Feuerstein's Biotech Mailbag

Welcome back to the Biotech Mailbag, where this week, thankfully, we won't be talking about Dendreon(DNDN Quote) (directly, at least, as you'll see below). But a Dendreon-free mailbag can still be fun and informative, right? Remember to email me here.

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Mike W. writes, "What is your opinion on DORB? Will OrBec be approved?"

Mike is referring to minuscule market-capped DOR BioPharma(DORB Quote) and its drug OrBec, which goes in front of the Oncologic Drug Advisory Committee of the Food and Drug Administration on May 9.

I've actually received a bunch of email about DOR since the Dendreon advisory panel last month because there are similarities between the two companies. DOR is seeking FDA approval of OrBec, a cancer-related drug, based on a clinical trial that failed its primary endpoint but which later showed that OrBec patients were living longer.

The statistics supporting this survival benefit are controversial, and it will be up to an advisory panel of experts to hash it all out and offer a recommendation to the FDA.

Is this Dendreon déjà vu, or what? Yes and no. There is at least one significant difference of which you should be aware (and wary).

OrBec is an oral (pill) reformulation of a well-known topical steroid that aims to treat the gastrointestinal aspects of graft-versus-host disease, or GVHD, in cancer patients who have undergone bone marrow transplant. In GVHD, immune cells from the donated bone marrow attack the recipient's organs and tissue -- most often in the GI tract. There are no approved drugs to treat GVHD, although steroids and other immunosuppressants are often used.