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Earnings season is getting ready to rev into high gear, but earnings are unlikely to be the talk of the sector in the days to come, with three big Food and Drug Administration actions expected in the coming week.
No headaches for Allergan shareholders
Up first is the PDUFA decision on Allergan's (UNKNOWN: AGN.DL ) inhaled migraine medication Levadex on Monday. MAP Pharmaceuticals received a complete response letter for Levadex in March 2012 because of manufacturing deficiencies and its delivery device. Levadex wasn't denied, though, based on safety or efficacy. This was a clean cue to investors that Levadex's approval seemed like a sure thing barring it worked hand-in-hand with the FDA to meet its demands. With Allergan taking that cue as a reason to buy MAP earlier this year for $958 million, Monday represents decision day as to whether the company has made adequate fixes to its delivery device and manufacturing process to satisfy the FDA.
Levadex's approval or rejection could also mean a good or bad day for Nektar Therapeutics (NASDAQ: NKTR ) , which looks to gain from royalty rights based on its contributions to Levadex's development. While impossible to predict, I'm going to go out on a limb and project an approval for Allergan.
A revolutionary COPD treatment?
On Wednesday, chronic obstructive pulmonary disease, or COPD, treatment collaborators GlaxoSmithKline (NYSE: GSK ) and Theravance (UNKNOWN: THRX.DL ) are set to go before the FDA's panel with their combo Breo Ellipta. This revolutionary drug combines Theravance's long-acting beta-2 agonists with Glaxo's long-acting muscarinic antagonists into a dry powder inhaler to provide long-term COPD relief.
Studies of Breo Ellipta didn't show statistically significant effects at all doses examined (clinical trials are a bit of trial and error on dosing), but they all showed a measurable improvement in lung function, although not all increases were dubbed significant. In addition, the adverse event profile of Breo Ellipta was similar to the current standard of treatment.
As for Wednesday, I believe the patient pool should be enough to satisfy the FDA panel, but I'm concerned that it may focus on some of its non-statistically significant trials as a sticking point. Overall, I'm leaning toward a positive review from the FDA's panel, but we'll find out more on Wednesday.
Is this the End-o for Aveed?
Finally, on Thursday we have an FDA panel meeting for Endo Health Solutions' (NASDAQ: ENDP ) Aveed, with is an extended-release male hypogonadism treatment.
The drug itself was acquired when Endo purchased Indevus Pharmaceuticals in early 2009 and is on its second go-around after receiving a complete response letter in its first attempt to gain approval. That CRL spelled out the FDA's concerns regarding very rare, but serious, adverse side effects, which included post-injection anaphylaxis and pulmonary oil microembolism. The FDA also noted that Endo's risk evaluation and mitigation strategy was insufficient.
It's been more than three years since that initial CRL, so this should definitely be an interesting FDA panel meeting to say the least. Safety remains the primary concern, which the FDA panel may touch on and will more than likely determine how likely Aveed is to be approved once it goes before the FDA itself.
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