Press Releases

Cipher provides product update

    Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, Jan. 8 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND),
an emerging specialty pharmaceutical company, today provided an update on
recent developments with its products.


    In June 2007, Cipher appealed the position taken by the U.S. Food and
Drug Administration (FDA) in its approvable letter for CIP-ISOTRETINOIN,
Cipher's novel formulation of the acne medication isotretinoin. Subsequently,
the Company has had two meetings with the FDA as part of the first stage of
the formal dispute resolution process. In its most recent response to Cipher,
the representative from the FDA agreed with the Division of Dermatology and
Dental Product's original view that a clinical study is needed to further
demonstrate the safety of CIP-ISOTRETINOIN. The Company has chosen to place
the formal dispute resolution process on hold, and has requested a meeting
with the Division to discuss their views on the appropriate design of a phase
III safety study. Cipher may still choose to continue the formal dispute
resolution process, however, regulations do not allow the Company to pursue
both options concurrently.
    "In the appeal response and subsequent discussions with the FDA, we were
encouraged to work closely with the Division should we choose to pursue a
safety study. At this time, we feel it is prudent to further explore this
option so that we fully understand the FDA's expectations concerning study
design, following which we will determine the best path forward," said Larry
Andrews, President and CEO of Cipher. "Our discussions with the FDA have been
constructive and have strengthened our belief that our product could represent
an advance in the treatment of severe acne. We expect to meet with the FDA in
late January 2008."


    In December 2007, Cipher announced that it had appealed the position
taken by the FDA in its approvable letter for the Company's extended-release
formulation of tramadol, using the FDA's Formal Dispute Resolution process.
Cipher received an approvable letter from the FDA in May 2007 pertaining to
its New Drug Application (NDA) for CIP-TRAMADOL ER.
    The Company met with the FDA on December 17, 2007 and expects a response
by the end of January.

    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(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

    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,;
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext
324, (905) 602-0628 fax,