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MALVERN, PA and ALLSCHWIL/BASEL, SWITZERLAND – 23 February 2012 – Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Actelion Ltd. (SIX: ATLN) announced today that they have entered into a long-term partnership for the development, supply and commercialization of XIAFLEX® (collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren’s contracture and Peyronie’s disease. Under the terms of the agreement, Actelion will receive exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in these countries.
XIAFLEX has been approved by the U.S. Food and Drug Administration and the European Medicines Agency as a treatment for Dupuytren’s contracture, and is also in development in Japan. In addition, XIAFLEX has been accepted for review by Health Canada for the treatment of Dupuytren’s contracture in Canada and regulatory action is expected in the second half of 2012. Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren’s contracture in Australia, Brazil and Mexico over the next 12 months. XIAFLEX is also being evaluated in a global phase III development program for Peyronie’s disease with top-line data expected in late second quarter 2012.
Adrian Adams, Chief Executive Officer and President of Auxilium commented: “Today, Actelion and Auxilium have forged a partnership, which we believe has the opportunity to offer, subject to regulatory approval, the first, effective nonsurgical treatment for two diseases in multiple new geographies. With the strength of Actelion’s commercialization and development organization in these diverse and far-ranging markets, this relationship should further enhance our ability to bring this potentially groundbreaking product to a global audience.”
Philippe de Lavenne, VP, Head of Europe, Canada, Latin America, Middle East & Africa commented: “This tailored partnership has been designed to leverage Actelion’s regulatory and marketing expertise, as well as our established local operating companies in these markets. Auxilium has done an outstanding job in the development of this innovative product, and we look forward to contributing to making XIAFLEX a global success.”
Under the terms of the agreement, Actelion will pay Auxilium $10 million upfront and will also make up to $16 million in potential regulatory, pricing and reimbursement milestone payments and $42.5 million in potential sales milestone payments. Auxilium will also receive increasing tiered double-digit royalties based on sales of XIAFLEX in Actelion’ territories and will supply product to Actelion at a predetermined cost.
Auxilium will remain primarily responsible for the global development of XIAFLEX in Peyronie’s disease and will be responsible for all clinical and commercial drug manufacturing and supply. Actelion will be responsible for clinical development activities and associated costs corresponding to any additional trials required for specific territories.
ALLSCHWIL/BASEL, SWITZERLAND – 09 January 2012 – Actelion Ltd (SIX: ATLN) Actelion Ltd (SIX: ATLN) announced today that Jean-Paul Clozel, M.D., Chief Executive Officer of Actelion, will present at the upcoming J. P. Morgan Healthcare Conference on Tuesday, 10 January 2012 at 9.30 a.m. Pacific time / 6.30 p.m. Swiss time at the Westin St. Francis Hotel in San Francisco, CA.
Following a brief review of the journey that Actelion has taken from a start-up company in 1997 to Europe’s largest biopharmaceutical company today, Dr. Clozel will describe Actelion’s current status and the company’s focus on generating value creation opportunities.
2011 financial performance update
Dr. Clozel will highlight the excellent operational performance in an increasingly difficult, competitive environment and confirm fiscal year 2011 product sales guidance of mid-single digit growth in local currencies.
However, as the sovereign debt crisis in Europe continued to worsen in the second half of 2011, Actelion considers it prudent to make a provision in the range of EUR 30 – 35 million in the 2011 accounts for amounts owed to the company by public hospitals and institutions in Southern Europe. Excluding this provision Actelion would have met its guidance of low-double-digit Non-GAAP EBIT growth in local currencies.
Dr. Clozel will also describe that the provision for the verdict in the case of Asahi Kasei Pharma Corp. v. Actelion Ltd. et al will be adjusted in the 2011 Full Year US GAAP financial statements to reflect the final award of USD 407.325 million, plus court-awarded USD 8.3 million pre-judgment interest and costs. Actelion’s appeal in this case was filed with the California Courts of Appeal in December 2011.
2012 product performance outlook
Dr. Clozel will highlight that 2012 will be challenging for our commercial operations as Actelion currently foresees product sales – in local currencies – to decrease in the low-to-mid single digit range, mostly the result of increased pricing pressure globally and increased competitive pressure in the United States.
Jean-Paul Clozel commented: “Actelion is in a transition period following a phase of rapid growth and outstanding success driven by Tracleer. We are now getting ready for the next growth phase and we do so with a commitment to optimizing the earning power of the business.”
Strengthen existing PAH franchise
In 2011, Actelion expanded the bosentan pediatric program (FUTURE) to include three additional clinical studies recruiting more than 200 children suffering from PAH.
Additional work was also undertaken for Actelion’s two other marketed PAH medicines. As a result of the efforts, Veletri® (epoprostenol for injection) – launched in the US in 2010 – could become available in Europe and Japan in 2013.
Clinical Development update
Dr. Clozel will provide an updated overview of the company’s expanded development pipeline. During 2012, the company expects to report the results of several studies, including the Phase II dose-finding study for setipiprant in asthma, the Phase II study for ponesimod in psoriasis and the pivotal morbidity / mortality study with macitentan in PAH.
In addition, the company also expects to initiate the Phase III program for ponesimod in multiple sclerosis as well as to finalize the evaluation of potential strategic partnerships for both ponesimod and setipiprant.
Advance standard of care in PAH – new compounds
Dr. Clozel will present how the company hopes to gradually shift the standard of care in PAH from symptomatic treatment towards delaying or stopping disease progression. The company is focusing on two oral compounds macitentan, a highly potent dual endothelin receptor antagonist and selexipag, a selective IP receptor agonist.
Macitentan in PAH
Macitentan is being investigated in the landmark Phase III study, SERAPHIN, designed to evaluate the efficacy and safety of this highly potent, tissue-targeting, endothelin receptor antagonist. The primary endpoint is morbidity and all-cause mortality in WHO Class I patients with symptomatic PAH.
Global enrollment was completed in December 2009, with more than 700 patients included in the trial. The study is event-driven and, based on the progress observed, results are expected to become available in the first half of 2012.
Dr. Clozel commented: “We are at the final stage of this long-term study. In 2007 we embarked upon this innovative landmark trial, which will deliver an unsurpassed quantity of high quality data. If positive, clinical relevance of the primary endpoint, size of the trial and length of treatment and patient follow-up will provide all the information required to demonstrate a meaningful improvement in patient care and shift the standard of efficacy of PAH treatment.”
Selexipag in PAH
Selexipag is being investigated in a Phase III outcome study, GRIPHON, designed to evaluate the efficacy and safety of this first-in-class, orally available, selective IP receptor agonist in patients with pulmonary arterial hypertension. The primary endpoint is morbidity and all-cause mortality in patients with symptomatic PAH.
Recently, Actelion decided to increase the planned enrollment of patients to 1,150 as well as to increase the required number of events to 378, thereby maximizing the chance to observe a clinically relevant treatment effect. In addition, the company has included an interim analysis for efficacy and futility at around two thirds of the total number of required events.
Given current recruitment rates, the trial’s increased target enrollment is predicted to be completed by the end of 2012. Consequently, final results are expected to be available mid-2014. The results of the interim analysis could be available by mid- 2013.
Diversify disease and product portfolio
Beyond the company’s core competence in PAH, Dr. Clozel will present its mid-stage clinical development programs, which offer significant opportunities for diversifying the company’s disease and product portfolio in the areas of immunology, asthma and allergy.
Actelion’s immuno-modulation program with ponesimod made progress in 2011, with positive results from a Phase II dose-response study in relapsing-remitting multiple sclerosis. The evidence base continues to grow in this indication from data generated in the on-going open-label extension study. Following discussions with the US FDA, the company now has a clear direction for the Phase III program and initiation is planned for the first half of 2012. Additionally, in the second half of 2012, the company expects the results from the Phase II study in psoriasis. The company will also finalize during 2012, the partnering pathway for ponesimod.
Based on the positive results from a proof-of-mechanism study in asthma reported in 2009 and the positive results from a dose-ranging study in allergic rhinitis reported in 2011, Actelion’s programs to target asthma / allergic disorders with setipiprant are also progressing well.
Capitalizing on the positive results and building the evidence to support value creation with this asset, Actelion initiated the first Phase III profiling study in allergic rhinitis in December 2011. The future development path and optimal partner selection is dependent on the ongoing Phase II dose-finding study results in asthma, which are expected in H1 2012.
Continuing to innovate
During 2011, Actelion initiated Phase I programs for seven compounds, bringing the total of Phase I compounds to eight, which includes a follow-up compound to the S1P1 receptor agonist ponesimod.
Six novel compounds entered into man in 2011, these being a more potent CRTH2 antagonist (follow-up compound to setipiprant), a cardiovascular compound, an immunology compound, a dual orexin receptor antagonist (follow-up compound to almorexant), a compound addressing a metabolic disease and an anti-malarial compound.
Finally, following excellent preclinical results, a Phase I open-label study was initiated with macitentan in patients with recurring glioblastoma.
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 Web site. An archived replay will be available for 3 months beginning 24 hours after the live presentation.