August is going to be a big month in biotech, with a number of drugs up for FDA review. Here are two August PDUFAs that might fly under the radar, but that are worth watching as they roll around.
BioThrax sBLA – August 15.
On August 15, the FDA will serve up its judgment on a supplemental new biologics application (sNDA) for Emergent Biosolutions Inc (NYSE:EBS)’s BioThrax. The drug is an anthrax vaccination, and is currently approved and sold in a number of countries, including the US, Germany and Singapore. The company generates around $100 million in revenues from the product quarterly, primarily as the result of a government contract that requested a total of 44.75 million doses of the drug for delivery across a five-year period. The five-year period is about to draw to a close (September this year) and Emergent expects a follow on contract that will see an uninterrupted demand, supply situation. In this follow on lies the importance of the upcoming sBLA. Basically, Emergent wants to get a facility (called Building 55) approved for large scale manufacturing of BioThrax. The company is paid per dose, and so the approval will mean it can generate revenues faster than is currently possible. BioThrax is the only FDA approved anthrax vaccination, so there’s plenty of potential for long term supply contracts with the US and international governments. As such, the quicker Emergent can produce the doses, the more money it can bring in. The FDA completed an inspection of Building 55 mid-June, with no issues raised. As such, markets are expecting an approval of the building for manufacture come PDUFA. Expect some immediate upside if the agency gives the facility the green light, and look to a renewal of the BioThrax supply agreement as a compounder of this upside.
Andexanat alfa – August 17
On August 12, the FDA will rule on an NDA submitted by Portola Pharmaceuticals Inc (NASDAQ:PTLA) for the approval of andexanet alfa, an FXa inhibitor antidote. FXa inhibitors are used as anticoagulants – they inhibit action of what’s called factor X, which is an enzyme that plays a vital role in the coagulation cascade (the process through which the blood clots). They are used to counter certain blood related conditions – conditions that are caused by too thick blood. The problem is, they can sometimes have an excessive impact on the patients in question. In such scenarios, antidotes are required. FXa inhibitors inhibit the action of Factor X, which thins the blood. FXa inhibitor antidotes, such as andexanet alfa, reverse the inhibition, and thicken the blood once more.
On August 17, the FDA will decide whether or not to approve Portola’s therapy. It’s a big deal for Portola, as it fits in with the company’s wider portfolio. Specifically, a Factor X inhibitor that the company is developing called Betrixaban. If Portola can pick up an approval for both Betrixaban and andexanat alfa, it will have two drugs that it can use to corner the market. Having said this, Portola reported data on the former back in March, and things don’t look that great. The trial compared the drug to a currently approved drug (the SOC in the space) called enaxoparin. The primary endpoint was a statistically significant improvement for Betrixaban over enaxoparin. The trial missed its primary endpoint, as the former failed to show any real benefit over the latter. However, despite the missing of the endpoint, and based on what Portola referred to as Net Benefit, the company plans to push forward with an NDA submission. The chances of this submission gaining approval are pretty slim, but not entirely non existent.
So there we go. Two companies with PDUFA dates in August that will likely not pick up too much major coverage in other media. Despite their under the radar status, however, they are massively important for the companies in question, and as such, have the potential to inject some immediate upside into their respective market capitalizations come decision day.
To reiterate, August 15 for Biosolutions’ BioThrax, and August 17 for Portola’s Andexanat. Stick with us for updates ahead of, and subsequent to, the announcement.
Note: This article is written by Mark Collins and originally published at Market Exclusive.