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Letter published in Lancet re-confirms levodopa as 'gold standard' therapy for Parkinson's Disease

Use of entacapone with levodopa significantly enhances symptom control
Espoo, August 19, 2002 - Since the late 1960's levodopa has remained the most widely used treatment for Parkinson's disease. While originally hailed as a 'miracle' drug, questions have been raised over the past decade about the long-term effects of levodopa. In a letter to the Lancet published August 16, 02, three leading neurologists pointed out that associated motor complications are not so much an inherent problem of levodopa itself, but occur as a result of the method of administration. If administered correctly, not only are the side-effects minimal but levodopa may have neuro-protective properties. Professor Agid, head of neurology at the Hospital de la Salpetriere, Paris, France remarked 'Levodopa is absolutely the most effective treatment used in the management of Parkinson's disease and should remain the gold standard'.
Professor Yves Agid, along with Professor Mizuno, Juntendo University, Japan and Professor Warren Olanow, Mount Sinai School of Medicine, New York, USA, recently co-chaired an International Levodopa Consensus Meeting in Zurs, Austria. The meeting concluded that levodopa, which will be required by all patients at some stage in their disease, remains the most effective anti-parkinsonian treatment.
The group of 28 internationally renowned experts concluded that the problems associated with levodopa are not caused by the medication itself, but the mode of delivery by which levodopa is given and the natural progression of the disease. Levodopa has a relatively short half-life, which means that the dopamine receptor is stimulated in an on/off, pulsatile manner. Recent studies1,2 indicate that a more effective way of delivering levodopa in a sustained, continuous manner is in combination with a COMT-inhibitor (such as entacapone). It is believed that this produces significantly fewer motor complications, which can have a dramatic improvement on function for Parkinson's disease patients.
The Zurs meeting is the second such meeting chaired by Professor Agid. In 1998 a similar consensus meeting was held in Paris to discuss when and how levodopa should be prescribed. One of the themes of the 1998 meeting was to establish whether levodopa was neurotoxic. At this time, the panel concluded there was no evidence that levodopa caused nerve-cell death. Over the past three years however, new evidence has emerged that levodopa may possess neuroprotective properties. This new evidence led to a second consensus meeting being held.
The most recent meeting, concluded that levodopa deservedly remains unchallenged as the 'gold standard' therapy for the treatment of Parkinson's disease. Professor Agid, commented 'Levodopa provides benefit throughout the course of the disease and is the only medication that has been shown to have an effect on quality of life'. Life expectancy has also improved with the widespread use of levodopa.
Orion Pharma
is a research and development-orientated pharmaceutical division of the Orion Group. The Orion Group (HEX:ORI) is one of the leading companies in the healthcare sector in the Nordic area of Europe. The 2001 net sales of the Group were EUR 970.8 million. The Orion Group employs around 5,800 people. Pharmaceutical R&D at Orion Pharma produce new innovative drugs in four core therapy areas: CNS therapies, cardiology and critical care, hormonal therapies, and respiratory therapies. Entacapone, a COMT enzyme inhibitor, is Orion Pharma's patented molecule discovery, which Orion Pharma developed through multinational clinical trials. Entacapone is available globally as Comtess and Comtan. For further information please consult and
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71 000 people and operate in over 140 countries around the world. For further information please consult
This release contains certain forward-looking statements relating to the Company's business and to potential future sales or approvals of levodopa and/or entacapone. Such forward-looking statements 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 of any future commercialization or approvals of levodopa or entacapone in any market. Any such commercialization or approvals can be affected by, among other things, unexpected regulatory delays, further clinical trial results regarding efficacy or safety of these products, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the 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 described herein as anticipated, believed, estimated or expected.-
1. Stocchi F, De Pandis MF, Vacca L, Valente M, Brusa L, Ruggieri S. Entacapone efficacy in Parkinson's disease. Mov Disord 2000; 15 (Suppl 3): 127
. P Jenner, G Al-Barghouthy, L Smith, M Kuoppamaki, M Jackson, S Rose and CW Olanow. Initiation of entacapone with L-DOPA further improves antiparkinsonian activity and avoids dyskinesia in the MPTP primate model of Parkinson's disease. Poster presentation at AAN April 2002-