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, 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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New Interferon Formulations Promise to Eliminate Injections in Multiple Sclerosis Treatment

SAN DIEGO, CA January 12, 2009/MarketWire/-- Nerveda Inc. and Aegis Therapeutics
LLC today announced preclinical results from their joint collaboration aimed at
developing non-injectable formulations of the beta-interferons. The beta interferons,
beta-1a (tradename Rebif®), and beta 1b (tradenames Betaseron® and Betaferon®) are
closely related injectable protein drugs in the interferon family that are used to treat both the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). The beta interferons are currently administered by subcutaneous injection and have been proven clinically to slow the advance of multiple sclerosis and reduce the frequency of attacks. Current worldwide combined annual sales of Rebif®, Betaseron® and Betaferon® are approximately $4 Billion.

Because proteins are large and fragile molecules, they cannot be administered orally
and are typically administered by injection. They are often subject to instability due to aggregation of the protein molecules – particularly upon storage and handling at nonrefrigerated temperatures. The resulting protein aggregates are more poorly absorbed
into the blood stream upon injection due to their increased size, and induce development of circulating antibodies to interferon in patients that reduce the effectiveness of the drug over time.

Leading medical scientists at Johns Hopkins University, expert in the treatment of
neurological diseases, in collaboration with Nerveda and Aegis have applied Aegis’
Intravail® transmucosal absorption enhancement, and ProTek® protein stabilization
technologies to address these problems and have demonstrated for the first time that the beta interferons can be administered intranasally to prevent nerve damage in preclinical animal models of multiple sclerosis. In addition, the new formulations were shown to reduce or eliminate the immunogenicity of Betaseron® and Rebif®, administered either by injection or intranasally, while substantially increasing stability in a stress test involving constant agitation at elevated temperatures for extended periods of time.

Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in the
research, said, “since interferons will continue to be the foundation of MS therapy, it is critical that non-invasive delivery options for patients be developed.” Maggio also indicated, “the reduction in immunogenicity and the increase in stability also address a significant unmet need of the currently available beta-interferon therapies.”
Nerveda plans to begin testing the new formulation in clinical trials in early 2009 in
collaboration with clinicians and scientists at John Hopkins University Medical Center
and other sites.

* Rebif® is a registered trademark of Pfizer, Inc.
* Betaseron® is a registered trademark of Bayer Healthcare Pharmaceuticals
* Betaferon® is a registered trademark of Bayer Schering Pharma AG
* Intravail® and ProTek® are registered trademarks of Aegis Therapeutics, LLC

About Nerveda Inc.

Nerveda is a privately funded specialty pharmaceutical and diagnostic company focused
on improving the quality of life for patients suffering from neurodegenerative diseases
and their caregivers. Nerveda supports the clinical development of products licensed
from Johns Hopkins University, including neuroprotective compounds and stem cell
therapeutics that show promise in treating auto-immune disorders.

About Aegis Therapeutics

Aegis Therapeutics LLC is a drug delivery technology company commercializing its
patented or proprietary drug delivery and drug formulation technologies through productspecific licenses. Our patented Intravail® drug delivery technology enables the noninvasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection. Aegis’ Intravail® absorption enhancement agents provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal administration route. Intravail® has also been successfully applied to buccal, oral, and rectal administration of small molecule, peptide, and nucleotide-analog type drugs. Our patented ProTek® technology allows creation of proprietary, easily manufacturable, and stable aqueous or lyophilized dosage forms that maintain the integrity and physiological activity of many protein and peptide therapeutics. ProTek® technology is applicable to injectable, intranasal, and other dosage forms of peptide or protein therapeutics.

For more information about Aegis, please visit the Aegis website at: htpp://www.aegisthera.com.

Contact:
Aegis Therapeutics LLC
Ralph Barry, Chief Business Officer
1-858-618-1400 Ext. 102
Email: rbarry@aegisthera.com

Contact:
Nerveda Inc.
Cam Gallagher, CEO
1-(858) 705-2365
Email: CGallagher@NervedaBio.com

Magnetic Resonance Imaging Can Predict Who Will Develop Multiple Sclerosis: Presented at WCTRMS

By Louise Gagnon

MONTREAL -- September 24, 2008 -- Specific magnetic resonance imaging (MRI) scans can predict which patients will develop multiple sclerosis (MS), according to retrospective research presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

The Betaferon/Betaseron in Newly Emerging MS for Initial Treatment (BENEFIT) study is a randomised, double-blind, placebo-controlled, parallel-group clinical trial that was carried out among 468 patients whose first clinical event suggestive of MS happened within 60 days of trial entry. The study found that treatment with interferon (INF) beta-1b 250 mcg prevented the onset of clinically definite multiple sclerosis (CDMS) by 1 year.

Patients in the BENEFIT study were assigned to either early treatment, which was IFN beta-1b from the start of the trial, or delayed treatment, which was initial placebo followed by IFN beta-1b therapy after conversion to CDMS or upon completing 2-year follow-up.

Principal investigator Bastiaan Moraal, MD, VU Medical Center, Amsterdam, Netherlands, speaking at an oral session here on September 19, said that this analysis examined radiological rather than clinical endpoints.

"We were looking at which type of lesions measured at baseline would predict conversion to clinically definite multiple sclerosis or McDonald multiple sclerosis," said Dr. Moraal.

In this analysis, blinded raters assessed baseline MRI parameters using T2-weighted and postcontrast T1-weighted sequences. Statistical analysis was employed to assess the predictive value of each baseline MRI parameter and treatment interaction.

Investigators found overall conversion to CDMS was 42%, with factors such as the presence of =>9 T2 lesions and =>3 periventricular lesions demonstrating predictive value. They found that conversion rose with the cumulative number of positive criteria. No specific advantage was demonstrated for a threshold of =>3 Barkhof criteria.

"Patients whose treatment was delayed and had 4 positive Barkhof criteria had a higher chance of conversion to CDMS and McDonald MS compared to those with early treatment and fewer positive Barkhof criteria at baseline," explained Dr. Moraal.

Investigators found that prognostic value was affected by treatment (P = .002) for 4 positive Barkhof criteria. The prognostic value was not influenced by therapy for CDMS.

"We saw that, with one exception, the predictive value of MRI values was not affected by treatment," said Dr. Moraal.

Future analysis will examine the predictive value of MRI variables at 3, 6, and 9 months to assess the impact of those variables on conversion to either CDMS or McDonald MS.


[Presentation title: Baseline Magnetic Resonance Imaging Predictors for Conversion to Clinically Definite Multiple Sclerosis and McDonald Multiple Sclerosis, Based on Integrated 3-Year Data From the BENEFIT Study. Abstract 51]

New Data on Disease-modifying Therapies for Multiple Sclerosis

Mark J. Tullman, MD

Introduction

New data from key clinical trials of disease-modifying therapy were presented at the 60th Annual Meeting of the American Academy of Neurology. The results of some of these studies, along with the potential clinical implications of those results, are presented below.

Efficacy of Interferon Beta-1b and Glatiramer Acetate in Patients With Relapsing-Remitting Multiple Sclerosis: The BEYOND Trial

Results of the Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose (BEYOND) trial, which was funded by Bayer Healthcare Pharmaceuticals, were presented in a late-breaking session by Paul O'Connor, MD.[1] This trial was designed to compare the efficacy of 250 micrograms (mcg) and 500 mcg of interferon beta-1b given subcutaneously (SC) every other day in patients with relapsing-remitting multiple sclerosis (RRMS). The efficacy of these two doses of beta interferon-1b was also compared with glatiramer acetate (20 mg SC administered daily).

The trial randomized treatment-naive patients with RRMS with Expanded Disability Status Scale (EDSS) scores equal to or less than 5. Patients also had to have at least one relapse in the year prior to entry into the study. A total of 2244 patients were randomized in a 2:2:1 ratio to the 500-mcg dose of beta interferon-1b (n = 899), the 250-mcg dose of interferon beta-1b (n = 899) or to the 20-mg dose of glatiramer acetate (n = 448) for a period of 104 weeks or longer. Patients underwent clinical evaluations every 3 months and brain magnetic resonance imaging (MRI) scans annually.

The trial's primary endpoint was relapse risk. A per-protocol analysis and an intent-to-treat analysis were performed on the data. The clinical efficacy of each of the 3 treatment groups (beta interferon-1b 250 mcg, beta interferon-1b 500 mcg, and glatiramer acetate 20 mg) was similar in each of the analyses.

There were several supportive endpoints, including relapse rate, proportion of relapse-free patients, and time to first relapse. Secondary outcome variables were time to confirmed EDSS progression and T1 black hole development. Other endpoints of interest included the number and volume of T2 lesions. The annualized relapse rate fell by nearly 80% compared with the year prior to enrollment in the study, but there were no significant differences among the treatment groups.

There were some MRI endpoints that showed statistically significant differences between the treatment groups. The cumulative number of T2 lesions up to the last scan was significantly higher in the group receiving glatiramer acetate compared with the groups receiving 250 mcg (P = .17) or 500 mcg (P = .001) beta interferon-1b. Additionally, patients receiving 250 mcg or 500 mcg beta interferon-1b had a significantly lower increase in T2-lesion volume compared with the group receiving glatiramer acetate (P < .001 and P = .001, respectively). The authors note that it is unclear whether there is any long-term clinical significance to these findings.

All 3 treatments were generally well-tolerated. Dropout rates for 250 mcg interferon beta-1b, 500 mcg interferon beta-1b, and glatiramer acetate were 13%, 19%, and 17%, respectively. It is important to note that although this was a double-blind study for the interferon beta-1b groups (ie, they were unaware which dose they were receiving), this was not a double-blind trial for the patients who received glatiramer acetate. This may explain the higher dropout rate in the group receiving glatiramer acetate (17%) compared with the group receiving 250 mcg interferon beta-1b (13%) because the patients receiving interferon beta-1b were aware that there was a 50% chance that they could be receiving the higher, and potentially more effective, dose of interferon beta-1b.

The adverse events observed were similar to the known adverse event profiles of these compounds. Flulike symptoms were more common with interferon beta-1b and injection-site reactions (eg, pain, pruritis) were more common with glatiramer acetate.

The Results of the BEYOND trial[1] are similar to the recently presented results from the REGARD trial[2] that compared interferon beta-1a 44 mcg SC 3 times a week to glatiramer acetate. In these 2 studies, more than 2000 patients were randomized to either high-dose interferon or glatiramer acetate. Patients did very well and there were no major differences in terms of efficacy between the therapies. Unfortunately, the 500-mcg dose of interferon beta-1b was no more effective than the 250-mcg dose. In the absence of clear superior efficacy data between the high-dose interferons and glatiramer acetate, it seems to me that a high-dose interferon and glatiramer acetate are both reasonable initial treatment options for most patients with RRMS. Patients should be well informed and part of the treatment decision process. Some patients may prefer starting with a daily injection with fewer side effects and others would rather take a medication that has fewer injections but the potential to cause more side effects and requires periodic blood work.

Furthermore, for patients on a high dose interferon of glatiramer acetate who experience persistent side effects, switching from one agent to the other might improve tolerability and enhance quality of life without sacrificing efficacy.

Efficacy of Glatiramer Acetate in Delaying Conversion to Clinically Definite Multiple Sclerosis: The PreCISe Trial

Results from the Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to CDMS of Subjects Presenting With a Clinically Isolated Syndrome (CIS) (PreCISe) trial, were presented in a late-breaking session by Giancarlo Comi.[3] The PreCISe trial was a randomized, double-blind, placebo-controlled, multicenter, 3-year study designed to evaluate the efficacy of early treatment with glatiramer acetate in delaying the progression to clinically definite MS (CDMS) in patients with clinically isolated syndromes (CIS), which are considered to be first events suggestive of MS.

The study randomized 481 patients who had a minimum of 2 T2-weighted brain lesions at least 6 mm in diameter shown on MRI and who had experienced a first clinical event to receive glatiramer acetate 20 mg/day SC (n = 243) or placebo (n = 238). Only patients with a unifocal disease manifestation were included. Key baseline characteristics were: age (31.1 ± 6.9 years), time from first event to randomization (74.0 ± 14.9 days), and corticosteroid use for first attack (64% of patients). There was no difference between the study arms in EDSS (1.0 ± 1.0), number (31.5 ± 30.7) and volume (6.0 ± 6.2ml) of T2 weighted lesions, and number (1.5±2.9) and volume (0.3 ± 0.6ml) of gadolinium enhanced lesions.

The primary endpoint of the study was time to CDMS based on a second clinical attack. The trial was stopped prematurely by the data and safety monitoring committee after a preplanned interim analysis. The group initially receiving placebo was then switched to active treatment on an open-label basis. At this point, about 80% of the planned drug exposure had been given, and CDMS had developed in about 43% of those patients in the placebo group compared with just 25% in the glatiramer acetate group. The odds ratio for progression to CDMS was 0.41 (P < .0001) and the hazard ratio for progression to CDMS was 0.55 (95% CI 0.40-0.77; P = .0005) in the group taking glatiramer acetate compared with the placebo group. This translates in to a 45% risk reduction for progression to CDMS in the group on active treatment compared with the group on placebo. Additionally, the 25th percentile time to CDMS was prolonged from 336 days in the placebo group to 722 days (115% increase in time to CDMS onset) in the group receiving glatiramer acetate.

The results of MRI scans also favored the group receiving glatiramer acetate compared with the group receiving placebo. The mean number of new T2-weighted lesions was reduced by 61% in the patients receiving glatiramer acetate compared with the patients receiving placebo (P < .0001). Similarly, patients receiving glatiramer had a 61% reduction in new T1 gadolinium-enhancing lesions compared with the group receiving placebo (P < .0001).

Glatiramer acetate was well tolerated, and side effects were similar to those previously reported in patients with CDMS, including local injection-site reactions and transient postinjection reactions including chest pain, flushing, dyspnea, palpitations, and anxiety.

The open-label extension phase of the study will continue to a 5-year follow-up to evaluate the potential for glatiramer acetate to prevent or delay clinical progression of the disease. Patients will receive glatiramer acetate and will be followed until the development of CDMS.

The PreCISe study results are really not surprising. However, we now have strong evidence that the interferons and glatiramer acetate are effective when initiated after a first MS attack in patients with at least minimally abnormal brain MRI. The 5-year PreCISe data may provide additional evidence that early treatment with MS immunomodulatory therapy prevents the development of disability.

This activity is supported by an independent educational grant from Teva Neuroscience.

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]

Basel, May 26, 2008 - 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.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "plans", "will", "should" or similar expressions, or by express or implied discussions regarding potential new indications, labeling or regulatory filings or approvals for Extavia® or regarding potential future revenues from Extavia®. Such forward-looking statements reflect the current views of the management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Extavia® to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Extavia® will be approved for any additional indications or labeling by the European Commission or that Extavia will be approved for any indications in any additional markets. There can also be no guarantee that Extavia® will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Extavia® could be affected by, among other things, introduction of new MS therapies, unexpected regulatory actions or delays or government regulation generally or involving Extavia®, interferon beta-1b; 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 growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and 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 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1] Data on file. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2007.
[2] Multiple Sclerosis International Federation at www.msif.org Accessed 15 May 2008.
[3] Comi G et al. Oral FTY720 (fingolimod) in patients with relapsing multiple sclerosis. 3-year extension shows sustained low relapse rate and MRI activity. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago, 12-19 April 2008.
[4] National Multiple Sclerosis Society at www.nationalmssociety.org, Accessed 15 May 2008.
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Bayer's Betaferon Doesn't Work Better at Higher Dose (Update3)

By Eva von Schaper

Oct. 29 (Bloomberg) -- Bayer AG, Germany's largest drugmaker, will take a 152 million-euro ($219 million) charge after dropping plans to market a higher dose of its Betaferon multiple sclerosis treatment.

A study found the 500-microgram dose wasn't more effective at preventing patients' relapses than the 250-microgram form or Teva Pharmaceutical Industries Ltd.'s Copaxone, Leverkusen, Germany-based Bayer said in an e-mailed statement today.

Betaferon is one of the products Bayer needs for growth as it waits for income from newer medicines such as the cancer treatment Nexavar. Bayer gained Betaferon, also sold as Betaseron, in its 17 billion-euro purchase of German rival Schering AG.

``The standard Betaferon 250-microgram dose is the optimal Betaferon dose,'' Douglas Goodin, a professor of neurology at the University of California, San Francisco, said in the statement.

Bayer today said it expects revenue from Betaferon, which had first-half sales of 500 million euros, to rise between 7 and 9 percent this year and next. Bayer said it won't ask regulators to allow the higher dose version of the drug to go on sale.

The third-quarter charge will cover the writedown of assets from the study, dubbed BEYOND, as part of the Schering purchase, Bayer said.

Bayer shares fell 49 cents, or 0.8 percent, to 57.79 euros in Frankfurt. They've risen 42 percent this year.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .

Last Updated: October 29, 2007 12:44 EDT