As of the end of April, Dey, an affiliate of Merck KGaA of Germany, began promoting Critical Therapeutics'
While approval is highly likely in this case, the real challenge will be selling the drug once it's approved. There are concerns about elevated liver enzymes (specifically one called ALT for short) associated with using Zyflo, which caused original developer Abbott
However, even with the likely FDA approval, the controlled-release Zyflo still faces strong competition from Merck's
Shares of Critical Therapeutics have been trading near their yearly low recently despite the deal with Dey, which provides marketing muscle for Zyflo and a source of non-diluting capital -- if the drug is approved. While shares may get a brief bounce upon FDA approval, this may not be a case of "if you approve it, they will prescribe" because of Singulair's place in the market, the reluctance of pharmacy benefit managers to cover Zyflo, and the fact that many physicians are unaware of Zyflo.
The bottom line for Fools is to stay away from Critical Therapeutics. If you are interested in other speculative biotechs with better prospects, check out these articles:
- Heads Up, Biotech Investors
- Heads Up, Biotech Investors: Chapter 2
- Heads Up, Biotech Investors: Chapter 3
- On Deck in Biotech
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.