Xoma, Genentech Warn FDA Filing for Psoriasis Treatment Likely Will Be Delayed
Shares of Xoma Ltd. tumbled Friday after the biopharmaceutical company warned a regulatory filing for its experimental psoriasis treatment likely would be delayed.
Xoma, Berkeley, Calif. , is co -developing the drug, Xanelim, with South San Francisco, Calif. -based Genentech Inc. (DNA). The drug is now in late-stage clinical trials.
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The Food and Drug Administration in October ordered a study be done to determine if Xanelim made by Xoma and used in earlier clinical trials was the equivalent of Xanelim made by Genentech and produced in large-scale manufacturing.
The study found the Xanelim made by Genentech remained in patients' blood at higher levels than the Xanelim made by Xoma, and therefore doesn't meet the definition of "comparability."
As a result, Xoma and Genentech said they may be forced to delay filing the marketing application for Xanelim. The companies hoped to make the filing, already delayed once, by this summer. A Genentech spokeswoman declined to speculate when the companies would make the filing.
"We continue to enroll patients into ongoing Xanelim clinical trials," Susan D. Hellmann, Genentech's chief medical officer, said in a written statement.
In late-morning trading on the Nasdaq Stock Market, shares of Xoma were down $ 2.98, or 39%, to $4.65. Genentech shares were down $2.95, or 6%, to $46.04 on the New York Stock Exchange.
The shares were hammered amid fears that the filing delay could be advantageous for other treatments for psoriasis now under development.
Amevive, a psoriasis treatment made by Biogen Inc. (NasdaqNM: BGEN - news) (BGEN), is awaiting marketing approval from the FDA. Biogen said Monday that the FDA would call a special committee May 23 to review the filing for Amevive. Immunex Corp. (NasdaqNM: IMNX - news) 's ( IMNX) blockbuster rheumatoid arthritis therapy Enbrel also is being tested to treat psoriasis. Protein Design Labs (NasdaqNM: PDLI - news) Inc. (PDLI), MedImmune Inc. (NasdaqNM: MEDI - news) (MEDI) and Isis Pharmaceuticals Inc. (ISIS) are studying their own compounds in psoriasis patients.
Psoriasis is a chronic, genetic skin disorder. Skin cells grow abnormally, resulting in swollen and scaly patches where the old skin hasn't shed quickly enough. Inflamed patches of skin topped with silvery white scales are symptomatic of plaque psoriasis, the most common form of the disease.
Psoriasis patients often take cyclosporin or methotrexate. However, despite their effectiveness, cyclosporin harms the kidneys, and methotrexate destroys the liver over the long term. Because of these side effects, safer treatments are being sought.
Friday's disappointing news follows a March 20 announcement that a federal court dismissed without prejudice three shareholder lawsuits that alleged Xoma and Genentech made misrepresentations and omissions about when the filing would take place. |
