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Merck announced this week that it is creating a separate cancer business, as it braces for the loss of patent protection on Keytruda, the cancer treatment that accounts for nearly half of the company’s revenue.
Merck is taking steps to evolve the structure of its Human Health organization, creating two separate divisions, one for cancer and one for the rest.
Why now? They are facing two threats to the revenue they get from Keytruda, the #1 selling drug in the world (not just for cancer, #1 overall and about half of Mercks revenue).
The first threat is the “patent cliff” everyone is talking about, meaning they will lose the exclusivity they have for Keytruda, allowing others to create their own version of Keytruda.
The second threat is that for the first time, there is a potential competitor, Imfinzi by AstraZeneca (using PD-L1 instead of PD-1), and once the first competitor succeeds and the consensus is broken, other competitors start popping up as well.
Merck creating the cancer business means they are looking for solutions, exploring M&A for example, which brings up the idea of Alpha Tau Medical (NASDAQ: DRTS).
Merck is already running a trial combining Keytruda with Alpha DaRT by DRTS, and the results are outstanding.
Instead of a 19% response rate for Keytruda alone, a small sample size trial with DRTS boosted the numbers all the way to 100% response rate (it was reported as 75% response rate, which is also amazing, but that took into account patients that died before treated by DRTS, but of those that were treated all responded).
So while Keytruda is loosing its exclusivity and facing its first real competitor, boosting the results from 19% to 100% (and from 5% complete response to 50% complete response), could be what not only saves the revenue for Merck but could even spark growth.
Now the bear case would be Merck unable to manage the new transition well, getting to the end of the patent unprepared, or the DRTS trial numbers not translating when tested in larger trials.
For me personally I’m not too worried, as Merck stocks have risen since the announcement showing the market has confidence, and the DRTS treatment just got approved in Japan and is already submitting Phase 3 data to the FDA which isn’t a guarantee but is definitely promising.