involvement of generic manufacturers has helped accelerate the availability of generic versions of rilpivirine within the licensing territory.

Summary of impact and forward looking information

As a result of the early licensing of rilpivirine, generic manufacturers were able to initiate development work for the single agent and fixed dose combination prior to the US FDA and EMEA approval. This will allow Janssen’s licensees to accelerate regulatory filings and the availability of generic versions upon inclusion in WHO and national treatment guidelines.

Partnership information

Company(ies) Johnson & Johnson

Partner(s) Aspen Pharmacare, Emcure Pharmaceuticals, Hetero Drugs (India), Mylan, Strides Arcolab

Type of Partner(s) Generic Manufacturers

Therapeutic Focus Infectious Diseases

Disease(s) HIV/AIDS

Program Type(s) Availability of Treatment - Differential Pricing, Availability of Treatment - Technology Transfer - Manufacturing and Entrepreneurial Know-How

Targeted Population(s) Patients in needs of treatment

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 107

Country(ies) Afghanistan, Angola, Antigua and Barbuda, Armenia, Bahamas, Bangladesh, Barbados, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, French Guiana, Gabon, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritania, Mauritius, Moldova, Mongolia, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, Thailand, The Gambia, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe

Start Date 2008

More information Janssen Global Access

Anticipated completion date Ongoing