We are quickly closing in on the end of the week and it’s been a pretty big one in the biotechnology space for a whole host of reasons. The FDA scored a record number of approvals for the year with a trio of unexpected, early green lights and some of the biggest names in the sector have put out data indicative of success in late-stage trials.
As we kick off the session on Thursday, then, here’s a look at which companies are moving, why they are moving and – in our opinion – where they are moving to next.
The two companies in focus for the session today are AbbVie (NYSE:ABBV) and Aeterna Zentaris Inc. (NASDAQ:AEZS).
Let’s hit the ground running with AbbVie.
So, this one is rooted in some trial data that hit press mid-session on Wednesday. Specifically, the company put out data from a phase III trial of one if its lead development assets, a drug called upadacitinib, or ABT-494. The drug is targeting an indication of patients with moderate to severe rheumatoid arthritis (RA) and, specifically, those patients in this population that haven’t shown a response to treatment with methotrexate, which is the first line drug in this space. The drug is what’s called a JAK1 inhibitor and it has the potential to be a real blockbuster (so, more than $1 billion in annual revenues but potentially up to $3.5 billion according to company expectations) if it picks up a regulatory green light on the back of the data that just hit press.
So what did the numbers tell us?
Well, from an efficacy perspective, things look pretty good. The trial met its primary endpoint and a host of key secondary endpoints. At week 14, 68/42/23 percent of patients switched to 15 mg once-daily upadacitinib and 71/52/33 percent of patients switched to 30 mg once-daily upadacitinib achieved an ACR20/50/70 response, compared to 41/15/3 percent respectively of patients continuing methotrexate.
From a safety perspective, however, things don’t look quite as rosy. One patient died on the trial of a hemorrhagic stroke caused by a ruptured aneurysm, though said patient reportedly had some pre-existing cardiovascular risk factors. Additionally, there was also one event of pulmonary embolism (PE) in the study, again in a patient with pre-existing risk factors, but this time for PE.
So what’s next?
There are six of these trials set to complete before submission and this was the third, so more data is set to hot press throughout early 2018 related to this program. When this data comes in, we’ll get a clearer indication of exactly what the AE rate might mean for the program’s chances of success.
Moving on, Aeterna Zentaris.
This one is rooted in a regulatory approval (yes, another one) that was announced after hours on Wednesday. The company put out the news yesterday evening detailing the FDA’s green light for a drug called Macrilen, or macimorelin, which is designed to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). The drug is what’s called an orally available ghrelin agonist and it’s designed to stimulating a patient’s growth hormone (GH) secretion. After this stimulation, the patient is then assessed for levels of GH and, if they remain low post-stimulation, it’s confirmation that they are suffering from AGHD. Once confirmation of this diagnosis is in place, the patient can then be prescribed standard of treatment for the indication.
Right now, the SOC is what’s called an insulin tolerance test (ITT) and there are somewhere around 40,000 of these tests carried out each year. Macrilen has some real advantages over ITT, however, not least the fact that it’s an oral administration asset so the patient doesn’t have to risk IV, and Aeterna thinks it can quickly pick up at least 50% of the market on the back of its advantages of SOC.
The drug should hit the shelves at some point during the first quarter of next year and – as per analyst estimates – is looking at annual peak sales somewhere in the region of $70 million.
As expected, Aeterna is climbing on the news, trading up around 60% after hours on Wednesday. We expect this climb to continue heading into normal participation today.