JANSSEN HIGHLIGHTS ITS HEPATITIS C CLINICAL DEVELOPMENT IN ADVANCE OF AASLD

Related - FDA approves simeprevir-sofosbuvir combo for hepatitis C
November 5, 2014 - Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved OLYSIO® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

Janssen Highlights its Hepatitis C Clinical Development Program in Advance of 2014 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

BOSTON, Nov. 7, 2014 /PRNewswire/ -- Janssen R&D Ireland (Janssen) highlights its hepatitis C (HCV) clinical development program in advance of The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held November 7-11, 2014 in Boston, Massachusetts.

Given the size, complexity and diversity of the HCV patient population, physicians will continue to need multiple treatment options and combinations in order to offer patients an opportunity for cure into the next decade.

The Janssen HCV clinical development program includes studies that investigate the use of simeprevir in several interferon-free regimens using selected combinations of direct-acting antivirals with different mechanisms of action targeting diverse patient populations. These studies are focused on potentially offering alternative and more immediate treatment options for physicians and patients where there is a high unmet need today or anticipated in the near future. Ongoing clinical studies include:

• Phase 3 OPTIMIST studies examining the safety and efficacy of simeprevir and the nucleotide analog NS5B polymerase inhibitor sofosbuvir without interferon or ribavirin for the treatment of chronic HCV infection for treatment-naïve and treatment-experienced patients with and without cirrhosis.
• Phase 2 IMPACT study evaluating the efficacy, safety and pharmacokinetics of simeprevir administered once daily in combination with sofosbuvir and the NS5A replication complex inhibitor daclatasvir in treatment-naïve and treatment-experienced patients with HCV genotype 1 and 4 infection and decompensated liver disease.

With the closing of the acquisition of Alios Biopharma, Inc. earlier today, Janssen now holds a platform of nucleotide analog polymerase inhibitors, the early-clinical stage compounds AL-335 and AL-516.

"Janssen is committed to combating hepatitis C by exploring the potential to bring forth, in a timely manner, an in-house interferon-free combination regimen to make a difference in patients' lives," said Gaston Picchio, Ph.D., Hepatitis disease area leader, Janssen.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is a major global public health concern. Approximately 170 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About 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 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 R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OLYSIO®?

• If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO®. It is not known if OLYSIO® will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO®.
  • Females must use an effective form of birth control during treatment with OLYSIO®. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO®.
• OLYSIO® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO®.
  • Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO®.
  • Limit sunlight exposure during treatment with OLYSIO®.
  • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO®.
  • Call your healthcare provider right away if you get any of the following symptoms:
    • burning, redness, swelling or blisters on your skin
    • mouth sores or ulcers
    • red or inflamed eyes, like "pink eye" (conjunctivitis)

• You should not take OLYSIO® alone. OLYSIO® should be used together with other medicines to treat chronic hepatitis C infection.

What should I tell my healthcare provider before taking OLYSIO®?

Before taking OLYSIO®, tell your healthcare provider if you:

• have liver problems other than hepatitis C virus infection
• have ever taken any medicine to treat hepatitis C virus infection
• had a liver transplant
• are receiving phototherapy
• have any other medical condition
• are of East Asian descent
• are breastfeeding. It is not known if OLYSIO® passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO® or breastfeed. You should not do both.

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• OLYSIO® and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO® or other medicines in your body, which may affect the way OLYSIO® or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

• Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone®, Pacerone®), amlodipine (Norvasc®), atazanavir (Reyataz®), atorvastatin (Lipitor®, Caduet®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), cisapride (Propulsid®, Propulsid Quicksolv®), clarithromycin (Biaxin®, Prevpac®), cobicistat-containing medicine (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), darunavir (Prezista®), delavirdine mesylate (Rescriptor®), dexamethasone, digoxin (Lanoxin®), diltiazem (Cardizem®, Dilacor XR®, Tiazac®), disopyramide (Norpace®), efavirenz (Sustiva®, Atripla®), erythromycin (E.E.S.®, Eryc®, Ery‑Tab®, Erythrocin®, Erythrocin Stearate®), etravirine (Intelence®), felodipine (Plendil®), flecainide (Tambocor®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®, Onmel®), ketoconazole (Nizoral®), lopinavir (Kaletra®), lovastatin (Advicor®, Altoprev®, Mevacor®), mexiletine (Mexitil®), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept®), nevirapine (Viramune®, Viramune XR®), nicardipine (Cardene®), nifedipine (Adalat CC®, Afeditab CR®, Procardia®), nisoldipine (Sular®), oxcarbazepine (Oxtellar XRTM,Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pitavastatin (Livalo®), posaconazole (Noxafil®), pravastatin (Pravachol®), propafenone (Rythmol SR®), quinidine (Nuedexta®, Duraquin®, Quinaglute®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), rifapentine (Priftin®), ritonavir (Norvir®), rosuvastatin (Crestor®), saquinavir mesylate (Invirase®), sildenafil (Revatio®, Viagra®), simvastatin (Zocor®, Vytorin®, Simcor®), sirolimus (Rapamune®), St. John's wort (Hypericum perforatum) or products containing St. John's wort, tadalafil (Adcirca®, Cialis®), telithromycin (Ketek®), tipranavir (Aptivus®), triazolam (Halcion®), verapamil (Calan®, Covera‑HS®, Isoptin®, Tarka®), voriconazole (Vfend®).
• This is not a complete list of medicines that could interact with OLYSIO®. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
• Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of OLYSIO®?

• The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea.

• The most common side effects in combination with sofosbuvir are tiredness, headache and nausea.

• Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

When taking OLYSIO® in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO® in combination with sofosbuvir, you should also read its Patient Information leaflet.