3 Upcoming FDA Meetings You Should be Watching

With three FDA panel meetings to close out the month investors should have their eyes on these three companies.

Mar 21, 2014 at 2:05PM

Just because we're out of earnings season doesn't mean there aren't big data-driven events happening in the health care sector. Between now and the end of the month there are three Food and Drug Administration panel meetings that are bound to tantalize and intrigue health-care-savvy investors.

Let's take a closer look at what's on the line for companies, investors, and patients in these upcoming meetings.

A revolutionary diagnostic test
First up on Thursday is diagnostics company Exact Sciences (NASDAQ:EXAS) with its Cologuard DNA-based test for colorectal cancer and pre-cancerous polyps.

Doctor Patient Consult

Source: National Cancer Institute, Wikimedia Commons.

Without getting too technical, we shed healthy cells from our colon in our stool which release DNA. Cancerous and pre-cancerous adenomas and polyps also release cells through a patient's stool, although these cells will have an altered or mutated DNA signature. Cologuard allows patients to simply send in a stool sample to Exact Sciences' lab for processing of the cells contained within the sample. By analyzing this sample Cologuard can determine whether a patient tests positive for abnormal DNA.

Cologuard is not meant to be used as a colon cancer or pre-cancerous end-all predictor, but as Exact Sciences notes it's an adjuvant diagnostic tool that can be a reason to be referred for a colonoscopy if it comes back with a positive indication.

After releasing positive clinical trial data from its 10,000-patient DeeP-C study last year, Exact Sciences published its detailed findings in the New England Journal of Medicine earlier this week. Some of the additional highlights from the publication include:

  • The sensitivity of Cologuard was 92% compared to just 74% for the most commonly used noninvasive fecal immunochemical screening test.
  • Sensitivity for patients with advanced pre-cancerous lesions was 42% compared to 24% for the fecal immunochemical screening test.
  • Cologuard detected 69% of patients with polyps with high-grade dysplasia compared to just 46% for the control diagnostic test.

Long story short, Exact Sciences' diagnostic tool appears to work much better than the current noninvasive diagnostic test. Investors were a little displeased with just 42% of pre-cancerous lesions being detected when the data first came out in April 2013, but overall I personally believe the FDA Molecular and Clinical Genetics Panel will view Cologuard quite favorably.

Will anyone win with dalbavancin?
Poor dalbavancin, a proposed treatment for acute bacterial skin and skin structure infections, or ABSSSI); it's the pharmaceutical equivalent of a hot potato that no one wants.

The drug was originally developed by Vicuron Pharmaceuticals. Pfizer (NYSE:PFE) shelled out $1.9 billion in 2005 to purchase Vicuron primarily to get its hands on dalbavancin. However, between 2005 and 2007 the FDA rejected dalbavancin on three separate occasions, saying Pfizer would need to run additional studies to get the ABSSSI drug approved. Eventually, Pfizer parted ways with dalbavancin by selling it to Durata Therapeutics (NASDAQ:DRTX) for a mere $10 million and the consideration of a $25 million milestone payment, which can ultimately be delayed up to five years if the drug is approved in the EU and U.S. 

The question now is whether dalbavancin will ever live up to anyone's expectations.

From an ease-of-use standpoint dalbavancin is practically unmatched. Because it has a durable half-life of five to seven days per dose it can be administered as a once-weekly 30-minute intravenous dose. Furthermore, this opens up the potential to dose patients in outpatient settings, freeing up hospitals to work with more seriously injured and sick patients, and possibly lowering the overall cost of treating these patients. 

In its additional phase 3 trials (DISCOVER 1 and DISCOVER 2) that compared dalbavancin to vancomycin, dalbavancin met both its primary and secondary endpoints.  Top-line data in the DISCOVER 2 trial demonstrated noninferiority with a 1.7% better response in reducing lesion size by 20% or greater, while the secondary endpoint of end-of-treatment status also favored dalbavancin by 0.9%, according to the investigators' assessment. 

I'm leaning toward believing that dalbavancin will finally be approved this time around, but I'm also not going to hold my breath. From an ease-of-use standpoint it could provide an enormous benefit, but we'll know a lot more following the scheduled FDA panel review on Monday, March 31. If dalbavancin does get a favorable view consider this a big boost for Durata and a very minor win for Pfizer, which could still receive a $25 million milestone payment.

ABSSSI times deux!
That's right, as my Foolish colleague Todd Campbell pointed out yesterday the FDA panel will be reviewing not one, but technically three ABSSSI therapies on March 31, including dalbavancin and two versions of Cubist Pharmaceuticals' (NASDAQ:CBST) tedizolid phosphate – an injection and a tablet version.

Cubist acquired tedizolid phosphate as part of its acquisition of Trius Therapeutics last year. Prior to its acquisition Trius announced that its ABSSSI therapy met its primary endpoint in the ESTABLISH 2 trial by reducing lesion area size by a minimum of 20% within the 48-hour to 72-hour period in 85.2% of all cases. This was better than Pfizer's Zyvox, which produced the same result in 82.6% of instances. What's more impressive, though, is that telizolid phosphate achieved its end results in just six days of treatments, while Zyvox is given for 10 days. Even the adverse event profile favored tedizolid phosphate, with just 20.5% of patients noting an AE compared to 24.8% for Zyvox. Unsurprisingly, it also met its secondary endpoints including a sustained clinical response. 

Like dalbavancin, it looks poised to receive a favorable review in its FDA panel meeting on March 31, but it could hold an even bigger edge over competing drugs with its shortened treatment regimen and the fact that it can be administered as an injection or taken as a tablet. This would mark a solid win for Cubist, but it would also be potentially good news for Bayer (NASDAQOTH:BAYRY) which is Cubist's (formerly Trius') collaborative development and commercialization partner outside of the U.S., Canada, and the EU.

A positive review could make these stocks pop, but even then they may struggle to keep pace with this top stock in 2014
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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.

The Motley Fool owns shares of, and recommends Cubist Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

4 in 5 Americans Are Ignoring Buffett's Warning

Don't be one of them.

Jun 12, 2015 at 5:01PM

Admitting fear is difficult.

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Our team of analysts wrote down every single word Buffett and Munger uttered. Over 16,000 words. But only two words stood out to me as I read the detailed transcript of the event: "Real threat."

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David Hanson owns shares of Berkshire Hathaway and American Express. The Motley Fool recommends and owns shares of Berkshire Hathaway, Google, and Coca-Cola.We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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