Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) announced it has entered into an agreement to sell its branded U.S. pharmaceutical business to an affiliate of Apotex for $100 million in cash. The transaction requires approval from Cumberland shareholders.

The Nashville-based specialty pharmaceutical company will retain its pipeline of product candidates and its majority ownership in Cumberland Emerging Technologies Inc. following the deal's completion.

"Our business has two distinct profiles - with established commercial operations typical of a specialty pharmaceutical company and an exciting development pipeline often associated with a biotechnology firm," said A.J. Kazimi, Cumberland's CEO.

Cumberland is developing ifetroban, a thromboxane antagonist, through multiple programs targeting unmet medical needs. The company reported breakthrough results in a Phase II clinical study of ifetroban for patients with cardiomyopathy associated with Duchenne muscular dystrophy. The program has received Orphan Drug, Rare Pediatric Disease and Fast Track designations from the FDA.

The company also has Phase II clinical programs evaluating ifetroban in patients with Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. Enrollment in the Systemic Sclerosis study has been completed, while enrollment in the Idiopathic Pulmonary Fibrosis study continues at medical centers across the U.S.

Apotex, headquartered in Toronto, describes itself as the largest Canadian-based pharmaceutical company. The company operates globally with regional offices in the United States, Mexico and India.

"This transaction will strengthen our ability to support patients in some of the most critical moments of their care journey," said Jeff Watson, Apotex's President and CEO.

Cumberland intends to file a proxy statement with the SEC regarding the special shareholder meeting for the proposed transaction.