Good review. Thank you.
I was looking at a recent Credit Suisse report and this is their view on MRK's pipeline.
Singulair is expected to drain up to 2% off revenues. Januvia , Suvourexant and Tredaptive have 45% upside potential over and above estimates of $13 billion in sales for 2015 and higher for 2020. Same report gives upside potential of 75% above current estimates going out to 2020 with Setia, Odanasatib and Anacetrapib kicking in.
MRK Catalysts Profile Building over the Next 12
Months
Exhibit 2: MRK Catalysts Profile
Timing Catalyst/Event Sensitivity Fundamentals
1H 2012
Roche's dalcetrapib (competitor
to anacetrapib): Interim Phase 3
data release
*
Dalcetrapib interim results from the 15,800-patient trial are expected early next year, with a first set of final
results by December 2012.
June 9-13, 2012
Suvorexant (MK-4305): Phase III
data presentation in SLEEP Annual
Meeting
** We anticipate Phase III data presentation in SLEEP meeting in June 2012
Mid-2H 2012
Odanacatib: Interim Analysis (70%
and 85%)
**
Merck anticipates two interim analyses of odanacatib in the Phase III fracture outcomes trial, at 70% and
85% of hip fracture events.
2H 2012 Suvorexant (MK-4305): FDA Filing ** MK-4305 is a new mechanism for treating insomnia. We anticipate FDA filling 4-8 months from now.
4Q 2012
Tredaptive: Topline data from HPS2-
THRIVE
** Top line data from HPS2-THRIVE outcomes trial likely to be released prior to end of 2012.
December 2012
Additional IMPROVE-IT Interim
Look
**
Bottom line, we believe the outcome of IMPROVE-IT study is slightly more positive than consensus
expectations of 10-20% chance that the trial would stop, which means 80-90% chance that it would
continue to 2013. What’s positive is that the Data Safety Monitoring Board (DSMB) decided to add
another look at the data before 100% of the events are complete (e.g., 9 months from now or late 2012).
This could be because they believe that the difference may be substantial before reaching 100% of the
event, and we know, from our statistical analysis that the earlier the stoppage, the more likely the result
will be positive and the magnitude of difference will be greater between Vytorin and placebo.
2012 Various filings * MRK plans to file Bridion (US), Elonva (US), Suvorexant (US), and V503 for HPV.
2012 Corifollitropin alfa: FDA Filing *
Long-acting version of Follistim, for controlled ovarian stimulation (COS). Key safety risk to watch for is
ovarian hyperstimulation syndrome (OHSS). Already approved in the EU but filing in the US not expected
until 2012 or beyond.
2012 MK-3102: Phase 3 trial start * MK-3102 is the new DPP-4 once weekly dose, phase 3 trial is scheduled to start in 2012.
2012 MK-3222: Phase 3 trial start * MK-3222 is the new anti-IL-23 antibody for psoriasis, phase 3 trial is scheduled to start in 2012.
2013 Various filings * MRK plans to file AIT grass (US), AIT ragweed (US), odanacatib, and Tredaptive (US, 1H2013).
2013
Roche's dalcetrapib (competitor
to anacetrapib): Phase 3 data
release
***
Dalcetrapib interim results from the 15,800-patient trial are expected early next year, with final results by
December 2012. It could provide readtrough to MRK's anacetrapib (proof of concept for the CETP class).
2013 Odanacatib: FDA Filing *
Selective and reversible inhibitor of Cathepsin K (Cat K). Phase III Fracture outcomes trial ongoing. It is
fully enrolled with >16,000 postmenopausal women. Based on the accumulation of clinical events to date,
Merck now anticipates filing an NDA with the FDA for MK-0822 in 2013
2013
Vytorin: IMPROVE-IT CV outcomes
trial outcome
*** IMPROVE-IT CV outcomes trial is fully enrolled (>18,000 patients) with anticipated completion in 20 |
