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Interpreting the news in the Trial Results Show Teva's AZILECT(R) 1 mg Tablets Slow Progression of PD thread

June 18, 2008
http://www.michaeljfox.org/research_...ticle.cfm?ID=8

Rasagiline (Azilect) as Disease-modifying Treatment for Parkinson’s Disease?

UPDATE, JULY 14, 2008: Teva has announced plans to report top-line data from the ADAGIO Study at the 12th Congress of European Federation of Neurological Societies (EFNS) on August 26, 2008 in Madrid, Spain.

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On Monday, June 16, 2008, Israeli drugmaker Teva issued a press release reporting that Azilect (rasagiline) was on track to become the first disease-modifying treatment for Parkinson’s disease. The company has completed the ADAGIO Phase 3 clinical trial, in which Azilect tablets met three clinical endpoints demonstrating that the drug could slow progression of Parkinson’s disease.

The Michael J. Fox Foundation spoke with Karl Kieburtz, MD, PhD, Professor of Neurology and Community and Preventive Medicine at the University of Rochester Medical Center and chair of the Parkinson Study Group, about how patients should interpret the news.

NOTE: The medical information contained in this article is for general information purposes only. The Michael J. Fox Foundation has a policy of refraining from advocating, endorsing or promoting any drug therapy, course of treatment, or specific company or institution. It is crucial that care and treatment decisions related to Parkinson’s disease and any other medical condition be made in consultation with a physician or other qualified medical professional.

MJFF: In the simplest terms, what is Teva reporting and why is it potentially important for people with Parkinson’s?

KK: Teva’s press release reported that rasagiline, which Teva sells under the brand name Azilect, can slow functional decline in early-stage PD patients who have not yet been treated with dopamine-replacement therapies, such as levodopa. This means that rasagiline could be the first PD treatment to receive the label “disease-modifying” from the Food and Drug Administration (FDA).

MJFF: Do we know for sure that rasagiline is disease-modifying?

KK: No, we don’t know that with certainty yet. I want to emphasize strongly that the press release was not a scientific one. Commercial entities are obligated by the Securities and Exchange Commission (SEC) to put out communications such as this when they have information that they know may affect their share prices. As of this week, the scientific data resulting from the trial have not been made public. In the future, when the data have been made public, the results of this trial may be seen differently.

The good news is that at least some scientific results should be forthcoming as soon as within the next few weeks. Some of the data from the ADAGIO trial will be presented during the week of June 23 at the Movement Disorders Society Congress in Chicago, and we would also expect to see publication in a peer-reviewed journal within a relatively short timeframe. [Editor’s note: Watch the MJFF Web site for further updates in coming weeks.]

[B]MJFF: What kind of drug is rasagiline? Are there other similar drugs that could exert a similar effect?

MJFF: Are there negative side effects or other concerns people should have before asking their doctor for Azilect? Should everyone with PD now consider taking the drug?

MJFF: Was there earlier evidence that rasagiline could be disease-modifying?

MJFF: How did the researchers design the ADAGIO trial to test for disease modification?

MJFF: What is a delayed-start trial and how does it work?

MJFF: Bottom line: How excited should patients and their loved ones feel about this news?

KK: So, while the news reported this week is potentially very exciting, it is not yet actionable. The clinical and research community awaits further understanding of the trial results in order to effectively advise patients on best next steps.

* Read a biosketch of Karl Kieburtz
* Read the press release issued July 14

READ answers to all the quesitons

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Excerpts from Bloomberg article:

Azilect, Teva's second original product, was introduced in 2005 to treat the symptoms of Parkinson's, an incurable disease that destroys patients' nerve functions. Teva needs to replace revenue from its first original drug, Copaxone for multiple sclerosis, before it loses patent protection in 2014. Peak sales of the pill may now surpass $1 billion, instead of an estimated $250 million a year, said Ronny Gal, who follows Teva at Sanford C. Bernstein in New York, in a June 16 interview.

``The importance of this news is that there is scientific confirmation that has been presented before an audience of doctors,'' said Yoav Burgan, an analyst at Leader Capital Markets Ltd. in Tel Aviv.

Today's data may increase Azilect's share of the $3.68 billion global market for Parkinson's disease medicines, said Moshe Manor, who heads up Teva's innovative drug development.

``Now it's proven that if you treat earlier, you can protect the patient from further deterioration,'' Manor said in a telephone interview today. ``This slowing down effect will probably continue to be sustained over time.''

Burning Dopamine

Teva rose 29 cents to $46.87 at 4 p.m. in New York. In Tel Aviv, the stock closed up 2.8 shekels, or 1.7 percent, at 166.80 shekels.

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Neurologists will want to examine the trial results before changing their prescribing habits for Azilect, said Kieran Breen, director of research at the U.K. society, in an Aug. 11 telephone interview.

``That's one of the big problems with Parkinson's -- it's such a heterogeneous condition you have to look at a large number of people over a long period of time,'' Breen said.

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Azilect prescription numbers began to climb on June 16, when Teva first said that the study had achieved all its main goals without disclosing what the goals were, Manor said. He declined to say how much sales have increased.