Monday, September 26, 2016 - 13:30

Clinigen Group and Cumberland Pharmaceuticals launch Ethyol® in the U.S. 

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, ‘Cumberland’), a specialty pharmaceutical company, announce today that Cumberland has launched Ethyol® (amifostine) for injection in the U.S.

Ethyol is a key global brand within the Specialty Pharmaceuticals division of Clinigen Group and is the first product that Cumberland has licensed from Clinigen under an exclusive strategic alliance entered into in 2015. The U.S. launch represents an important milestone in ensuring patients have the best opportunity to be treated with Ethyol, should they need it.

Ethyol is an FDA approved, hospital-based cytoprotective drug indicated to reduce the incidence of xerostomia (dry mouth) in patients undergoing post-operative radiation treatment for head and neck cancer.  Xerostomia can significantly impact the daily lives of head and neck cancer patients during their survivorship. Ethyol provides an important option for patients and their physicians to consider prior to starting radiotherapy treatment. It also reduces the cumulative renal toxicity for women with ovarian cancer from their cisplatin chemotherapy, allowing them the best chance of completing their treatment course.

Cumberland will be responsible for all hospital sales, promotion, distribution, and medical support of Ethyol in the U.S. In preparation for the product’s launch, Cumberland’s sales and medical organization has completed a comprehensive training program. The company has also stocked the product at wholesalers serving hospitals nationwide, and recently introduced a product website to support healthcare professionals by providing information about Ethyol.

Ethyol is Cumberland’s first oncology product and complements its current portfolio of specialty hospital pharmaceuticals.

Shaun Chilton, Deputy Chief Executive Officer of Clinigen Group, said:

“The U.S. launch of Ethyol represents a major step forward in Clinigen Group’s mission of ensuring patients worldwide have access to the medicines they need. Patients in the U.S. are now able to access Ethyol to manage the side effects of their vital cancer treatment.

“Our strategic alliance with Cumberland is a key part of our global revitalization strategy for Ethyol, an important treatment for cancer patients.”

A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals, said:

“We are pleased to be able to start offering Ethyol to oncology patients throughout the United States. We have worked diligently to prepare for the introduction of Ethyol and are excited to expand our activities into hospital-based oncology and this new patient population.”




Contact Details

Clinigen Group plc 

Tel: +44 (0) 1283 495010
Peter George, Group Chief Executive Officer
Shaun Chilton, Group Deputy Chief Executive Officer
Martin Abell, Group Chief Financial Officer

Numis Securities Limited

Tel: +44 (0) 20 7260 1000
Michael Meade/Freddie Barnfield (Nominated Adviser)
James Black/Tom Ballard (Corporate Broking)

Peel Hunt LLP – Joint Broker

Tel: +44 (0) 20 7418 8900
James Steel/Dr Christopher Golden

Instinctif Partners – Media Relations

Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell/Jen Lewis/Emma Barlow

Cumberland Pharmaceuticals

Investor Contact:

Erin Smith
Cumberland Pharmaceuticals
Tel: +1 615-255-0068

Media Contact:

Rebecca Kirkham
Lovell Communications
Tel: +1 615-297-7766


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. Xerostomia, or diminished saliva production, can lead to difficulties eating, speaking, and swallowing.


About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

For more information, please visit


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, Omeclamox-Pak® for the treatment of H. pylori and duodenal ulcer disease, and Ethyol® (amifostine) for Injection, for the treatment of oncology patients  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


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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