October 29, 2010

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Oct. 29 /PRNewswire-FirstCall/ – Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that it has completed patient enrolment in its Phase
III safety study of CIP-ISOTRETINOIN, the Company’s novel, patented
formulation of isotretinoin, which is used in the treatment of severe,
nodular acne. The Phase III safety study is being conducted under a
Special Protocol Assessment that was granted by the U.S. Food and Drug
Administration (FDA). The study is a randomized, double-blinded trial
comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved,
commercially available isotretinoin product. A total of 931 patients
were enrolled in the trial, of which 626 have completed treatment to

“This is the largest, most comprehensive trial conducted on
isotretinoin, and we are pleased that the clinical investigators,
working with our internal team, met this important clinical milestone
on target,” said Dr. Jason Gross, Cipher’s Vice President of Scientific
Affairs. “Following an estimated six-month treatment period, the last
subject enrolled should complete treatment in April 2011. We expect to
have top-line study results in early Q3 2011, which would be followed
by an FDA submission in Q4 2011.”

Mr. Larry Andrews, President and CEO of Cipher, added: “Isotretinoin
remains the most effective treatment for severe, nodular acne. We
believe our product’s unique attributes, particularly the more
consistent absorption profile, would provide a significant advancement
in the treatment of this disease and offer dermatologists an excellent
alternative. We look forward to completing this final clinical study as
Cipher and its partner, Ranbaxy Pharmaceuticals, work toward
commercialization of the product in the $700 million U.S. isotretinoin

In the clinical studies that formed the basis of its New Drug
Application with the FDA, CIP-ISOTRETINOIN demonstrated significantly
more consistent absorption under variable dietary conditions compared
with existing isotretinoin products on the market. To achieve optimal
absorption, current isotretinoin formulations are prescribed to be
taken with meals, which proves to be a compliance challenge for many
teenagers.  CIP-ISOTRETINOIN uses the patent-protected Lidose(R) drug
delivery system, which delivers super-bioavailability for relatively
water-insoluble compounds. Cipher was issued a patent for
CIP-ISOTRETINOIN by the United States Patent and Trademark Office in

About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a commercial-stage 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 is being marketed in the United States by Kowa
Pharmaceuticals America under the label Lipofen(R). Cipher’s second
product, an extended-release version of the pain reliever tramadol,
received FDA approval in May 2010 and the Company’s third product, a
novel formulation of the acne treatment isotretinoin, is in its final
Phase III safety study.

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. The words “may”, “will”,
“could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”,
“anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”,
“hope” and “continue” (or the negative thereof), and words and
expressions of similar import, are intended to identify forward-looking
statements. 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

SOURCE Cipher Pharmaceuticals Inc.

Source: newswire

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