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					My life with MS
                A step by step guide towards
                maintaining an active lifestyle
                                                                                        8   Long-term experience
                                                                                            with Betaferon®

                For people newly diagnosed with MS:

           1    Multiple Sclerosis – An introduction
           2    Diagnosis and what happens next
           3    Symptomatic treatment of MS

                For people with MS on beta-interferon therapy:

           4    An introduction to modern MS treatments
           5    Betaferon® – Benefits of a modern MS therapy
           6    Betaferon® – The convenient therapy
           7    Living with MS
           8    Long-term experience with Betaferon®
           9    Physical exercise, well-being and MS

 Bayer Schering Pharma AG · 13342 Berlin · Germany ·
                                                                Table of contents

    This brochure deals with the history of Betaferon®                   Introduction             ...........................................4
    and long-term experience with the drug. Betaferon®
    was not only the first drug of its kind to be approved               The dawn of a new era . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
    for the treatment of multiple sclerosis (MS), it is still
    one of the most widely prescribed treatments for                     The benefits of early treatment . . . . . . . . . . . . . . . . . . . . 8
    people with MS in Europe today.
                                                                         Dose-dependent efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
    Please note that this brochure is one of a series
    that deals with various aspects of MS and its                        Glossary       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
    therapy. You may also find it useful to read one
    or all of the others.

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                      Multiple sclerosis (MS) existed, of course, long before   1957                 The first identification
                      the discovery of interferons in medicine (1957), and      The first            of interferons as
                      the emergence of Betaferon® (interferon beta-1b)          of interferons
                                                                                                     naturally occurring
                      as the first interferon to be approved in MS therapy                           substances goes
                      in 1993.                                                                       back to 1957.
                                                                                                     The body produces
                      In fact, the first known case of what may have                                 different types of
Figure 1:             been MS was described back in the 15th century.                                interferon. Inter-
Historical texts      St. Lidwina of Schiedam (figure 1), who lived in the                           feron beta plays a role in
reveal that           Netherlands (1380-1433), suffered from an illness                              “reducing” relapse rate and
St. Lidwina of
Schiedam (1380 –
                      where many of the symptoms described were similar                              MS progression. Interferon gamma, in contrast,
1433) had a           to those of MS to the extent that a retrospective                              may increase the activity of MS. This fundamental
condition that        diagnosis of MS could be justified. This dates the                             difference between the two interferons became
shared many of
                      disease back to the 15th century.                                              the key to interferon therapy in MS.
the characteristics
of MS
                                                                                1985                 While a study with natural beta-interferon yielded
                                                                                Larger quantities    promising results in the 1980s, the drug had to be
                                                                                of beta-interferon
                                                                                could be produced
                                                                                                     injected into the spinal cord, which was not practical
                                                                                                     for long-term treatment. By the mid 1980s scientists
                                                                                                     had discovered new techniques that allowed them
                                                                                                     to produce beta-interferon in larger quantities. At
                                                                                                     this time scientists really began to focus their efforts
                                                                                                     on the therapeutic potential of beta-interferon.

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                                                                           The dawn of a new era

                  16 years of clinical experience                          1993            Until the 1960s, very little was known about MS and
                                                                           Betaferon®      how to treat it. A new era dawned when Betaferon®
                                                                           became the
1988              Betaferon® (interferon beta-1b) retained the activity    first drug to
                                                                                           became the first drug to be approved on July 23,
The first large   of native human beta-interferon, but in a more stable    be approved     1993 for the treatment of people with relapsing-
study with
                  and potent form. As a result, the earlier problems of                    remitting MS. This pioneering approval in the US
was launched      availability, potency, and purity rapidly vanished and                   was followed by an approval in the European Union
                  positive data came from new trials in MS. In 1988,                       in 1995, and even today, Betaferon® remains one of
                  the first large study with Betaferon® was launched                       the most widely prescribed medications for MS.
                  in North America and the follow-up is still ongoing
                  today. Overall, 16 years of clinical experience have                     In 1999, it also became the first available treatment
                  been documented. This is the longest and most                            for the secondary progressive type of MS in the EU.
                  extensive collection of data on any interferon treat-                    Finally, in the year 2006 Betaferon® received approval
                  ment for people living with MS to date.                                  for use in the very early stages of MS, i.e. as early as
                                                                                           after the first clinical event and MRI (magnetic
                                                                                           resonance imaging) features suggestive of MS.
                                                                                           Today Betaferon® is the MS drug with the broadest
                                                                                           approved spectrum for use in MS.

                                                                                            Since its launch, Betaferon® has shown a good
                                                                                               safety and tolerability profile in studies with
                                                                                                over 3,500 patients and a total of more than
                                                                                                 150,000 users worldwide. This has led to
                                                                                                              the collection of a great deal of
                                                                                                                  data confirming the long term
                                                                                                                  benefits, efficacy and the good
                                                                                                                  safety profile of Betaferon® in
                                                                                                                  many people with different
                                                                                                                  types of MS.

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The benefits of early treatment                                       Dose-dependent efficacy

         Over the last few years the concept of a very early treat-            In the treatment of MS, there is evidence that the
         ment in MS has been recommended by MS experts                         efficacy of beta-interferon may be dose-dependent.
         throughout the world. However, before treatment can                   A recent clinical trial (called OPTIMS) compared
         start, a clear diagnosis of MS needs to be made. This                 two different doses of Betaferon® (the currently
         process needs time, because the neurologist requires                  recommended dose and the one and a half times
         information from different sources (please refer to                   dose). The study revealed that the higher dose
         module no. 2 for further details). People get their                   showed greater benefits as measured by MRI with
         diagnosis sometimes quite a long time after they                      a comparable profile.
         experienced the first symptoms. The resulting uncer-
         tainty not knowing ‘what’s going on with my body’,                    There are also signs that doubling the currently
         ‘what’s wrong with me’ is sometimes hard to endure.                   recommended Betaferon® dose might provide even
         MS can now be diagnosed much earlier, because of                      more effective results. One of the largest MS trials
         recent advances in MRI, but also due to the new                       (called BEYOND) to date is currently examining this
                           McDonald criteria which allows an                   question. Hopefully, the results of this study will
                           MS diagnosis to be made sooner and                  provide the answer as to whether higher doses
                           with a higher degree of certainty.                  of Betaferon® will lead to even greater benefits
                                                                               for people with MS.
                           Evidence from the BENEFIT study has
                           shown that immediate treatment right                Leading the way in MS research
                           after the first steroid-treated syndrom
                           indicative of MS had a positive effect              Although at present there is no cure for MS, many
         on the course of the disease over the present study                   companies and research labs around the world are
         period of 3 years, providing a better outcome for those               actively working to find a cure. The level of research
         that received prompt treatment as compared to delayed                 in this field has grown exponentially in the last 20
         treatment. Of course, every doctor will decide when                   years and a number of promising drugs are in the
         each of their patients should start therapy on an indi-               early stages of development. Hopefully in the next
         vidual basis, as early treatment may not necessarily suit             few years, one of these drugs will provide new and
         every person with MS.                                                 improved options for the treatment of people with MS.

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Glossary                                                              Notes
           BENEFIT study: Betaferon® in Newly Emerging
           Multiple Sclerosis For Initial Treatment

           Beta-interferons: Can modify specific actions of
           the body’s immune system and are therefore used
           to treat people with MS.

           BEYOND study: Betaferon® Efficacy Yielding
           Outcomes of a New Dose

           PPMS: The primary progressive type of MS. This form
           is rare and only affects about 10% of all MS patients.
           Disease progression from onset is steady. Symptoms
           progressively worsen and disability gradually increases.

           RRMS: The relapsing-remitting form of MS is the
           most common type of the disease, affecting more
           than 80% of patients. In the early phases symptoms
           may be lacking, sometimes even for several years.
           But attacks are unpredictable and symptoms may
           occur at any time. In between relapses, there seems
           to be a lack of disease progression.

           SPMS: The secondary progressive course of MS
           is the more advanced form of the disease. It is
           considered the second stage of the disease for
           more than 40% of patients initially suffering from
           RRMS. After periods of attacks and remissions,
           disability and symptoms continuously worsen.

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