This week’s Biotech Digest will focus exclusively on one biotech company and the unique opportunities its holds, which is the type of analysis that is offered in every issue of BTA’s Monthly Biotech Focus subscription newsletter. Our analysis goes from a thorough reading of the company’s product, market, potential, and probability of success. Our full Monthly Biotech Focus includes more advanced analysis such as balance sheet analysis and more in-depth detailing of the studies behind these biotech companies. This week’s company is Merrimack Pharmaceutical (MACK).
What is a pancreas, exactly?
For all the talk about pancreatic cancer, how many actually know what it is, where it is located, and why it is so difficult to treat? The pancreas is an organ located behind your stomach that is composed of two glands (exocrine and endocrine). The pancreas releases “juice” into the intestines which helps digest food as it passes through the human body.
Pancreatic cancer, despite being only 3% of all diagnosed cancer, is one of the four deadliest cancers. Its toll on lives continues to tick up. Pancreatic cancer, in fact, is the third leading cause of cancer-related death in the United States. The American Cancer Society estimates that 48,960 people will be diagnosed with pancreatic cancer, and that 40,560 of those will die as a result.
One reason that pancreatic cancer is so difficult to fight is that the drugs used to combat cancer have difficulties going directly into the pancreas. The pancreas’ location makes it notoriously difficult to reach with common treatments for cancer. There are, however, a number of biotechnology companies that are seeking to alleviate the conditions of pancreatic cancer. One of these is Merrimack Pharmaceuticals.
Passing phase-3 FDA testing is a one of the more difficult hurdles a biotechnology company has to jump, with FDA approval as the ultimate goal. Merrimack Pharmaceuticals has accomplished that goal.
Merrimack (MACK) is a company that BTA has been following since summer 2015. MACK’s main product, Onivyde, was approved by the FDA in October 2015. Onivyde is an injection to be used in combination with other drugs during chemotherapy, and was found, during its phase-3 testing, to slow the growth of the tumors in patients with pancreatic cancer. It took, on average, twice as long for a tumor to grow when treated with Onivyde than without. It was also found to extend the life of the patient who took it by about 6 months, which is significant given that pancreatic cancer usually claims its victim’s life sometime within 5-10 years.
Recently, according to reports, Onivyde has been found to reduce the risk of death by 25 percent for patients with metastatic pancreatic cancer (in combination with other drugs). Lead investigator, Andrea Wang-Gillam, from the Siteman Cancer Center and Washington University School of Medicine, St. Louis, said recently that “the Onivyde combination regimen is well-positioned to become the standard of care… this new therapy offers hope for extended life expectancy in a patient population with limited options.”
The phrase “limited options” is also significant. Pancreatic drugs have difficulty entering the pancreas, as noted above, and thus not many drugs are developed for the disease, and those that are are rarely successful. Onivyde is one of a handful of drugs to be approved within the past 5 years and thus is one of the only products in a limited market.
Having a pipeline that continues to create a diverse number of products is another strong point for Merrimack Pharmaceuticals. For instance, Onivyde is being tested for front-line metastatic pancreatic cancer and not just post-gemcitabine metastatic pancreatic cancer. What this means is that the Onivyde is now being tested for use before patients are given a treatment with gemcitabine (another drug type), thus at a potentially earlier stage in the cancer’s development. Onivyde is also in Phase 1 testing for breast cancer and pediatric sarcoma. And that’s just Onivyde.
MACK also has a number of other drugs between pre-clinical and phase 2 testing, all treating some form of cancer, including lung cancer and breast cancer.
Probability of Success
We can now put together this information together to form a picture of Merrimack’s probability of success. One of the most difficult hurdles for emerging biotech companies is that of FDA testing. The fact that Onivyde has already been approved for us in combination with other drugs signifies that Merrimack already has a successful (in terms of testing) product to market. This will help the company as it continues its testing on Onivyde for other treatment possibilities and its development of other drugs in its cancer treatment pipeline. In total, Merrimack Pharmaceuticals is a biotech company to keep an eye on as it has already made significant strides in a field in which there has been, to date, limited success.
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