Cumberland Pharmaceuticals Begins U.S. Shipments Of Ethyol (Amifostine) For Oncology Patient Support

NASHVILLE, Tenn., Aug. 23, 2016 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), a specialty pharmaceutical company focused on the development of innovative treatments for underserved patient populations, will begin distributing Ethyol® (amifostine) for injection to U.S. wholesalers today. Ethyol is an FDA approved cytoprotective drug indicated to reduce the incidence of xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

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Ethyol is Cumberland's first oncology support product and complements its current portfolio of specialty pharmaceuticals. Cumberland is responsible for all distribution, promotion, and medical support of Ethyol in the U.S.

"We are delighted to make Ethyol available again for oncology patients throughout the U.S.," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to expanding our activities into hospital-based oncology while continuing to deliver products that improve the quality of care for patients and address poorly met medical needs."

Earlier this year, Cumberland signed an exclusive agreement with Clinigen Group plc, a global pharmaceutical, and services company, to commercialize Ethyol® in the United States. Clinigen acquired the worldwide rights to Ethyol® from AstraZeneca in 2014. This is the first product Clinigen has licensed to Cumberland under the Strategic Alliance the two companies signed late last year.

About Ethyol® (amifostine)

Ethyol is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. It is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on acquisition, development, and commercialization of high-quality products that improve the quality of care for patients. The Company has a diverse product portfolio with a focus in the areas of hospital acute care and gastroenterology.

Cumberland's marketed products include Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States, Kristalose® (lactulose) for Oral Solution, a prescription laxative, Vaprisol® (conivaptan) Injection, for the treatment of hyponatremia and Omeclamox-Pak® for the treatment of H. pylori and duodenal ulcer disease.  Cumberland is dedicated to also developing innovative products that address unmet medical needs. The Company's product candidates in clinical development include: Hepatoren® (ifetroban) Injection for the treatment of hepatorenal syndrome, Boxaban® (ifetroban) Oral Capsule for patients suffering from aspirin exacerbated respiratory disease, and VasculanTM(ifetroban) Oral Capsule for the treatment of systemic sclerosis. For more information on Cumberland Pharmaceuticals Inc., please visit www.cumberlandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company's most recent Form 10-K and subsequent 10-Q's as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

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SOURCE Cumberland Pharmaceuticals Inc.

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