* New formulation of Acetadote to replace current product
* Co to immediately start U.S. launch activities
* Shares rise 20 pct after the bell (Adds details, updates stock movement)
Jan 13 (Reuters) - Cumberland Pharmaceuticals Inc (CPIX.O) said U.S. health regulators approved a new formulation of its drug for treating acetaminophen poisoning and it would replace the currently marketed product.
The approval comes at a strategic time for Cumberland as the marketing exclusivity associated with the orphan drug status on the drug, Acetadote, is set to get over in January.
Also, in December, the regulator had denied to approve the use of the drug in a new indication, thus making the new formulation the only way open through which the company can try to maintain the drug’s exclusivity.
Orphan drug status is granted by the U.S. Food and Drug Administration (FDA) to drugs that treat a condition affecting less than 200,000 Americans. The status gives the drugmaker a marketing exclusivity of seven years in the United States.
Cumberland, which will stop manufacturing the older formulation, said it will immediately commence U.S. launch activities for the next generation Acetadote injection.
Acetadote has been available in the United States since 2004 and is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen.
Acetaminophen is a common ingredient in many over-the-counter pain relief and fever-reducing drugs.
Cumberland also obtained approval for an extended shelf life of 30 months with the new product, up from the 24 months for the original formulation.
The company’s shares rose 20 percent in after-hours trading on Thursday, after closing at $5.67 in regular trade on Nasdaq. They have lost 7 percent since it voluntarily recalled 6 lots of Acetadote in December due to presence of fine particles in some vials. (Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier)