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Concordia Healthcare Corp. announces FDA agreement on Special Protocol Assessment for Phase 3 Clinical trial on new therapy to treat perihilar cholangiocarcinoma
Date:1/13/2014

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, and 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), 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 approval of a New Drug Application for PDT with PHOTOFRIN®, the enrollment of patients into the Phase 3 clinical trial, the acceleration of product development, the ability to obtain necessary approvals, the development of PDT with PHOTOFRIN® as a new treatment for certain rare forms of cancer, the ability of PDT with PHOTOFRIN® to combat certain forms of cancer 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 the company, including risks regarding the pharmaceutical industry, the receipt of approval of PDT with PHOTOFRIN® as a New Drug Application, the ability to enrol patients into the Phase 3 clinical trial, the ability to accelerate product development, the development of PDT with PHOTOFRIN® to treat certain rare forms of cancer, the ability of PDT with PHOTOFRIN® to combat certain forms of cancer, the ability to further develop Concordia's products, the failure to obtain regulatory approvals, 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].  http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm


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