UPDATE 2-Cumberland says FDA rejects liver drug's new indication

Wed Dec 22, 2010 11:33am EST

By Rajarshi Basu
BANGALORE, Dec 22 (Reuters) - Cumberland Pharmaceuticals Inc (CPIX.O) said U.S. health regulators did not approve the use of its liver drug for an additional indication, sending its shares down as much as 16 percent.

The drug, Acetadote, is currently approved to treat liver failure caused by an overdose of acetaminophen, a common ingredient in painkillers.

The FDA rejection raises the possibility that the drug's exclusivity may not get extended, Jefferies & Co analyst David Windley told Reuters.

Acetadote's orphan status will get over in January, which means threat from competitors is near.
In March the company had filed a supplementary new drug application for an indication of the drug to treat liver failure caused by factors such as hepatitis B and autoimmune hepatitis.
The Food and Drug Administration said the indication did not offer sufficient evidence of efficacy in increasing survival in all patients with acute liver failure.

Analyst Michael Tong of Wells Fargo Securities said in a note that the new indication could have added $30-$40 million to Acetadote's sales over the next 3-5 years.
Cumberland had annual sales of $43.5 million last year.

In October, Cumberland also submitted an application to the FDA for approval of a new, second generation formulation of Acetadote to replace the current product.

Analyst Windley said the company expects to get exclusivity on the new formulation.
Cumberland, whose products include Caldolor injection to treat fever and pain and laxative Kristalose, reported quarterly revenue of $12.2 million in its third quarter.
Shares of Nashville, Tennessee-based Cumberland have gained 5 percent since August when the FDA extended the review date for the drug's new indication by three months.
They were down 7 percent at $6.39 in late morning trade on Wednesday on Nasdaq in heavy trading. They touched a low of $5.79 earlier in the session. (Reporting by Rajarshi Basu in Bangalore; Editing by Don Sebastian, Unnikrishnan Nair)
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