Replies to post #75499 on Biotech Values

[genisi]

Agree that the potential unique feature of clevudine will be a durable SVR after stopping therapy, which will be an unusual event in HBV with nucleoside therapy. However, the hint seen in earlier trial needs to be replicated in the phase 3 studies and I'm not convinced it will. So if it shows only modest benefit over Hepsera, in phase III trials, I think it still holds potential in combo if the combo prevents resistance, which is a key issue with monotherapy.

Btw, use of interferon in Europe is still high, due to the high rate of HBeAg seroconversion, and in part cause of guidelines.

[DewDiligence]

Re: Clevudine MoA

the company also believes clevudine is unique in having better activity in reducing cccDNA, which could in theory contribute to better sustained response off therapy

I’m skeptical of these MoA claims about cccDNA. Let’s back up: Clevudine was created by a Korean company, Bukwang, who licensed the drug to VRUS but retained the commercial rights in Asia.

In Korea, where HBV is widespread, Clevudine thus has the dual advantages of being marketed by a Korean company and having more years on the market than any second-generation HBV drug. If Clevudine also had a MoA that was far superior to other second-generation nukes in its ability to clear cccDNA, wouldn’t you expect Clevudine to by the leading second-generation nuke in Korea by a wide margin? I would.

But, in fact, Baraclude outsells Clevudine in Korea despite the fact that it comes from a foreign company and it has been on the market for less time than Clevudine.

Something here doesn’t compute, and I think it’s VRUS’ outsized claims about Clevudine’s MoA.

[DewDiligence]

Caveat Emptor Re Nifty MoA Diagrams!

This is the diagram VRUS formerly employed to tout the
(allegedly) differentiated MoA of Clevudine compared to
other nucleoside polymerase inhibitors for HBV:



Well, that was the spin. What about the reality?

It’s unlikely, IMO, that Clevudine’s MoA was materially different from
Tyzeka’s MoA because Tyzeka and Clevudine are structurally as close
as two drugs could possibly be: Tyzeka (left), Clevudine (right).