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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: M. Ramle who wrote (918)	6/22/1998 7:20:00 PM
From: Ed Ajootian	Respond to of 10280

Mazen, My understanding is that the 12 month rule only applies for certain "critical" drugs which would not likely include an athsma drug), and applies from the date the FDA formally accepts the application, not the date it was actually submitted.

To: M. Ramle who wrote (918)	6/22/1998 9:36:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 10280

Mazen, I believe the clock starts only when the FDA accepts the application as complete, and that under the user-fee legislation there is a one-year deadline. Thus we might still have a few months to go. On another issue, here is an excerpt from the European Pink Sheet showing that the half-life issue for Prozac is indeed a significant one: SB, Lilly Countercharges On SSRI Claims Accepted By U.K. Ad Board Both SmithKline Beecham and Lilly can claim victory in cases before the U.K. Prescription Medicines Code of Practice Board in which they objected to each other's marketing of SSRIs. The board concurred with SB's complaint that Lilly misrepresented half-life benefits for its SSRI entry Prozac (fluoxetine) in a U.K. journal ad, according to panel's May Code of Practice Review. At the same time, the panel agreed with most of Lilly's complaints about an SB detail aid for the paroxetine (Paxil in the U.S. and Seroxat in the U.K.) sales force distributed between May and September 1997. The board determined that the Lilly ad claim, "So Prozac makes it easier for you and your patients on stopping treatment or if therapy is interrupted," taken in context with "two positive claims about Prozac and discontinuation syndrome," had "created the impression that there were no unfavorable consequences associated with the long half-life of Prozac and this was not so." In arguing that Lilly had misrepresented the ramifications associated with the long half-life of fluoxetine, SB highlighted drug interaction risks. Based on a four to six day half-life for fluoxetine, and a four to 16 day half-life for its active metabolite norfluoxetine, the active medicine could remain in the body for up to three months, SB asserted. The company argued that "this meant that in the event of a patient requiring abrupt discontinuation of therapy, fluoxetine/norfluoxetine could not be cleared from the body," the panel noted. SB maintained that patients and health care workers should be aware of possible "serious" interactions that could occur in the period during which the drug is still in the patient's system, according to the Code of Practice Review. In addition, the company argued that the potential for interaction might restrict the use of further antidepressant therapy. According to the document, Lilly responded that SB "had taken the claim out of context" and emphasized that "the sentence occurred in the context of the remainder of the advertisement which dealt with fluoxetine and its relationship to discontinuation symptoms." Lilly also pointed out that the ad included Prozac prescribing information, which noted the disadvantages of the drug's long half-life. The panel determined that a violation of the Code of Practice had occurred despite the inclusion of prescribing information. It is "an accepted principle of the Code that material could not be qualified by way of a footnote or in the prescribing information." Therefore, the panel "considered that the claim was too general and was therefore misleading." The May Code of Practice Review is the second consecutive issue of the publication to include a ruling against Lilly regarding statements about half-life. In the previous issue, released in February, the board stated that a Lilly sales piece had misrepresented the comparative half-life benefits for fluoxetine and paroxetine in favor of Prozac ("The Pink Sheet" March 30, p. 14). The May document also includes a ruling against SB's argument that the same Prozac journal ad that prompted the complaint about half-life representations "implied that the occurrence of discontinuation symptoms after cessation of an antidepressant was highly clinically relevant," the board reported. SB had maintained that "discontinuation events were not a new phenomenon" and could be minimized by dose tapering. ----------- Bottom line here is that I'm becoming more hopeful that Lilly will go with SEPR on the Prozac ICE. Peter