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Actelion to present at the 32nd J.P. Morgan Healthcare - Delivering on our Strategy - Strong Opsumit Uptake

2.6 from 9 votes
Tuesday, January 14, 2014

ALLSCHWIL/BASEL, SWITZERLAND  - Actelion Ltd (SIX: ATLN) announced  that Otto Schwarz, Chief Operating Officer of Actelion, will present at the J. P. Morgan Healthcare Conference on January 14, 2014 at  9:30 AM Pacific Standard Time 18:30 Central European Time at the Westin St. Francis Hotel in San Francisco, CA.

Otto Schwarz will describe the progress made during 2013 in delivering on the three elements of Actelion's strategy for value creation.

1) Sustain and grow the PAH franchise

Otto Schwarz will report strong demand uptake for Opsumit® (macitentan), a novel endothelin receptor antagonist (ERA), launched in early November 2013 in the United States of America, less than two weeks after FDA approval on 22 October 2013.

Otto Schwarz will comment "Opsumit, which is indicated for the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group 1), has been very well received by US-based prescribers, as evidenced by the strong demand since market introduction. Over the first two months, the average number of Opsumit weekly prescriptions for new patients were more than 200 percent - or more than double - the average weekly Tracleer prescriptions for new patients prior to the Opsumit launch. Since the Opsumit launch, the number of weekly Tracleer prescriptions for new patients are down by 50 percent."

Tracleer was the first ERA to be approved for the treatment of PAH patients when Actelion introduced it in the US market in December 2001.

Otto Schwarz will continue: "This trend suggests that we are already gaining new patient market share from ERA therapies. These weekly Opsumit prescription levels also indicate that physicians are switching some Tracleer patients to Opsumit, earlier than anticipated."

Otto Schwarz also reports that Opsumit has already been included early in some formularies. In parallell, current off-formulary reimbursement requests for individual coverage are proceeding well. As part of its commitment to patients, Actelion has established a patient assistance program forOpsumit.

On 20 December 2013, Opsumit 10mg was also approved in the European Union for the long-term treatment of PAH with a label which is substantially different in comparison to existing ERA therapies. The first launch in an EU country is expected to take place in Germany by mid-February 2014.

Otto Schwarz will also report that Veletri® (epoprostenol for injection) continues to enjoy a very favorable market uptake, especially in Japan, the second largest i.v. epoprostenol market in the world, where the product has been launched in June 2013 under the name Epoprostenol "ACT". Actelion already markets this product as Veletri in the United States and in Canada under the trade name Caripul®. During 2012 Actelion received approval to market as Veletri in Switzerland. In 2013, through a decentralized procedure, Actelion received approval for Veletri in European Countries, as a result of this, Veletri is now available in the UK and the Netherlands. Market introductions are forthcoming in France, Spain, Italy and other European markets.

Actelion is also well on track to obtain top-line Phase III results by mid-2014 for the Company's investigational selective IP receptor agonist, selexipag. Developed together with Nippon Shinyaku, Selexipag has now achieved more than 95 percent of events in GRIPHON, a pivotal study also designed to demonstrate a reduction in the risk of morbidity/mortality events in patients with PAH.

2) Build an additional specialty franchise

Otto Schwarz will also report on the recent US market introduction of ValchlorTM, an FDA approved mechlorethamine gel presentation applied topically once a day and indicated to treat patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received prior skin-directed therapy.

Valchlor was developed by Ceptaris, a US-based company acquired by Actelion in September 2013. Actelion launched Valchlor in the US mid-November 2013, with a focus on centers of excellence for the disease.

Currently, Actelion is building a dedicated business unit to commercialize Valchlor to a wider presciber audience by spring 2014. In the future, this unit could serve as the foundation for additional specialty or orphan franchised products.

The antibiotic franchise is starting to take shape with the start of the Phase III program for cadazolid to assess the efficacy and safety in patients with Clostridium difficile-associated diarrhea (CDAD). The program, expected to report results by early 2016, is designed to determine whether the clinical response after administration of cadazolid is non-inferior to vancomycin in patients with CDAD, and whether administration of cadazolid is superior to vancomycin in the sustained clinical response.

These and other efforts with additional investigational compounds will provide Actelion with the foundation for its mid-term goal of building an diversified specialty portfolio beyond PAH.

3) Optimize profitability

As the third element to Actelion's strategy, the company is committed to profitable growth in the coming years and to continue to create shareholder value. Otto Schwarz confirmed that the company will meet 2013 local currency guidance of core earnings growth crossing into double digit territory.

Guidance (in local currencies) beyond 2013 also remains currently unchanged. For 2014, Actelion expects core earnings to be at least at the same level as for the current year and for 2015, earnings growth is expected to be at least in the single-digit percentage range. Should the strong Opsumit launch dynamics be sustained, Actelion will review and accordingly upgrade its guidance.

The presentation is available in pdf-format on 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.

 

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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 in patients with cutaneous T-cell lymphoma.

Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including 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:

Roland Haefeli

Senior Vice President, Head of Investor Relations & Public Affairs

Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil

+41 61 565 62 62

+1 650 624 69 36

www.actelion.com

 

The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates",  "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks",  "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions.  Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

 

 
Source: Actelion Ltd
2.6 from 9 votes
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