I spoke briefly with Chelsea Therapeutics' (CHTP) CEO Joe Olivetto this morning about Tuesday's positive Northera FDA advisory panel and next steps for the company.
For those who missed it, the FDA panel voted 16-1 to recommend the approval of Northera for the treatment of neurogenic orthostatic hypotension (NOH), a chronic disease characterized by dangerously low blood pressure.
The FDA approval decision date for Northera is Feb. 14. FDA rejected Northera following a positive panel vote in 2012, so there are no guarantees. However, I believe it will be much more difficult for FDA to reject Northera again. Two positive panels following a very thorough presentation and discussion of all the issues with the Northera clinical data justifies an FDA approval.
That's how I see it.
Anyway, back to Olivetti's comments from our quick chat this morning.
His reaction to Tuesday's panel:
I was very happy with the outcome. Even with the vote being dramatically positive, you still worry about mis-understandings. Did the panelists get it? Did they understand the issues? Was the vote based on mis-perceptions? I don't think we saw any of that. The panelists did a great job. They were prepared and they dove right in.
On the company's strategy going into the panel and why the panelists votes to recommend Northera's approval:
We had been discussing the issues about Northera with the FDA for awhile so there were no surprises. We were prepared to discuss the issues and articulate them as clearly as we could. And the panelists were also really prepared....
The key was in the second half of the day, emphasizing the unmet medical need [for NOH.] This is not a disease that causes a little dizziness. It is a complicated disease that really affects peoples' lives. And it's a disease that is really hard to study... Our experts did a great job. We also had something like 18 people testify [during the open public hearing], including 10 NOH patients who talked about their experience with the disease and taking Northera.
On his prediction on the FDA's upcoming approval decision:
We feel good about Northera going into the PDUFA date. I think the FDA got good advice from the panel that they can take back with them and use to weigh in on their final decision.
On what the Northera label might look like, assuming FDA approval:
Part will depend on whether FDA grants Northera full approval or approval based on subpart H [accelerated approval], which would come with a requirement for a follow-through trial.
There could be a range of labels. The worst possible label would include a contra indication saying that Northera is not to be used after 1-2 weeks. Now, I don't know of any drug that has that kind of label, except maybe for safety reasons, so I think there is low chance for this to happen with Northera.
Other label possibilities might have FDA include a statement saying Northera has not been proven to show a durable response beyond 1-2 weeks, or the agency could put the clinical data in the label, showing that response wasn't statistically significant after 1-2 weeks.
If the FDA includes language in the Northera label about the benefit of the drug lasting only 1-2 weeks, will this have an effect on how insurance companies reimburse for the drug?
This is a relatively new issue, so I could only really speculate at this time. We need to study it but I'm sure this will be a question investors will ask.
On the timeline for a Northera commercial launch, again, assuming FDA approves the drug on Feb. 14:
We're looking at about a six-month timeline between final approval and launch... We have all our marketing plans in place from last time and we believe they are still good... We'll be using a contract sales organization [to sell Northera] so they will have to be hired. And production of Northera will need to be teed up, which will start on approval.
Shares of Chelsea have been volatile, particularly as doubts about the panel outcome took hold in the past few weeks. But the stock rallied nicely after the positive vote on Tuesday:
CHTP data by YCharts
Back to my take: I like Chelsea and believe the stock has more upside following approval. There's a chance FDA delays a decision by three months since the agency only has one month to digest the recommendations of the panel and nail down the Northera label. But as one smart analyst said to me Tuesday night (we were talking about the panel), a short delay in Northera's approval for what are basically administrative reasons could actually be a benefit to Chelsea and the net present value of Northera since the commercial launch and drug manufacturing still need to be nailed down.
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