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UPDATE 1-FDA deems Akela lead drug studies invalid

Mon Feb 4, 2008 7:52am EST

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TORONTO, Feb 4 (Reuters) - Akela Pharma Inc (AKL.TO) said on Monday it received a letter from the U.S. Food and Drug Administration saying that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.

The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.

Fentanyl Taifun is Akela's lead product for the treatment of breakthrough cancer pain and is a formulation of pain reliever Fentanyl delivered using the company's Taifun dry powder inhaler platform.

Late last year, Akela said it would not go ahead with a planned 5.3 million share public offering in the United States, citing unfavorable market conditions for small and microcap companies.

The company said it was still exploring finance options and still intended to list its shares on a U.S. exchange.

On Friday, Akela shares closed at C$2.68 on the Toronto Stock Exchange, down nearly 19 percent since the beginning of the year. (Additional reporting by Jennifer Robin Raj in Bangalore)

($1=$1 Canadian)

(Reporting by John McCrank; Editing by Scott Anderson)



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