Actelion to present at upcoming investor conferences - Actelion 2015-2020 - Transformation on the way

Actelion Pharmaceuticals Ltd / Actelion to present at upcoming investor conferences - Actelion 2015-2020 - Transformation on the way . Processed and transmitted by Nasdaq OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 11 January 2016 - Actelion Ltd (SIX: ATLN) announced today that representatives from Actelion will present at upcoming investor conferences. 

• Jean-Paul Clozel, Chief Executive Officer of Actelion, will present at the 34^th J. P. Morgan Healthcare Conference on 12 January 2016 at 08:00 AM Pacific Standard Time / 17:00 hrs. Central European Time (CET) at the Westin St. Francis Hotel in San Francisco, US.
• Otto Schwarz, Chief Operating Officer of Actelion, will present at the Helvea Swiss Equities Conference on 14 January 2016.
• Jean-Paul Clozel will then present again at the Bank am Bellevue "Bellevue Meets Management Seminar" on 15 January 2016. 

At J. P. Morgan, Jean-Paul Clozel will describe the progress made during 2015, the ongoing transformation of Actelion's PAH franchise, how the company is transforming beyond PAH, and what's ahead in 2016.

Jean-Paul Clozel commented: "With the impressive take-off of Opsumit^® (macitentan) and now Uptravi^® (selexipag) on the market, we have a great platform to invest in our future. I am looking forward to presenting the progress we have made in 2015. The transformation of our PAH franchise is fueling our pipeline outside PAH, with several promising compounds advancing in the clinic. The transformation of Actelion is now well underway."

The company will confirm that the strong operating performance, driven by the unabated launch trajectory of Opsumit, is expected to lead to core earnings growth that crosses the 20% mark at constant exchange rates and excluding prior-year US rebate reversals.

Jean-Paul Clozel continued: "2015 was yet another exciting year for Actelion and I am confident that there is much more excitement ahead as we transform Actelion, which I hope to give a flavor of in my presentation. We have the products, we have the ideas, we have a fully integrated infrastructure and, very importantly, we have the money to finance this transformation without compromising our profitability."
At Helvea Swiss Equities Conference, Otto Schwarz will provide an overview of the business dynamics for Actelion's products, in particular in relation to the transformation of the PAH portfolio.

Otto Schwarz commented: "Our PAH franchise has evolved from a single product into a portfolio of unique and complementary products, which cover the continuity of care in this severe disease. The dynamics of this transformation is reflected in the performance of our products in the market. Opsumit has had a highly successful launch and we are confident to continue this momentum into 2016. As a result of the success of Opsumit, we have seen a decline in Tracleer sales, which is expected to accelerate as generic competition becomes available in the US."

Otto Schwarz concluded: "Of course, all eyes will be on the launch of Uptravi, which is now available to patients in the US. Feedback from prescribers has been very positive and they are very excited to add this first outcome-based oral prostacyclin product to their treatment options."

On 21 December 2015, the US FDA approved the use of the orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag), originally discovered and synthesized by Nippon Shinyaku, for the treatment of pulmonary arterial hypertension (PAH). Uptravi is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Adverse reactions occurring more frequently on Uptravi compared to placebo  - greater than or equal to 3% - over the course of the study, were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite and rash. Uptravi became commercially available in the US on 04 January 2016. Submission of the registration dossier to other Health Authorities is ongoing, with regulatory reviews underway in Australia, Canada, Europe, New Zealand, South Korea, Switzerland, Taiwan and Turkey.

CLINICAL UPDATE
Actelion's promising R&D pipeline comprises novel compounds addressing a broad range of diseases, including cardiovascular and immunological disorders as well as central nervous system disorders and infectious diseases. 
 
Actelion's late-stage product candidates include the novel antibiotic cadazolid, under investigation for Clostridium difficile-associated diarrhea (CDAD) and a S1P₁ receptor modulator, ponesimod, investigated in multiple sclerosis. 

At the end of 2015, the initial results of the Phase II MELODY study with macitentan became available. MELODY was a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group, 12-week study to evaluate the safety and tolerability of macitentan in subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction. In the exploratory Phase II study, macitentan was generally well tolerated in this Group 2 pulmonary hypertension patient population with heart failure. In addition, encouraging hemodynamic effects were observed. The company will now fully evaluate the data and, together with the results of the current Phase II study with a new endothelin receptor antagonist (ERA), make a decision on the future development strategy of Actelion's ERAs beyond PAH.

Despite encouraging preclinical data, results from the Phase I/Ib open-label studies in patients with recurring glioblastoma and newly diagnosed glioblastoma disappointingly do not support further investigation in this indication. Dose escalation had reached 300 mg per day, without any significant tolerability issues, before the decision was made to stop the investigation.

At the end of 2015, a New Chemical Entity entered Phase I clinical development for cardiovascular disorders.

DEVELOPMENT PIPELINE

Pipeline status as of 31 December 2015


2016 NEWSFLOW

• FY 2015 Financial Results reporting on 9 February 2016
• Cadazolid - IMPACT fully recruited
• Clazosentan - Phase II results
• ERA - Phase II results for specialty cardiovascular disorders
• Lucerastat - Phase Ib results in Fabry disease
• Macitentan - MERIT results
• Ponesimod - Update on Phase III MS program
• S1P₁ modulator - Systemic lupus erythematosus
• Selexipag - CHMP Opinion & EC decision
• Early stage pipeline progression

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Notes to Editor:

The J. P. Morgan presentation by Jean-Paul Clozel is available in PDF-format from www.actelion.com. To access the live and subsequently archived webcast of the presentation, visit "Events" in the Investor Relations section of Actelion's corporate website. An archived replay will be available for 3 months beginning 24 hours after the live presentation.

Actelion Ltd.
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Although not available in all countries, Actelion has treatments approved by health authorities for a number of specialist diseases including Type 1 Gaucher disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.

Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including Europe, the US, Japan, China, Russia and Mexico, Actelion has its corporate headquarters in Allschwil / Basel, Switzerland.

Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI^®). All trademarks are legally protected.

For further information please contact:
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;