Nuvelo CEO Ted Love: An Interview With “The Pink Sheet” DAILY

A day after Nuvelo releases disappointing Phase III results for Bayer-partnered alfimeprase, Love discusses Nuvelo’s next steps for the thrombolytic, and other options in the company’s pipeline.

Nuvelo CEO Ted Love spoke with "The Pink Sheet" DAILY Dec. 12 about his firm's strategy following the announcement of disappointing Phase III results for thrombolytic alfimeprase.

The company said Dec. 11 that it would halt patient enrollment in ongoing trials of the compound after two Phase III trials failed to meet endpoints (¹ (Also see "Nuvelo To Consider In-Licensing Deals In Wake Of Negative Alfimeprase Data" - Pink Sheet, 11 Dec, 2006.)). Nuvelo, based in San Carlos, Calif., partners the drug ex-U.S. with Bayer.

"The Pink Sheet" DAILY : Have you continued discussions with alfimeprase partner Bayer and is there anything new to report?

Ted Love: There have been a few e-mails - very nice e-mails, actually - that have flown back and forth between me and Arthur Higgins, the chairman of Bayer.

But we've made no decisions and I think the plan really is to do what we announced yesterday, which is collect all the data and ultimately get outside experts to help us look at that data and think it through carefully. But we've had very dynamic and fluid interactions with Bayer, and I think that's going to continue.

"The Pink Sheet" DAILY : Is there a timeframe for meeting with outside experts and FDA?

Love: I think its months, and it's hard to know whether it will be three or whether it will be six. But I think it is months because effectively what we're going to do is much of what you would do when you get ready to do a submission. There are a lot of trials. We need to get all that information in-house and do some analysis of it and then present those analyses to these groups, and they will likely have a number of questions even after we give them the first set of data.

It will likely be an iterative process, which I would imagine would take some time. And it is important to do this right. Developing investigational drugs really needs to be done with the focus on making an important invention that's going to ultimately help patients, and recognizing that while you're studying that experimental agent, you're exposing human beings to the agent.

So you need to be very, very thoughtful about whether or not you've got something here that could be exciting for even introducing it into humans. Then, as you generate that data, you've got to be very careful about how you analyze that data before you continue to dose patients, if you find yourself in a circumstance that we're in.

"The Pink Sheet" DAILY : It seems that development of the drug could still move forward. What is your outlook for the compound?

Love: I think it is possible, but we didn't want to signal a probability one way or the other. And in fact, part of the reason that we want to do that is that we want this analysis done by our data safety monitoring board and other outside experts to be unbiased so we really didn't feel it was appropriate for us to take a position on what that advice would be until we actually go out and properly get that advice.

"The Pink Sheet" DAILY : Have you been in contact with FDA regarding the negative trial results?

Love: We actually have. We called the FDA yesterday and let them know where we are. It was more than anything else a courtesy call and it was extremely warm and positive.

"The Pink Sheet" DAILY : When you announced the alfimeprase trial results yesterday, you also said you would focus on in-licensing opportunities. What therapeutic areas are you concentrating on?

Love: We've continued to keep the business focus on cardiovascular and cancer because we think those are areas where a small company can really build itself, if you really focus on the hospital-based type sales force.

"The Pink Sheet" DAILY : How close are you to announcing a deal?

Love: We've always had lots of conversations going. It's kind of the nature of how we run the company in terms of business development - in-licensing discussions. So we've always had some discussions going, and we continue to have discussions since yesterday.

"The Pink Sheet" DAILY : Is the company going to ramp-up efforts in the early-stage pipeline?

Love: I'm not sure I would characterize it as ramp-up. We've continued a strategy of trying to advance a whole portfolio that we anticipated would be behind the launch of alfimeprase. We've always been trying to move those programs as aggressively as possible. And obviously now, I think, in retrospect that was a very good strategy.

"The Pink Sheet" DAILY : Of your early-stage compounds, which are most exciting?

Love: I think all the compounds are very exciting, actually. But they are at different stages and the one which is at the most advanced stage is the rNAPc2 tissue factor inhibitor.

That compound is very interesting for a couple of reasons. One is that we've generated a lot of excellent data that suggests that it could be a superior anticoagulant for acute coronary syndrome, suggesting that you could prevent more cardiac ischemia than with any other therapy available, and that can be very exciting.

We've demonstrated that in Phase II trials and have introduced that compound to more than 700 patients, so we know a lot about the compound.

The other reason why that compound is interesting is that tissue factor is not only a well established target in blood anticoagulation, but it's an increasingly important target in cancer. And we've generated a significant amount of internal data, some of which actually was presented at [the American Society of Hematology meeting] this year that suggests it's an exciting target for cancer.

And based on data we've generated internally, as well as other data, we're moving that same compound into patients with colorectal cancer to try to demonstrate if we can change survival and tumor progression in patients with metastatic cancer.

- Christopher Hollis ([email protected])

[Editor's note: Nuvelo's Ted Love was one of five participants in a Bay Area biotech roundtable sponsored earlier this year by "The Pink Sheet" DAILY (² (Also see "Bay Area Biotech Roundtable: What Does It Take To Excel In The Global Marketplace? (Part 1 of 3)" - Pink Sheet, 6 Nov, 2006.)).]