See a need. Fill a need.

This call to action has been a guiding principle for Cumberland Pharmaceuticals since the company was founded in 1999 and has led to the company's newest venture. "We're announcing the formation of a new division just to focus on oncology," said Chairman and CEO A.J. Kazimi.

"Oncology is a particularly rewarding and valuable field," he continued. "Many of us are touched by it either personally or through family and friends so it's exciting to start to get involved and help these patients."

The oncology division will be the company's third vertical where Cumberland Pharmaceuticals establishes deep expertise, joining the acute care and gastroenterology divisions. The announcement builds off the recent U.S. launches of Cumberland's two FDA-approved oncology support drugs of Ethyol^® and Totect^®.

Strategic Growth

Starting with two employees, Cumberland has now grown to more than 100 team members across the country promoting and developing the biopharmaceutical company's product lines. Kazimi noted Cumberland is coming off a strong year that saw 25 percent revenue growth in 2017.

"In fact, we were the top-performing stock in the healthcare community here in Nashville," he said. "We're coming off a great year, and now the challenge is to continue that momentum."

To that end, Cumberland crafted a strategic growth plan several years ago with a commitment to adding at least one brand per year through acquisition or development. However, Kazimi stressed, product additions had to be intentional and targeted to fit the niche expertise central to the company's mission of answering unmet needs.

As pharmaceutical companies in America merged and became larger and larger, Kazimi said the focus shifted to blockbuster drugs to fuel growth. "We felt there was an opening to start a new company to get involved in brands - developing and commercializing - that maybe weren't a match for those big boys but still very important to the doctors and nurses who provide them and especially to the patients who need them."

The company's first product, Acetadote^® (acetylcysteine), has become standard-of-care for the treatment of acetaminophen poisoning and is found in more than 3,000 hospitals across the country. Since then, another six products have made it to market. "We've added them one by one. Some we developed in-house, and others we actually went out and acquired and moved them here to Tennessee," said Kazimi. "We've had a very active development and acquisition program, and we're on the hunt for more," he continued.

That hunt has led Cumberland to oncology products. The company's medical advisory board shared the growing need for supportive drugs as more and more patients are being diagnosed with cancer and surviving longer.

"We heard that, and so our first two moves are with two brands that don't cure cancer but help the patients as they go through their cancer treatments," he explained. "The question is can you help them tolerate their treatment and help them with their quality of life after?"

Ethyol^®

The branded name for amifostine, which Kazimi said was discovered at Walter Reed as the military and space programs looked to help protect soldiers and astronauts from radiation.

"That work led to the development of this pharmaceutical product to help protect patients from the harmful effects of radiation," Kazimi explained.

Although a small pharmaceutical company successfully launched the drug in America, the company was acquired by a larger firm ... which was then acquired by an even larger firm in Great Britain ... and the product languished. "It actually disappeared as a brand in the United States," said Kazimi.

Teaming up with Clinigen Group, plc, another British firm that had acquired the worldwide rights to amifostine, Cumberland entered an exclusive agreement to commercialize Ethyol in the United States in late 2016 and rolled the product out last year.

"If you're being treated for cancer, this can distinguish between your cancerous cells and your healthy cells," Kazimi noted. "Radiation has become more precise, but we find there is still a need for a product like this."

He continued, "For example, it's FDA-approved to protect your salivary and other glands when you're getting treated for head and neck cancer."

Xerostomia (dry mouth) occurs in up to 80 percent of patients undergoing radiotherapy. For some, xerostomia impacts the ability to eat, chew, taste and swallow for the rest of a patient's life. "By providing Ethyol, it can help prevent that from happening," Kazimi said.

He added, "It also will help women who are treated for ovarian cancer with a chemotherapeutic agent to help protect the kidneys." In clinical studies, the use of Ethyol significantly reduced the number of patients experiencing treatment-limited nephrotoxicity compared to patients who did not receive Ethyol treatment.

In addition to the current FDA-approved uses, Kazimi said a number of physicians are successfully using Ethyol in prostate cancer patients to protect the intestine while a tumor is being radiated and in lung cancer patients to protect as much of the lung as possible.

Totect^®

Introduced late last year, Totect (dexrazoxane) is an emergency intervention for patients whose anthracycline chemotherapy agent leaks out of their blood vessels and circulates into surrounding tissue, which causes severe damage and serious complications. Totect limits the damage without the need for additional surgeries and procedures, allowing the patient to continue their cancer treatment. In clinical trials, Totect eliminated the need for surgery in 98 percent of patients with anthracycline extravasation.

"It's really almost like an antidote," explained Kazimi. "It stops that poisoning and damage to your tissues that your chemotherapeutic agent can cause." He added, "This is the only product approved for that problem."

Additionally, dexrazoxane has a popular off-label use as a cardioprotective agent that is often utilized for pediatric leukemia patients and increasingly for women with breast cancer as research points to a raised risk of heart disease following cancer treatment.

Although not approved for that indication, Kazimi said at the time they landed the U.S. rights to Totect as part of the strategic alliance with the Clinigen Group, there had been a national shortage of dexrazoxane. "The minute the FDA put it on their website that it was available, we were bombarded by children's hospitals and major cancer centers from all over the country asking for emergency shipments because they needed it so their cancer patients could continue their treatments. That was a really rewarding and really exciting time."

Next Steps

"We've got a pretty robust pipeline today of products in development to address patient conditions where there's nothing available to help them," Kazimi said. "The problem with that is as valuable and exciting as that is when you get there, it takes time ... and it takes money ... and there's risk along the way.

"We're two for two with Acetadote^® and Caldolor^®, and we have four more on the way. But while we're waiting for their arrival, we're looking at other products we can bring in that are already approved," he continued.

"Now we've got three different areas we're involved with - acute care, gastroenterology and oncology - and the logical choice for us for our next move is to add something in one of those three. We plan to continue to grow the lines of products and grow the teams supporting those products across the country," Kazimi concluded.

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