Clinigen 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.”

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