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Cumberland Pharmaceuticals (CPIX) and Pernix Therapeutics, Inc. (PTX) Enter Into Exclusive Agreement to Promote Omeclamox-Pak®


10/28/2013 10:10:52 AM

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NASHVILLE, Tenn. and THE WOODLANDS, Texas, Oct. 28, 2013 /PRNewswire/ -- Cumberland Pharmaceuticals Inc.(NASDAQ:CPIX) and Pernix Therapeutics, LLC (NYSE: PTX) today announced an agreement for the promotion of Omeclamox-Pak covering the United States.

Omeclamox-Pak® is a branded prescription product that combines omeprazole, amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. It is the first FDA approved triple combination medication to contain omeprazole as the proton pump inhibitor and is prescribed over a shortened treatment period of ten days.

Under the terms of the agreement, Cumberland will promote the product to gastroenterologists across the United States through its field sales force which also promotes its Kristalose brand. Pernix will promote the product through its specialty sales force focusing on select primary care physicians. The companies will cooperate in the marketing and other activities needed to support the commercialization of the brand.

"We have been searching for an FDA approved gastroenterology product that can be featured by our field sales force," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We have been very selective in the brands that we bring into our portfolio, and believe that Omeclamox-Pak is an excellent fit for our field sales organization. We look forward to featuring this important product to caregivers and their patients suffering from ulcers caused by h. pylori infections."

Dr. Brian Fennerty, M.D. Professor of Medicine, Division of Gastroenterology at Oregon Health & Science University said, "Published studies show that a single ten-day regimen of twice-daily therapy with omeprazole, amoxicillin and clarithromycin eradicates 80 to 90 percent of H. pylori infections."

"Gastroenterologists are the leading prescribers of h. pylori treatments and we are excited to partner with Cumberland to reach that key audience for the Omeclamox-Pak brand," said Cooper Collins, Chief Strategic Officer of Pernix Therapeutics. "We believe that together we should be able to build a great brand from the strong existing foundation that has been created by the Pernix sales team."

About Omeclamox-Pak®

Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. The safety and effectiveness of Omeclamox-Pak in the pediatric population has not yet been established. Omeclamox-Pak was approved by the U.S. Food and Drug Administration in 2011.

About Helicobacter pylori

H. pylori is a bacterium acquired largely by people living in developing countries. Researchers suspect the bacteria are passed through contact with human saliva and waste, or contaminated food and water. If H. pylori is left untreated, it can damage the stomach and small intestine wall causing peptic ulcer disease, specifically duodenal ulcers. Symptoms of H. pylori-induced duodenal ulcers generally surface in adults and may include burning pain in the abdomen, nausea, vomiting, bloating, and weight loss. Nearly two-thirds of the world population is infected with H. pylori, including 50 percent of adults older than age 60 and 20 percent of adults under 40 years old.

About Duodenal Ulcers

Despite common belief, healthcare providers do not attribute the cause of duodenal ulcers to stress, alcohol consumption or spicy foods, though all can further inflame the small intestine wall. Patients with duodenal ulcers caused by H. pylori can be diagnosed through a series of simple tests, including blood, urea breath and stool antigen sampling. Other more invasive procedures can include both an upper gastrointestinal (GI) series and endoscopy. Patients who suffer severe abdominal pains, or blood in stool or vomit, may have ulcers which perforated the duodenal wall.

About Pernix Therapeutics LLC

Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded, generic and OTC pharmaceutical products. The Company manages a port-folio of branded and generic products. The Company's branded products for the pediatrics market include CEDAX®, an antibiotic for middle ear infections, NATROBA, a topical treatment for head lice marketed under an exclusive co-promotion agreement with ParaPRO, LLC, a family of prescription treatments for cough and cold (BROVEX®, ALDEX® and PEDIATEX®). The Company's branded products for gastroenterology include OMECLAMOX-PAK®, a 10-day treatment for H. pylori infection and duodenal ulcer disease, and REZYST, a probiotic blend to promote dietary management. The Company promotes its branded pediatric and gastroenterology products through its sales force. Pernix markets its generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals. A product candidate utilizing cough-related intellectual property is in development for the U.S. OTC market. Founded in 1996, the Company is based in The Woodlands, TX.

Additional information about Pernix is available on the Company's website located at www.pernixtx.com.

About Cumberland Pharmaceuticals Inc.

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States; and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients.

For more information, please visit the company website at www.cumberlandpharma.com.

Important Note Regarding 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.

SOURCE Cumberland Pharmaceuticals Inc.



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