Shares in Swiss biotechnology group Actelion closed up 9.6% at 109 Swiss francs on October 20 after the firm decided to unveil its nine-month results, which significantly beat expectations, earlier than planned in a bid to impress shareholders.

The company, which has just two marketed products, booked net profit of 103.8 million francs for the first nine months of the year, marking impressive growth of 61.7% from the like, year-earlier period. Basic earnings per share jumped to 4.66 francs from the year-earlier period’s 2.92 francs.

Profit was driven by a robust increase in total net revenues, which leapt almost 40% on a better-than-anticipated performance of the company’s flagship product for pulmonary arterial hypertension, Tracleer (bosentan). This comfortably buffered an increase in operating expenses, which grew to 26.4% to 351.0 million francs.

Tracleer turned in a particularly strong performance for the period, raking in 455.1 million francs, marking growth of 39.9%. The agent, an orally-active endothelin receptor agonist, was approved for the treatment of PAH by the US Food and Drug Administration in 2001 [[21/11/01f]]. Since then, Tracleer has won a regulatory nod in 34 countries across the world and, if successful, the group’s assessment of the drug in other indications will boost its sales and reputation even further.

However, Tracleer is facing major competition in the form of Pfizer’s Viagra (sildenafil), which is likely to gain clearance for PAH early next year, Frances Macdonald, General Manager at Actelion, told PharmaTimes News Online. But she believes that Pfizer’s marketing muscle will be countered by its lack of long-term data for Viagra in this indication – Actelion has been collecting information on Tracleer since 2002 – placing the companies on an even keel. In fact, she points out that the introduction of Viagra for this indication may even be beneficial to Tracleer’s performance, as it will likely widen the market.

On the back of the strong nine-month results, the group has upped its net revenue expectations for the full year, now expecting 640-655 million francs compared to its original forecast of 600 million-615 million francs.

Commenting on the group’s current standing, chief executive Jean-Paul Clozel said: “Actelion has made substantial advances in implementing its long-term strategy of growing above and beyond Tracleer in PAH. Our preclinical and clinical programmes are making rapid progress. Line-extension studies for our two marketed products, Tracleer and Zavesca (miglustat), will report data before year-end. Over the coming 18 months, Actelion also expects important clinical results from several pipeline projects with the potential to radically improve treatment of various diseases.”

In terms of its future, things are looking relatively good for the firm. Its R&D pipeline currently houses 12 late-stage clinical programs, most of which are line extensions for its two marketed products, three projects in mid-stage development and 10 in the preclinical stage. Although the focus has to-date been on specialised areas of therapy stemming from in-house research, Actelion is seeking to broaden its horizons with development of more generalised medicines, be it from internal research or in-licensing, for future growth, Frances told PharmaTimes News Online.