We’ve seen two major developments in the drug development space as we head into the middle of this week, both of which have had a strong impact on the share price of the companies to which they relate.
Here is what happened and what it means.
The two companies and focus today are on opposite ends of the market capitalization spectrum, one big and one small – SIGA Technologies, Inc. (NASDAQ:SIGA) and Novartis (NYSE:NVS).
Of course, based on the size of these companies, one of the developments is drawing a lot more mainstream attention than the other (that is, the Novartis development as opposed to the SIGA development) but, from our point of view, both are as important as the other and the SIGA development is probably even more so when you look at it from a shareholder perspective as it has had a real impact on shareprice in a short space of time.
So, with this in mind, let’s kick things off with SIGA.
This form relates to a drug called Tpoxx, which the company is trying to get approved in a target indication of smallpox.
This one’s a pretty interesting month is worth spending a bit of time looking at background. For anybody not familiar with smallpox, it is an incredibly deadly disease that has been around for thousands of years but that in the 1980s, was eradicated on the back of a global program.
However, it’s not all been destroyed – there remain certain samples of smallpox virus in various locations around the globe and the worry is that if one of these is released, there exists no cure at the current time.
There is a vaccine but the side effects are too severe to justify regular preventative vaccination. So, with Tpoxx, SIGA is essentially developing a drug that doesn’t have any use right now and hopefully won’t have any use effort, but that would likely be stockpiled by a huge number of nations around the world as a protective measure against any potential breakout in the future.
In other words, there is a big market for this one.
And the latest development is great news for the company and its shareholders.
As per the news, an FDA Antimicrobial Drugs Advisory Committee voted 17 to 0 that benefits of Tpoxx outweigh its risks for the treatment for smallpox, which bodes incredibly well heading into the PDUFA date for a final approval decision by the FDA, which is slated for August 8, 2018.
Moving on, let’s look at Novartis.
On Tuesday, the company announced that the FDA has approved its CAR-T drug, called Kymriah, in an indication of patients with relapsed or refractory (r/r) large B-cell lymphoma.
Some reading might already be familiar with this asset, with it having already been approved in the US back in August last year in a target indication of Acute Lymphoblastic Leukemia.
For those that are not, and as mentioned, it is a CAR-T drug, which is a type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells (the T cells are taken from a patient’s blood.)
As per the data that underpins the approval (i.e., the data that supported the application that just picked up a regulatory greenlight), the drug demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response.
In a condition like large B-cell lymphoma, this is an incredible result and it has led to the drug being referred to as one of the most exciting assets in the industry by a number of leading physicians in the space.
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