Akela Pharma Receives Letter from the FDA Regarding its Pre-clinical Toxicology Studies for Fentanyl Taifun

Akela Pharma Receives Letter from the FDA Regarding its Pre-clinical Toxicology Studies for Fentanyl Taifun

MONTREAL, Feb. 4 - Akela Pharma Inc. , a drug development company focused on developing therapies for the inhalation and pain markets, today announced that it has received notice from the FDA that, due to GLP deviations the 6-month inhalation toxicology studies were deemed invalid. No toxicological reasons were cited. We are currently evaluating several alternative remedies and are confident that the submission for regulatory approval will not be delayed by more than 6 months. 
 
Conference call information:

Akela will host a conference call at 9:00 am, on Monday February 04, 2008, 2008. Interested parties may also access the conference call by webcast at www.akelapharma.com.

The telephone numbers to access the conference call are 1-800-732-9303 or 416-644-3415. A replay of the call will be available until February 11, 2008. The telephone numbers to access the replay are 416-640-1917 and 1-877-289-8525 with code number 21262067#.

About Akela Pharma Inc.:

Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain markets. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, growth hormone deficiencies and controlled substance abuse deterrent formulations.

Akela's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "AKL" with 11.7 million shares outstanding.

This news release contains certain forward-looking statements that reflect the current views and/or expectations of Akela Pharma Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

CONTACT: visit Akela's website at www.akelapharma.com, or contact:Frederic Dumais, Vice-President, Investor Relations, (514) 315-3330 ext.106, Fax: (514) 315-3325

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.