Replies to post #38062 on Biotech Values

[DewDiligence]

>For later entrants to win meaningful market share away from a first entrant such as Vertex, they would have to prove they have a decisive advantage in terms of safety, side effects, efficacy, convenience, cost, or marketing muscle.<

This depends on what the author means by later entrants. It will likely be 2-3 years before VX-950 is on the market. Any drug entering phase-3 before then—such as NM283—will merely have to show a benefit relative to the current SoC (pegifn + ribavirin).

Moreover, VX-950 has not even been tested in non-genotype-1 patients, leaving a pretty big hole for other drug candidates to exploit.

The Barron’s critique you cited comes up short, IMO.

[nerdseeksblonde]

if you read my post,
you could read my comments onthe matter.

Think patent lifetime, rational drug design, resistance
strain creation in vitro, production lifecycle...

[dewophile]

re critique:

1. it quotes 2 medical researchers (Dr brown from columbia was also quoted and felt similarly)..it is true dieterich may be biased as he is a consultant, but the article also mentioned he participates in vx-950 trials as well, so I'm not sure the extent of bias. dr. brown, to my knowledge, has no close ties to idix

2. the size of themarket is going to remain huge. first off it is not clear vx-950 will beat nm-283 to market. even if it does, as long as both perform well, it's going to be neck and neck. vx-950 probably won't work against non-genotype 1 (and polymerase inhibitors in theory should, as they are not designed to be geno 1 specific). vx-950 thus far primarily includes riba-peg follow on...the same treatment which prevents most hep C patients from taking meds in the first place. And, most people don't even know they have hep C as it is indolent for years, so even if vx-950 had a significant first mover advantage (and not clear it will), the population size will remain HUGE

3. Drugs with FDA agreed protocols in registration-type trials shouldn't be subject to a new "standard" (whether clinicians post-approval will Rx those meds is another story..i have expounded on the numerous complicated scenarios in hep c that shoudl allow more than 1 direct antiviral to play a role clinically even if antiviarl effect inferior)

my 2 cents