FDA Approves Optiguide® DCYL700 Fiber Optic Diffuser Series flexible fiber

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

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Mar 26, 2014, 08:00 ET

TORONTO and BANNOCKBURN, Ill., March 26, 2014 /PRNewswire/ -- Concordia Healthcare Corp. ("Concordia" TSX:CXR) 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.

FDA approved the Optiguide DCYL700 Fiber Optic Diffuser Series, a light delivery system used in Photodynamic Therapy (PDT) with PHOTOFRIN(R) (porfimer sodium). The system features a more flexible, narrower cylindrical diffuser design that may assist physicians in treating rare head and neck cancers. The flexible fiber is manufactured by Concordia Healthcare Corp. subsidiary Pinnacle Biologics. (PRNewsFoto/Concordia Healthcare Corp.) (PRNewsFoto/CONCORDIA HEALTHCARE CORP.)

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.

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SOURCE Concordia Healthcare Corp.