OREANDA-NEWS. 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."

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).

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.