* 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 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
(Reporting by Esha Dey in Bangalore; Editing by Gopakumar