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Schering-Plough Launches PEG-INTRON(TM) and REBETOL(R) Combination

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  • claudine intexas
    Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial
    Message 1 of 1 , Oct 4, 2001
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      Peginterferon alfa-2b plus ribavirin compared with
      interferon alfa-2b
      plus
      ribavirin for initial treatment of chronic hepatitis
      C: a randomised
      trial

      <A
      HREF="http://www.natap.org/2001/sep/peginterferon_alfa.htm">
      http://www.natap.org/2001/sep/peginterferon_alfa.htm</A>

      Schering-Plough Launches PEG-INTRON(TM) and REBETOL(R)
      Combination
      Therapy

      in U.S. for Chronic Hepatitis C


      KENILWORTH, N.J., Oct. 3 /PRNewswire/ --
      Schering-Plough Corporation
      (NYSE:

      <A HREF="aol://4785:SGP">SGP</A>) today announced the
      U.S. launch of
      combination therapy using PEG-INTRON(TM)
      (peginterferon alfa-2b) Powder
      for
      Injection and REBETOL(R) (ribavirin, USP) Capsules for
      treating chronic
      hepatitis C. REBETOL Capsules, approved in July 2001
      as a separately
      marketed product, currently are being shipped to trade
      customers and
      are
      expected to be available at pharmacies nationwide in
      two to three
      weeks.

      REBETOL is packaged in bottles containing either 42,
      56, 70 or 84
      capsules

      each. PEG-INTRON, approved in January 2001, is
      available nationwide.


      REBETOL Capsules are indicated for use only in
      combination with
      PEG-INTRON
      for the treatment of chronic hepatitis C in patients
      with compensated
      liver
      disease who have not been previously treated with
      interferon alpha and
      are at
      least 18 years of age, or with INTRON(R) A (interferon
      alfa-2b,
      recombinant)
      Injection for the treatment of chronic hepatitis C in
      patients with
      compensated liver disease previously untreated with
      alpha interferon or
      who
      have relapsed following alpha interferon therapy. The
      safety and
      efficacy of
      REBETOL Capsules with interferons other than
      PEG-INTRON or

      INTRON A products have not been established.


      REBETOL had been available in the United States only
      as a component of
      REBETRON(TM) Combination Therapy, which contains
      REBETOL Capsules and
      INTRON
      A Injection in a single package. Schering-Plough will
      continue to
      market

      REBETRON Combination Therapy in the United States.


      REBETOL is an oral formulation of ribavirin, a
      synthetic nucleoside
      analog.

      Schering-Plough has exclusive worldwide rights to
      market oral ribavirin
      for

      hepatitis C through a licensing agreement with ICN
      Pharmaceuticals,
      Inc.

      (NYSE: <A HREF="aol://4785:ICN">ICN</A>) of Costa
      Mesa, Calif.


      PEG-INTRON, which is approved for dosing according to
      patient body
      weight,

      is the first and only pegylated interferon product
      approved for
      marketing in

      the United States. PEG-INTRON is a longer-acting form
      of INTRON A that
      uses

      proprietary PEG technology developed by Enzon, Inc. of
      Piscataway, N.J.
      PEG-INTRON,

      recombinant interferon alfa-2b linked to a 12,000
      dalton polyethylene
      glycol

      (PEG) molecule, is a once-weekly therapy designed to
      optimize the
      balance

      between antiviral activity and elimination half-life.
      Schering-Plough
      holds

      an exclusive worldwide license to PEG-INTRON.


      INTRON A is a recombinant version of naturally
      occurring alpha
      interferon,

      which has been shown to exert both antiviral and
      immunomodulatory
      effects.

      Schering-Plough markets INTRON A, the world's
      largest-selling alpha

      interferon, for 16 major antiviral and anticancer
      indications
      worldwide.


      WARNING


      -- REBETOL monotherapy is not effective for the
      treatment of chronic

      hepatitis C virus infection and should not be used
      alone for this

      indication. (See WARNINGS.)

      -- The primary toxicity of ribavirin is hemolytic
      anemia. The anemia

      associated with REBETOL therapy may result in
      worsening of cardiac
      disease

      that has lead to fatal and nonfatal myocardial
      infarctions. Patients
      with a
      history of significant or unstable cardiac disease
      should not be
      treated with
      REBETOL. (See WARNINGS, ADVERSE REACTIONS, and DOSAGE
      AND
      ADMINISTRATION.)

      -- Significant teratogenic and/or embryocidal effects
      have been
      demonstrated

      in all animal species exposed to ribavirin. In
      addition, ribavirin has
      a

      multiple-dose half-life of 12 days, and so it may
      persist in nonplasma

      compartments for as long as 6 months. Therefore,
      REBETOL therapy is

      contraindicated in women who are pregnant and in the
      male partners of
      women

      who are pregnant. Extreme care must be taken to avoid
      pregnancy during

      therapy and for 6 months after completion of treatment
      in both female

      patients and in female partners of male patients who
      are taking REBETOL

      therapy. At least two reliable forms of effective
      contraception must
      be

      utilized during treatment and during the 6-month
      post-treatment
      follow-up

      period. (See CONTRAINDICATIONS, WARNINGS,
      PRECAUTIONS-Information for

      Patients and Pregnancy Category X.)

      -- Alpha interferons, including PEG-INTRON and INTRON
      A, may cause or

      aggravate fatal or life-threatening neuropsychiatric,
      autoimmune,
      ischemic

      and infectious disorders. Patients should be
      monitored closely with

      periodic clinical and laboratory evaluations.
      Patients with
      persistently

      severe or worsening signs or symptoms of these
      conditions should be

      withdrawn from therapy. In many but not all cases
      these disorders
      resolve

      after stopping therapy with PEG-INTRON or INTRON A.
      (See WARNINGS,
      ADVERSE

      REACTIONS.)


      PEG-INTRON


      There are no new adverse events specific to PEG-INTRON
      as compared to
      INTRON

      A, however, the incidence of some (e.g., injection
      site reactions,
      fever,

      rigors, nausea) were higher. The most common adverse
      events associated
      with

      PEG-INTRON were "flu-like" symptoms, occurring in
      approximately 50% of

      patients, which may decrease in severity as treatment
      continues.

      Application ite disorders were common (47%), but all
      were mild (44%) or

      moderate (4%) and no patient discontinued, and
      included injection site

      inflammation and reaction (i.e., bruise, itchiness,
      irritation).
      Injection

      site pain was reported in 2% of patients receiving
      PEG-INTRON.
      Alopecia

      (thinning of the hair) is also often associated with
      alpha interferons

      including PEG-INTRON.


      Psychiatric adverse events, which include insomnia,
      were common (57%)
      with

      PEG-INTRON, but similar to INTRON A (58%). Depression
      was most common
      at

      29%. Suicidal behavior including ideation, suicidal
      attempts, and
      completed

      suicides occurred in 1% of patients during or shortly
      after completing

      treatment with PEG-INTRON. PEG-INTRON is
      contraindicated in patients
      with

      autoimmune hepatitis and decompensated liver disease.


      The following serious or clinically significant
      adverse events have
      been

      reported at a frequency < 1% with PEG-INTRON or
      interferon alpha:
      Severe

      decreases in neutrophil or platelet counts,
      hypothyroidism,
      hyperglycemia,

      hypotension, arrhythmia, ulcerative and hemorrhagic
      colitis,
      development or

      exacerbation of autoimmune disorders including
      thyroiditis, RA,
      systemic

      lupus erythematosus, psoriasis, pulmonary disorders
      (dyspnea, pulmonary

      infiltrates, pneumonitis and pneumonia, some resulting
      in patient
      deaths),

      urticaria, angioedema, bronchoconstriction,
      anaphylaxis, retinal
      hemorrhages

      and cotton wool spots.


      Renal failure patients should be closely monitored for
      signs and
      symptoms of

      interferon toxicity and PEG-INTRON should be used with
      caution in
      patients

      with creatinine clearance < 50 mL/min. Patients on
      PEG-INTRON therapy

      should have hematology and blood chemistry testing
      before the start of

      treatment and then periodically thereafter.


      INTRON A


      All patients receiving INTRON A therapy experienced
      mild-to-moderate
      side

      effects. Some patients experienced more severe side
      effects, including

      neutropenia, fatigue, myalgia, headache, fever, chills
      and increased
      SGOT.

      Other frequently occurring side effects were nausea,
      vomiting,
      depression,

      alopecia, diarrhea and thrombocytopenia. DEPRESSION
      AND SUICIDAL
      BEHAVIOR,

      INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND
      COMPLETED SUICIDES,
      HAVE

      BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA
      INTERFERONS,
      INCLUDING
      INTRON A THERAPY.


      Some 4 million Americans are infected with the
      hepatitis C virus (HCV)
      and

      approximately 70 percent of infected patients go on to
      develop chronic
      liver

      disease, according to the Centers for Disease Control
      and Prevention
      (CDC).

      Hepatitis C infection contributes to the deaths of an
      estimated 8,000
      to

      10,000 Americans each year and this toll is expected
      to triple by the
      year

      2010, according to the CDC. The CDC has reported that
      HCV-associated

      end-stage liver disease is the most frequent
      indication for liver

      transplantation among adults. It is predicted that
      direct U.S. medical

      costs to treat HCV-related disease will exceed $13
      billion for the
      years

      2010 through 2019, according to a study published in
      the American
      Journal of

      Public Health.


      DISCLOSURE NOTICE: The information in this press
      release includes
      certain

      "forward-looking" statements concerning, among other
      things, the
      potential

      market for REBETOL Capsules for use in combination
      therapy with
      PEG-INTRON

      or INTRON A as well as the projected availability date
      of REBETOL
      Capsules.

      The reader of this release should understand that
      there are no
      assurances as

      to the extent that these combination therapies will be
      prescribed. The

      forward-looking statements may be adversely affected
      by general market

      factors, competitive product development, product
      availability, current
      and

      future branded and generic competition, federal and
      state regulations
      and

      legislation, the regulatory process for new products
      and indications,

      existing manufacturing issues and new manufacturing
      issues that may
      arise,

      timing of trade buying, patent positions, litigation
      and
      investigations.

      For further details and a discussion of these and
      other risks and

      uncertainties, see the company's Securities and
      Exchange Commission
      filings,

      including the company's 2000 annual report on Form
      10-K and subsequent

      quarterly reports on Form 10-Q.


      Schering-Plough is a research-based company engaged in
      the discovery,

      development, manufacturing and marketing of
      pharmaceutical products

      worldwide.



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