Akela Pharma announces approval to initiate Fentanyl TAIFUN(R) Phase 3 study in Europe and initiation of clinical program in Japan



    www.akelapharma.com
    Toronto Stock Exchange Symbol: AKL

    MONTREAL, Sept. 4 /CNW Telbec/ - Akela Pharma Inc. (TSX: "AKL"), a drug
development company focused on developing therapies for the inhalation and
pain markets, today announced that Finnish Regulatory Authorities have been
the first one to grant approval to initiate a Phase 3 clinical study with
Fentanyl TAIFUN(R). Further approvals are expected in the near future.
    This approval triggers the first in a series of 3 milestones to be paid
by Janssen Pharmaceutica NV in relation to the initiation of the Fentanyl
TAIFUN(R) Phase 3 program. Janssen Pharmaceutica is the licensee for the
product in Europe, Canada, Middle East and Africa.
    At the same time Akela's development and commercialization partner in
Japan, Teikoku Seiyaku, announced the initiation of its clinical development
program in Japan. Teikoku Seiyaku is now conducting Phase 2 and Phase 3
studies that are essentially similar to AKELA's European development program,
amended to reflect local regulatory requirements and treatment practices.

    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.

    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.
    %SEDAR: 00003466EF




For further information:

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

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