Concordia Healthcare Corp. Provides Clinical Trial and Corporate Update

TORONTO, Nov. 28, 2014 /PRNewswire/ - 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. 

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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.