cobicistat and darunavir

cobicistat and darunavir

Treatment for HIV Infection

Janssen Submits NDA for a Fixed-Dose Combination of Darunavir with Cobicistat

RARITAN, NJ, April 1, 2014 – Janssen Research & Development, LLC (Janssen), today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen R&D Ireland and marketed as Prezista® in the U.S., with cobicistat, an investigational pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc. (Gilead) for use in combination with other human immunodeficiency virus (HIV-1) medicines.

Once-daily Prezista is indicated for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. Prezista is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines. If approved, the fixed-dose combination tablet will be marketed under a new brand name and will, for the first time, offer an additional therapeutic option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.

In June 2011, Janssen announced a license agreement with Gilead for the development and commercialization of a once-daily tablet fixed-dose combination product of darunavir and Gilead’s cobicistat. Under the terms of the agreement, Janssen R&D Ireland and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the darunavir and cobicistat fixed-dose combination worldwide. Gilead will retain sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

“Darunavir is the most prescribed HIV protease inhibitor in the United States1 and we are excited to be taking this important step in our efforts to offer it with an alternative boosting agent in a fixed-dose combination tablet,” said Johan van Hoof, M.D., Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen.“ This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease.”

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, 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. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)

1. IMS Health. IMS National Prescription AuditTM. February 2014.

Source: Janssen Research & Development, LLC

Posted: April 2014

cobicistat and darunavir FDA Approval History

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