La Jolla Pharmaceutical Company (NASDAQ:LJPC) is picking up some end of the week strength this week on some fresh news in the biotechnology space. The company announced after hours that the Food and Drug Administration (FDA) in the US has approved one of its lead development assets and markets are piling into its stock ahead of year end on the back of the news.
Here’s what happened.
The drug in question is called GiaprezaTM, or angiotensin II, and it’s targeting an indication of increasing blood pressure in adults with septic or other distributive shock. When patients go into septic shock, their blood pressure drops to a dangerously low level after an infection. The reduced blood pressure translates to a reduction in the amount of blood and oxygen that reaches the body’s organs which, in turn, stops them working properly.
GiaprezaTM is added to conventional treatment in the space and, in some pretty widespread late stage trials, proved that it could result in an across-the-board increase in blood pressure.
So what just happened?
The FDA has approved the drug, as noted, and La Jolla is up around 15% after hours (and a little bit more during premarket activity on Friday.
This is great for the company and its shareholders but there’s a wider arc here that’s worth touching on. This marks the fifth FDA approval to have hit press this week alone. It’s been a pretty well known fact over the last six months (maybe a little bit more) that policymakers in the US have been pushing the FDA to speed up its review process for new drugs.
This late spate of approvals not only makes 2017 a record year for regulatory approvals on new drugs, it puts the agency well past the post. When you combine this with the fact that most of the recent approvals have come in early (as compares to the expected PDUFA dates for each) then it really underlines the idea that the FDA has made an effort to comply with policymaker requests.
Of course, this can be a double edged sword. If the decisions prove smart ones, no one will complain – the patient populations get new drugs, the company gets a new revenue source and shareholders get a boost I the value of their portfolio.
If one of these decisions proves hasty, however (say, for example, some unexpected safety issues arise longer term for one of the drugs that the agency just rushed to approve) it could derail the accelerated approval push.
Anyway, right now, it looks like it’s a good thing. We’re going to be watching the commercialization programs carefully heading into 2018 to make sure things stay that way. La Jolla expects to launch its fresh blood pressure raising asset as part of a US commercial push during the first quarter of next year.
Next up on today’s list is Biogen Inc. (NASDAQ:BIIB).
This one is not quite as positive a bit of news for the company in question and its shareholders as was the La Jolla news outlined above.
During the session yesterday, Biogen announced that an Independent Data Monitoring Committee had determined that a phase II trial that was set up to investigate a drug called BAN2401 for the treatment of Alzheimer’s disease, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint.
This is a disappointment for the company and markets are selling off on the news but, when you take a step back, it’s not as bad as it seems.
The trial in question wont actually complete until 18 months post-dosing (so, another six months from the recent analysis) and these sorts of drugs generally take 18 months to show any real impact. Biogen set up this 12-month analysis as a sort of moon shot, with the hope that it could get started on a phase III trial ahead of time and – in turn – save on some development capital.
As such, while the data didn’t meet the endpoint at this time, not everyone expected it to and it doesn’t really say much about the chances of success when the trial closes out against its 18-month timeframe.
Data will hit press at the end of summer, 2018.