Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Nov. 23, 2011 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:
DND) today announced that it has submitted an amendment to its pending
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for CIP-ISOTRETINOIN, its novel, patented formulation of the acne
medication isotretinoin. Cipher is seeking approval to market
CIP-ISOTRETINOIN for the treatment of severe, nodular acne.
Cipher's NDA amendment provides additional clinical information
requested by the FDA in support of obtaining approval. Subject to FDA
acceptance as a complete response to its outstanding comments, Cipher
expects the review under the Prescription Drug User Fee Act (PDUFA) to
be completed in six months.
FDA acceptance as a complete response will trigger a US$1.0 million
milestone payment from Cipher's marketing partner.
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 growing specialty pharmaceutical company
that commercializes novel formulations of successful, currently
marketed molecules. Cipher's strategy is to in-license clearly
differentiated products, advance them through the clinical development
and regulatory approval stages, and out-license to international
marketing partners. The Company's first product is a fenofibrate
formulation marketed in the United States as Lipofen®. Cipher's second
product, an extended-release tramadol, is marketed in the United States
as ConZip™ and will be marketed in Canada as Durela™. The Company's
third product, a novel formulation of the acne treatment isotretinoin,
recently completed its final Phase III safety study, with regulatory
submissions planned in the United States and Canada in Q4, 2011.
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
SOURCE Cipher Pharmaceuticals Inc.
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