Biotech Values

[DewDiligence]

MNTA – Excerpts from 16-Mar-2007 Craig Wheeler
interview in The Pink Sheet. (Emphasis and bracketed
annotations added; sorry, no link for this post.)

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Momenta Chief Executive Officer Craig Wheeler recently met with "The Pink Sheet" DAILY at its editorial offices. Wheeler, who has been at the helm since joining the firm in September [2006], previously served as president of Chiron BioPharmaceuticals, where he lead that company's efforts to refocus on oncology and infectious disease.

"The Pink Sheet" DAILY: Momenta's strength is in the characterization technology, especially as applied to sugar sequencing. Can you describe more about this technology, how it is different from other companies' technologies, and what advantages it has?

Craig Wheeler: Momenta's core technology is actually based on years of research out of Massachusetts Institute of Technology. The company was founded in 2001. It really got going around 2002, really using characterization technology to understand complex mixtures. The first drugs that we actually looked at were heparins — heparin-based drugs like Lovenox — because they are highly complex drugs.

You had asked how I would characterize our technology as different. I think our technology uses components or elements of things that we've been working with for a long time, things like nuclear magnetic resonance and mass spectrometry. But really, it is putting it together in a way that actually allows us to essentially make a photocopy of the existing complex mixture of drugs. That's a simplistic way of putting it, but it's how we think about what's necessary to really characterize the drug.

There are three components to the technology. The first is a set of analytics, and those analytics are tailored and customized to whatever complex mixture you're looking at. The second is usually enzymes, or enzymatic digestion, things where you can cut up those specific things into simpler portions so you can analyze them. And the third is basically a bio-informatics platform that allows you to integrate all that data to be able to predict and show exactly what's in the mixture. So we've taken and enhanced existing technologies, but really are using them in a different way to understand exactly what's in a complex mixture.

"The Pink Sheet" DAILY: Is your business strategy going forward going to partner with companies such as the deal with Sandoz, or will you seek to market products on your own?

Wheeler: We think of ourselves as a product company, but like many or most early-stage biotechnology companies, as we're beginning to develop our capabilities, we need broader capabilities to bring things to the market quickly. Partnering with a company like Sandoz brings a lot of capabilities that would have taken many years for us to build on our own, so we really do see that that partnership has really enabled us to grow and advance our technology much more quickly than we could have on our own.

We're not committed to becoming a fully-integrated pharma company. If we find the opportunity and it's in the best interest of our shareholders, we certainly will do that. Our company has two sides of what we're doing: it's the generic and bio-similar business as well as an innovative pipeline that we're also developing.

"The Pink Sheet" DAILY: Can you talk a little bit more about how your collaboration with Sandoz has progressed since the deal, worth up to $263 million, was signed in July [2006]?

Wheeler: Even before that deal was signed, we had a partnership with Sandoz. We had a partnership on M-Enoxaparin, which is currently filed with the FDA. That new deal, actually, we looked at it as a very powerful deal for us… because it really validated our technology. Sandoz came in and essentially reinvested in the company, in a broader portfolio, even before we got the first product approved.

That deal essentially did a couple of things for us. One, it's actually a four-program deal. One is M-Enoxaparin in Europe, so it allows us to introduce our characterization technology into the European regulatory environment. The second is a partnership on another NDA-based compound. We're trying to make a generic version of Teva's multiple sclerosis therapy, Copaxone. And that is important to us because it extends our technology from the sugar-based complex-mixture drug to a peptide-based complex-mixture drug.

Then finally, and probably most important for the long term, is we partnered on two programs that were ongoing Sandoz programs, two glycoprotein programs. We haven't named what those programs are, but the important thing for us is we actually get now to really utilize and develop our tools in the glycoprotein space on programs that are actually well-developed, which really accelerates our ability to leverage this technology into the glycoprotein space.

"The Pink Sheet" DAILY: Can you provide any additional details on those two Sandoz programs you are partnered on?

Wheeler: The other two products are glycoproteins. The reason we don't tend to disclose the programs we're working on is that we are competing in a generic space, and so it is important to us—if our science and technology allows us—to be able to get into the agency, be first to file, get the exclusivity, and if there's any patent litigation, get in front on the patent litigation.

"The Pink Sheet" DAILY: When do you think you would actually disclose what those glycoprotein follow-on candidates are?

Wheeler: I think you're most likely to find out about these things once the file has been accepted and we know what our position is at the agency. But of course that's really something we'd have to decide with our partner.

"The Pink Sheet" DAILY: Would Momenta be open to a possible acquisition by Sandoz or another company, or would you like to remain an independent company?

Wheeler: We're a public company, so we really don't comment on our deliberations about acquisitions, M&A. [There’s a standstill agreement between the companies until July 2008 (#msg-25377212).]

"The Pink Sheet" DAILY: Obviously, you had some very good news in February with a federal court invalidating a key Lovenox patent. There is still a case pending from Sanofi against your firm. What do you believe is the impact of the court's decision? Are you expecting a positive ruling because the court ruled in favor of generic firms?

Wheeler: There will be no need for our case should the patent decision be upheld… so they don't need to litigate against us for infringement on the patents. And so what we're anticipating will happen is that there will be an appeal by Sanofi-Aventis, but based upon the strength that we see in the court's ruling, we think that that appeal will go the same direction, and that ultimately their patent that was overturned will be confirmed in the appellate court, and so we will not need to pursue that case at that point in time, once the patents are gone. [The opening arguments in the appeal take place tomorrow, 8-Jan-2008.]

"The Pink Sheet" DAILY: Assuming that a Sanofi appeal will be settled by the end of the year, and it would still be in your favor, when do you think you could actually launch M-Enoxaparin?

Wheeler: There's one other hurdle for us in terms of being able to launch and it is that we were not the first to file, and therefore there's 180-day exclusivity out there. So there are multiple ways in which we would be able to resolve that problem. If we were approved and Teva and Amphastar were not approved, we could either seek to discuss with them access to 180 days, or we could seek to petition the FDA for the 180 days. If they were approved and they weren't interested in dealing, we would have to wait 180 days for it to be able to launch.
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