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June 8, 2014

Momenta Pharma receives FDA orphan drug designation for pancreatic cancer drug

Momenta Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its necuparanib, a heparan sulfate mimetic indicated for treatment of pancreatic cancer.

By Mekala ShivaramPrasad

Momenta Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its necuparanib, a heparan sulfate mimetic indicated for treatment of pancreatic cancer.

Momenta Pharmaceuticals chief medical officer Jim Roach said there is a great need for new medications for patients suffering from pancreatic cancer.

"We are encouraged by the progress of the programme to date, and in the next several months, we anticipate completing Part A of our ongoing Phase I/II study of necuparanib in combination with Abraxane and gemcitabine," Roach said.

"In the next several months, we anticipate completing Part A of our ongoing Phase I/II study of necuparanib in combination with Abraxane and gemcitabine."

"We look forward to sharing the results from Part A and advancing the product into the Phase II part of the study in the second half of 2014."

Necuparanib has recently been adopted as the unique non-proprietary name for M402 by The United States Adopted Names.

The drug is derived from unfractionated heparin. It has been engineered to have significantly reduced anticoagulant activity while preserving the relevant antitumor properties of heparin.

Part A dose escalation component of the Phase I/II trial, which is evaluating necuparanib in combination with Abraxane (nab-paclitaxel) and gemcitabine in advanced metastatic pancreatic cancer patients, is expected to be completed in the next several months.

The company is expected to report the clinical data from Part A in the second half this year. The company also plans to begin Part B of the study by the year-end.

Part B will be a randomised, controlled, proof-of-concept study to assess the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone.

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