Momenta Pharmaceuticals, Inc.: Good News from Courts and the FDA Ahead?

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Momenta Pharmaceuticals (MNTA) released second-quarter earnings last week. While the report included sales of Momenta's and partner Novartis AG's (NVS 1.93%) Glatopa, the generic version of Teva Pharmaceutical Industries' (TEVA 0.63%) once-daily Copaxone, investors should focus on the potential approval of the generic three-times-weekly version of Copaxone.

Momenta Pharmaceuticals results: The raw numbers

Data source: Momenta press release.

What happened with Momenta Pharmaceuticals this quarter?

• While revenue dropped precipitously, the decline was entirely due to collaboration revenue, not sales of Glatopa, which came in at $20.7 million in the second quarter. The year-ago quarter only had $19.2 million in product revenue from sales of Glatopa by Novartis, although that number was reduced by $9 million to reimburse Novartis for legal expenses.
• Glatopa has nearly 38% of the once-daily Copaxone market, but that market is less than a third the size of the three-times-weekly version, as Teva Pharmaceuticals has switched patients to protect its revenue.
• Momenta and partner Shire (NASDAQ: SHPG) have completed enrollment for the clinical trial required to gain approval of M923, their biosimilar version of AbbVie's Humira. The companies will report top-line data for the trial later this year, and assuming the drug works as designed, file a market application next year.
• In bad news, a phase 2 trial of necuparanib in pancreatic cancer was stopped because it's clear the drug isn't helping patients.

What management had to say

Craig Wheeler, Momenta's president and CEO, noted that the FDA tries to make decisions about generic drugs before the exclusivity runs out on the branded product; he said that the company does "expect to see a tentative approval before we could legally launch" the three-times-weekly version of Copaxone.

On the transfer of its partnership for M923 from Baxter to Baxter's spinoff Baxalta and eventually to Shire, which recently closed its acquisition of Baxalta, Wheeler was diplomatic while pointing out that it's possible Shire may not want to be in the biosimilar business: "We think that the combination of Shire and Baxalta would be a good partner for us, but they have to make their own portfolio decisions. And it may provide an opportunity for us to get the product back as well. So we'll have to just to see what their decisions are," Wheeler said.

Looking forward

Momenta still expects an approval for the three-times-a-week generic version of Copaxone this year, which would allow for a launch as early as the first quarter of next year, once Teva's exclusivity runs out.

Before then, a decision from the U.S. Patent Office is expected no later than August 25 on the inter partes reviews (IPRs) filed by Mylan (MYL) and Amneal Pharmaceuticals, which are also developing three-times-weekly versions of Copaxone. And then Momenta's and Novartis' lawsuit to invalidate Teva Pharmaceuticals' patents on the three-times-weekly version of Copaxone is scheduled for September.

While all eyes are on the hoped-for near-term launch of the three-times-weekly version of Copaxone, work continues on the biosimilar project with Mylan, which should garner Momenta another $60 million milestone payment later this year.