Novartis Launches Extavia, A New Therapeutic Option To Help Patients Combat Devastating Symptoms Of Multiple Sclerosis

* Multiple sclerosis (MS) causes progressive disability and affects   2.5 million people worldwide including many young adults[1] 
* Extavia offers patients and physicians a new branded version of   standard-of-care interferon beta-1b 
* Approved to treat MS patients from first signs of active disease to   more advanced, relapsing forms 
* Launch marks start of planned long-term partnership between   Novartis and MS community 

BASEL, Switzerland, January 22, 2009 - Novartis has today announced the launch  of Extavia®, a new version of  the standard-of-care for relapsing  forms of multiple sclerosis (MS), providing patients and physicians with an alternative option to help manage this devastating disease.

 Extavia, a new  branded version of  interferon beta-1b, is  available initially in  Germany and  Denmark with  other European  launches  to follow during  2009.  It  is  approved to  treat  a  broad  range  of patients, from  those with  early  signs of  MS  to those  with  more advanced relapsing forms of the disease.

 "Extavia will  provide patients  and  physicians with  an  additional option for receiving a mainstay of  care in MS," said Trevor  Mundel, MD, Global Head of Development at Novartis Pharma AG. "This important first step  also  opens the  way  for Novartis  to  build  supportive partnerships with  the  MS community  and  lays the  foundations  for providing innovative approaches to MS care."  Extavia is the same medicinal  product as Betaferon®*, an  interferon beta-1b. This has  a well characterised  efficacy and safety  profile with more  than 700,000  patient-years' experience[2]  and a  17-year track record of clinical use - the longest for any interferon beta in the treatment of MS[3].

 MS is estimated to affect up to 2.5 million patients worldwide and is one of  the  leading  causes  of  neurological  disability  in  young adults1. The disease typically presents in relapsing forms  involving acute  self-limiting   attacks   of  neurological   dysfunction   (or "relapses"), followed by complete or partial restoration of function.

 Data have shown that interferon  beta-1b produces a 34% reduction  in annualized relapse rates (p<0.001), and patients are almost twice  as likely to remain relapse-free for over two years compared to those on placebo (31% vs. 16%, p=0.007)[4]. Treatment with interferon  beta-1b can  also  slow   disease  progression.  After   two  years,   nearly three-quarters of patients  who had experienced  a single episode  of neurological disease lasting at  least 24 hours  did not progress  to clinically definite MS[5].

 The launch of Extavia  in Europe by  the Pharmaceuticals Division  of Novartis marks the beginning  of a long-term  commitment to meet  the therapeutic  needs  of  the  MS  community.  This  will  include  the establishment of a support program for Extavia users that will foster cross-communication between patients and their physicians and nurses.

In  turn,  this  will  lay  the  foundations  for  future   potential innovations in MS therapy. The rollout of Extavia in key EU countries is expected during the coming months.

 Novartis acquired the rights to its own branded version of interferon beta-1b in an agreement with Bayer Schering, the company that markets Betaferon. In  backing  Extavia, Novartis  brings  over 50  years  of neuroscience expertise  and  resources  to  the  MS  community.  This expertise has helped to pioneer  early breakthrough treatments for  a number of  neurological and  pathological conditions,  some of  which remain important therapies to this day.

 MS is a chronic autoimmune disease of the central nervous system that causes inflammation and neurodegeneration. Pathology is characterised by the destruction  of myelin, which  helps neurons carry  electrical signals in  the brain[6].  The disease  causes problems  with  muscle control  and  strength,   vision,  balance,   sensation  and   mental function[6].

 The beneficial effects of interferon beta  are believed to be due  to its modulation of  the immune system  to reduce inflammatory  damage.

Specifically, interferon beta limits  the activation of immune  cells that  attack  myelin,  suppresses  the  production  of   inflammatory cytokines -  a  type  of  protein  that  amplifies  the  inflammatory response causing damage to myelin - and stimulates the production  of anti-inflammatory cytokines.

 Extavia has been filed with the  US Food and Drug Administration  for the treatment of  relapsing forms of  MS to reduce  the frequency  of clinical exacerbations  (or  relapses).  Patients  with  MS  in  whom efficacy has been demonstrated include  those who have experienced  a first clinical episode and have features consistent with MS as  shown by magnetic resonance imaging (MRI)[7].

 Extavia  is  administered  by   subcutaneous  (or  under  the   skin) injection. Patients will have the choice  of using either a fine  (30 gauge) needle for manual injection or a convenient autoinjector.

 * Betaferon® is a registered trademark of Bayer Schering Pharma AG.

 Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," "planned," "long-term," "can," "will," "likely," "commitment," "future," "potential," "expected," "estimated," "believed," or similar expressions, or by express or implied discussions regarding potential additional marketing approvals for Extavia, the roll-out of Extavia in potential additional markets, the potential development of additional MS therapies, or regarding potential future revenues from Extavia or additional MS therapies. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that will be approved for sale in any additional markets. Nor can there be any guarantee that Extavia will be launched in any additional markets.  Neither can there be any guarantees that Novartis will successfully develop and bring to market any additional MS therapies. Nor can there be any guarantee that Extavia or such additional therapies will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Extavia and any such additional MS therapies could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.

Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 About Novartis Novartis AG provides healthcare  solutions that address the  evolving needs of  patients  and  societies.  Focused  solely  on  healthcare, Novartis offers a  diversified portfolio  to best  meet these  needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis  is the only company with leading positions in these areas. In 2007,  the Group's  continuing  operations   (excluding  divestments  in   2007) achieved net sales  of USD  38.1 billion and  net income  of USD  6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered  in Basel, Switzerland,  Novartis Group companies employ approximately 97,000 full-time associates  and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

 References [1] World Health Organization. Neurology atlas, 2004. Accessed 16 Jan 2009.

http://www.who.int/mental_health/neurology/neurogy_atlas_review_references.pdf [2] FDA approves Betaseron® for use after the first event suggestive of multiple sclerosis [press release]. Wayne, NJ: Berlex: 23 October 2006.

[3] Ebers G, Traboulsee A, Langdon D, Goodin D, Konieczny A. The interferon beta-1b 16-year long-term follow-up study: the results.

Presented at the 16th meeting of the European Neurological Society; 27-31 May, 2006.

[4] The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurology.

1993;43:655-661.

[5] Kappos L, Freedman MS, Polman CH, et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007;370:389-97.

[6] National Multiple Sclerosis Society website.

http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx.

Accessed January 12, 2009.

[7] Extavia proposed US Prescribing Information.
 

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Posted: January 2009


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