Actelion to present at the 32nd J.P. Morgan Healthcare - Delivering on our Strategy - Strong Opsumit Uptake
Actelion Pharmaceuticals Ltd /
Actelion to present at the 32nd J.P. Morgan Healthcare - Delivering on our
Strategy - Strong Opsumit Uptake
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ALLSCHWIL/BASEL, SWITZERLAND - 13 January 2014 - Actelion Ltd (SIX: ATLN)
announced today that Otto Schwarz, Chief Operating Officer of Actelion, will
present at the J. P. Morgan Healthcare Conference on January 14, 2014 at Â 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 OpsumitÂ® (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
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 for Opsumit.
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 VeletriÂ® (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 CaripulÂ®. 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
Valchlor(TM), 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-
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
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).Â The program, expected to
report results by early 2016,Â 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
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
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 SMIÂ®). All trademarks
are legally protected.
For further information please contact:
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
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",Â "believes", "expects", "may", "are expected
to", "will", "will continue", "should", "would be", "seeks",Â "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions.Â 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.
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