Shares of Biovail took a dive this morning after the company announced that the FDA expects to take six months to review its application for BFV-033, a once-daily version of buproprion, which is sold as Wellbutrin for depression. Biovail says the new formulation has a better safety profile than the currently marketed therapy, but the company has been stymied in gaining an approval. The FDA issued a non-approvable letter [1] last summer, though Biovail says it responded in October after reanalyzing its data. Biovail had been hoping for a quicker response from the agency. So did investors, who took a nine percent bite out of Biovail's stock price in retaliation for the disappointment. Sales of Biovail's extended release form of Wellbutrin plunged 57 percent against generic competition in the third quarter.
- see this Biovail release [2]
- check out the AP report [3] on Biovail
Related Articles:
FDA hands Biovail a non-approval letter [1]
Biovail's Melnyk to step down amid SEC probe [4]
Biovail chairman charged with securities violations [5]
Biovail loses effort to stop generic Wellbutrin [6]
Biovail to spin off older drugs, start new pharma co. [7]
Links:
[1] http://www.fiercebiotech.com/story/fda-hands-biovail-non-approval-letter/2007-07-20
[2] http://www.fiercebiotech.com/press-releases/press-release-biovail-confirms-fda-class-2-status-bvf-033-submission
[3] http://money.cnn.com/news/newsfeeds/articles/apwire/5a79c2976c7756a2bb375bad57f8396e.htm
[4] http://www.fiercebiotech.com/story/chutes-ladders-biovail-s-melnyk-to-step-down-amid-sec-probe/2007-05-16
[5] http://www.fiercebiotech.com/story/biovail-chairman-charged-with-securities-violations/2006-08-01
[6] http://www.fiercebiotech.com/story/biovail-loses-effort-to-stop-generic-wellbutrin/2006-09-14
[7] http://www.fiercebiotech.com/story/biovail-to-spin-off-older-drugs-start-new-pharma-co/2005-11-16