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Akela Pharma repeats its Fentanyl TAIFUN(R) preclinical toxicology studies |
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08 Jul 2008 |
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Akela Pharma a drug development company focused on developing therapies for the inhalation and pain markets, today announced that as previously requested by the FDA, it has started over again the required inhalation toxicology studies
MONTREAL, CANADA | July 8, 2008 | Akela Pharma Inc. (TSX: "AKL"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced that as previously requested by the FDA, it has started over again the required inhalation toxicology studies. The studies performed at US based CRO are expected to produce results allowing Akela to start the longer term safety arm of the Fentanyl TAIFUN(R) Phase III clinical trial in patients in the second quarter of 2009. "We are still on track to deliver the required toxicology studies results in time to allow us to meet our previously disclosed regulatory submission timelines of Q1-2010 for the E.U. and Q3-2010 for the U.S." said Dr. Halvor Jaeger, CEO of Akela Pharma Inc.
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. PharmaForm, Akela's wholly owned subsidiary, is a leading specialty contract service provider offering a portfolio of innovative technologies in drug product development, manufacturing and analytical testing to the pharmaceutical and biotechnology industries. Through its diverse offerings, PharmaForm solutions help clients reduce development costs and accelerate time-to-market. Akela's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "AKL" with 21.6 million shares outstanding.
SOURCE: Akela Pharma Inc. |