Concordia Healthcare Corp. enters into collaboration agreement with Orphan Canada

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Sep 02, 2014, 07:00 ET

TORONTO AND CHICAGO, Sept. 2, 2014 /PRNewswire/ - 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.