Replies to post #172796 on Biotech Values

[ariadndndough]

Merck. From CS. Very interesting


Merck & Co.: MK-3475 May Now Have the Lead Over BMY’s Nivolumab in Melanoma, But BMY Does Have Interim Checkpoints in Its Trials and Has Access to a Rolling Submission Process as Well

With the rolling submission for MK-3475, Merck & Co. (MRK) is now likely to enter the market in advanced melanoma (post-Yervoy) by early 2015 (rolling submission to complete by 1H 14). Consensus expectations have very little (<$30M) by way of 2015 sales for MK-3475, with CS expecting an early 2016 launch so this should lead to an increase in estimates for the product and for MRK in the 2015-2016 timeframe.

MRK may now have the lead over BMY in melanoma. MRK's MK-3475 has at the very least significantly closed the gap vs. Bristol-Myers’s (BMY) nivolumab and, based on formal timelines is now ahead of BMY in getting their anti-PD- 1 to the market. However, BMY does have interim checkpoints built into its nivolumab registrational trials, and also has access to a rolling submission process given its Fast Track status so BMY may also enter the market ahead of current projections.

? Post-Yervoy setting: Nivolumab’s (BMY) phase 3 monotherapy registrational trials (1st line and post-Yervoy) end in 2015 suggesting a ’16 launch. However, we think that interim checkpoints in the nivolumab trials combined with its fast track designation could suggest an earlier launch, potentially even in-line with MRK’s MK-3475.

? Front-Line setting: Interestingly, ClinicalTrials.gov now shows that MK- 3475’s (MRK) phase 3, melanoma front-line registrational trial primary completion date has moved up to Jul 2014 (previously late 2014), thus potentially building for a 2015 launch in this setting as well. Formal timelines suggest a '16 launch for BMY, however, here too, we think BMY’s launch could come earlier.

[DewDiligence]

I'm guessing that ‘masterlongevity’ likes the brand name, Zontivity :- )

[DewDiligence]

FDA approves MRK’s Zontivity (f/k/a vorapaxar), an antiplatelet drug, for secondary prevention of MI:

http://in.reuters.com/article/2014/05/08/us-merck-fda-idINKBN0DO1OF20140508

This approval has been a long time coming. Zontivity was once the leading drug candidate in Schering-Plough’s pipeline, but it sank into a deep pothole when the phase-3 data showed it increased major bleeding and mortality for patients with a prior stroke. Thus, patients with a prior stroke are explicitly excluded from the FDA label, which spceifies secondary prevention of MI for patents with a prior MI or existing PAD.