What Trends Did You See at This Year's JP Morgan Healthcare Conference?

Pharmaceutical Executive: What trends did you see at this year's JP Morgan Healthcare Conference?
Clay Siegall: I’ve been going to this conference for 25 years. In some years, it’s very exciting. In other years, it’s down. I’ve seen it all. This year, there was good vibe in the hallways and the investors were upbeat.

The investors are looking for clinical data, which is always number one. It’s where the big value comes from. There was data from a fair number of companies, and clinical data leads to M&A activity, which is what investors expect in biotech.

The playbook for big companies is to do their own work and have their own great pipelines, but also to supplement that by acquiring biotechs, especially ones that have proof-of-concept or approvals.

PE: What happens post-JP Morgan Healthcare Conference?
Siegall: The JP Morgan Healthcare Conference kicks off the year. A lot of companies look at is a place to come out with new information, data, financings, or partnerships. It’s an exciting time, but the month following is a really good follow up.

PE: How have recent technological advances impacted the development timeline?
Siegall: We started working on putting together our modules before we had Phase III data. We knew from Phase II that we had an exceptional drug. Of course, you must run Phase III since it doesn’t always match Phase II.

In the case of Varegacestat, the Phase III data was very close to the Phase II data. It was exceptional data. We started assembling and working on the things we need to get a submission to FDA and to plan out our commercial team, packaging, delivery of the product, and working out the logistics.

PE: After presenting topline results from Phase 3 trials, what's next for Varegacestat?
Siegall: We presented topline data. When you complete a Phase III trial, there’s a lot of data. There are many different endpoints: primary, secondary, and tertiary.

It’s important to present this data at a peer-reviewed medical conference. That’s where the investigators of the trial and presents the full data set. What’s standard is to put out topline data that is enough to tell the world what generally happened in the trial.

It’s enough data for everyone to understand whether the trial was successful or not. The rest of the data gets presented at a medical conference. For Varegacestat, we put out Phase III data in December. This showed that our drug can help patients more than existing therapies can.

Our goal is to submit for FDA for approval. There’s a lot of modules to the submission package, such as manufacturing, quality control, efficacy, and all of the different modules. I’ve done this for many drugs over the years, so this is something that I’m excited about.

When you submit, you wait on FDA to file the submission. You don’t want to get a refuse-to-file. At some point, FDA will review it and make a decision, and we fully expect to get approved because we have great data. Then we can start commercializing in the United States. We’ll then go through a similar process in other, foreign markets.