Actelion sought to dispel concerns about sales declines for its pulmonary arterial hypertension drugs - Tracleer (bosentan) and Ventavis (iloprost) -during a presentation to outline its first-quarter 2008 financial data April 22.

The firm said the actual number of patients treated with the two drugs is on the rise, but currency fluctuations and buying-pattern variations combined to lessen actual performance.

Tracleer sales totaled CHF287.6 million ($286.9 million), up 18 percent year-to-year in local currencies, but down 9 percent quarter-to-quarter on local-currency basis. Ventavis sales were CHF17.4 million ($17.35 million) during the quarter, down 19 percent from fourth-quarter 2007 in local currency.

Jean-Paul Clozel, Actelion's CEO, said his company's PAH franchise is performing well and the PAH market is expanding, partly due to efforts by Actelion.

"I also must emphasize that the overall good Tracleer market performance, with an increase in the number of treated patients in all markets worldwide including the U.S., is not reflected in the actual category sales numbers due to the adverse currency environment and due to ongoing buying pattern variations," he said.

Asked during a question-and-answer period where exactly Actelion was seeing patient increases, Clozel said, "We see it everywhere. Everywhere, including the U.S., it's growing."

At least one industry analyst suggested Actelion was trying to avoid the appearance of losing market share to Gilead's Letairis (ambrisentan), which tallied first-quarter 2008 sales of $20 million.

Letairis, the only other endothelin receptor antagonist approved for PAH, received FDA marketing clearance in June 2007 (¹ Also see "Gilead Letairis Will Be Available Through LEAP Restricted Distribution Program" - Pink Sheet, 15 June, 2007.).

In an April 22 note, Guillaume van Renterghem of Canaccord/Adams said the strong Swiss franc against the dollar, British pound and Euro is an inadequate explanation for Tracleer's disappointing first-quarter financials.

"Sales still decreased 9 percent quarter/quarter in local currencies, the worst decrease in local currencies ever," he wrote. "We believe that Tracleer is now seeing the first impact of the launch of [Letairis]. We expect buying pattern variations to intensify over the coming quarters, translating into reduced Tracleer performance."

Firm continues to focus on Tracleer's label expansion

Perhaps mindful of increasing competition, Clozel outlined a pair of strategies during the call for Actelion to maintain and strengthen its PAH market share. The first part is a continued emphasis on label expansion for Tracleer.

"I believe the key to continue to grow Tracleer sales going forward lies in another important challenge in the PAH market," Clozel said. "How can we move towards the identification and screening of early PAH patients at risk before they worsen?"

Clozel added that peer-reviewed data would be published soon and added to the Tracleer label. He predicted this will "continue to highlight the clinical data supporting safe and efficient use of Tracleer in a multitude of different PAH patient populations - data that clearly and positively differentiates us from all other therapeutic options available today."

Another PAH therapy added to the pipeline

He also noted that, the day before, Actelion finalized a partnership with Japan's Nippon Shinyaku to codevelop a novel, orally available prostaglandin I-2 receptor agonist (NS-304), which the companies believe will provide PAH therapy by stimulating PG1-2 receptors in blood vessels and exerting vasodilating effects.

Nippon Shinyaku, which discovered the compound, will receive undisclosed upfront and milestone payments, along with royalties if the compound is commercialized. The drug is in Phase IIa, with Actelion planning to begin a Phase IIb dose-finding study later this year.

Actelion also has four Phase III compounds in its pipeline, notably the orexin receptor antagonist almorexant, which Clozel touted as having "the potential to transform the field of sleep medicine," and Actelion-1, a tissue-targeting endothelial receptor antagonist which could add to the firm's PAH franchise (² Also see "Actelion Launches 500-Patient Phase III Trial For Next-Generation PAH Drug" - Pink Sheet, 19 December, 2007.).

Clozel said Actelion has determined it needs to find a partner to maximize the potential of almorexant, and began the process at the end of 2007. Actelion is enrolling a dose-finding study in elderly patients for almorexant, he added (³ Also see "Actelion Will Take Novel Sleep Therapy Into Phase III This Year" - Pink Sheet, 15 June, 2007.).

No longer in the pipeline, however, is tezosentan, which was being investigated for cardiac indications, most recently cardiac bypass separation (⁴ Also see "Actelion Stops Tezosentan Trial" - Pink Sheet, 8 November, 2004.). Clozel said event rates in a recently completed study were lower than expected and Actelion has decided to cease development of tezosentan so resources can be directed elsewhere.

Despite his negative outlook for Tracleer, van Renterghem increased his valuation of Actelion stock, saying Canaccord/Adams expects an almorexant partnership to be signed by the end of 2008, "providing the only significant stock catalyst for the year."

Upgrading his valuation of Actelion stock from "sell" to "hold," van Renterghem increased his target share price CHF1 ($1) to CHF45 ($44.83). "In our view, the economics of the (almorexant) deal will be key to share price performance," he wrote.

Overall, Actelion reported total net revenues of CHF321.6 million ($320.4 million) for the quarter.

-Joseph Haas (j.haas@elsevier.com)

Actelion Vows To Keep PAH Lead, Despite First-Quarter Dip

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