Outstanding business results and rapid progress in the R&D pipeline
 |
The global rollout of Tracleer® continued in 2005, reaching a total of 36 countries where the product is available. In June, we launched in the crucial market of Japan, which will continue to add to our sales momentum. Other launches in 2005 included Brazil, Turkey and the Czech Republic.
Our second marketed product, Zavesca®, contributed to top-line growth in 2005 with sales of CHF 14.4 million, and is now available in 18 countries. To capture the full potential of this innovative oral therapy for lipid storage disorders, we expanded our licensing agreement to all phases of manufacturing and supply.
Our highly professional sales force mastered the challenges of conducting business on a global scale while expanding the market for Tracleer® in PAH. To maximize market impact, we significantly increased the number of territory managers, part of the expansion of Actelion’s workforce from 854 in 2004 to over 1,000 in 2005.
R&D supporting a multi-track strategy for growth
The ambitious number of clinical trials conducted by Actelion in 2005 reflects our multi-track strategy. We want to expand the number of indications for our two currently approved products while creating the foundation to commercialize the new compounds in our R&D pipeline, several of which are potential blockbusters.In the first category, there were positive results in 2005 from our clinical trials with Tracleer® in BREATHE-5 (Eisenmenger’s syndrome) and RAPIDS-2 (digital ulcers related to systemic sclerosis). While BUILD-1 and -2 (idiopathic and scleroderma-related pulmonary fibrosis) did not meet an endpoint, strong trends in reducing morbidity/mortality justify the start of a broader study in idiopathic pulmonary fibrosis. Additional studies are also underway to further evaluate the use of Tracleer® in chronic thrombo-embolic pulmonary hypertension and in pulmonary hypertension secondary to sickle cell disease. Clinical programs evaluating Zavesca® in lysosomal storage disorders other than type 1 Gaucher are ongoing.
In terms of new compounds, our worldwide alliance with Merck on renin inhibitors reached the second milestone, moving into full pre-clinical development. Other innovative compounds moving forward in our pipeline include the immuno-modulator S1P1 and an orexin antagonist, a novel sleep-enhancing agent. Our R&D Day, held in September in our new Research Center, showed the breadth of our Drug Discovery and tracked the progress of a number of key projects.
Clinical trials are part of our strategy to manage the impact of new competitors in PAH and related indications. In 2005, we presented data from the Tracleer® Post Marketing Surveillance Program (TRAX PMS™) of over 5,000 patients, which reconfirmed the long-term safety of Tracleer® in PAH. Two new trials launched in 2005, COMPASS-1 and -2, are designed to evaluate the combination of Tracleer® and sildenafil, the new market entry in PAH from Pfizer.
Drawing on the experience of our Board and management
The Board of Directors welcomed two distinguished new members in 2005: Juhani Anttila, former CEO of the Ascom Group and the Swisslog Group and Chairman of the Executive Board of Nokia (Deutschland) GmbH; and Carl Feldbaum, former President of the Biotechnology Industry Association in Washington, DC and former President of the Palomar Corporation as well as former Assistant to the US Secretary of Energy and Inspector General for Defense Intelligence in the US Department of Defense.The company’s senior managers, the Actelion Executive Committee, tapped into the wealth of professional experience on our Board of Directors on a regular basis during 2005. This close collaboration allowed us to fine-tune the company’s growth strategy and validate key decisions. A number of important changes were made during the year on the Actelion Executive Committee. Christian Chavy took on the expanded role of President of Business Operations to better coordinate global Marketing and Sales. Simon Buckingham filled the newly created post of President of Corporate and Business Development to coordinate our internal portfolio management and maximize external opportunities. Roland Haefeli, Head of Investor Relations and Public Affairs, joined the Executive Committee, reflecting the importance of transparency and open communications in relations with external and internal stakeholders.
Powered by the drive and determination of our employees
In our knowledge-based industry, where complex problems can only be solved by closely coordinated teams of specialists, people are the essential factor to success. During the past year, I saw many examples of how the people of Actelion “live” our core values: innovation, results-driven behavior, open communication, trust and teamwork. Our employees should feel proud of their outstanding achievements in 2005. I am convinced that our shared drive and determination will keep us on the fast track of growth and propel us toward the next level of excellence as a company.Robert E. Cawthorn
Chairman of the Board
