I am a Celgene shareholder in addition to LGND, so I've been following the MM story:
1. First off, it's Kyprolis, not "Krypolis".
2. The issue of cardiovascular AE is a class effect and has been studied and published extensively. Actually, in comparison with Velcade (bortezomib), Kyprolis has a better overall AE profile and twice as many patients complete the treatment as with Velcade.
"While cross-trial comparisons are inherently flawed, it is notable that 9% of patients completed the planned bortezomib therapy of 8 cycles of 21 days plus 3 cycles of 35 days (1.3 mg/m2) in the APEX trial compared with 19.0% of patients who started at least 12 28-day cycles of carfilzomib. Similarly, 37% of patients in the APEX trial19 and 22% in the SUMMIT trial33 discontinued bortezomib due to an AE compared with 14.8% for carfilzomib. "
3. Results from 4 trials where Kyprolis was used as mono therapy indicate that it has an acceptable AE profile, even with pts who have pre-existing cardiovascular conditions:
""...Additionally, the incidence of discontinuations or dose reductions attributable to adverse events was low. These data demonstrate that single-agent carfilzomib has an acceptable safety profile in heavily pre-treated patients with relapsed/refractory multiple myeloma. The tolerable safety profile allows for administration of full-dose carfilzomib, both for extended periods and in a wide spectrum of patients with advanced multiple myeloma, including those with pre-existing comorbidities.
This "note" from CELG is basically an attempt to fend off competition from Kyprolis, In reality, there is plenty of opportunity for both CELG and AMGN/LGND in the MM space.
thanks for your insight. i am still doing DD. but why rate me negative if i am honost on this board. lesson learned in this F*** up market is: always "panic first" then find out if you should buy back...
...i said: "still love the story". will be back once i understand what this CV tox. might mean and what not. , but thx again fpr your knowledgeable insight
From high $50's to low $30's on Krypolis? That would be a huge over reaction base on this bear raid due to old news dug up by Krypolis's primary competition Celgene and discussed in today's the BoAML note. This CV issue is already known...it's a class effect (also seen in Velcade) and is already in the Kryplis PI. And it is of a low incidence... see ash abstract 3187, which suggests "Among all Btz-treated pts, the rate of grade ≥3 heart failure was 2.0%; the rate was 2.0% in newly diagnosed pts and 1.9% in relapsed and/or refractory pts. In the comparative studies (APEX, VISTA) and pooled pre-ASCT induction analysis, the overall rates across the Btz and non-Btz arms were 2.0% and 1.6%, respectively (p=0.41). Risk factors, including prior anthracycline exposure and history of cardiac complications, were balanced between Btz and non-Btz arms."
Even if worse case, and Krypolis was to be taken off the market completely starting in say 2H14, in my long term model the forward value of lost royalties payments to the DCF of $LGND is far less a percent of total than the 10% in MCap $LGND has already lost from the peak today when this so-called "news" started to impact $LGND's price.
go to twitter: search $LGND / $AMGN ...see adam feuerstein or others. i can`t post 3rd party links here, but seems it was a CLGN note. i am still trying to understand. might buy back soon. but wanted to let you all know for now.
"-Increased thought leader focus on AMGN’s Kyprolis cardiovascular toxicities
among centers with extensive treatment experience, with emerging view that
irreversible proteasome binding potentially leads to differential toxicity vs. Velcade.
CELG’s current outlook is that Kyprolis/Revlimid/dex may be reserved for high-risk
myeloma, while BMY’s elotuzumab could be a better choice with Revlimid/dex in
lower-risk myeloma. Either way, CELG believes Revlimid/dex is a key backbone of
front-line myeloma therapy.
CELG is working to position Pomalyst/dex as a key second/third-line"