Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, Aug. 13 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that the U.S. Food and Drug Administration (FDA) has responded
to the Company's request for formal dispute resolution of the decision to
issue an approvable action for Cipher's CIP-ISOTRETINOIN New Drug Application
(NDA). In the letter to Cipher, the representative from the FDA agreed with
the Division of Dermatology and Dental Products's view that an additional
clinical study is needed to further demonstrate the safety of
CIP-ISOTRETINOIN.
    "While we continue to believe that the clinical question raised was
adequately addressed in the NDA, we are reviewing their response to determine
the most appropriate path forward to achieve approval," said Larry Andrews,
President and CEO of Cipher.

    About Cipher Pharmaceuticals Inc.

    Cipher Pharmaceuticals is a drug development company focused on
commercializing novel formulations of successful, currently marketed molecules
using advanced drug delivery technologies. Cipher's strategy is to in-license
products that incorporate proven drug delivery technologies and advance them
through the clinical development and regulatory approval stages, after which
the products are out-licensed to international partners. Because Cipher's
products are based on proven technology platforms applied to currently
marketed drugs, they are expected to have lower approval risk, shorter
development timelines and significantly lower development costs. The Company's
lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and
Drug Administration and Health Canada in the first quarter of 2006. Beginning
in the fourth quarter of 2007, the product will be marketed in the United
States by ProEthic Pharmaceuticals under the label Lipofen(TM). In addition,
Cipher is developing formulations of the pain reliever tramadol and the acne
treatment isotretinoin.

    Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and
has approximately 24 million shares outstanding. For more information, please
visit www.cipherpharma.com.

    Forward-Looking Statements

    Statements made in this news release, other than those concerning
historical financial information, may be forward-looking and therefore subject
to various risks and uncertainties. Some forward-looking statements may be
identified by words like "may", "will", "anticipate", "estimate", "expect",
"intend", or "continue" or the negative thereof or similar variations. Certain
material factors or assumptions are applied in making forward-looking
statements and actual results may differ materially from those expressed or
implied in such statements. Factors that could cause results to vary include
those identified in the Company's Annual Information Form and other filings
with Canadian securities regulatory authorities, such as the applicability of
patents and proprietary technology; possible patent litigation; regulatory
approval of products in the Company's pipeline; changes in government
regulation or regulatory approval processes; government and third-party payer
reimbursement; dependence on strategic partnerships for product candidates and
technologies, marketing and R&D services; meeting projected drug development
timelines and goals; intensifying competition; rapid technological change in
the pharmaceutical industry; anticipated future losses; the ability to access
capital to fund R&D; and the ability to attract and retain key personnel. All
forward-looking statements presented herein should be considered in
conjunction with such filings. The Company does not undertake to update any
forward-looking statements; such statements speak only as of the date made.

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