Replies to post #163190 on Biotech Values

[oc631]

RE: P.I. Class

Well, simeprevir doesn't need to be boosted with ritonavir, as does ABT-450.

Ritonavir boosting is a clear indication that there's room for improvement.


Seeing 90+% SVR rates with the first generation oral combo from GILD brings into question the long-term utility of the P.I. class. The idea of developing a more potent, pan-genotypic P.I. is perhaps short-sighted because you are still working within a class with a history of safety issues and that doesn't co-formulate well with other drugs. The NS5A class is the second most desirable class for oral therapy due to it's benign safety profile alone or in combination. A best-in-class NS5A should safely fill in the efficacy gap (across genotypes) left by a highly-potent nucleotide backbone.

Put it this way. ABBV has a very competitive oral combo for GT1 therapy (including P.I.). Regardless no developer should be striving to replicate the ABBV model. It's flawed.

Medivir/JNJ will soon have an approved best-in-class P.I. The drug could see utility off-label as a second-line oral option. Maybe there will an oral licensing deal with a partner. I expect there will be a short window of opportunity within developed markets.

[DewDiligence]

ENTA/Medivir—[Ritonavir boosting] is why I'm content on continuing to hold Medivir, as opposed to swapping out my position for ENTA, which is about the same market cap.

ABT-450 has six all-oral trials in phase-3, while Simeprevir has zero all-oral trials in phase-3; that’s a pretty big distinction. Moreover, as noted in #msg-89505745, ABT-450 uses ritonavir at only half the normal PK-boosting dose.

[DewDiligence]

(Medivir)—JNJ disclosed today that one its drugs was recently denied the FDA Breakthrough Therapy designation. (Source: today’s webinar at http://www.fiercepharma.com/offer/appian_webinar .)

My guess is that the drug is Simeprevir.

[DewDiligence]

Medivir discontinues NS5A drug-discovery program:

http://finance.yahoo.com/news/medivir-makes-strategic-decision-focus-065100090.html