CELG partner EPZM (Epizyme) to be added to NBI (NASDAQ Biotechnology Index)and NASDAQ global select market..
Amazing how wrong he has been since a yr ago Dec. Surprised he is not too embarrassed to post
Citi, UBS, RBC, Cantor, Baird raise CELG targets - so for - more coming - every analyst must increase duration of therapy - the #1 EPS enhancement variable
See all reports on investor village CELG message board
Jeffries "MM-020 Data Supports Continuous Revlimid As First-Line Gold Standard - Maintenance/Continuous Treatment Pool Could Be Expanded By ~150%"
Maintenance/Continuous Treatment Pool Could Be Expanded By ~150%. CELG
currently estimates that only 40% of patients in the US/EU are being treated with
maintenance/continuous therapy Rd. CELG expects increased uptake in the US because of
MM-020 and subsequent label expansion. Further, in Europe, CELG believes it can still secure
strong pricing for Revlimid in the first-line indication even as continuous therapy. It will file
the data with regulatory authorities in both markets in 1Q14, which could enable a formal
first-line launch of Rd in 2015
ernstein "MM-020 delivered the definitive evidence that frontline Revlimid-dex followed by RLI maintenance should become the standard of care. · Potential for much longer duration of treatment than we currently model, possibly even "double-dipping"....
· Celgene’s MM-020 delivered the definitive evidence that frontline Revlimid-dexamethasone followed by Revlimid maintenance should become the standard of care. The study showed a clear, statistically significant improvement in progression free survival (PFS) for first line multiple myeloma patients (MM) in Arm A (Rev-dex followed by Rev maintenance – PFS 25.5 months, HR 0.72, p=0.00006) not only compared to the control Arm C (melphalan, prednisone and thalidomide for 18 months – 21.2 months) but also to Arm B (Rev-dex for 18 months fixed duration – 20.7 months). After a median of 3 years follow up, 23% of the patients in Arm A were still on therapy, compared to zero patients in Arms B and C, which suggests that the median treatment duration of 80 weeks on arm A will still get longer, at least in the real world. The improvement from maintenance (now called continuous Revlimid) was even greater for secondary endpoints, where the median time to progression and the median time to next anti myeloma treatment were both significantly (30-35%) increased by continuous Rd. The 8.6 month increase in time to progression and the 11.4 month increase in time to next AMT were consistent with our expectations for a long duration of benefit from the maintenance regimen. With so many patients still on drug in the active arm, the OS data were not mature, but trends in 4-year OS again favored Arm A (59.4%) compared to Arm C (51.4%), and also numerically higher than Arm B (55.7%). The incidence of all SPMs was comparable among the three study arms, and the rate of critical hematological SPMs was higher in the MPT arm compared to the Revlimid arms, putting to rest any concerns that the occurrence of SPMs would limit continuous treatment wit
READ ENTIRE REPORTS ON INVESTORVILLAGE CELG MESSAGE BOARD WONT FIT HERE
Really really think about what these comments mean - double duration, double dip. 150% incr in patient population - DURATION is #1 INCREMENTAL EPS ENHANCER (all models need to incr duration)....
JP Morgan "Perhaps most importantly, data argue for at least a 3-yr duration of therapy for Rd, which is well above Street models. Both the PI, Dr. Thierry Facon, & discussant Dr. Jesus San Miguel declared RLI maintenance as a new “standard of care"
JPM - Celgene: MM-020 Data Look Very Robust; Supports Long Duration of Therapy
Full phase 3 data from the MM-020 trial of Revlimid in first-line maintenance myeloma were just presented at ASH, and we wanted to pass along a few thoughts. Recall, there were 3 arms in the MM-020 study: Arm A (Revlimid/dex maintenance; Rd), Arm B (Rd for 18 cycles w/o maintenance; Rd18) and Arm C (melphalan/prednisone/Thalomid; MPT), with the primary analysis being Arm A vs. C. Overall, the full MM-020 data set were very robust and clearly support label expansion into the first-line setting. Perhaps most importantly, the data argue for at least a three-year duration of therapy for Rd, which is well above Street models. Both the PI, Dr. Thierry Facon, and discussant Dr. Jesus San Miguel declared Revlimid maintenance as a new “standard of care” with a physician from the audience citing the data as a “paradigm shift.” At Celgene’s Analyst event today, we will be looking for comments on the regulatory process (US/EU filing 1Q14), as well commentary on the benefit of Revlimid maintenance in patients who achieve a durable CR (noted by Dr. San Miguel in opening comments). We would be buyers of CELG shares; today’s MM-020 data are not only de-risking for approval, but are likely to extend current duration of therapy and dramatically increase first-line share for Revlimid.
Expect a few Target increase to over $200 by Weds. EVERY analysts LT duration and EPS and sales are low in 2015 and 2017. EVERY ANALYST.
SEE ALL ANALYST REPORTS ON INVESTORVILLAGE CELG BOARD. Wont fit on yahoo
Every analysts estimates in 2015 and 2017 are now low including William Blair and Citi despite raises. Every one
MM-020 very positive comments multiple Drs/analysts tonight from ASH...
Listen to the CELG webcast replay and make sure you go to Investorvillage CELG board and read all the reports and KOL comments.
Another higher high, higher low, all time weekly high, all time intra-day high and all-time closing high...perfect setup into ASH...with at least 10 target raises next week imo.
Coming up on CNBC Power Lunch - The Hottest Biotechs to buy for 2014....show starts in 15 minutes..eom
Starting to look more and more front line worldwide incremental could be closer to the $7.71 INCREMENTAL EPS Citi high end of range with DURATION OF THERAPY HUGELY UNDERSTATED IN CURRENT ESTS...
Remember 100% ownership worldwide, 95%+ margins, 16% tax rate and duration of therapy could double per former perma bear UBS.
Also they take time but do not underestimate longer term total sales in Mexico, Brazil, Canada, Australia, China and Japan.
And nearer term JAPAN front line will come soooner than modeled imo. That market is BIG BIG BIG.
At the end of the day my good friend Steve from RJ will be correct - Revlimid will be the largest selling cancer drug in history and over $10 billion maybe challenging Lipitor at some point.
CEO "its all about the SPA - go through it - study it and you will be able to come up with valuations. Will be available with SEC today" eom
CEO "I will be frank - we have a large exciting prospect with possibilities as large as Elk Antelope - its an elephant - we were keen on making sure we would be rewarded for that - you will hear more about this near future"
CEO"This is a transformational deal without caps or restrictions"
Deal gets better as he talks
CEO: "Receive license for PRL 39 Triceratops....other license renewals comments from Duma later"
Anticipating Updated Guidance in Jan ‘14─ We anticipate that mgt will likely
raise its 2015/17 EPS guidance by ~$1 and model $9.59 vs consensus $9.38 in ’15.
Client Call ─ Friday at 10am ET. 719-457-6823/1398207.
Revlimid’s Treatment Duration is Bound to Increase
One of the key tailwinds to Revlimid that we believe is overlooked is that Rd is now
the standard of therapy onto which all new drugs are added. As a result, the
treatment duration of Revlimid in both the first line setting (ELOQUENT-1 with
elotuzumab and TOURMALINE-MM2 with MLN-9708) as well as in the relapsed
refractory setting (ELOQUENT-2 with elotuzumab, TOURMALINE-MM1 with MLN-
9708, and ASPIRE with Kyprolis) should drive upside to expectations.
Recall that recent data has been very encouraging and showed much better overall
responses and mPFS over that seen previous studies with Rd alone in the r/r
myeloma setting.MM-020 Study Will Likely Show a ~27 Months mPFS On Rev/Dex in 1st Line Patients….
On Sunday at ASH, the ph 3 MM-020 study will be presented. We anticipate that the
MPT arm likely will show a PFS benefit of ~21 months that is in-line with the
historical data (see our previous MM-020 analysis slide deck) and that the Rd arm
will show ~27 months (28% mPFS benefit).
With a strong overall survival trend showing a 22% reduction in death, this was the
best case scenario for this study (see our MM-020 data note).What is particularly
impressive is that Rd (2 drugs) beat MPT (3 drugs).
In our view, the MM-020 data is likely too premature to yield any conclusions about
how arm A (continuous therapy with Revlimid) will stack vs arm B (18 months fixed
Rd). Our recent call with a thought leading expert noted that all patients in his
academic center will likely get 2 years of Revlimid regardless of this data and that
the key question will be whether the MM-020 will prove that treating for 2 years is
beneficial (see our recent note).
As Rd will be the new standard of care, future drugs are being combined with this
regimen (ie triple regimen) and this should boost mPFS to be 30-36 months in the