Actelion Strong Buy!! - 500 Beiträge pro Seite

[DR.DIAMOND]

Actelion wurde heute von Goldman Sachs hochgestuft.
Das faire Kursziel sehen die Amerikaner bei SFR.180.-!

[mr.motte]

17.01.2005
Actelion "reduce"
Helvea - A Pictet Company

Die Börsenexperten der Helvea stufen die Aktie des Schweizer Unternehmens Actelion (ISIN CH0010532478/ WKN 936767) unverändert mit "reduce" ein.

Das Unternehmen leide nach Ansicht der Börsenspezialisten immer noch unter seiner Enttäuschung über die ausgesetzte Versuchsreihe des Herzmedikaments Veletri. Weitere Ergebnisse aus den Tests mit den Präparaten Tracleer und Clazosentan seien nicht vor Ende des Jahres 2005 oder 2006 zu erwarten. Unterdessen verschärfe sich der Wettbewerb für Tracleer angesichts der Veröffentlichung der Sitaxentan-Daten von Encysive und der Einführung von Sildenafil durch Pfizer.

Abgesehen von den Medikamenten Tracleer und Clazosentan erhalte man nur begrenzte Informationen zum R&D-Portfolio des Unternehmens. Die Wertpapierspezialisten der Helvea seien der Ansicht, dass sich die Bekanntgabe der Clazosentan-Ergebnisse, die für das erste Halbjahr 2006 angesetzt sei, durchaus verzögern könne. Da kurzfristig nicht mit positiven Nachrichten zu rechnen sei, würden die Börsenspezialisten der Helvea an ihrem Kursziel von 105,00 Schweizer Franken festhalten.

Aufgrund ihrer Analyse halten die Wertpapierspezialisten der Helvea an ihrer Bewertung "reduce" der Actelion-Aktie fest.

[AcapCapital]

We see no reason to change our numbers for Tracleer (peak sales $550m) on the back of today`s phase III STRIDE2 Thelin data, partly because the primary efficacy read-out indicates that both drugs are comparable, and partly because the safety and clinical worsening data is incomplete at this stage. In the absence of this data, our $550m forecast allows for the presence of at least one direct competitor to Tracleer (excluding sildenafil, which can be considered a complementary, or combination therapy). We look to the release of the full phase III detail some time in the next few months as the opportunity to fully assess Thelin`s ability to take market share from Tracleer. In the mean time we reiterate our 2-Equalweight rating and SFR130 price target on the stock.

Today`s data is from the placebo controlled 18 week portion of the STRIDE2 study, in which 246 patients were randomized to receive one of four treatments: 50 mg of Thelin once daily, 100 mg of Thelin once daily, placebo once daily, or Tracleer twice daily. Encysive has already stated that it only intends to pursue a filing for the 100mg doese. The six minute walk test (6MWT) improvement at 18 weeks was comparable for both drugs (29.5m in the Tracleer open-label arm of the STRIDE2 study and 34m in the pivotal Tracleer BREATHE-1 study, 31.4m in the Thelin arm of STRIDE 2).

However, the clinical worsening outcome is less clear. This is an important endpoint as it looks at the drug`s underlying impact on disease, combining rate of mortality, hospitalisation and use of intravenous therapy (i.e. in case of diminishing response). Tracleer achieved this endpoint in BREATHE-1 at 16 weeks and 26 weeks and is indicated for symptomatic relief as well as reduction in the rate of clinical worsening. Sildenafil did not achieve this endpoint and the absence of a p-value in Encysive`s press release suggests that Thelin did not achieve this endpoint either at the 18 week stage in the study.

However, the measurement of this endpoint is conducted by measuring the seperation of drug and placebo curves over time and an increased seperation at 26 weeks (assuming the trial is designed to allow such a comparison) might allow Thelin to record a statistically significant result at that stage. In this respect, the magnitude of the difference between the Thelin event rate (5) and placebo (13) supports the assertion that, with more time, the difference between Thelin and placebo may become statistically significant.We will investigate on today`s call whether the trial is designed to allow such a longer-term comparison (details below). If Thelin did not reach this endpoint, we would see it as a minor competitor to Tracleer and would not change our numbers.

Note that, given the fact that the Tracleer arm is open-label (i.e. Tracleer patients knew they were on Tracleer), the comparison between clinical worsening event rates in the Tracleer arm (15 events) and Thelin (5 events) is only partially meaningful and Encysive will not be able to use any claim of superiority in marketing the drug.

The liver abnormality profile looks superior to Tracleer, with a 3% rate of liver abnormalities versus Tracleer at 11% (consistent with BREATHE-1), but we note that in STRIDE1 liver abnormalities with Thelin were recorded later on in treatment (post-12 weeks), such that the 3% figure may increase when patients are exposed to the drug during the open-label follow up period of the study (i.e. post-18 weeks). This data should be forthcoming over the next year. In contrast, most Tracleer-related liver abnormalities are recorded in the first 10 weeks of treatment. In any case, we expect Thelin to carry the same black box warning relating to liver abnormalities and monthly monitoring as for Tracleer.

We also note that Thelin carries a statistically significantly increased risk of bleeding compared to placebo, as measured by increased `INR`. This is a function of Thelin`s interaction with warfarin, whose dose has to be lowered in patients starting Thelin therapy. Tracleer has no such clinically meaningful interaction. While this is not a reason for the drug to not be approved, it is a possible reason for some physicians/patients to be less enthusiastic about the drug`s convenience.

Thelin`s ability to take market share will also be dependent on it replicating the 2-year data that shows that Tracleer reduces the long-term death rate in PAH and we would not expect this data for Thelin for another 18 months, at least. Approval should come around mid-2006 assuming Encysive files by mid-2005.