Momenta: Oh, Sugar!

Momenta Pharma said this morning that FDA had rejected the ANDA for its m-enoxaparin (Lovenox) generic antithrombotic because it doesn't address the potential for immunogenicity. The bad news was delivered to Momenta's partner, Sandoz (Novartis' generics arm) late yesterday.

It came as a shock, particularly given the confidence that Momenta's management had, until now, expressed in their relationship with the regulators. The immunogenicity concern "is the only issue in the letter. And it is the first time in 26 months we’ve been at the agency that they asked a question about this," Momenta CEO Craig Wheeler said on a conference call with investors today.

So is the company re-evaluating where it stands with FDA's office of generic drugs in light of this kind of ambush? "We are surprised in this question coming at this specific time. I don’t know what’s happening at the agency. But based on where we thought we were with the review … there are a lot of questions we have as well," Wheeler declared.

If FDA or the OGD was aiming to provide fodder for conspiracy theorists, their last-minute "oh-by-the-way" immunogenicity information request will probably be deemed a success.

Let's take a step back. The m-enoxaparin ANDA was in many ways a test case for whether or not it's possible to adequately characterize complex molecules--a question of particular relevance to the scope and nature of a future pathway for large molecule generics (even though, as a generic version of the complex sugar mixture Lovenox, this isn't quite a bio-generic--or should we say biosimilar...).

Momenta claims that its proprietary sugar characterization technology gives it a unique characterization capability that other would-be Lovenox generics purveyors lack. If it's right, the company might have had a more than decent shot at taking a large chunk of the low molecular weight heparin market. That's not pocket change: Sanofi-Aventis racked up more than €2.4 billion in Lovenox sales in 2006.


It's unclear whether other generix enoxaparin players like Teva have received similar letters from FDA, although Wheeler noted during today's call that FDA has communicated to the company that this was a general issue--one that would appear to concern all generic enoxaparin ANDAs, not just Sandoz/Momenta's.

Unlike a few recent high-profile snafus among biotechs in late stage clinical trials or at FDA (such as Novacea and GPC), Momenta isn't likely to collapse under the weight of this setback--though its market value was cut in half as of this morning. The company broadened its alliance with Sandoz last summer to include a handful of projects and has quite a bit of cash--approx $130 million at year-end, as predicted by analysts.

It's impossible to say what FDA will ask Momenta to do, or to show, to get back on track with m-enoxaparin until the company meets with the agency, Wheeler said today, and so the costs associated with the delay or future trials are as yet undetermined. But whatever happens, this issue may yet reverberate beyond Momenta and further delay biosimilars' already slow progress to market in the US.