Healthcare Industry News:  fast track designation 


 News Release - October 13, 2006

Roche Advances Oral Polymerase Inhibitor into Phase II Study in Patients with Chronic Hepatitis C

FDA Grants Fast Track Status To R1626

NUTLEY, N.J.--(HSMN NewsFeed)--Roche today announced the initiation of the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has also been granted fast track designation by the U.S. Food and Drug Administration (FDA), a program designed to facilitate the development and to expedite the review of new drugs with the potential to help treat serious or life-threatening conditions.

R1626, which has been shown to have a strong antiviral effect, uses a different mechanism of action from the current standard HCV treatment. In a Phase I study, the drug achieved significant reductions in viral levels in chronic hepatitis C patients infected with genotype 1, the most difficult to treat form of the virus. While patients with genotype 1 virus in clinical trials with Roche's currently-available hepatitis C therapies, PEGASYS® (peginterferon alfa-2a) and COPEGUS (ribavirin), had an approximate 50 percent chance of achieving a sustained virologic response (SVR). A strong medical need remains for new therapies to improve these response rates.

By moving R1626 into its first Phase II trial, Roche signifies its commitment to improving therapeutic options for patients with hepatitis C. The trial will evaluate the safety and antiviral effect of R1626 in combination with PEGASYS and COPEGUS.

"New medicines such as R1626 have strong antiviral activity and the potential to help more patients achieve treatment success, especially when used in combination with current treatments," said Dr. Paul Pockros, Head of the Division of Gastroenterology/Hepatology at The Scripps Clinic in San Diego and principle investigator of the study. "A product that could potentially improve treatment success rates, particularly for the hardest-to-treat forms of the virus, is much needed."

About the Phase II Study

The study announced today is an on-going multicenter Phase II trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment. Patients are randomized into four treatment groups:

  • Group A: R1626 1500mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week for 4 weeks
  • Group B: R1626 3000mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week for 4 weeks
  • Group C: R1626 1500mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week + COPEGUS 1000-1200mg daily for 4 weeks
  • Group D: PEGASYS 180mcg as a subcutaneous injection every week + COPEGUS 1000-1200mg daily (standard of care group) for 4 weeks

Following the first four weeks of treatment, all patients will receive PEGASYS 180mcg subcutaneously every week with COPEGUS 1000-1200mg daily for another 44 weeks, for a total treatment duration of 48 weeks. The objectives of the study are to evaluate the four-week safety and antiviral effect of combining R1626 with PEGASYS and/or COPEGUS.

The study is currently enrolling patients in the U.S. Patients and healthcare providers interested in the trial can find more information at

About Fast Track Status

The criteria under which FDA grants Fast Track status require that the product's indication represents a serious or life-threatening condition, and the product has the potential to meet an unmet medical need in treating the condition. This designation allows for increased communication between the sponsor and FDA during the product's development and enables a "rolling submission," which means Roche may submit reviewable portions of the NDA before submitting the complete NDA in order to facilitate the eventual review process for R1626.

"We are delighted to be granted fast track designation from the FDA," said Nick Cammack, Head of Viral Diseases Research, Roche. "The development of R1626, along with our extensive partnerships with other companies and our ongoing research with PEGASYS, underscores our long-term commitment to improving outcomes for patients living with chronic hepatitis C."

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.


PEGASYS, in combination with COPEGUS, are indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).

PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a week. COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed PEGASYS with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.

Important Safety Information about PEGASYS

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have hepatitis C or hepatitis B and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

PEGASYS (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.

COPEGUS (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings).

Who should not take PEGASYS and COPEGUS?

Do not take PEGASYS alone or with COPEGUS if:

  • You are pregnant or your partner is pregnant
  • You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
  • You are breastfeeding
  • You have hepatitis caused by your immune system (autoimmune hepatitis)
  • You have unstable or severe liver disease before or during treatment
  • You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
  • You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)

What if I am pregnant or thinking about having a baby?

If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you are not pregnant.

During treatment and for 6 months after treatment, female and male patients must:

  • Use two forms of birth control (one being a condom with spermicide)
  • Tell your doctor right away if you or your partner becomes pregnant. You or your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214

What medication should I avoid when I am taking PEGASYS and COPEGUS?

You should not take didanosine with COPEGUS. Talk to your doctor about all medications that you are taking.

What are the possible side effects?

The most common side effects of PEGASYS and COPEGUS are:

  • Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches)
  • Tiredness
  • Upset stomach (like nausea, taste changes, diarrhea)
  • Blood sugar problems (may lead to diabetes)
  • Skin problems (like rash, dry or itchy skin, redness and swelling at injection site)
  • Hair loss (temporary)
  • Trouble sleeping

The most serious side effects of PEGASYS and COPEGUS are:

  • Risks to pregnancies
  • Mental health problems (such as irritability, depression, anxiety, aggressiveness, trouble with drug addiction or overdose, thoughts about suicide, suicide attempts, suicide and thoughts about homicide)
  • Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems)
  • Infections (which sometimes cause death)
  • Lung problems (like trouble breathing, pneumonia)
  • Eye problems (like blurred vision, loss of vision)
  • Autoimmune problems (such as psoriasis, thyroid problems)
  • Heart problems (including chest pain and, rarely, a heart attack)
  • Liver problems (rarely, liver function worsens). Patients with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. If you have a rise in this blood test you may need to be watched more closely with additional blood tests.

Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: or

Source: Roche

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