Novartis: Triple-Combination Should Assure Leadership

Novartis' Parkinson's disease drug Stalevo has been launched in the US.

September 18, 2003 6:45 PM GMT (Datamonitor) - Stalevo will provide Novartis with an opportunity to gain leadership in
the $2.3 billion Parkinson's disease market. In 2002, Novartis' two products in the sector, Comtan and Parlodel
(bromocriptine), attained global sales of around $102 million and $67 million respectively. However, Novartis' new
novel triple-drug product could draw even stronger returns.

The FDA approved Novartis' new treatment for Parkinson's disease (PD) in June 2003. Now launched, Stalevo (carbidopa,
levodopa and entacapone) is the first new treatment for PD in three years, and the first new form of levodopa in more
than a decade. Launch in the EU is expected in early 2004, where it will be co-promoted with Novartis' collaborative
partner and originator of the drug, Orion.

Stalevo is a novel drug, which combines the gold standard PD therapy levodopa and carbidopa with Novartis' existing
brand Comtan (entacapone) into one convenient pill. Carbidopa is often used with levodopa to help prevent the
peripheral conversion of levodopa to dopamine and the resultant nausea and vomiting that can occur. This adverse effect
is due to stimulation of dopamine receptors in the postrema region of the brain not protected by the blood brain
barrier. However, even with this combination, only 10% of dopamine reaches the brain intact, due to it being converted
by peripheral COMT to an inert metabolite.

COMT-inhibitors, such as Comtan, prevent this conversion and can prolong levodopa's availability to the brain. This
action allows patients to stay active for longer between doses and reduces some of the burdensome symptoms of PD.

However, the problem with taking Comtan is that it greatly increases the number of pills a patient has to take every
day: one Comtan pill has to be taken with every levodopa/carbidopa pill up to three times daily.

Novartis and Orion believe their one tablet formulation, the first triple combination product for PD, will simplify the
treatment of the disease, which in turn will increase compliance. For Orion, the partnership with Novartis to develop
and market the product will help further establish the biotech company's position in the lucrative US pharmaceutical
market.

In addition to Stalevo, the predicted launch of Novartis' pipeline PD drug (the neuroprotectant TCH-346) by 2006 will
further leverage the company into the market, making it one of the leading players over the next eight years.

SOURCE: Datamonitor / UK Comment Wire, UK
http://www.commentwire.com/commwire_story.asp?commentwire_ID=4823

Reference:

NEWS: FDA Approves Stalevo (TM) for Treatment of Parkinson's
http://neuro-mancer.mgh.harvard.edu/ubb/Forum71/HTML/008554.html

FDA APPROVES First New Drug for PD in over 3 years
http://neuro-mancer.mgh.harvard.edu/ubb/Forum71/HTML/008656.html

New Parkinson’s Disease treatment Stalevo available in US pharmacies
http://www.novartis.com/

STALEVO is a new therapy for people with Parkinson’s disease (PD). In addition to carbidopa and levodopa (active
ingredients in Sinemet®*), STALEVO contains entacapone (active ingredient in COMTAN®), a substance that enhances the
benefits of levopoda.
http://www.stalevo.com:80/index.jsp?checked=y

New York/Basel, 17 October 2002 – At its Pharmaceuticals 'R&D day' in New York today, Novartis is unveiling details of
its pipeline, a strong R&D engine to sustain the launch of innovative medicines.
SNIP
TCH346 (Parkinson's disease) is currently undergoing Phase II clinical trials for Parkinson's disease and amyotrophic
lateral sclerosis. Preclinical trials suggest that TCH346 has a unique pharmacological action that may offer
neuroprotection, bringing much benefit to the rapidly growing population of Parkinson's disease sufferers.
http://tinyurl.com/nx83

Current Clinical Trials at IND
SNIP
Parkinson’s Disease Trials
For those newly diagnosed with Parkinson's Disease (PD):
SNIP
TCH346: An agent that shows promise in slowing down the disease process of Parkinson’s disease and the development of
symptoms.
http://www.indd.org/research/clinical.html

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