Growing business on a global scale

Actelion’s revenue of CHF 663.6 million in 2005 was generated across the markets of North America, Europe, Asia-Pacific, Australia and Brazil. These impressive figures and the broad geographic distribution of sales prove that a small, professional and highly motivated Marketing and Sales organization can achieve world-class results. A focused strategy, new organizational structures and continued expansion into new markets reflect the growing maturity of Actelion as a commercially successful biopharmaceutical company. In 2005, Tracleer® was launched in Japan, Brazil, Turkey and the Czech Republic, with new regulatory approvals in Thailand and Taiwan.

Christian Chavy, President of Business Operations, leads the Strategic Marketing and Medical Marketing functions at the corporate level as well as Actelion’s Marketing and Sales organization worldwide. Global Brand Teams – each consisting of a marketing expert, a medical marketing expert, a life cycle team leader and representatives of the five largest affiliates – ensure that decisions reflect both the global strategic brand intent and local market conditions, and can be implemented rapidly and effectively.

The strategy for the company’s flagship product, Tracleer®, includes marketing initiatives aimed at cardiologists, pulmonologists and rheumatologists inside and outside of hospitals and specialist centers. This is combined with satellite symposia and continuing medical education (CME) credits at medical congresses to raise awareness about pulmonary arterial hypertension (PAH) and treatment options. In parallel, there are educational efforts designed to help other specialists and general practitioners recognize the symptoms of PAH – a life-threatening disease that is still frequently misdiagnosed.

Established position as a long-term therapeutic option

The established position of Tracleer® as the “cornerstone therapy” in pulmonary arterial hypertension is based on years of efficacy and safety data. TRAX PMS™, a post-marketing surveillance study of close to 5,000 European patients completed in 2005, confirmed the existing safety profile of Tracleer®. Given Actelion’s leadership position in PAH, new competitors such as Pfizer’s sildenafil are often viewed by treating physicians as potentially complementary. Accordingly, Actelion has launched two clinical trials (COMPASS-1 and -2) to evaluate the combination use of Tracleer® with sildenafil in PAH. Already in 2005, the increased awareness for PAH created by the entry of a large pharmaceutical company into the market has provided additional interest to diagnose and treat this disease, reinforcing Actelion’s on-going educational initiatives on pulmonary arterial hypertension and efforts to capture previously undiagnosed patients.

Zavesca® has strong assets

For Zavesca®, Actelion’s second product on the market, the situation is different. The current market leader in treating type 1 Gaucher disease is Genzyme’s imiglucerase. This enzyme replacement therapy (ERT) must be administered by intravenous injection. Zavesca®, a small molecule, today indicated for mild to moderate type 1 Gaucher patients unwilling or unable to undergo ERT, combines a novel mode of action with a convenient oral form. These assets are reflected in a satisfying growth in sales since the product was launched in 2003 in type 1 Gaucher disease. The key to accelerate growth in this approximately USD 900 million market will be the results of the initiated Phase III MAINTENANCE study, evaluating whether the disease continues being stabilized by Zavesca® therapy after a switch from ERT in adult patients with stable type 1 Gaucher disease. In parallel, there are a number of clinical trials designed to evaluate the safety and efficacy of Zavesca® in very rare diseases (see section on Clinical Development). In 2005, the licensing agreement on Zavesca® was expanded so that Actelion now has full control over the manufacturing and supply chain, as well as the management of patent-related activities.

Dynamic sales force, global markets and new opportunities

Actelion continued to expand its global Marketing and Sales presence in 2005. Tracleer® is now available in 36 countries, including recent launches in the major market of Japan, as well as in Brazil, Turkey and the Czech Republic. To keep step with its expanding geographical presence and maximize market opportunities for its current products, Actelion increased its Marketing and Sales organization by 27% in 2005, to 570 professionals in 21 affiliates.

The combination of scientific expertise, key account management techniques and specialized selling skills has made the Actelion sales force a unique asset that helps the company retain maximum value from its products. This has also opened up new business opportunities in a niche unoccupied by “Big Pharma.” Biotech companies without a dedicated sales force are approaching Actelion to capitalize on its expertise in marketing specialized products on a global scale.

New business processes built on the pioneering spirit

Simon Buckingham, President of Corporate and Business Development, leads another new business process that attests to the growth and evolution of Actelion. The first task of this department is to develop, in collaboration with all major functional areas, the long term Strategic Plan of the company and adapt it on an ongoing basis. Using this as the base to guide the future, the second task is to optimize the life-cycles of existing products, Tracleer® and Zavesca®, as well as to manage the portfolio of new compounds reaching development. The third task is to evaluate external opportunities that could complement in-house R&D in the form of partnerships (such as the current alliance with Merck in renin inhibitors), mergers, acquisitions or in-licensing individual compounds. Actelion’s strong cash generation gives the company considerable strategic and operational freedom.

Actelion’s vision is to bring innovative, highly differentiated medicines to patients with unmet medical needs. These medicines are leading compounds from new drug classes that improve or prolong patients’ lives. The work of every function at Actelion should be guided by this vision, so that all employees understand how their individual contributions fit into the bigger picture. Clear parameters are set for concentrating on focused therapeutic fields and developing new drugs that achieve a balance between business opportunities and addressing unmet medical needs. At the same time, the vision and strategy retain enough flexibility to follow the path of innovation wherever it leads. Actelion is and will always be a company based on the spirit of discovery and pioneering achievements in new frontiers of science.