Replies to post #50842 on Biotech Values

[DewDiligence]

VRUS / Clevudine factoids:

>what would be the earliest [Clevudine] could move to market - 2009?

Late 2010 or (more likely) 2011.

>although it made it through to registration in Korea... what does it face in [FDA] P3 trials, that it did not face in S. Korea?<

The Korean trials included only 24 weeks of treatment and compared Clevudine to placebo. The total number of patients in the two Korean trials was only 337 (of which only 89 were e-negative).

The FDA phase-3 trials will treat patients for 48 weeks* and will compare Clevudine to Hepsera. The expected number of patients in the two FDA trials is 850-900.

>it appears there are high expectations for Clevudine...<

It’s hard to say because VRUS is below the radar screen of most investors. However, the enterprise value of VRUS is certainly out of whack with the EV of IDIX. Anyone who would consider VRUS a good buy at its current EV would have to be nuts not to think that IDIX was a great buy at its EV. Regards, Dew

*The primary efficacy endpoint will be based on an evaluation at 48 weeks, but patients will be treated for 72-96 weeks to assess safety and SVR.

[mskatiescarletohara]

Clevudine-LFMAU appears there is are high expectations for Clevudine

Years ago this drug was licensed from Bukwang to another company GILD eventually bought. The CEO of that company known as VIRS, thought Clevudine would be a breakthrough for treating HBV, it was licensed based on woodchuck models. When GILD bought the company, the rights/licensure of Clevudine was dissolved and returned to Bukwang. Pharmasset then licensed the compound.

what does it face in P3 trials, that it did not face in S. Korea?

Dew stated it's being compared to GILD's Hepsera. GILD returned Clevudine to Bukwang for two reasons. 1). The original stakes i.e. royalty, expenses, deal structure was considered too high at the time the GILD bought the company. 2). GILD had Hepsera on the market, with GSK being the marketeer in Asia.

possible SVR for HBV?

I remember speaking about Clevudine results with two execs from VIRS at a shareholder meeting, they thought the drug was demonstrating compelling efficacy after a small 28 day dose escalation study, without any safety issues.

I'm certainly interested to see the data from the upcoming pivotals. With 63 million on hand, I expect VRUS to raise more capital to launch the studies. One advantage Asia has is more rapid enrollment given patient pool vs. America and Europe, the PR stated Americas so perhaps they will enroll in South America. These pivotals will require many enrollment sites in order to file an NDA by 2009/10.

katie....