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Merrimack Alters Endpoint in Cancer Drug Trial, Raises Funds

Merrimack Pharmaceuticals, Inc . MACK announced that it has filed an amendment to its ongoing phase II study on pipeline candidate, MM-121 (seribantumab), with the FDA

MM-121, a fully human monoclonal antibody targets ErbB3, is being evaluated for the treatment of patients with heregulin-positive non-small cell lung cancer (NSCLC). The amendment mainly includes a change in primary endpoint to overall survival. Merrimack believes that the change in primary endpoint will facilitate a potential registration opportunity for MM-121.

The phase II study will evaluate MM-121 in combination with docetaxel or Alimta compared to docetaxel or Alimta alone in patients with heregulin-positive, locally advanced or metastatic NSCLC.

The amended primary endpoint of the phase II study will be overall survival, while the secondary endpoints include progression-free survival, objective response rate, safety, and quality of life measures. The company expects survival data in 2018.

We remind investors that MM-121 had previously failed to meet the primary endpoints in two of three study cohorts with the third cohort failing to pass its planned interim analysis in its phase II trial for NSCLC. Moreover, MM-121 did not meet the primary endpoints in phase II studies in patients with ovarian and breast cancers. The company had a collaboration agreement with Sanofi SNY for MM-121, which was terminated.

Separately, Merrimack announced that it has closed a private placement of senior secured notes for an aggregate principal amount of $175 million. The notes were sold to qualified institutional buyers only at a price equal to 100% of the principal amount of the notes. The notes are scheduled to mature on Dec 15, 2022 and bear interest at the rate of 11.5% per year, payable semi-annually.

Merrimack plans to use the net proceeds to repay all outstanding obligations under its loan and security agreement, as amended, with Hercules Technology Growth Capital, Inc. as well as for working capital and other general corporate purposes.

The company expects that with a better cash position, it can independently pursue the potential registration opportunity for MM-121 in NSCLC. Merrimack also plans to use funds from this transaction to support the late-stage development of MM-302 and MM-121, and continue investing in Onivyde.

We remind investors that the FDA approved Onivyde in Oct 2015 for use in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following a Gemzar (gemcitabine)-based therapy.

Merrimack is working on expanding Onivyde's label into front-line pancreatic cancer, front-line gastric cancer, pediatric solid tumors and glioma among others.

Merrimack Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. ANIK and Baxalta Inc. BXLT . Both sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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