Stalevo, Orion's new treatment for Parkinson's disease approved by the FDA

Orion Pharma has received an approval from the US FDA  (Food and Drug Administration) for Stalevo, which combines levodopa and carbidopa with entacapone in one tablet for the treatment of Parkinson's disease (PD). Stalevo represents the first new treatment for PD in over three years, for patients with idiopathic PD who experience signs and symptoms of end-of-dose "wearing-off". Novartis will be the marketer of Stalevo in the USA. A European marketing application for the product is currently under review by the EMEA (European Medicinal Evaluation Agency). Marketing authorisation is anticipated in the latter half of 2003.

 

Stalevo contains levodopa, accepted as the most widely used and most effective agent available for Parkinson's disease, plus carbidopa and entacapone.  Entacapone and carbidopa optimise levodopa therapy by blocking the enzymes that break down levodopa in the periphery. This allows for more levodopa to reach the brain in a more consistent and reliable fashion, extending and enhancing its therapeutic benefits.

 

For many patients who start treatment with levodopa therapy, the effects of levodopa can initially last up to eight hours.  But within two to six years of treatment, many patients notice that the effects of levodopa last for shorter periods of time, a phenomenon known as "wearing-off". Eventually, the effect of levodopa lasts for only one to two hours.  Practically all Parkinson's disease patients will experience "wearing-off" and in about 15 to 20 percent of patients, "wearing off" becomes extreme and disabling.

 

The effectiveness of levodopa, carbidopa and entacapone in the treatment of Parkinson's was established in three 24-week multicenter, randomised, double blind placebo-controlled trials in patients with PD 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, dress, and maintain hygiene. The combination treatment was shown to be well tolerated; the most commonly reported adverse events were unwanted or uncontrolled movements (sometimes called dyskinesias) and loss of muscular activity.  These side effects were generally mild to moderate in nature.

 

"We are proud to see that Stalevo went through the US registration procedure in a very short review time. This implies that the development process of the product has been most successful and well managed. Stalevo is the next step on our way to reinforce entacapone's status as an agent enhancing the effect of levodopa. In particular, we rely here on the strong market knowhow and experience of Novartis, our long-term partner as the marketer of Comtan", says Dr. Risto Miettunen, President of Orion Pharma.

 

Novartis markets Stalevo and Comtan in the US. A milestone payment of around EUR 22 million from Novartis to Orion Pharma was triggered by the US marketing approval and the recently amended marketing agreement.

 

Stalevo is a significant new product introduction from the R&D pipeline of Orion Pharma. Orion is the originator and manufacturer of entacapone, the leading COMT-inhibitor and used as an important adjunct to levodopa in the treatment of PD. Entacapone was launched in 1998-1999 world-wide as Comtess and Comtan, and it soon became the best-selling product of Orion.

                                                                    

Orion Corporation

 

Jukka Viinanen                               Risto Miettunen
President and CEO, Orion Group     President, Orion Pharma                                                              

 

 

 

Jukka Viinanen, President and CEO, Orion Group, phone +358 10 429 3710

Risto Miettunen, President, Orion Pharma, phone +358 10 429 4299

 

 

Parkinson's disease, a chronic and progressive neurological condition, affects more than 1% of people over 65 years old.  While its cause is unknown, Parkinson's results from a destruction of dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls movement. Symptoms include limbs that tremble when relaxed; 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. 

 

 

Orion Pharma is a research and development-orientated pharmaceutical division of the Orion Group (HEX:ORIA, ORIB), which is one of the leading companies in the healthcare sector in the Nordic area of Europe. Pharmaceutical R&D at Orion Pharma focuses on three core therapy areas: CNS therapies, cardiology and critical care, and hormonal therapies. Entacapone, a COMT enzyme inhibitor used in the treatment of Parkinson's disease, is Orion Pharma's patented molecule discovery, available globally as Comtess and Comtan. For further information please consult http://www.orion.fi.

 

 

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 www.novartis.com

 

 

 

Corporate Administration

Orionintie 1, 02200 Espoo

Homepage: www.orion.fi

 

Corporate communications:

Heikki Vuonamo, Corporate VP, Communications

Phone +358 10 429 4967

Fax  +358 10 429 4435

Mailto: heikki.vuonamo@orion.fi