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Stalevo is not a new drug. It is a new package. Stalevo is indeed nothing but a fixed ratio combination of levodopa/carbidopa and entacapone. The claim that Stalevo would be the "first new medicine" for Parkinson's is a gross misrepresentation of the facts. All three components of these pills are in general use for Parkinson's already, with success. Whether a fixed ratio combination of the three chemicals will be useful remains to be determined. Unless Novartis plans to make it cheaper than buying generic levodopa/carbidopa and Comtan, it offers only the advantage of convenience. However, it probably will not be as versatile in dose adjustments that are often required. I predict that the loss in versatility and adjustment capability will be more important than the gains in convenience for most people and physicians. I was not surprised about the comments regarding Novartis. It is a very successful pharmaceutical company which markets not only brand name products but also generics and over the counter medications. For the first quarter of 2003, Novartis reported total sales of 5.721 billion dollars. Their net income from these sales was 1.063 billion, or 18.6% of revenues were net income, a percent that is extremely high by any corporate criteria. This was true even after taking into account that they absorbed a huge loss by Roche Pharmaceuticals. Otherwise the net income would have been about 27%. These figures can be confirmed on line in a report by Novartis to their stockholders: http://www.novartis.com/downloads/q1_2003_e.pdf Jorge Romero ----- Original Message ----- From: "Murray Charters" <[log in to unmask]> To: <[log in to unmask]> Sent: Friday, June 13, 2003 8:58 AM Subject: FDA Approves Stalevo (TM) for Treatment of Parkinson's Disease New Drug Reduces Signs and Symptoms of Disease. > FDA Approves Stalevo (TM) for Treatment of Parkinson's Disease New Drug Reduces Signs and Symptoms of Disease. > > NVS $40.24 -0.22 -0.5% > > EAST HANOVER, N.J., Jun 13, 2003 /PRNewswire via COMTEX/ -- Novartis Pharmaceuticals Corporation today announced that > the U.S. Food and Drug Administration (FDA) has approved Stalevo (carbidopa, levodopa and entacapone) tablets, the > first new drug for Parkinson's disease in over three years, for patients with idiopathic Parkinson's disease (PD) who > experience signs and symptoms of end- of-dose "wearing off." Stalevo contains levodopa, the most widely used agent for > Parkinson's disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone > extends its benefits, permitting Parkinson's disease patients to have an improved ability to perform everyday tasks and > a reduction in symptoms associated with the disease. > > Within one to two years, almost 50 percent of PD patients receiving levodopa therapy begin to notice that their > levodopa lasts for shorter periods of time, known as "wearing off." In about 15 to 20 percent of patients, "wearing > off" becomes extreme and disabling. Eventually, the effect of a levodopa dose may decrease from eight hours when > patients begin levodopa therapy to only one to two hours. > > "Levodopa is recognized as the cornerstone of Parkinson's disease therapy, but its long-term use is limited by its > reduced ability to fully control Parkinson's disease symptoms," said Warren Olanow, MD, professor and chairman, > Department of Neurology, Mount Sinai School of Medicine in New York City. "By blocking the enzymatic breakdown of > levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include > more "on" time during which Parkinson's symptoms are well-controlled and daily activities are improved, and simpler, > more convenient dosing." > > "We are proud to introduce a product like Stalevo which can enhance the daily lives of many people with Parkinson's > disease," stated Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation. "As the fourth Parkinson's drug > Novartis has introduced in the United States, Stalevo is a clear example of our company's ongoing commitment to the > Parkinson's community." > > The effectiveness of levodopa administered with carbidopa and entacapone in the treatment of Parkinson's disease was > established in three 24-week multicenter, randomized, double blind placebo-controlled trials in patients with > Parkinson's disease experiencing "wearing off." In these trials, this combination increased "on" time, reduced "off" > time and improved motor function and daily activities such as patients' ability to walk and dress. The most common side > effects of Stalevo therapy are dopaminergic in nature (e.g. dyskinesia, nausea). These side effects may be manageable > with alteration in the drug dosing schedule. Other common side effects include diarrhea, hyperkinesias, urine > discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations. For full > prescribing information, visit www.stalevo.com. > > Parkinson's disease, a chronic and progressive neurological condition, affects approximately 1.5 million Americans. > While its cause is unknown, the symptoms of Parkinson's disease are primarily the result of degeneration of > dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement. > Symptoms include limbs that tremble; slowness of movement; stiffness and rigidity of limbs and gait or balance > problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and > function. > > Entacapone alone is sold in the United States as Comtan (R) and like Stalevo is marketed by Novartis Pharmaceuticals > Corporation and manufactured by Orion Pharma. > > This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business, > which can be identified by the use of forward-looking terminology, such as "new", "can" and "introduce" or similar > expressions, or by discussions of strategy, plans or intentions. Such forward looking statements involve known and > unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any > future results, performance, or achievements expressed or implied by such statements. Commercialization can be affected > by, amongst other things, uncertainties relating to regulatory actions or delays or government regulation generally, > the ability to obtain or maintain patent or other proprietary intellectual property protection and 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. > > Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription > drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ > transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The > company's mission is to improve people's lives by pioneering novel healthcare solutions. > > Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG > (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of > USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. > Headquartered in Basel, Switzerland, Novartis Group companies employ about 77,200 people and operate in over 140 > countries around the world. For further information please consult http://www.novartis.com. > > For more information and for a copy of the complete prescribing information, please contact: > > Media > Kate King, Novartis Pharmaceuticals Corporation > Office: 862 778 5588, Mobile: 917 446 7400 > > Matthew Audette, Feinstein Kean Healthcare > Office: 413 585 8979 > > Investor Relations > Kamran Tavangar, Novartis Corporation > Office: 212 830 2433 > > SOURCE Novartis Pharmaceuticals Corporation > > CONTACT: Media: Kate King of Novartis Pharmaceuticals Corporation, > Office: +1-862-778-5588, Mobile: +1-917-446-7400; or Matthew Audette of > Feinstein Kean Healthcare, +1-413-585-8979; or Investor Relations: Kamran > Tavangar of Novartis Corporation, +1-212-830-2433 > > > URL: http://www.novartis.com > http://www.prnewswire.com > > Copyright (C) 2003 PR Newswire. All rights reserved. > > Keywords: > Business, Healthcare, Pharmaceuticals, Pubco select, Pubco select2, Public companies, Wall street, Arthritis, Business, > Cancer, Cardiovascular, Community, Consumer, Disease, Drugs, Government, Health, Healthcare, Media > > SOURCE: PR Newswire / MacroWorld Investor > http://www.mworld.com/m/m.w?lp=GetStory&id=64761251 > > * * * > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto:[log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn