TORONTO AND CHICAGO, Sept. 2, 2014 /CNW/ - Concordia Healthcare Corp. ("Concordia") (TSX:CXR) (OTCQX: CHEHF), a diverse healthcare company
focused on legacy pharmaceutical products, orphan drugs, and medical
devices for the diabetic population, today announced that its
subsidiary, Pinnacle Biologics, Inc. ("Pinnacle"), a biopharmaceutical research and development company specializing in
rare diseases, has signed a collaboration agreement for PHOTOFRIN® (porfimer sodium) with Orphan Canada, a Toronto-based specialty
pharmaceutical company that in‐licenses therapies for rare disorders
and specialty medicines within Canada. Under the agreement, Pinnacle
and Orphan Canada will partner to support the continued supply of
Photodynamic Therapy (PDT) using PHOTOFRIN in Canada.
PHOTOFRIN is approved in Canada for the treatment of certain forms of
gastrointestinal, lung and bladder cancers.
"Orphan Canada will provide a distribution infrastructure for Concordia
within Canada," said Mark Thompson, CEO of Concordia. "This
relationship should provide us with operating flexibility and a depth
and scale of product development that may increase access to treatments
for patients with rare forms of cancer."
PHOTOFRIN was granted orphan drug designation by the U.S. Food and Drug
Administration (FDA) in 2004 for cholangiocarcinoma (CCA), a rare bile
duct cancer. There are approximately 3,000 CCA cases diagnosed in the
U.S. annually1 and there is currently no approved therapy for this cancer type.
In January, Concordia received FDA approval to enroll patients with
perihilar CCA in a pivotal Phase 3, multicenter clinical trial using PHOTOFRIN. This international trial will enroll patients from the U.S.,
Switzerland, Germany, South Korea and Canada. The trial will study the
efficacy and safety of PDT with PHOTOFRIN for injection as treatment
for unresectable advanced perihilar CCA Bismuth type III/IV. Two sites,
CHUM-Hopital St-Lux, Quebec and St. Michael's Hospital, Ontario, have
currently been selected to participate with more sites expected to be
operational within the next months.
"Orphan Canada's experience in the rare disease space enables us to
deliver multi-dimensional support for our partners like Concordia who
are developing orphan products," said Jason Flowerday, chief commercial
officer, Orphan Canada.
About PHOTOFRIN
Photodynamic therapy with PHOTOFRIN® is a two-stage process requiring administration of both drug and light.
The first stage of PDT is the intravenous injection of PHOTOFRIN®. The second stage of therapy uses illumination with nonburning laser
light 40-50 hours following injection with PHOTOFRIN®. When injected, PHOTOFRIN® is attracted to certain tissues, especially cancer cells. Tumor
destruction results from biochemical reactions, not heat. Tumor
selectivity occurs through a combination of preferential retention of
PHOTOFRIN® by the tumor and selective delivery of light to the tumor site.
PHOTOFRIN® is indicated for the treatment of esophageal cancer, non-small-cell
lung cancer and high-grade dysplasia in Barrett's esophagus in both the
U.S. and Canada. PHOTOFRIN® was granted orphan drug designation (ODD) by the FDA in October 2001
for the ablation of High-Grade Dysplasia in Barrett's Esophagus in
patients who are not considered to be candidates for esophagectomy, in
November 2004 for cholangiocarcinoma (CCA), a rare cancer in the bile
ducts that carry bile from the liver to the small intestine, and in
December 2011, as adjuvant therapy to surgery for the treatment of
malignant pleural mesothelioma.
About Orphan Canada
Orphan Canada is a specialty pharmaceutical company that is committed to
commercializing therapies for genetic and rare diseases within the
Canadian marketplace. Orphan Canada provides research-based companies
and licensors with a commercial partner that is uniquely positioned to
deliver value to all stakeholders.
About Concordia
Concordia is a diverse healthcare company focused on legacy
pharmaceutical products, orphan drugs, and medical devices for the
diabetic population. The company's pharmaceutical business consists of
ADHD-treatment Kapvay® (clonidine extended release tablets), Head Lice
Treatment Ulesfia® (benzyl alcohol) Lotion, Asthma-related medication
Orapred ODT® (prednisolone sodium phosphate orally disintegrating
tablets) and Irritable Bowel Syndrome treatment Donnatal® (belladonna alkaloids,
phenobarbital). Concordia's Specialty Healthcare Distribution (SHD) division, Complete
Medical Homecare, distributes medical supplies targeting diabetes and
related conditions. Concordia's orphan division, Pinnacle, markets
PHOTOFRIN® in the United States.
Concordia operates out of facilities in Oakville, Ontario; Lenexa,
Kansas (near Kansas City, Missouri); Chicago, Illinois; Bridgetown,
Barbados; and Charlottesville, Virginia.
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Concordia and
its business, which may include, but are not limited to, statements
with respect to the relationship between Orphan Canada and Concordia,
Concordia's operating flexibility and depth and scale of product
development, Concordia's ability to increase access to certain
treatments, the ability of licensing and/or collaboration arrangements
to deliver value to Concordia and/or its stakeholders, the addition of
new sites approved to enroll patients into clinical trials, the
outcomes and success of clinical trials, the ability to enroll new
patients into clinical trials, the ability to obtain necessary
approvals, the approval and development of PDT with PHOTOFRIN® as a new
treatment for certain forms of cancer, the ability of PDT with
PHOTOFRIN® to combat certain forms of cancer, the acceleration of
product development and other factors. Often, but not always,
forward-looking statements can be identified by the use of words such
as "plans", "is expected", "expects", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes" or variations
(including negative and grammatical variations) of such words and
phrases, or state that certain actions, events or results "may",
"could", "would", "might" or "will" be taken, occur or be achieved.
Such statements are based on the current expectations of Concordia's
management, and are based on assumptions and subject to risks and
uncertainties. Although Concordia's management believes that the
assumptions underlying these statements are reasonable, they may prove
to be incorrect. The forward-looking events and circumstances discussed
in this release may not occur by certain specified dates or at all and
could differ materially as a result of known and unknown risk factors
and uncertainties affecting the company, including risks regarding the
pharmaceutical industry, risks relating to licensing and/or
collaboration arrangements, the failure to obtain regulatory approvals,
risks relating to clinical trials (including, without limitation, with
respect to patient enrollment into clinical trials), risks relating to
the use of Concordia's products to treat certain diseases, economic
factors, market conditions, the equity markets generally, risks
associated with growth and competition and many other factors beyond
the control of Concordia. Although Concordia has attempted to identify
important factors that could cause actual actions, events or results to
differ materially from those described in forward-looking statements,
there may be other factors that cause actions, events or results to
differ from those anticipated, estimated or intended. No
forward-looking statement can be guaranteed. Except as required by
applicable securities laws, forward-looking statements speak only as of
the date on which they are made and Concordia undertakes no obligation
to publicly update or revise any forward-looking statement, whether as
a result of new information, future events, or otherwise.
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1 http://www.cancer.net/cancer-types/bile-duct-cancer/statistics
SOURCE Concordia Healthcare Corp.
