Momenta Pharmaceuticals, Inc. (MNTA)

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Q&A with Momenta's Craig Wheeler
by Ben Fidler | Published March 30, 2012

The guidelines for the U.S. Food and Drug Administration's approval system for biosimilars -- generic biologic drugs -- are now in draft form, just in time for a wave of patent expirations for several of the world's blockbuster biologics, among them cash cows Enbrel, Remicade and Herceptin. The onset of a new multibillion-dollar market is near, and the arms race has begun.

Partnerships are springing up across the pharmaceuticals sector, most notably among large-cap powerhouses angling to get a part of what research firm IMS Health Inc. expects will be a market worth as much as $2.6 billion by 2015. (Biologic drugs represented a $138 billion market in 2010, according to IMS.)

Among the partnerships are Biogen Idec Inc. and Samsung Biologics as well as Amgen Inc. and Watson Pharmaceuticals Inc. Others, such as Merck & Co., Teva Pharmaceutical Industries Ltd. and Boehringer Ingelheim GmbH, are creating in-house divisions. Clearly, biosimilars will be a business geared toward companies with significant financial wherewithal.

Amid all that firepower is a middle-market entity out of Cambridge, Mass., Momenta Pharmaceuticals Inc. that produces generics and has two branded compounds in clinical development. Momenta's business is based on a technology developed at the Massachusetts Institute of Technology to analyze and understand complex biologic mixtures.

CEO Craig Wheeler -- the former president of the biotech division of Chiron Corp. before it was sold to Novartis AG in 2006 -- says Momenta initially intended to use the technology to do more efficient and rational drug design. But improvements to the technology paved the way for Momenta to create generic pharmaceuticals. including a copycat version of blood clot-prevention medicine Lovenox that was approved in July 2010 and has given it the revenue stream to fund the development of its pipeline.

Momenta's latest discovery may prove to be its most lucrative: the platform can be used to create biosimilars.

Now, Momenta has the chance to be at the forefront once Congress signs off on the FDA's guidelines. Momenta signed a collaboration agreement with Baxter International Inc. on Dec. 22 to develop and commercialize biosimilars. Under the deal, Baxter will decide which drugs to develop, and Momenta will get the backing to distribute them globally.

Wheeler earned degrees in chemical engineering from Cornell University and an M.B.A. from the Wharton School. Prior to Chiron, he spent 13 years in Boston Consulting Group's healthcare practice. In an interview with The Deal, Wheeler discusses the

FDA's approval process for biosimilars, the battle for market share in generic biologics and why Momenta might be well positioned to profit.

The Deal magazine: How did Momenta Pharmaceuticals end up with the capability to produce biosimilars?

Craig Wheeler: It was about four years ago -- a year and a half after I came -- when our research group said that we could take these tools and make a generic biologic. We didn't have a lot of money then, because we didn't have an approved product.
So basically, I gave them a challenge, I said, "Prove it." I said, "I don't care if you bring me a product. I don't have the money to fund it right now. Take a cell line, take a gene, and show me you can make a generic version that is indistinguishable in every attribute from a brand. Pick your molecule."

So they did. Our analytic tools were good, but we had to develop all the process tools to manipulate a cell-based process as opposed to a synthetic process. About 18 to 24 months ago, they came back to one of our portfolio steering committees and said they did it. At that point I said, "OK, we're going into this business." So we started investing in it, really in making the tools more robust so that we could really go after molecules.
Why did Momenta team up with Baxter?

started talking about who we could partner with a couple of years ago, but two things really opened up the gates for us. One is showing we could actually use our technology to get a product approved with [generic] Lovenox, and the other was, there is a pathway that now allows us to take advantage of the technology. It was very hard to say we were going to use this to reduce clinical trials and get [interchangeability] when the FDA had no pathway for it.

So people can partner with us with a lot more assuredness because a pathway exists. And the FDA has accepted our approach technologically. So that kind of opened the door for a partnership.

How do you think the market for biosimilars will take shape?
This is a brand-new business, and it's probably the only multibillion-dollar healthcare business being created from ground zero in as many years as I can remember. The market's going to evolve. I think what you've seen in the last few months is, the battle lines are really being drawn. This is a market that requires deep pockets and science.

And so you're seeing Samsung and Biogen. Amgen and Watson. Us and Baxter. And then drug companies -- Pfizer, Merck, Novartis with [its generics arm] Sandoz coming in and then a couple of large generic players, Teva most notably -- that can cobble it together on their own because they have experience in making new drugs. So there's a large set of players. Korea has also made a big commitment to try to corner this market. They've put billions into it.

So it's going to be a market of big players. There's a lot of players who are on the periphery, but I really think it's going to start to settle into these big partnerships for big entities.
How has the FDA created its guidelines?

They basically put a public-meeting process in place where they would invite stakeholders in to advise and react to the FDA's thoughts in terms of how they would develop the [approval] pathway. So we, as a company, and also as members of [the Biotech Industry Organization], were present in those discussions. And those discussions are constrained by what the law says because there are lots of interpretations.

So there were lots of political positions going back and forth in those discussions. Should we ever have interchangeability [an FDA designation allowing a biosimilar to be substituted for its reference product without involving the prescribing physician]? Should we require people to do clinical trials?

In the end, I think the FDA came up with a very fair process, and it was signed on to by all sides. The process will allow companies, at their own discretion, to take advantage of different types of meetings.

The key meeting for us is what's called the "type 3" meeting, in which the FDA will accept your data package on physiochemical and biologic characterization as well as your process -- all the nonclinical things. And they will review it within 120 days, and then you'll have a meeting. And at that meeting they will give you guidance in terms of what kind of clinical trials are required and the potential for interchangeability.

How will Momenta try to get an edge over other developers in creating biosimilars and getting them approved?

We want to have discussions with [the FDA] with the goal of reducing the clinical-trial requirements as well as going directly towards an interchangeable generic. That's what we're hoping for.
Other companies can choose to go directly to clinical trials and do the full clinical trials, and whether they get interchangeability or not is going to be figured out down the road, after they get clinical experience.

[But] for us, we're trying to get interchangeability out of the blocks, and hopefully set the standard for the FDA and actually get those advantaged approvals [such as a proposed 180-day exclusivity window, or even de facto exclusivity for a branded biologic's first approved biosimilar]. If we can succeed with that, this is going to be a tough market for a lot of people who aren't interchangeable.

Assuming Congress ratifies the draft guidelines, how quickly could you bring biosimilars to the market?
It depends on how the FDA pathway evolves. If we go in and take advantage of this pathway and the type 3 meeting, and the FDA agrees with us that we don't have to do major Phase 3 trials, it could be relatively quick. If they're not quite ready to do that, and we have to do full trials, then it's going to take a little while because we're going to have to execute the full set of trials.

In terms of taking advantage of the pathway, I would hope once the pathway is fully up and running that would be a less-than-12-month process. But I don't expect it to be that way out of the blocks. This is brand new for the FDA; they're just staffing it up. It's going to be slower, so I'm kind of thinking it will be more in that 18- to 24-month range.

I hope it's much quicker, but I am also a realist. I have been burned many times before.

Read more: Q&A with Momenta's Craig Wheeler - The Deal Pipeline (SAMPLE CONTENT: NEED AN ID?) http://www.thedeal.com/magazine/ID/045648/dealmakers/movers-shakers-a-qa-with-momentas-craig-wheeler.php#ixzz1qhzLeZMh