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3 Can't-Miss FDA Actions This Week

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By Sean Williams, The Motley Fool

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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 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 , 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 and Theravance 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‘ 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

From: http://www.dailyfinance.com/2013/04/14/3-cant-miss-fda-actions-this-week/

Business, Finance, Occupation & Industry

Why Theravance Shares Soared

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By Sean Williams, The Motley Fool

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Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.

What: Shares of biotechnology company Theravance shot up as much as 18% after brokerage firm Piper Jaffray insinuated that a positive outcome from the FDA regarding Breo Ellipta, which has a PDUFA date of March 7, could create a takeover opportunity.

So what: Breo Ellipta — which combines a long-acting beta agonist with an inhaled corticosteroid for 24-hour, long-term COPD relief — uses components from both Theravance and GlaxoSmithKline . Glaxo actually owns a 25% stake in Theravance to begin with, and they currently have multiple COPD treatments in clinical trials and/or working their way through the FDA review process, so a buyout, assuming approval, could make logistical sense.

Now what: Don’t say I haven’t already climbed this tree — because I have. My exact words on Jan. 25 with regard to which biotech was the next buyout candidate were, “Personally, I’d call a hookup between Theravance and GlaxoSmithKline a no-brainer. Theravance and Glaxo have been like peanut butter and jelly when it comes to developing revolutionary new COPD treatments.” I really don’t see anything on the safety side of things that would preclude Breo Ellipta from an approval later this week, so I’d agree that Piper Jaffray is probably wise to be speculating on a buyout in the near future.

Craving more input? Start by adding Theravance to your free and personalized watchlist so you can keep up on the latest news with the company.

While you can certainly make huge gains in biotechs like Theravance, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool’s free report “3 Stocks That Will Help You Retire Rich” names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.

The article Why Theravance Shares Soared originally appeared on Fool.com.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

4 Can't-Miss Health-Care Events This Week

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By Sean Williams, The Motley Fool

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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 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 and Theravance 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 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 , 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.

While you can certainly make huge gains in biotech and pharmaceuticals, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool’s free report “3 Stocks That …read more
Source: FULL ARTICLE at DailyFinance