Replies to post #161400 on Biotech Values

[DewDiligence]

MRK—I'd bet that the 20mg dose [of suvorexant] gets approved this round.

I’m inclined to agree.

[DewDiligence]

Speaking of MRK…according to management, the company’s four most economically consequential drug candidates (among those still in the clinic) are:

• Anacetrapib (CETP inhibitor for cardiovascular disease)

• MK-8931 (BACE inhibitor for AD)

• Odanacatib (osteoporosis)

• Lambrolizumab (anti-PD-1 for cancer)

That’s a pretty strong foursome, IMO. If one or two succeed, the revenue needle will move considerably, even for a company as large as MRK.

[DewDiligence]

FDA panel 12-4 in favor of MRK’s Suvorexant on efficacy. More to follow.

[DewDiligence]

MRK—Nice call on the 20mg Suvorexant dose. Given the panel votes today (#msg-88202674, #msg-88207202), the 15mg and 20mg doses would seem to be in good shape with the FDA.

I'm glad the panel didn't support a new clinical trial on a (probably subtherapeutic) 10mg dose, which would've been a waste of time, IMO. The vote on that question was 10-5 against.

[DewDiligence]

FDA issues CRL for MRK’s Suvorexant; issues relate to dosing and it appears that Suvorexant can be approved without new trials:

http://finance.yahoo.com/news/merck-receives-complete-response-letter-120000242.html

In the Complete Response Letter, the FDA advised Merck that:

• the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients;

• 10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved;

• 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and

• for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary.

In addition, the FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg.

Patinets who want to take 30mg or 40mg will have to double-up, if they can find an MD to prescribe it.