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With no PDUFA decisions on the plate this week, we'll instead turn our attention to two important FDA panel meetings and two earnings reports that simply can't be missed.
On Monday, DepoMed (NASDAQ: DEPO ) is expected to go before the FDA panel with its menopausal hot-flash drug, Serada. As TheStreet.com's Aafia Chaudrey noted in early February, DepoMed's first two Breeze trials were largely unsuccessful, with neither hitting their primary endpoints and dropout rates running very high. The Breeze-3 trial, from which this new drug application originates, demonstrates a reduction and frequency of hot flashes relative to placebo but still showed a higher number of patients dropping out of the trial because of adverse events than the placebo (16.7% to 11.5%). It's really difficult to tell how the FDA's panel will perceive this data at the moment.
Later in the week, on Thursday, GlaxoSmithKline (NYSE: GSK ) and Theravance (NASDAQ: THRX ) will face the FDA panel with their long-term COPD solution, Breo Ellipta. The inhaled drug combines a long-acting beta agonist with a once daily inhaled corticosteroid to provider 24-hour relief to COPD suffers. In two mid-stage trials spanning 1,620 patients, the first trial demonstrated statistical significance at all three dosing levels, while the second demonstrated statistical significance at the lowest and mid-tiered dosing level. Both studies exhibited a reduction in COPD exacerbations, though not all figures were numerically significant. In short, Glaxo and Theravance could have a blockbuster on their hands, as long as the FDA panel feels the results show a marked improvement over existing treatments. Thursday is a key day for these two companies!
On the earnings front, I'm going to be looking forward to hearing from Aegerion Pharmaceuticals (NASDAQ: AEGR ) on Wednesday. Aegerion, which had its homozygous familial hypercholesterolemia, or HoFH, drug, Juxtapid, approved early by the FDA, beat Sanofi and Isis Pharmaceuticals' HoFH drug, Kynamro, to market. However, Kynamro's pricing of "just" $176,000 per year significantly undercuts Aegerion's $235,000-$295,000 annual cost. All told, I'm very interested to see how this might alter Aegerion's pricing strategy and guidance moving forward. At a valuation nearing $800 million Aegerion is no longer cheap by any means, and it'll need a pretty pristine forecast to impress shareholders.
Finally, on Thursday we'll hear from Sarepta Therapeutics (NASDAQ: SRPT ) , which is expected to report its fourth-quarter results. Sarepta won over investors' hearts last year with the amazing results of Eteplirsen in trials for Duchenne muscular dystrophy. Like most clinical-stage results, the actual figures won't matter nearly as much as what CEO Christopher Garabedian has to say with regard to a potential accelerated new drug filing for Eteplirsen. Pay close attention to Garabedian's comments on Thursday and, as a side note, keep an eye on Sarepta's cash burn rate.
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