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Momenta Blocked

By Brian Orelli, PhD - Feb 19, 2016 at 4:20PM

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Novartis, the biotech's partner on Glatopa, is having trouble capturing more of the Copaxone market.

Momenta Pharmaceuticals (MNTA) released fourth-quarter earnings on Thursday with all eyes on sales of Glatopa, its generic version of Teva Pharmaceuticals' (TEVA 1.53%) Copaxone.

Momenta Pharmaceuticals results: The raw numbers

 

Q4 2015 Actuals

Q4 2014 Actuals

Growth (YOY)

Revenue

$22.4 million

$21.2 million

5.7%

(Loss) From Operations

$(29.5 million)

$(16.1 million)

N/A

(Loss) Per Share

$(0.43)

$(0.31)

NA

What happened with Momenta Pharmaceuticals this quarter?

  • While revenue only increased 5.7%, the year-ago quarter had a $12 million contribution from Baxalta for reaching a milestone for their biosimilar drug.
  • Product revenue more than tripled year over year thanks to the $15.6 million from Momenta's half of Glatopa sales by marketing partner Novartis (NVS 0.71%).
  • Glatopa has "over 30%" of the once-daily Copaxone 20 milligram market according to management, up a little from "approximately 25% to 30%" of the market that management cited during the third-quarter call.

What management had to say 
"As we look ahead, the challenge now is to define strategies to continue to increase Glatopa's market penetration. Teva has switched approximately 75% of once-daily Copaxone 20 milligram patients to three times weekly Copaxone 40 milligram product," said Craig Wheeler, Momenta's president and CEO, noting that Teva is making it difficult for Novartis to establish contracts because Teva is tying rebates on the 40 milligram version to the continued use of Teva's 20 milligram version.

While the focus has rightfully been on multiple sclerosis (MS) patients switching from Copaxone to Glatopa, Wheeler pointed out another segment that could potentially grow, "How do we expand, for example, the new patients? Can we begin to get into formularies where this agent could actually be the agent of choice for new MS patients before they went onto other therapies? It has significantly fewer risky side effects that could happen in some of the orals and at little lower cost and have equal efficacy data."

Looking forward
Without a doubt, the approval of Momenta and Novartis' 40 milligram version of Copaxone is clearly Momenta's most important near-term event. Management hopes that'll happen this year with a launch as early as the first quarter of next year. The 40 milligram version will open up the other 75% of the market that are on that version of the drug, but it'll also make it harder for Teva to block access to patients still taking the 20 milligram version.

The biosimilar program continues to advance with the first one -- a biosimilar version of AbbVie's Humira that's partnered with Baxalta -- potentially on the market in 2018. Momenta and its new partner, Mylan, plan to initiate a clinical trial for M834, their biosimilar version of Bristol-Myers Squibb's Orencia, in the middle of the year, which puts it on track to launch the biosimilar in the 2020 time frame.

Momenta continues to advance its novel products as well. Clinical trial data from the phase 2 trial of necuparanib in pancreatic cancer will be available in the second half of 2017, delayed slightly after having to pause enrollment in the trial to adjust the protocol for diagnosing and managing thrombocytopenia, low blood platelet counts that may be a side effect of the drug.

The company also plans to start clinical trials in the middle of the year for a new drug, M281 that targets the neonatal Fc receptor (FcRn). Binding to FcRn results in a reduction of antibodies, which should help patients with autoimmune diseases.

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Stocks Mentioned

Novartis AG Stock Quote
Novartis AG
NVS
$84.77 (0.71%) $0.60
Teva Pharmaceutical Industries Limited Stock Quote
Teva Pharmaceutical Industries Limited
TEVA
$7.95 (1.53%) $0.12
Momenta Pharmaceuticals, Inc. Stock Quote
Momenta Pharmaceuticals, Inc.
MNTA

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