2014

Pinnacle Biologics and INTERmedic Medical Devices announce strategic manufacturing and distribution agreement for cancer laser technology

BANNOCKBURN, Ill., June 26, 2012 /PRNewswire/ -- Pinnacle Biologics, Inc., a bio-pharmaceutical technology company developing and manufacturing novel therapies for oncology and rare diseases and European-based INTERmedic, a medical laser and light technology company, announced a global manufacturing and distribution agreement of INTERmedic's latest photodynamic therapy (PDT) laser for exclusive use with Pinnacle's PHOTOFRIN ® (porfimer sodium) for injection. 

PDT is a two-step process, which uses a photosensitizing drug activated inside the body by laser light to kill cells. The agreement creates a customized PDT application combining PHOTOFRIN, a photoactivated agent, with INTERmedic's newest endoscopic laser delivery device. The device is already approved in Europe. Pinnacle anticipates registration in the United States and other global markets within the next 12-18 months.

"PDT is an impactful, yet under utilized treatment strategy," said Guillermo Herrera, Pinnacle Executive Chairman and CEO. "Pinnacle's goal is to support worldwide development of PDT with PHOTOFRIN in a way that elevates awareness and use among physicians and alerts patients to this cancer treatment option."

Pinnacle acquired PHOTOFRIN in March 2011 with the goal of 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 as new indications for use of PDT.

Pinnacle is working 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 for cancer is an advanced therapeutic approach that needs to be expanded and further developed," said Patrick Ross, MD, Ph.D., professor of clinical surgery and Chairman of Pinnacle's Scientific Advisory Board. "Pinnacle's strategic development of PDT with PHOTOFRIN and its commitment to extending its indications and applications are clear signals we can achieve those goals."

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, 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 BiologicsBV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About INTERmedic

INTERmedic is a dynamic laser & light technology company in a flux of constant expansion. The company is dedicated to the development, production and marketing of innovative laser and highly advanced pulsed light systems as well as other new technologies covering a wide range of medical applications. INTERmedic is one of Europe's leading laser manufacturers and marketers.

INTERmedic offers attending physicians innovative, patient-friendly solutions, well adapted to use by the applicant in aesthetics, dermatology, vascular medicine, plastic and general surgery. The company's solid standing in vascular surgery, with the minimally invasive method to treat varicose veins, guarantees its position as the world's number one in endovenous laser treatments.

SOURCE Pinnacle Biologics, Inc.




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