Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat

Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV                                    Therapy  PR Newswire  RARITAN, N.J., April 1, 2014  RARITAN, N.J., April 1, 2014 /PRNewswire/ -- 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 combinationtablet 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 States^[1] 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 PREZISTA^® PREZISTA^® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. PREZISTA^® is always taken with and at the same time as ritonavir (Norvir^®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA^® should also be taken with food.    oThe use of other medicines active against HIV in combination with     PREZISTA^®/ritonavir (Norvir^®) may increase your ability to fight HIV.     Your healthcare professional will work with you to find the right     combination of HIV medicines   oIt is important that you remain under the care of your healthcare     professional during treatment with PREZISTA^®  PREZISTA^® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA^®.  Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA^® is right for you.  Important Safety Information  What is the most important information I should know about PREZISTA^®?    oPREZISTA^® can interact with other medicines and cause serious side     effects. See "Who should not take PREZISTA^®?"   oPREZISTA^® may cause liver problems. Some people taking PREZISTA^®,     together with Norvir^® (ritonavir), have developed liver problems which     may be life-threatening. Your healthcare professional should do blood     tests before and during your combination treatment with PREZISTA^®. If you     have chronic hepatitis B or C infection, your healthcare professional     should check your blood tests more often because you have an increased     chance of developing liver problems   oTell your healthcare professional if you have any of these signs and     symptoms of liver problems: dark (tea-colored) urine, yellowing of your     skin or whites of your eyes, pale-colored stools (bowel movements),     nausea, vomiting, pain or tenderness on your right side below your ribs,     or loss of appetite   oPREZISTA^® may cause a severe or life-threatening skin reaction or rash.     Sometimes these skin reactions and skin rashes can become severe and     require treatment in a hospital. You should call your healthcare     professional immediately if you develop a rash. However, stop taking     PREZISTA^® and ritonavir combination treatment and call your healthcare     professional immediately if you develop any skin changes with these     symptoms: fever, tiredness, muscle or joint pain, blisters or skin     lesions, mouth sores or ulcers, red or inflamed eyes, like"pink eye."     Rash occurred more often in patients taking PREZISTA^® and raltegravir     together than with either drug separately, but was generally mild  Who should not take PREZISTA^®?    oDo not take PREZISTA^® if you are taking the following medicines:     alfuzosin (Uroxatral^®), dihydroergotamine (D.H.E.45^®, Embolex^®,     Migranal^®), ergonovine, ergotamine (Cafergot^®, Ergomar^®),     methylergonovine, cisapride (Propulsid^®), pimozide (Orap^®), oral     midazolam, triazolam (Halcion^®), the herbal supplement St. John's wort     (Hypericum perforatum), lovastatin (Mevacor^®, Altoprev^®, Advicor^®),     simvastatin (Zocor^®, Simcor^®, Vytorin^®), rifampin (Rifadin^®,     Rifater^®, Rifamate^®, Rimactane^®), sildenafil (Revatio^®) when used to     treat pulmonary arterial hypertension, indinavir (Crixivan^®),     lopinavir/ritonavir (Kaletra^®), saquinavir (Invirase^®), boceprevir     (Victrelis™), or telaprevir (Incivek™)   oBefore taking PREZISTA^®, tell your healthcare professional if you are     taking sildenafil (Viagra^®, Revatio^®), vardenafil (Levitra^®, Staxyn^®),     tadalafil (Cialis^®, Adcirca^®), atorvastatin (Lipitor^®), rosuvastatin     (Crestor^®), pravastatin (Pravachol^®), or colchicine (Colcrys^®,     Col-Probenecid^®). Tell your healthcare professional if you are taking     estrogen-based contraceptives (birth control). PREZISTA^® might reduce the     effectiveness of estrogen-based contraceptives. You must take additional     precautions for birth control, such as condoms  This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.  What should I tell my doctor before I take PREZISTA^®?    oBefore taking PREZISTA^®, tell your healthcare professional if you have     any medical conditions, including liver problems (including hepatitis B or     C), allergy to sulfa medicines, diabetes, or hemophilia   oTell your healthcare professional if you are pregnant or planning to     become pregnant, or are breastfeeding         oThe effects of PREZISTA^® on pregnant women or their unborn babies          are not known. You and your healthcare professional will need to          decide if taking PREZISTA^® is right for you        oDo not breastfeed. It is not known if PREZISTA^® can be passed to          your baby in your breast milk and whether it could harm your baby.          Also, mothers with HIV should not breastfeed because HIV can be          passed to your baby in the breast milk  What are the possible side effects of PREZISTA^®?    oHigh blood sugar, diabetes or worsening of diabetes, and increased     bleeding in people with hemophilia have been reported in patients taking     protease inhibitor medicines, including PREZISTA^®   oChanges in body fat have been seen in some patients taking HIV medicines,     including PREZISTA^®. The cause and long-term health effects of these     conditions are not known at this time   oChanges in your immune system can happen when you start taking HIV     medicines. Your immune system may get stronger and begin to fight     infections that have been hidden   oThe most common side effects related to taking PREZISTA^® include     diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not     a complete list of all possible side effects. If you experience these or     other side effects, talk to your healthcare professional. Do not stop     taking PREZISTA^® or any other medicines without first talking to your     healthcare professional  You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.  Please refer to the ritonavir (Norvir^®) Product Information (PI and PPI) for additional information on precautionary measures.  Please see full Prescribing Information for more details, available at http://PREZISTA.com/sites/default/files/pdf/us_package_insert.pdf  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. Please visithttp://www.janssenrnd.comfor more information.  (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.comor 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.  Media contacts: Craig Stoltz Phone: (609) 730-2823 cstoltz@its.jnj.com  Ronan Collins Phone: +44 (0)7876 257 746 rcollin5@its.jnj.com  Investor contacts: Stan Panasewicz Phone: (732) 524-2524  Louise Mehrotra Phone: (732) 524-6491  SOURCE Janssen Research & Development, LLC  Website: http://www.janssenrnd.com