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Biotech / Medical : Celgene-CELG -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (182)	12/1/1998 2:24:00 PM
From: Rudy Saucillo	Respond to of 804

My understanding is that thalidomide is an excellent candidate for off-label use as a treatment of multiple myeloma (and potentially graft vs. host disease) based on the provisions of the FDA Modernization Act. If this is true, CELG may see revenue from thalidomide for the treatment of multiple myeloma in CY99 - much sooner than pivotal Phase III trials could be completed. The specifics of the off-label use requirements (or restrictions) are currently in litigation. The nature of the litigation deals with requirements for dissemination of information on the off-label indication. Generally speaking, industry wants less restrictive requirements on the type of info as well as on types of studies which support the off-label indication. Given the significance of results in the formal (and relatively large) trial conducted by J. Mehta et al., the above doesn't seem to be an issue. No doubt Celgene will aggressively pursue additional uses of thalidomide and the FDA's off-label policy looks like a natural for MM. Here's a summary of the FDA's off-label use requirements (as per the House and Senate bills) which was published by BioCentury in Oct. 1997: "The bills contain similar provisions on dissemination of information about off-label uses of approved drugs and biologics, but the language differs substantially. Dissemination of written information on the safety, effectiveness or benefit of approved drugs by a manufacturer to a health care practitioner, pharmacy benefit manager, HMO or other MCO, or a health care insurer or government agency is permitted. Such information must only be a copy of a peer-reviewed article from a scientific or medical journal or reference textbook. It may not be false or misleading or pose a significant risk to the public health. Manufacturers must submit a certification to FDA that studies needed to file a supplemental application for such a use will be completed within 6 months of dissemination. Alternatively, they can submit a proposed protocol as well as a schedule for submission of a supplemental application within 36 months that is acceptable to the agency. The bills allow for deadline extensions, as well as exemptions for cases in which trials would be unethical or prohibitively expensive. Information to be disseminated must be submitted to the FDA 60 days prior to distribution and the agency may require the addition of additional information to ensure that the package is "objective and balanced." FDA can order a manufacturer to cease dissemination of information if the supplement is not approved or the manufacturer is not acting with due diligence to file a supplement." Rudy