Key Developments: Actelion Ltd (ATLN.VX)

ATLN.VX on Virt-X Level 1

23 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Actelion Ltd submits selexipag for EMA marketing authorisation in patients with pulmonary arterial hypertension
Monday, 1 Dec 2014 06:00pm EST 

Actelion Ltd:Announces submission of centralized Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for selexipag (Uptravi) in treatment of pulmonary arterial hypertension (PAH).Says submissions to US Food and Drug Administration and other territories are forthcoming.  Full Article

Actelion Ltd raises FY 2014 core earnings outlook
Tuesday, 21 Oct 2014 01:00am EDT 

Actelion Ltd:Now expects FY 2014 core earnings growth to be in the low twenties percentage range at constant exchange rates.Previously guided for FY 2014 core earnings to increase in at least mid-teens percentage range.  Full Article

Actelion Ltd announces that Selexipag meets primary endpoint in pivotal Phase III GRIPHON outcome study in patients with pulmonary arterial hypertension
Sunday, 15 Jun 2014 07:00pm EDT 

Actelion Ltd:Announces top-line results of pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH) with selexipag, first selective oral prostacyclin IP receptor agonist.Initial analysis shows that the event-driven outcome study has met its primary efficacy endpoint with high statistical significance.Selexipag decreased risk of a morbidity/mortality event versus placebo by 39 pct. (p <0.0001).Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy.Patients were treated for up to 4.3 years.Overall tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies.  Full Article

Actelion Ltd gives FY 2014 and FY 2015 core earnings outlook
Wednesday, 16 Apr 2014 08:00pm EDT 

Actelion Ltd:Expects core earnings (core operating income) growth in low-single digit range for FY 2014.Expects FY 2015 core earnings to grow in single-digit percentage range.FY 2013 core earnings of 619 million Swiss francs.  Full Article

Asahi Kasei subsidiary announces judgment of lawsuit against Actelion
Thursday, 13 Mar 2014 04:00am EDT 

Asahi Kasei Corp:Says Supreme Court of California dismissed an appeal filed by Actelion Ltd against previous judgment to pay $415.7 mln, on March 12 (local time).The lawsuit against Actelion was filed by Asahi Kasei's subsidiary Asahi Kasei Pharma Corporation, claiming compensation on license contract.  Full Article

Actelion Ltd to propose dividend
Wednesday, 12 Mar 2014 08:00pm EDT 

Actelion Ltd:Proposes to increase the dividend by 20pct to 1.20 swiss francs.Payable on May 15.  Full Article

Actelion Ltd provides an update in regard to Asahi litigation
Thursday, 19 Dec 2013 01:00am EST 

Actelion Ltd:Says that the California Court of Appeal has affirmed the amended final judgment that a California trial court entered against Actelion in Nov. 2011 (Case No. CIV478533 in the California Court of Appeal).Says that final judgment was for $407.325 mln, which includes punitive damages of $30 mln against certain individual officers of the company.Says in addition, the Court awarded $8.3 mln in pre-judgment interest and costs.Says the company and its external advisors believe that the decision of the Court of Appeal is not supported by the facts and is incorrect as a matter of law.Says that company strongly believes that there are significant reasons why that decision should not stand.Says in particular, the decision that a parent corporation can be liable for tortuously interfering with a contract of its wholly owned subsidiary is inconsistent with the decision of the Supreme Court of California in the Applied Equipment case.Says the company will take all necessary steps to file a petition in the Supreme Court of California, requesting that the Court review the Court of Appeal's decision.  Full Article

Actelion Ltd Receives US FDA Approval Of Opsumit For The Treatment Of Pulmonary Arterial Hypertension
Friday, 18 Oct 2013 04:16pm EDT 

Actelion Ltd announced that the United States Food and Drug Administration (FDA) has approved the use of the orally available endothelin receptor antagonist Opsumit (macitentan) 10 mg once daily for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression. Opsumit is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.  Full Article

Actelion Ltd Closes Acquisition Of Privately-held Ceptaris Therapeutics
Thursday, 19 Sep 2013 01:00am EDT 

Actelion Ltd announced that it has concluded the acquisition of Ceptaris Therapeutics, Inc. following US Food and Drug Administration (FDA) approval for Valchlor (mechlorethamine) gel 0.016% and the satisfaction of additional closing conditions. Ceptaris was a privately held, specialty pharmaceutical company established to develop the gel formulation of mechlorethamine for the treatment of early stage mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL). The terms of the acquisition were not disclosed.  Full Article

Actelion Ltd Appoints André C. Muller As New Chief Financial Officer
Tuesday, 27 Aug 2013 01:01am EDT 

Actelion Ltd announced that it has appointed AndrĂ© C. Muller as the Company's Chief Financial Officer and member of Actelion's Executive Committee (AEC). He succeeds Andrew J. Oakley, who will focus on opportunities outside Actelion. Mr. Muller will take office on September 01, 2013.  Full Article

BRIEF-Actelion submits selexipag for EMA marketing authorisation in patients with pulmonary arterial hypertension

* Announced on Monday the submission of centralized Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for selexipag (Uptravi(R)) in treatment of pulmonary arterial hypertension (PAH)

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