Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, June 7, 2011 /PRNewswire/ - Cipher Pharmaceuticals Inc. (TSX:
DND) today provided top-line safety and efficacy results from the Phase
III safety study of CIP-ISOTRETINOIN, the Company's novel, patented
formulation of isotretinoin for the treatment of severe, nodular acne.
The 925-patient study was a randomized, double-blinded trial comparing
the safety profile of CIP-ISOTRETINOIN to a commercially available
Summary of Results
From a safety perspective, the top-line data was positive showing no
overall statistical differences in the adverse event profile between
the two products. The most frequent side effects that were observed
were dry skin and dry lips. In addition, initial statistics on
psychiatric disorders, eye disorders, ear disorders, musculoskeletal,
vascular disorders, cardiac disorders, and gastrointestinal disorders,
illustrate there are no significant differences in the extent of
adverse events between CIP-ISOTRETINOIN and the reference product.
The efficacy component of the study had two co-primary endpoints: (1)
the total change in lesion counts between baseline and at the end of
week 20; and (2) the total number of subjects that had at least a 90%
clearing at the end of 20 weeks of treatment. These two co-primary
endpoints were analyzed using the per-protocol population (PP) as well
as the intent-to-treat population (ITT). The PP analysis comprised all
subjects who completed the study according to the protocol. In this
analysis both co-primary endpoints met the non-inferiority margins
established for the study. The ITT population comprised all subjects
who entered the study, including those who did not conclude the study
for whatever reason. Those who dropped out early were assigned
treatment efficacy scores based on the last observation recorded for
that subject, also known as last observation carried forward (LOCF). In
the LOCF analysis of the ITT population, the first primary endpoint was
achieved while the second endpoint fell slightly outside the
non-inferiority margin target.
"These results show CIP-ISOTRETINOIN has a safety profile that mirrors
commercially available isotretinoin products, which was the key outcome
we were hoping for from this study," said Dr. Jason Gross, Cipher's
Vice President of Scientific and Medical Affairs. "In addition, this
comprehensive study yielded valuable and substantial efficacy data to
support our FDA submission later this year."
The safety, efficacy, and population pharmacokinetic data generated from
this study, together with previously submitted data, will be used to
complete a revised New Drug Application (NDA) being prepared for
submission to the FDA in Q4 2011. The FDA review of this submission
under PDUFA is expected to be six months.
The study was a randomized, double-blinded non inferiority trial
comparing CIP-ISOTRETINOIN to a commercially available isotretinoin
product in patients with severe, nodular acne. The study was approved
by the FDA under a Special Protocol Assessment and conducted in the
United States and Canada at 50 sites. Of the 925 patients who enrolled
in the study, 813 patients completed the 20-week trial. As per the
protocol, subjects were directed to always take their medication with
In the pharmacokinetic studies that formed the basis of its original
NDA, CIP-ISOTRETINOIN demonstrated more consistent absorption under
variable dietary conditions compared with existing isotretinoin
products. 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® drug delivery system, which delivers more
consistent bioavailability for relatively water-insoluble compounds.
Cipher was issued a patent for CIP-ISOTRETINOIN by the United States
Patent and Trademark Office in 2008.
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®. 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, just completed
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.
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 made.
SOURCE Cipher Pharmaceuticals Inc.