Merrimack Pharmaceuticals Inc. (NASDAQ: MACK) saw its shares halted for “news pending” due to an approval from the U.S. Food and Drug Administration. The FDA announcement said that Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, has been approved to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

While Merrimack has a $1.1 billion market cap, at least ahead of the news, this could be a big gain for the company. Revenues were almost $103 million in 2014, and they are expected to be almost $104 million in 2015 and $165 million in 2016.

What matters here is that the National Cancer Institute (NCI) defines what Merrimack could receive, depending on how this drug gets priced. The FDA press release showed that the NCI projects that there will be some 48,960 new cases of pancreatic cancer diagnosed in the United States in 2015. Unfortunately, there is projected to be nearly the same number of deaths caused by the disease — 40,560.

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Pancreatic cancer has remained an elusive and deadly cancer. The fatality rates versus the diagnosed rates above should highlight that. Here is what was said of the study data behind the FDA approval:

The effectiveness of Onivyde was demonstrated in a three-arm, randomized, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy. The study was designed to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone lived longer than those receiving fluorouracil/leucovorin. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin.

In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumor growth compared to those who received fluorouracil/leucovorin. The average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months compared to 1.5 months for those receiving fluorouracil/leucovorin.

The safety of Onivyde was evaluated in 398 patients who received either Onivyde with fluorouracil/leucovorin, Onivyde alone or fluorouracil/leucovorin. The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever (pyrexia). Onivyde was also found to result in low counts of infection-fighting cells (lymphopenia and neutropenia). Death due to sepsis following neutropenia has been reported in patients treated with Onivyde.

The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea. Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.

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The FDA’s Priority Review designation for the application for Onivyde means that patients will have earlier access to a drug that helps extend survival. The FDA granted Priority Review and orphan drug designations for Onivyde. The orphan drug designation effectively gives incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.

Merrimack shares were down 1.6% at $9.85 prior to the halt. Again, its market cap is a mere $1.1 billion. Merrimack also has a 52-week range of $7.57 to $13.84 and a consensus analyst price target of $15.00.

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