Xolair: breathing easy over FDA approval

Xolair, developed by Genentech, Novartis and Tanox, reduces the number of attacks in severe allergic asthmatics. However prescribing restrictions, safety concerns and high cost are expected to limit sales to $593 million by 2010. The drug's best chance of success is through label extensions for pediatric use and for allergic rhinitis.<BR />

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Xolair's proposed EU label may prove disappointing for Novartis

Novartis has received a positive opinion from a European committee recommending marketing authorization be granted to Xolair for severe persistent allergic asthma. Although Xolair has delivered impressive results, the restrictive label, together with high treatment costs, will limit its sales potential in the EU, meaning Novartis, and partner Genentech, may prefer to focus on the US market.

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XL: taking risks

XL Europe's $50 million capacity injection will place further strain on the already overstretched liability market and escalate fears that it is already starting to soften. XL's proven track record in liability business should enable it to win a substantial share of attractive risks and lessen its own exposure to an increasingly challenging market environment.

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Xigris: struggling to overcome its problems

The once lauded drug Xigris is struggling to recover from a series of setbacks, despite existing in a potentially lucrative market with little competition. After disappointing US sales, Xigris has now been launched in Europe. Datamonitor's Michael Randle asks if Eli Lilly can take advantage of its status as the only approved severe sepsis treatment and breathe new life into its sleeping giant.

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Xigris: Lilly's sepsis flop misses out

Eli Lilly's Xigris sales have proved disappointing, for the year-to-date period ending February 28 2002 sales reached just $14 million, bringing total sales to $35 million since the drug's launch in late November 2001. Industry analysts had predicted sales of between $300 and $500 million in 2002, but this now seems unrealistic, so where did it all go wrong?

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Xfera: going into hibernation

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Xenova/QLT: tackling multidrug resistance

UK biotech Xenova and its North American ally QLT will trial tariquidar for multidrug resistance in non-small cell lung cancer. As long as the results are positive, tariquidar should have a bright future: multidrug resistance is an increasingly serious problem in cancer treatment, and the developers look set to provide strong marketing support.

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Xarelto data raise questions at the 2010 American Heart Association Scientific Sessions

Results from the ROCKET-AF trial of Xarelto in stroke prevention in atrial fibrillation have been presented at this year's Scientific Sessions of the American Heart Association. While positive, the data show that Xarelto has by no means outperformed Pradaxa. Clinicians may start to see the two drugs as complementary alternatives, based on their respective performance in various subgroups.

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Xanthus: more hurdles to clear for Symadex

Xanthus Life Sciences has begun dosing patients in a phase II trial of Symadex in recurrent colorectal cancer. While this is clearly a positive step in Symandex' development, the drug candidate still has phase III trials to contend with and, even if Symandex proves fit for launch here, Xanthus will need to find a marketing partner to help it achieve commercial success in the tough cancer market.

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Xanthus Pharmaceuticals: trial hopes to meet unmet need in secondary leukemia

Xanthus Pharmaceuticals has begun patient dosing in a Phase III trial of its drug Xanafide. Patients with secondary acute myeloid leukemia are poorly served by existing drug therapy; physicians are therefore likely to be enthusiastic about a drug which can improve treatment outcomes. At this stage of development, however, it is too early to forecast the chances of Xanthus's drug being successful.

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