Momenta (MNTA): Positive Read-through from FDA Biosimilars AdCom - Stifel

Stifel analyst, Thomas Shrader, think Momenta (NASDAQ: MNTA) is in a good position heading into the FDA Advisory Committee tomorrow. The verbage in the FDA briefing document appears to explain away some potential flaws in the submission leading to a likelihood of acceptance. No change to Buy rating or $29 PT.

The FDA Arthritis Advisory Committee will commence tomorrow and weigh-in on the approval and extrapolation of CT-P13, a Remicade biosimilar. The FDA briefing document appears unusual with the agency actually explaining away some potential flaws in the submission. It appears the FDA is quite favorably disposed toward biosimilars.

The tone of the FDA seems unusually positive despite all the efficacy data for a U.S. submission having been generated in comparison to the EU form of Remicade and seemingly before a U.S. submission was ever contemplated. In addition, it is fairly clear that the levels of anti-drug antibodies are higher for the biosimilar but the FDA seems to dismiss this issue with comments suggesting that the comparison might have been made with a very good batch of branded U.S. Remicade. In our experience, FDA documents are generally full of potential concerns for the panel to discuss.

In somewhat of a surprise, the FDA seems focused on average TNF-alpha binding properties of CT-P13, but released figures clearly show a wider spread in this parameter for CT-P13 than for either U.S, or EU Remicade. They view this idea of potential “bad batches” to be a hot button for biosimilars that innovators are likely to target in counter detailing. They think it’s likely that a truly bad batch could end the use of a biosimilar. They believe Momenta with its focus on process development and analytical characterization is less likely than most entrants in this field to be derailed by this issue.

For an analyst ratings summary and ratings history on Momenta Pharmaceuticals click here. For more ratings news on Momenta Pharmaceuticals click here.

Shares of Momenta Pharmaceuticals closed at $11.00 yesterday.

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