Cipher receives tentative FDA approval for extended-release tramadol capsules



    Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, Feb. 17 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that it has received tentative approval from the U.S. Food and
Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release
formulation of the analgesic tramadol, which is indicated for the management
of moderate to moderately severe chronic pain such as osteoarthritis. While
the product meets all the FDA's requirements for manufacturing quality,
clinical safety and efficacy, the Company must resolve certain patent issues
related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is
commercialized.
    "Tentative approval of our extended-release tramadol is another important
achievement for our organization and validates the safety and efficacy of this
product, which has an attractive profile for a chronic pain medication," said
Larry Andrews, President and CEO of Cipher. "We are working diligently on the
remaining steps toward commercialization, including securing a U.S. marketing
partner and addressing the outstanding intellectual property issues."
    Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was
submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S.
patents for the approved product held by a third party, Cipher was required to
certify to the FDA concerning any patents listed in the FDA's Orange Book
publication at the time of submission. Cipher's application contained a
paragraph III certification acknowledging that the listed patent had not
expired and that final approval would be sought after patent expiration in
2014. A paragraph IV certification, which states that the listed patent is
invalid, unenforceable, or will not be infringed by the manufacture or sale of
the drug, may trigger patent infringement litigation and a stay of up to 30
months under the Hatch-Waxman Act. To date, this certification has not been
filed.
    CIP-TRAMADOL ER capsules are based on patented oral controlled-release
bead technology and feature both immediate-release and extended-release
properties.

    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 Kowa Pharmaceuticals America
under the label Lipofen(R). In addition, Cipher is developing formulations of
the pain reliever tramadol (tentative FDA approval in February 2009) 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. Except as required by Canadian securities laws,
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 and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext
324, (905) 602-0628 fax, landrews@cipherpharma.com


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