Cipher Pharmaceuticals receives approvable letter from FDA for CIP-ISOTRETINOIN



    Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, April 27 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that it has received an approvable letter from the U.S. Food
and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for
CIP-ISOTRETINOIN, the Company's innovative formulation of the acne medication
isotretinoin. Cipher received an approvable letter from the FDA in May 2006
and submitted its response in October 2006.
    In its most recent letter, the FDA indicated that Cipher's application is
approvable subject to the resolution of two remaining issues. In addition to
one question related to chemistry, manufacturing and controls (CMC), the FDA
has requested that Cipher provide additional clinical data. Cipher believes
that the clinical question raised has been adequately addressed in the NDA
submission, and the Company will appeal the position taken by the FDA in its
approvable letter using the Formal Dispute Resolution process.

    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. Cipher
currently has three late-stage drugs in its pipeline. 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. In addition,
Cipher is developing formulations of the pain reliever tramadol (currently
under regulatory review by the FDA) and the acne treatment isotretinoin
(currently under regulatory review by the FDA).
    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.

    %SEDAR: 00020415E




For further information:

For further information: Craig Armitage, Investor Relations, The Equicom
Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com;
Larry Andrews, President & Chief Executive Officer, Cipher Pharmaceuticals,
(905) 602-5840 ext 24, (905) 602-0628 fax, landrews@cipherpharma.com


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