Extavia® approved in European Union for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis

* Extavia is Novartis brand for interferon beta-1b - an established therapy with more than 700,000 patient-years’ experience to date[1]

* Launch of Extavia for early and relapsing forms of multiple sclerosis (MS) planned for US and Europe in first half of 2009

* Novartis committed to MS through extensive research and development programs, including novel oral therapy FTY720 currently in Phase III trials

* MS, a devastating disease causing progressive disability, affects an estimated 2.5 million people worldwide, including many young adults[2]

The European Commission has approved Extavia® (interferon beta-1b) for the treatment of early and relapsing forms of multiple sclerosis (MS) - the first in a new portfolio of medicines from Novartis that is planned to include both established treatments and innovative therapies for patients with MS.
Extavia is the Novartis branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of MS. Interferon beta-1b has been available globally for more than 13 years and is supported by more than 700,000 patient-years of experience[1].
Formerly known as NVF233, Extavia is the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer-Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer-Schering related to the acquisition of Chiron.
“Novartis is committed to MS and to providing effective treatments for patients with this disease,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “The approval of Extavia means we are able to offer the MS community a current standard of care while preparing for the introduction of innovative therapies such as FTY720.”
Novartis also recently filed for approval of interferon beta-1b with the US Food and Drug Administration. Launches in the US and EU are planned for the first half of 2009, in line with an agreement with Bayer-Schering that established the opportunity for Novartis to introduce its own branded version of interferon beta-1b.
By the end of 2009, Novartis also plans to file for approval of the innovative oral therapy FTY720 (fingolimod). Results of an ongoing Phase II study extension presented in April show sustained benefits in patients with relapsing MS after three years of treatment with FTY720. Data showed that 68-73% of patients in the study remained free from relapses after three years’ continuous treatment[3].
A number of other compounds for treating MS are also in early stage development by Novartis.
Multiple sclerosis is the most common disorder of the central nervous system in young adults2. It is a progressive and debilitating disorder caused by the destruction of myelin, which helps neurons carry electrical signals in the brain. MS causes problems with muscle control and strength, vision, balance, sensation and cognitive function2. MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or “relapses”) followed by complete or partial restoration of functions[4].
In the EU, Extavia is approved for patients with relapsing-remitting MS, the most common form of the disease involving relapses followed by complete or partial restoration of function, and for a steadily worsening form of the disease known as secondary progressive MS with relapses.
In addition, Extavia is approved to treat patients with early MS who:

* Have experienced a single episode involving loss of myelin (or “demyelinating event”)
* Have an active inflammatory process that is severe enough to need treatment with intravenous corticosteroids, if alternative diagnoses have been excluded
* Are at high risk of developing clinically definite MS.