By Dow Jones Business News, September 27, 2013, 05:31:00 PM EDT
By Anna Prior
Achillion Pharmaceuticals Inc. ( ACHN ) said Friday the U.S. Food and Drug Administration has decided against lifting
its clinical hold on sovaprevir, the company's experimental hepatitis C treatment.
Shares, which were halted briefly on the news, plunged 45% to $4.00 in after-hours trading.
The FDA's response indicated that while Achillion's submission addressed all the issues noted in the FDA'sJune 29
letter, the FDA concluded that the removal of the clinical hold is not warranted, said the company.
"While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed
all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens
for the treament of [hepatitis C virus]," said Chief Executive Milind Deshpande.
In July, Achillion had said the FDA put the drug on clinical hold after the company's early-stage study of drug
interactions in healthy patients resulted in elevated liver enzymes tied to higher-than-expected exposures to sovaprevir
and another drug, atazanavir.
The company had voluntarily stopped dosing in the study after finding high levels of the liver enzymes in several
people enrolled in the study. Its preliminary investigation found that dosing with both of the drugs caused a metabolic
interaction that substantially increased the plasma concentration of both drugs.
No serious adverse events were reported at that time.
The FDA has continued to allow the enrollment of patients in a separate midstage study evaluating sovaprevir in
combination with other drugs in patients with hepatitis C.
On Friday, Achillion announced interim data from its ongoing Phase 2a clinical trial of two doses of sovaprevir in
combination with ACH-3102 and ribavirin, saying to date the combination has been well tolerated with no drug-related
serious adverse events, no clinically significant changes in vital signs or electrocardiograms, no graded increases in
liver unciton tests, and no other laboratory abnormalities were noted with the exception of decreases in hemoglobin
observed and attributed to ribavirin.
Achillion is competing with Bristol-Myers Squibb Co. ( BMY ) and Gilead Sciences Inc. ( GILD ) to bring an all-oral
hepatitis C regimen to market, hoping to capitalize on what is expected to be a multibillion-dollar market for the
Through the close, Achillion's stock was down 9.6% since the start of the year.
Write to Anna Prior at email@example.com
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