Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, May 13 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that a revised New Drug Application (NDA) has been submitted
to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its
extended-release formulation of tramadol. In May 2007, the Company received an
approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER.
    Cipher's revised NDA includes data from additional pharmacokinetic
studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.
    After considering feedback from the FDA appeal process and the results of
the additional statistical sensitivity analysis of existing data suggested by
the FDA, Cipher and its advisors concluded that submitting the revised NDA
provided the most expeditious path to final regulatory approval.
    Subject to FDA acceptance for filing, Cipher expects the review to be
completed by October 2008. It is possible that the submission could trigger
patent infringement litigation and a stay of up to 30 months under the
Hatch-Waxman Act.

    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. The
product is being marketed in the United States by ProEthic Pharmaceuticals
under the label Lipofen(R). In addition, Cipher is developing formulations of
the pain reliever tramadol (FDA approvable letter in May 2007) and the acne
treatment isotretinoin (FDA approvable letter in April 2007).
    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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