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FDA Approves Optiguide® DCYL700 Fiber Optic Diffuser Series Flexible Fiber

March 26, 2014

Supplemental approval will expand PDT with Photofrin® treatments in
specific lung and esophageal cancers

TORONTO AND BANNOCKBURN, IL, March 26, 2014 /PRNewswire/ – Concordia Healthcare
Corp. (Concordia or the Company) (TSX:CXR) (OTCQX: CHEHF) announced
today that its subsidiary Pinnacle Biologics, Inc. (Pinnacle), a
biopharmaceutical research and development company specializing in rare
diseases, was granted U.S. Food and Drug Administration (FDA) premarket
supplemental approval (PMA) for its Optiguide® DCYL700 Fiber Optic
Diffuser Series flexible fiber.

The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery
system used in Photodynamic Therapy (PDT) with PHOTOFRIN® (porfimer
sodium) approved for use in the treatment of non-small cell lung cancer
(NSCLC) and esophageal cancer. The system features a more flexible,
narrower cylindrical diffuser design that may assist physicians by
providing greater access to tumors located in the right upper lobe of
the lung and by improving maneuverability in other potentially
challenging anatomic areas of the bronchus.

According to thoracic surgeon Patrick Ross MD, Ph.D., chairman of the
Pinnacle Scientific Advisory Board, “One of the key benefits of this
new diffuser fiber is that it will offer improved compatibility with
current endoscopic equipment. This may allow doctors to use
bronchoscopes with smaller therapeutic channels and may allow easier
access to NSCLC tumors located in the right upper lobe of the lung as
well as other potentially challenging anatomic areas of the airways in
the lungs.”

The Optiguide®DCYL700 Fiber Optic Diffuser Series is the latest addition
to Pinnacle’s portfolio of photodynamic products. Pinnacle’s complete
PDT technology platform and the science behind it has enabled the
company to accelerate research into new indications. The company
announced in early January it has reached an agreement with the FDA
under a special protocol assessment (“SPA”) to enroll patients with an
advanced form of bile duct cancer in a pivotal Phase 3 clinical trial,
a cancer type for which there is currently no approved therapy.

“Pinnacle has continued to aggressively advance photodynamic technology,
design and materials in furtherance of its mission to expand and
improve treatment options for critically ill patients with rare diseases like lung and esophageal cancers, ” said Mark Thompson, CEO of
Concordia. “We are pleased that this newly approved Optiguide®DCYL700
Fiber Optic Diffuser Series device will give physicians a new and
important tool in their PDT armamentarium.”

About Photofrin

Photodynamic therapy with PHOTOFRIN® (porfimer sodium) 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. PHOTOFRIN® was granted orphan drug designation (ODD) by the
FDA in 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, the FDA granted a second ODD for PHOTOFRIN® as adjuvant
therapy to surgery for the treatment of malignant pleural mesothelioma.

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 legacy pharmaceutical business
consists of an ADHD-treatment drug, Kapvay® (clonidine extended release
tablets), Ulesfia® (benzyl alcohol) Lotion a Head Lice Treatment, an
Asthma-related medication, Orapred ODT® (prednisolone sodium phosphate
orally disintegrating tablets) . 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), Bannockburn, (near Chicago),
Illinois and Bridgetown, Barbados.

Notice regarding forward-looking statements:

This release includes forward-looking statements regarding Concordia and
its business, which may include, but is not limited to, statements with
respect to the benefits and assistance to be provided by the
Optiguide®DCYL700 Fiber Optic Diffuser Series, the impact of the device
on research into new indications 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 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 Concordia, including risks regarding the
pharmaceutical industry, the failure to obtain regulatory approvals,
economic factors, market conditions, the equity markets generally,
risks associated with growth and competition, risks associated with the
acquisition 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.

SOURCE Concordia Healthcare Corp.


Source: PR Newswire



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