News & Events

Concordia Healthcare Corp. Provides Clinical Trial and Corporate Update

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DATE: Nov. 28, 2014

TORONTO, Nov. 28, 2014 /CNW/ – 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.


iKey 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


iiBragazzi 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


iiiSEER 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.

For further information:
Please visit www.concordiarx.com or contact: Media: Molly Watson, Ritz Communications, 413-454-3926, molly.watson@ritzcommunications.com; Investors: Adam Peeler, TMX Equicom, 416-815-0700 x 225, apeeler@tmxequicom.com

Pinnacle Biologics, Inc., a subsidiary of Concordia Healthcare Corp., announces European site initiation of Phase 3 bile duct cancer trial using photodynamic therapy with PHOTOFRIN®

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DATE: October 7, 2014

TORONTO and CHICAGO, Ill., October 7, 2014 — Pinnacle Biologics, Inc. (“Pinnacle”), a subsidiary of Concordia Healthcare Corp., (“Concordia”) (TSX: CXR) (OTCQX: CHEHF), announced today the initiation of the pivotal Phase 3 trial (OPUS) in Germany for a rare form of bile duct cancer for which there is currently no acceptable therapy. OPUS is an Open-label, multicenter phase 3 on 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 Study. The primary end point is Overall Survival (OS).

The global trial will enroll 200 patients from the U.S., Switzerland, Germany, South Korea and Canada. The first European site to begin screening patients for purposes of enrollment is the University Medical Center Mannheim, which belongs to the Heidelberg University, Germany. Four more European sites are scheduled to be initiated in the coming weeks. In August, Thomas Jefferson University Hospital in Philadelphia was the first U.S. site approved to enroll patients.

CCA or bile duct cancer is uncommon with only about 2,000–3,000 and 900 new cases of CCA diagnosed annually in the United States and Germany, respectively1,2; perihilar CCA (or Klatskin tumor) is a subset of that disease. Bile duct cancer is more prevalent in Asia and the Middle East, mostly because of a common parasitic infection of the bile duct3.

“Bile duct cancer is rare and current treatment options are inadequate,” said Dr. Sebastian Belle, senior endoscopist and oncologist. “Photodynamic therapy with Photofrin has demonstrated promise as an effective treatment that can prolong life for these very ill patients. We hope the trial will provide important new information to guide development of this targeted cancer therapy for patients with uncommon and difficult-to-treat cancers.”

Pinnacle, a biopharmaceutical research and development company specializing in rare diseases, is a subsidiary of Concordia Healthcare Corp., a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population.

“Concordia has built a strong foundation around Pinnacle’s development of PDT therapy with PHOTOFRIN,” said Mark Thompson, CEO of Concordia. “Our experienced clinical team combined with calculated investment has enabled us to advance development of this treatment, which, because of its application, has the potential for use among a range of rare and difficult to treat cancers like mesothelioma and bile duct cancer.”

In January, Concordia announced an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) to enroll patients in this trial using PHOTOFRIN.

About PDT Therapy with PHOTOFRIN

PDT with PHOTOFRIN is a two-step cancer treatment process. PHOTOFRIN, a photosensitizing drug, is injected into the blood stream of patients where it accumulates in cancer cells. PHOTOFRIN is activated or “turned on” with laser light, which attacks cancer cells in nearby tissue. In addition to attacking cancer cells, PDT appears to shrink or attack tumors in two other ways4,5,6,7. The photosensitizer can damage blood vessels in the tumor, thereby preventing the cancer from receiving necessary nutrients. PDT also may activate the immune system to attack the tumor cells.

About PHOTOFRIN

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.

For additional information about PHOTOFRIN, please see full prescribing information available at www.PHOTOFRIN.com.

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), 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, 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 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, 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 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, 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.

SOURCE Concordia Healthcare Corp.

Please visit www.concordiarx.com or contact:

Media:
Molly Watson
Ritz Communications
413-454-3926
molly.watson@ritzcommunications.com

Investors:
Adam Peeler
TMX Equicom
416-815-0700 x 225

apeeler@tmxequicom.com

##########

1Key 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

2 De Groen PC, Gores GJ, Larusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med 1999; 341 (18): 1368-78.

3ibd.

4Dolmans, D., Fukumura, D., & Jain, R. Photodynamic therapy for cancer. Nature Reviews Cancer 2003; 3(5):380–387. [PubMed Abstract]

5Wilson, B. Photodynamic therapy for cancer: principles. Canadian Journal of Gastroenterology 2002; 16(6):393–396. [PubMed Abstract]

6Vrouenraets, M., Visser, G., Snow, G., & van Dongen, G. Basic principles, applications in oncology and improved selectivity of photodynamic therapy. Anticancer Research 2003; 23(1B):505–522. [PubMed Abstract]

7Dougherty, T., Gomer, C., Henderson, B., et al. Photodynamic therapy. Journal of the National Cancer Institute 1998; 90(12):889–905. [PubMed Abstract]

CONCORDIA HEALTHCARE CORP. ENTERS INTO COLLABORATION AGREEMENT WITH ORPHAN CANADA

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DATE: August 31, 2014

TORONTO and CHICAGO, Ill., August 31, 2014 — 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. annually 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.

Please visit www.concordiarx.com or contact:

Media:
Molly Watson
Ritz Communications
413-454-3926
molly.watson@ritzcommunications.com

Investors:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com

###

1 http://www.cancer.net/cancer-types/bile-duct-cancer/statistics

Roswell Park Gets Green Light for Phase II Clinical Trial Using Interstitial Photodynamic Therapy

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Innovative approach for treating recurrent head/neck cancer borrows techniques from radiation medicine
DATE: April 1, 2014

BUFFALO, N.Y., April 1, 2014 — Roswell Park Cancer Institute (RPCI) has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a phase II clinical trial that will use a unique and highly precise method of delivering interstitial photodynamic therapy (I-PDT) to recurrent tumors of the head and neck.

Most patients with recurrent and nonresectable head-and-neck cancer experience poor quality of life and a projected survival that is measured in months. I-PDT is an additional treatment option that may improve outcomes for patients who respond poorly to standard therapies.

“These patients have no effective treatment options,” says Gal Shafirstein, DSc, principal investigator of the study and a member of RPCI’s Departments of Cell Stress Biology and Head & Neck/Plastic & Reconstructive Surgery. “We hope to learn through this study whether we can improve their overall survival by adding interstitial photodynamic therapy to standard treatment approaches.”

PDT, a treatment approach developed at RPCI, uses laser light to activate a nontoxic drug called a photosensitizer. The process works in three ways: it destroys cancer, shuts down blood vessels that “feed” the tumor, and prompts the immune system to kill cancer cells throughout the body. It is associated with mild side effects and can be combined with standard chemotherapy and surgery, and followed with radiation therapy.

Initiated by Dr. Shafirstein, the phase II clinical trial will use the photosensitizer Photofrin®, manufactured by Pinnacle Biologics, Inc., which is funding the trial. The study will be conducted in collaboration with Thomas Foster, PhD, and Timothy Baran, PhD, both of the Department of Imaging Sciences at the University of Rochester Medical Center.

Treating physician Hassan Arshad, MD, a surgical oncologist in RPCI’s Department of Head & Neck/Plastic & Reconstructive Surgery, will be responsible for all clinical aspects of the study.

The clinical trial will borrow treatment-delivery techniques already used in the field of radiation medicine. Advanced treatment planning developed specifically for I-PDT will help the team to calculate the precise dose of laser light needed for each section of a tumor. That information will be used to treat tumors while minimizing damage to healthy tissue.

Patients enrolled in the study will undergo pretreatment imaging with computed tomography (CT). A three-dimensional image of the tumor will then be created with CT scans to determine the number and correct placement of the optical fibers that will deliver the laser light. The patients will receive Photofrin, followed by a two-day waiting period to allow the photosensitizer to be absorbed by the cancer cells. The treatment will be conducted while the patient is under general anesthesia. The optical fibers will be inserted through the skin and into the tumor at specific, predetermined points. A light-dosimetry system developed by Dr. Shafirstein in his RPCI lab will measure, in real time, the light being delivered by each optic fiber, giving the medical team the information needed to make necessary adjustments to meet the goals of the treatment plan.

“Collaborating with Roswell Park is an important step in expanding our clinical development platform for PDT with Photofrin,” says Mark Thompson, chief executive officer of Concordia Healthcare Corp., parent company of Pinnacle Biologics. “Increased education, awareness and use of the dosimetry device, and the statistically significant outcomes we have achieved in other rare and hard-to-treat cancers, will inform this process and will, we hope, lead to better and more options for critically ill patients.”

“We hope that these state-of-the-art approaches will maximize the potential benefit of this therapy for patients with recurrent head and neck tumors,” Dr. Shafirstein adds.

The study will enroll 19 patients over a period of two years. For more information, visit www.roswellpark.org/clinical-trials/list/235613, or call 1-877-ASK-RPCI (1-877-275-7724).

About Photodynamic therapy (PDT) and 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 non-burning laser light 24–50 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 FDA-approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. Photofrin® also is approved for high-grade dysplasia (HGD) in Barrett’s esophagus (BE) in North America. It also has Orphan Drug Designation (ODD) for cholangiocarcinoma and 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 Pinnacle

Pinnacle Biologics, Inc., a U.S.-based subsidiary of Concordia Healthcare Corp., is a biopharmaceutical research and development company specializing in orphan diseases. The company is headquartered in Bannockburn (suburban Chicago), Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About Roswell Park Cancer Institute

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.

Media Contact

Annie Deck-Miller, Senior Media Relations Manager
716-845-8593; annie.deck-miller@roswellpark.org

Concordia Healthcare Corp. announces FDA agreement on Special Protocol Assessment for Phase 3 Clinical trial on new therapy to treat perihilar cholangiocarcinoma

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Agreement represents continued movement forward in the development of a potential new treatment for rare cancers
DATE: January 13, 2014

TORONTO and BANNOCKBURN, Ill., Jan. 13, 2014 — Concordia Healthcare Corp. (“ConcordiaTSX:CXR) announced today that its subsidiary Pinnacle Biologics, Inc. (“Pinnacle“), a biopharmaceutical research and development company specializing in rare diseases, has reached an agreement with the U.S. Food and Drug Administration (the “FDA“) under a special protocol assessment (the “SPA“) to enroll patients with an advanced form of bile duct cancer in a pivotal Phase 3 clinical trial.  There is currently no approved therapy for this cancer type. The SPA is a written agreement between Pinnacle and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application submission.  The clinical trial will study 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.

“The agreement with the FDA to move into this Phase 3 clinical trial is a significant milestone for Pinnacle,” said Mark Thompson, CEO of Concordia.  Robert S. Altman, president of Pinnacle added, “Securing this agreement reflects the depth of our experience and industry relationships with regulators, top academic institutions and clinical opinion leaders. We expect to begin enrolling patients into this study in the first half of 2014, a process, which we believe will help accelerate product development for this rare and devastating disease.”

“For the first time, we have a path forward to an indication using a drug-device combination that may combat a complex cancer, which is difficult to treat and has extremely poor survival rates,” said PD. Dr. med. Maria Anna Ortner, Department of Gastroenterology and Hepatology, University Hospital Zurich, and a lead study investigator.

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[i], 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, 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

SOURCE Concordia Healthcare Corp.

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Concordia Healthcare Corp. Announces Acquisition Of Pinnacle Biologics, Inc.

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Newly listed company’s purchase adds new products and increases R&D strength
DATE: December 24, 2013

TORONTO, ON AND BANNOCKBURN, IL, Dec. 24, 2013 – Concordia Healthcare Corp., an integrated, specialty healthcare company focused on the acquisition of legacy pharmaceutical products and medical devices and the acquisition and/or development of orphan drugs, announced today that it has acquired Pinnacle Biologics, Inc., a U.S.-based biopharmaceutical company specializing in legacy pharmaceuticals which have the potential for development as orphan drugs to treat cancer indications in addition to those for which they have previously been approved.

Concordia is completing a year of rapid, strategic growth culminating with this acquisition and the conditional approval of the listing of Concordia’s common shares on the Toronto Stock Exchange (Ticker Symbol: CXR).

“The completion of our $34.5 million equity raise last week and listing approval on the TSX were major milestones for Concordia, enabling the completion of this transaction,” said Mark Thompson, chief executive officer of Concordia.  “The addition of Pinnacle Biologics begins an exciting new phase of growth for the Company. Concordia will be able to support the further development of Pinnacle’s unique oncology products as well as new indications for rare forms of cancer and, potentially, other diseases.”

One of Pinnacle’s on-market products includes PHOTOFRIN®, a photosensitizer used in photodynamic therapy (PDT) of tumors.  PDT with PHOTOFRIN® is a two-stage process.  The first stage is the intravenous injection of PHOTOFRIN®.  Clearance from a variety of tissues occurs over 40-72 hours, but tumors retain PHOTOFRIN® for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy.  Tumor selectivity in treatment occurs through a combination of selective retention of PHOTOFRIN® and selective delivery of light.

Pinnacle’s PDT with PHOTOFRIN is FDA approved for multiple indications including the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. PHOTOFRIN also is approved for high-grade dysplasia (HGD) in Barrett’s esophagus (BE) in North America. It has Orphan Drug Designation (ODD) for cholangiocarcinoma (cancer of the bile duct) and as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets.

“Being a part of Concordia and supported by re-invested revenue from its existing products, Pinnacle can continue to develop its world class science and, in particular, move forward with a pivotal Phase 3 clinical trial using PDT with PHOTOFRIN to treat a very rare form of bile duct cancer for which we have Orphan Drug Designation in the United States,” said Robert S. Altman, Ph.D., president of Pinnacle Biologics.

Concordia is an integrated healthcare company with three separate, but inter-related business divisions: legacy pharmaceutical products that generate predictable cash-flow, a specialized healthcare distribution (SHD) division servicing the diabetic market, and a division focusing on the acquisition and/or development of orphan drugs. The SHD division also intends to provide a specialty pharmaceutical distribution capability, through its licenced pharmacy, for orphan drugs/approved medicines, and will do so in support of the just acquired Pinnacle Biologics, Inc. and its current oncology products.

About Concordia

Concordia Healthcare is a diverse healthcare company focused on legacy pharmaceutical products, medical devices and orphan drugs. Concordia Healthcare was founded in December, 2012 by Mark L. Thompson.

The company’s legacy pharmaceutical business was acquired in May, 2013 and consists of an ADHD-treatment drug, Kapvay® (clonidine extended release tablets), a Head Lice Treatment, Ulesfia® (benzyl alcohol) Lotion, and an Asthma-related medication, Orapred ODT® (prednisolone sodium phosphate orally disintegrating tablets). Concordia’s SHD division (Complete Medical Homecare) was acquired in October, 2013.  Pinnacle’s therapeutic technology is the latest strategic acquisition by Concordia.

Concordia operates out of facilities in Oakville, Ontario, Lenexa, Kansas (near Kansas City, Missouri), Chicago, Illinois and Bridgetown, Barbados.

About Pinnacle

Pinnacle Biologics, Inc., a U.S. based subsidiary of Concordia, is a biopharmaceutical research and development company specializing in orphan diseases. The company is headquartered in Bannockburn, (suburban Chicago) Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

Notice regarding forward-looking statements:

This release includes forward-looking statements regarding Concordia Healthcare Corp.  and its business.  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. 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 integration of Pinnacle Biologics, Inc. with the business of Concordia, the further development of Concordia’s products, the growth of Concordia, failure to obtain regulatory approvals, economic factors, the equity markets generally 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.

Children’s Hospital of Wisconsin and Medical College of Wisconsin launch clinical trial for treatment of childhood brain tumors

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DATE: April 2, 2013

Children and adolescents with recurrent or progressive brain tumors will have an opportunity to participate in a new Phase 1 clinical trial conducted by Children’s Hospital of Wisconsin and the Medical College of Wisconsin investigating the safety of a novel brain cancer treatment.

The survival of pediatric patients with recurrent brain tumors is measured in months, with few long-term survivors. New therapies for children with brain tumors are needed. Photodynamic therapy (PDT) is a promising treatment for patients with recurrent, malignant brain tumors. PDT is a two-step cancer treatment process. A photosensitizing drug called PHOTOFRIN® is injected into the blood stream of patients where it accumulates in cancer cells in the brain. Immediately after surgical removal of the tumor, PHOTOFRIN® is activated with laser light killing any remaining cancer cells in the nearby brain. A previous clinical trial using PDT for the treatment of adults with recurrent, malignant brain tumors demonstrated long-term survival in 40%-50% of patients.

Harry T. Whelan, MD, the Bleser Professor of Neurology and Pediatrics and Hyperbaric Medicine at Children’s Hospital of Wisconsin, and Professor of Neurology at the Medical College of Wisconsin, is the lead investigator for the study. “We believe the findings from prior studies of PDT in adults warrants application in pediatric patients with recurrent/refractory, high-grade brain tumors. Children’s Hospital of Wisconsin (CHW) is one of the few centers in the country with experience utilizing PDT technology for the treatment of brain tumors. As a result we are uniquely poised to apply PDT treatment in pediatric patients.” Dr. Whelan‘s clinical research team has partnered with Pinnacle Biologics, Inc. who will provide PHOTOFRIN®, the laser and additional resources and expertise to make the study possible.

This is a Phase 1 limited dose-escalation study of PHOTOFRIN® in pediatric and adolescent patients with recurrent or refractory, malignant brain tumors. The primary objective of this study is to identify a maximum tolerated dose (MTD) and to characterize the side-effect profile of PHOTOFRIN® in children with recurrent brain tumors.

Eligible patients will have injection of PHOTOFRIN® followed by surgical resection of the tumor 24 hours later. Activation of PHOTOFRIN® in the tumor bed will be performed using an intra-operative laser. Patients will receive standard post-operative care and will be closely monitored at CHW during the first month for side effects associated with PHOTOFRIN® activation. Patients will then return to their referring facilities and receive any additional therapy for treatment of their cancer. Long-term study monitoring will be performed through referring facilities.

More information about the clinical trial can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT01682746

About Photodynamic therapy (PDT) and 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 non-burning laser light 24–50 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 FDA approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. PHOTOFRIN® also is approved for high-grade dysplasia (HGD) in Barrett’s esophagus (BE) in North America. It also has Orphan Drug Designation (ODD) for cholangio-carcinoma and 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 Pinnacle

Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About the Medical College of Wisconsin

The Medical College of Wisconsin is the state’s only private medical school and health sciences graduate school. Founded in 1893, it is dedicated to leadership and excellence in education, patient care, research and service. More than 1,200 students are enrolled in the Medical College’s medical school and graduate school programs. A major national research center, it is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In FY 2011 – 12, faculty received more than $166 million in external support for research, teaching, training and related purposes, of which more than $152 million is for research. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, College faculty direct or collaborate on more than 2,000 research studies, including clinical trials. Additionally, more than 1,350 physicians provide care in virtually every specialty of medicine for more than 425,000 patients annually.

About Children’s Hospital of Wisconsin

Children’s Hospital of Wisconsin is the region’s only independent health care system dedicated solely to the health and well-being of children. The hospital, with locations in Milwaukee and Neenah, Wis. is recognized as one of the leading pediatric health care centers in the United States and was named one of America’s Best Children’s Hospitals by U.S.News & World Report. Children’s Hospital provides primary care, specialty care, urgent care, emergency care, community health services, foster and adoption services, child and family counseling, child advocacy services and family resource centers. In 2010, Children’s Hospital invested more than $105 million in the community to improve the health status of children through medical care, advocacy, education and pediatric medical research. Children’s Hospital achieves its mission in part through donations from individuals, corporations and foundations and is proud to be a Children’s Miracle Network Hospital. For more information, visit the website at chw.org.

Pinnacle Biologics files for new PHOTOFRIN indication in Germany and France

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DATE: December 4, 2012

AMSTERDAM and BANNOCKBURN, Ill., December 04, 2012 – Pinnacle Biologics, BV., announced today it has filed a national pharmaceutical variation with the German and French health agencies, the Federal Institute for Drugs and Medical Devices and the National Agency for the Safety of Medicine and Health Products respectively, for Photodynamic therapy (PDT) with PHOTOFRIN® (porfimer sodium) for the therapeutic indication unresectable advanced hilar cholangiocarcinoma (CCA). Pinnacle is a bio-pharmaceutical technology company developing and manufacturing novel therapies for oncology and rare diseases.

Hilar CCA (Klatskin tumor) proposed in the above indication is a rare cancer subset arising at the convergence of the right and left hepatic duct1.

“This filing reflects our continued commitment to make PDT therapy available for physicians and patients worldwide and more importantly, to continue to develop therapies that treat rare diseases like cholangiocarcinoma,” said Guillermo Herrera, Pinnacle Executive Chairman and CEO.

About Photodynamic therapy (PDT) and 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 non-burning 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.
Currently approved indications for PHOTOFRIN in France are for the treatment of recurrences of non-small cell bronchial cancer or esophageal cancer, which have been previously treated loco-regionally. In Germany, approved indications for PHOTOFRIN are for the curative treatment of patients with histologically proven non-small cell endobronchial early carcinomas (Stage T is NO MO or T1 NO MO), who according to the responsible physician could not be curatively treated by surgery or radiotherapy.

Pinnacle recently acquired the laser and fiber technology used in PDT. The acquisition creates a complete portfolio for the company, which now includes all the Photofrin PDT treatment components.

Important Safety Information

For important safety information about the currently licensed indications please refer to the local PHOTOFRIN Patient Information Leaflet.

About Pinnacle

Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

Pinnacle Biologics acquires PDT laser technology

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DATE: December 4, 2012

Bannockburn, IL, December 04, 2012 – Pinnacle Biologics, Inc., a bio-pharmaceutical technology company developing and manufacturing novel therapies for oncology and rare diseases announced today the acquisition of laser technologies for use in photodynamic therapy (PDT). The acquisition includes the Diomed™ PDT 630 laser and the OPTIGUIDE™ fiber optic diffusers, which are currently the only FDA-approved devices for use in PDT with PHOTOFRIN ® (porfimer sodium) for injection. Financial terms were not disclosed.

Photodynamic therapy with PHOTOFRIN is a two-stage process requiring administration of both drug and light. Pinnacle’s acquisition of the laser and fiber technology creates a complete portfolio for the company, which now includes all the PDT treatment components.

“This acquisition delivers significant value to Pinnacle by ensuring we have the strongest platform possible from which to further develop PDT therapy,” said Guillermo Herrera, Pinnacle Executive Chairman and CEO. “Having access to all the PDT technology and science allows us to accelerate our push for new indications and treatments for cancer and other, more rare diseases.”

Pinnacle acquired PHOTOFRIN in March 2011 solidifying its corporate presence and global leadership in the photodynamic therapy field by normalizing product supply, expanding availability and education among current customers, and targeting areas of unmet medical need for use with PDT. The company continues to work with regulators, top academic institutions and opinion leaders to accelerate product development in areas where the product has shown evidence of safety and efficacy for the benefit of patients affected by rare and devastating diseases.

“PDT with PHOTOFRIN is an established treatment, however more work needs to be done to elevate awareness of this treatment among physicians and patients,” said Herrera.

About Photodynamic therapy (PDT) and 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 non-burning 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 FDA approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. PHOTOFRIN also is approved for high-grade dysplasia (HGD) in Barrett’s esophagus (BE) in North America. It also has Orphan Drug Designation (ODD) for cholangio-carcinoma and as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma.

For additional information about PHOTOFRIN, and safety information, please see the full prescribing information available at www.photofrin.com.

About Pinnacle

Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

Pinnacle Biologics Inc. announces appointment of Bioprojet Pharma as exclusive distributor in select European countries

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DATE: April 18, 2012

Pinnacle Biologics is pleased to announce the appointment of Bioprojet Pharma, effective March 15, 2012, as its exclusive distributor for ETHYOL (amifostine) and PHOTOFRIN (Porfimer Sodium) in select European countries.

Ethyol is a cytoprotective agent indicated to reduce the incidence of moderate to severe xerostomia (dry mouth) following radiation treatment for head and neck cancer and to reduce cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. Bioprojet has rights to distribute Ethyol in France, Italy, Spain, Germany, the Benelux and other countries in the Pinnacle territory where the product is approved by the regulatory authorities.

Photofrin is a photo-activated drug and is indicated for the treatment of thoracic malignancies, specifically non-small cell lung cancer and esophageal cancer. Bioprojet has rights to distribute the product initially in France, Germany and the United Kingdom.

About Pinnacle

Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About Bioprojet Pharma

Bioprojet Pharma is a privately held European pharmaceutical company with is headquarters in Paris, France. Bioprojet is a leading European research based specialty pharmaceutical company involved in the design and development of compounds from pre-clinical to Phase III. The company markets pharmaceutical products across Europe.