TORONTO, Nov. 28, 2014 /CNW/ - Concordia Healthcare Corp.,
("Concordia") (TSX: CXR) (OTCQX: CHEHF), announced today a clinical
trial and corporate update, including the status of patient
enrollment in its Phase 3 clinical trial to treat a rare form of
bile duct cancer, and the entering into of an exclusive trademark
license and product distribution agreement for China and other Asian territories with Union
Med. Limited.
First Patient Enrolled in Phase 3 Bile Duct Cancer
Trial
Concordia announced that
Thomas Jefferson University in
Philadelphia, PA is the first
North American institution to enroll the first patient in the OPUS
clinical trial. OPUS is an Open-label, multicenter,
randomized Phase 3 Study that will evaluate the efficacy and
safety of Photodynamic therapy (PDT) with
PHOTOFRIN® (porfimer sodium) for injection as treatment
for Unresectable, advanced perihilar cholangiocarcinoma
(CCA) Bismuth type III/IV.
CCA, or bile duct cancer, is a rare disease with only about
4,000 to 5,000 new cases diagnosed annually in the United Statesi; perihilar CCA
is considered "ultra orphan"ii and represents a very
small subset of the disease. Because the bile duct is located deep
inside the body, early tumors cannot be seen or felt by healthcare
providers during routine physical exams, leading to diagnosis only
after symptoms appear and the disease has advanced. There are
currently no approved, effective therapies available and as a
result, most people with perihilar CCA have about a two per
cent chance of surviving at least five
yearsiii.
"We are very grateful to the patients and the patients' family
for their participation in this trial," said David E. Loren, MD, associate director of
endoscopy and co-director of the Pancreaticobiliary Section at
Thomas Jefferson University Hospital.
"Bile duct cancer is rare so it is important we provide education
and awareness about our work to discover effective solutions to
treat this terrible disease so future patients have more and better
treatment options. Based on previous studies, photodynamic therapy
with PHOTOFRIN has the potential to innovate the way hard-to-reach
cancers like bile duct cancer are treated."
The clinical trial is designed to be an open label,
multi-center, international, randomized study with a planned
enrollment of 200 patients from North
America, Switzerland,
Germany, and South Korea.
"Conducting a clinical trial for a rare disease poses challenges
for investigators, scientists and pharma companies alike," said
Mark Thompson, CEO of Concordia. "We are extremely fortunate to work
with an experienced network of global investigators like Dr. Loren
who are committed to supporting this trial and contributing
scientific evidence that will inform future treatment options for
patients with rare cancers like CCA."
PHOTOFRIN is indicated for the treatment of esophageal cancer,
non-small-cell lung cancer and high-grade dysplasia in Barrett's esophagus. PHOTOFRIN was granted
orphan drug designation (ODD) by the FDA in 2001 for the ablation
of High-Grade Dysplasia in Barrett's Esophagus in patients who are not
considered to be candidates for esophagectomy, in 2004 for
cholangiocarcinoma (CCA), a rare cancer in the ducts that carry
bile from the liver to the small intestine, and in 2011 as adjuvant
therapy to surgery for the treatment of malignant pleural
mesothelioma.
For additional information about PHOTOFRIN, please see full
prescribing information available at www.PHOTOFRIN.com.
About the Trial
The U.S. Food and Drug Administration
has agreed to allow Concordia to
conduct the Phase 3 clinical trial per the conditions agreed to in
a special protocol assessment or SPA (ClinicalTrials.gov
identifier: NCT02082522). An SPA is an agreement with the FDA
that the proposed trial design, clinical endpoints and analyses of
results of just one trial are acceptable to support regulatory
approval.
Exclusive Distribution Agreement with Union Med.
Limited
Concordia also announced today
it has entered into an exclusive trademark license and product
distribution agreement (the "Distribution Agreement") with
Union Med. Limited ("Union"), a leader in providing
hospitals throughout China with
photodynamic therapies for cancerous and non-cancerous
tumors. Under the Distribution Agreement, Union will import,
clinically develop (if necessary), gain regulatory approval for,
distribute, market and sell PHOTOFRIN throughout the People's Republic of China, Hong Kong, Macau and Taiwan.
"We are extremely pleased to have partnered with Union Med.
Limited, a company that has an established track record of
distributing photodynamic therapies to hospitals throughout
China," said Mark Thompson, CEO of Concordia. "We believe that Union is an
excellent partner for expanding the adoption of PDT with PHOTOFRIN
in China."
About Union Med. Limited
Dedicated to promoting minimally invasive diagnostic and
therapeutic solutions for oncology, Union is China's leading system integrator and service
provider with a focus on PDT. As the exclusive Chinese
distributor for Diomed PDT Lasers since 2002, Union has helped
establish thirty PDT centers across China, in which, the company has trained PDT
physicians and conducted clinical application trials for more than
twenty different forms of cancer. Union has collaborated with
more than 300 hospitals in China.
In addition, Union's academic and market promotion activities are
well recognized and supported by academic societies such as Chinese
Society of Clinical Oncology (CSCO), European Platform for
Photodynamic Medicine (EPPM) and International Photodynamic
Association (IPA).
About Concordia
Concordia is a diverse
healthcare company focused on legacy pharmaceutical products,
orphan drugs, and medical devices for the diabetic population.
Concordia's legacy pharmaceutical
division, Concordia Pharmaceuticals Inc., consists of the following
products: 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),
irritable bowel syndrome treatment Donnatal® (belladonna
alkaloids, phenobarbital) and Zonegran® (zonisamide) for treatment
of partial seizures in adults with epilepsy. Concordia's specialty healthcare distribution
(SHD) division, Complete Medical Homecare, distributes medical
supplies targeting diabetes and related conditions. Concordia's orphan division, Concordia
Laboratories Inc., manufactures PHOTOFRIN. PHOTOFRIN is marketed by
Pinnacle Biologics, Inc. in the United
States.
Concordia operates out of
facilities in Oakville, Ontario;
Lenexa, Kansas; 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
addition of new sites approved to enroll patients into the clinical
trial, the ability to enroll patients into the clinical trial, the
ability to obtain necessary approvals, the approval and development
of PDT with PHOTOFRIN as a new treatment for certain forms of
cancer, the acceleration of product development, the ability and/or
potential of PDT with PHOTOFRIN to combat certain forms of cancer
(including the ability of PHOTOFRIN to innovate the way certain
cancers are treated), the ability of PHOTOFRIN to provide better
treatment options, the ability and/or potential of PDT with
PHOTOFRIN to prolong the life of anyone affected by certain forms
of cancer, medical community support and requirements for new
treatments such as PDT with PHOTOFRIN, the results and/or success
of clinical trials, the ability to expand existing sales of
Concordia's products in certain
markets, including PHOTOFRIN in various geographic regions, the
adoption of PDT with PHOTOFRIN in certain geographic regions, the
receipt of approval to market and distribute Concordia's products in certain markets, the
outcomes and success of distribution arrangements, market
opportunities for Concordia's
products, statements with respect to the relationship between
Concordia and Union 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, the
failure to obtain regulatory approvals, risks associated with
clinical trials (including, without limitation, in respect of
patient enrollment into clinical trials), risks relating to the use
of Concordia's products to treat
certain diseases, risks relating to distribution arrangements,
risks relating to the markets in which Concordia operates, 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.
______________________________
i Key Statistics about Bile Duct Cancer. (2013,
October 30). American Cancer Society,
Retrieved 9 September 2014
http://www.cancer.org/cancer/bileductcancer/detailedguide/bile-duct-cancer-key-statistics
ii Bragazzi MC, Cardinale V, Carpino G, Venere R,
Semeraro R, Gentile R, Gaudio E, Alvaro D. Cholangiocarcinoma:
Epidemiology and risk factors. Transl Gastrointest Cancer
2012;1:21-32. DOI: 10.3978/j.issn.2224-4778.2011.11.04
iii SEER Stat Fact Sheet: Cancer of the Liver
and Intrahepatic Bile Duct (SEER 18 2004-2010, All Races, Both
Sexes by SEER Summary Stage 2000). National Cancer Institute.
Retrieved 22 October 2014 from
http://seer.cancer.gov/statfacts/html/livibd.html
SOURCE Concordia Healthcare Corp.