We’re coming to the end of what’s been another busy week in the biotechnology space. The FDA has been active, we’ve seen data hit press and rumor and speculation is rife at all corners of the sector. This, of course, has translated to some pretty strong volatility market-wide.
Here’s a look at a couple of the midweek movers with a description of what’s going on and where we’re looking next for the companies in question.
The two companies in our crosshairs are Novo Nordisk A/S (ADR) (NYSE:NVO) and EXACT Sciences Corporation (NASDAQ:EXAS).
So let’s kick things off with Novo.
This one’s a good old FDA approval move for a well-established biotechnology incumbent. The company has been working on a treatment for hemophilia B called Rebinyn, or as it’s known in the lab, beta pegol; N9-GP. For those not familiar with hemophilia B, it’s a condition caused by a patient having a lack of, or a deficiency of, a blood clotting factor called factor IX. Without the blood clotting factor present the blood doesn’t clot and a patient can bleed pretty uncontrollably if he or she gets cut.
Rebinyn is an extended half-life factor IX molecule for replacement therapy in patients with hemophilia B. Basically the drug replaces the deficient factor and – as Novo hoped – helps the blood to clot in the event of a bleeding episode.
So the company was developing it and submitted a Biologics Licensing Application to the FDA in anticipation of an approval. And that’s the latest news. The agency has just green-lighted the drug for commercialization in the US, following a meeting of the Blood Products Advisory Committee meeting back on April 4, 2017.
Hemophilia as a whole is estimated to be a $10 billion market and the B type accounts for a fair portion of this total. With that said, this is a very large company we’re talking about, and so the jump in market capitalization that we see in response to an approval like this is never going to be as dramatic as it might be in a company that picked up approval for its lead development asset, which doesn’t also have a strong product portfolio already on the market. As such, we’ve seen a few percentage points tacked on to Novo’s market capitalization over the last twenty-four hours or so and we’ll probably see a bit more strength before the week draws to a close.
So, moving on, let’s look at EXACT.
This one’s not quite as straightforward, but it’s an important development nonetheless. The company has developed, and is now in the process of commercializing, a device called Cologuard. It’s a DIY colon test that the company is pitching as an alternative to a colonoscopy. Clinical trials proved it comparable, so there’s credence to the company’s claim and – by proxy – a degree of strength to its pitch, but there have been certain concerns surrounding cost and these have limited sales to date. The test costs between $500-600 depending on where you are, and for many, the inconvenience of a colonoscopy is worth shouldering to avoid the just mentioned price tag.
Well, it looks like this cost issue may no longer be a problem; or at least, that is, may be somewhat alleviated.
On Wednesday, the company announced that UnitedHealth Group Inc (NYSE:UNH) has agreed to cover the test as part of its standard plan and that this coverage will commence on July 1, 2017.
For those not familiar with UnitedHealth, it’s one of the biggest insurers in the US, covering around 45-50 million lives as of end last year, and that the company has green-lighted coverage on its popular plans is a real win for EXACT and its shareholders. The thing to recognize here is that this is a great product and one that serves a significant unmet need – people often won’t go for a colonoscopy for personal reasons or through inconvenience, and the ability to use a comparably effective test at home overcomes this problem.
As we’ve said, however, until now, only very few individuals were willing to shell out for the test. Now Exact has 45 million individuals to target over their lifetime, with what we’ve already said is a great product and a pretty easy pitch for the sales team.