MISSISSAUGA,
ON, July 24, 2014 /CNW/ -
Cipher Pharmaceuticals Inc. (TSX: DND) today announced it has
entered into a definitive distribution and supply agreement
with Ranbaxy Laboratories Ltd. ("Ranbaxy") under which Cipher
has granted Ranbaxy the exclusive right to market, sell and
distribute Cipher's isotretinoin capsules in Brazil. This agreement extends the current
relationship with Ranbaxy, which markets and distributes Cipher's
isotretinoin product in the United
States under the brand Absorica™.
Ranbaxy plans to promote the product through a
brand dermatology division in Brazil. Cipher's isotretinoin formulation is
expected to be a flagship product in Ranbaxy's dermatology
franchise in Brazil, once it
achieves regulatory approval.
"Ranbaxy has been an excellent partner on our
isotretinoin product and is a logical choice to commercialize it in
Brazil," said Shawn O'Brien, President and Chief Executive
Officer of Cipher Pharmaceuticals. "Brazil is the largest isotretinoin market in
Latin America, with annual sales
exceeding CDN$50 million, and the
market has been growing solidly, providing a compelling opportunity
for our novel formulation."
Under the terms of the agreement with Ranbaxy,
Cipher will receive an upfront payment and is eligible for
additional pre-commercial milestone payments. Cipher will supply
the product to Ranbaxy and product manufacturing will be done by
Cipher's partner, Galephar Pharmaceutical Research. Ranbaxy
will be responsible for all regulatory related activities
associated with gaining and maintaining regulatory approval of the
product in Brazil.
Cipher's isotretinoin product is a novel
formulation of isotretinoin, which is used in the treatment of
severe recalcitrant nodular acne. Isotretinoin is the most
effective severe acne therapy available to teenagers who suffer
from acne. The product is marketed in the
United States as Absorica™ and in Canada as Epuris®.
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited is an integrated, research based,
international pharmaceutical company producing a wide range of
quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued
focus on R&D has resulted in several approvals, in developed
and emerging markets many of which incorporate proprietary Novel
Drug Delivery Systems (NDDS) and technologies, developed at its own
labs. The company has further strengthened its focus on generics
research and is increasingly working on more complex and specialty
areas. Ranbaxy serves its customers in over 150 countries and has
an expanding international portfolio of affiliates, joint ventures
and alliances, ground operations in 43 countries and manufacturing
operations in 8 countries. Ranbaxy is a member of the Daiichi
Sankyo Group. Through strategic in-licensing opportunities and its
hybrid business model with Daiichi Sankyo, a leading global pharma
innovator headquartered in Tokyo,
Japan, Ranbaxy is introducing many innovator products in
markets around the world, where it has a strong presence. This is
in line with the company's commitment to increase penetration and
improve access to medicines, across the globe. For more
information, please visit www.ranbaxy.com.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND) is a growing
specialty pharmaceutical company with three commercial products and
a fourth in development. Our product candidates are typically
improved formulations of successful, currently marketed drugs. We
in-license a product, manage the required clinical development and
regulatory approval process, and either out-license it to a
marketing partner, or, in Canada, we may market the product ourselves.
Our core capabilities are in clinical and regulatory affairs,
product licensing, supply chain management, and marketing and
sales. Since the Company was founded in 2000, we have achieved
final regulatory approval in the U.S. and Canada for all three of our original
products and completed eight marketing partnerships, generating
growing licensing revenue.
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. These factors include, but are
not limited to; the applicability of patents and proprietary
technology; patent litigation and patent infringement; regulatory
approval of products in the Company's pipeline; marketing of
products; meeting projected drug development timelines and goals;
product liability and insurance; dependence on strategic
partnerships and licensees; concentration of the Company's revenue;
substantial competition and rapid technological change in the
pharmaceutical industry; the publication of negative results of
clinical trials of the Company's products; the ability to access
capital; the ability to attract and retain key personnel; changes
in government regulation or regulatory approval processes;
dependence on contract research organizations; third party
reimbursement; the success of the Company's strategic investments;
the possibility of shareholder dilution; market price volatility of
securities; and the existence of significant shareholders. 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.