Pinnacle Biologics Acquires PHOTOFRIN(R) and PHOTOBARR(R), Novel Photodynamic Therapy for Treating Various Types of Cancer

Technology News Wednesday March 30, 2011 08:47 —Biomedical

Pinnacle Biologics, Inc., a privately held specialty bio-pharmaceutical company announced today the global acquisition of PHOTOFRIN® and PHOTOBARR® from Axcan Pharma, Inc. Financial terms were not disclosed.

A novel therapeutic technique, PHOTOFRIN® is approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, Canada, several major European countries and Japan as well as several Latin American and Southeast Asian markets. Additional approved indications for PHOTOFRIN® in North America are high grade dysplasia (HGD) in Barrett's esophagus (BE) and papillary bladder cancer in Canada and Argentina.

PHOTOBARR® is approved only in the European Union under orphan drug status for HGD in BE.

"We are very excited about this important acquisition and unique technology," said Guillermo Herrera, Executive Chairman of Pinnacle Biologics. "Presently, the two primary indications for photodynamic therapy (PDT) are NSCLC and esophageal cancer. Pinnacle is committed to developing these products in additional indications where preliminary clinical data show superior efficacy and outstanding survival rates compared to current therapeutic options. There are a number of underserved areas with unmet medical needs. In these areas, PDT has the potential to become a standard of care. Pinnacle is committed to developing and commercializing the assets globally."

According to Patrick Ross, MD, PhD, Professor of Surgery and Chief, Division of Thoracic Surgery at Ohio State University Medical Center, "PDT is used for the management of a wide spectrum of clinical problems. Although initially proposed as a palliative tool in the management of end-stage esophageal or bronchogenic carcinoma, it has emerged as a modality which can effectively treat early as well as advanced endoluminal tumors, PDT has been incorporated into all aspects of our practice, including palliation, induction therapy, and definitive intervention for early-stage cancers of the aerodigestive tract. We have been pleased by our experience and are excited about the future impact photodynamic therapy will have on therapeutic options for our cancer patients." *

The products are activated by a laser light. This targeted therapeutic combination of PHOTOFRIN®/ PHOTOBARR® and the laser is known as photodynamic therapy. When injected, PHOTOFRIN®/ PHOTOBARR® are attracted to and linger in certain tissues, especially cancer cells. In addition to directly killing cancer cells, PDT appears to damage blood vessels in tumors causing them to shrink, and may activate the immune system to promote a systemic response to cancer cells. The laser uses red light to activate the drug, tumor destruction is by biochemical reaction, not by heat, keeping damage to healthy tissues minimal.

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

About Non-Small Cell Lung Cancer(1)

Lung cancer is the leading cause of cancer death in men and women. There are more than 200,000 patients with lung cancer each year. NSCLC is the most common type of lung cancer. It usually grows and spreads more slowly than small cell lung cancer.

There are several types of NSCLC including adenocarcinoma and squamous cell carcinoma. All can be treated with PDT at any stage.

About Esophageal Cancer(2)

Esophageal cancer (EC) forms in tissues lining the esophagus (the muscular tube through which food passes from the mouth to the stomach). There are two types of EC: squamous cell carcinoma and adenocarcinoma. Both types of cancer can be treated with PDT.

It is difficult to determine specific causes of EC. People with certain risk factors, however, are more likely to develop esophageal cancer. These risk factors include age 65 or older, male gender, smoking and heavy alcohol consumption. In 2010, there were approximately 16,600 new cases of EC and 14,500 deaths in the United States.

References:

1. National Center for Biotechnology Information -- PubMed Web Site http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004462

2. National Cancer Institute -- Web Site http://www.cancer.gov/cancertopics/types/esophageal

About Pinnacle Biologics, Inc.

Pinnacle Biologics specializes in revitalizing healthcare therapies to fulfill their true potential and to maximize favorable patient outcomes. This is accomplished through licensing and acquisition of specialty pharmaceuticals and medical devices. Our innovative approach to opportunity analysis, business development, lifecycle management, regulatory expertise and distribution leverage takes each product to its highest degree of potential and maximum patient benefit.

  • (DISCLOSURE: This press release was funded by Pinnacle Biologics, Inc. Dr. Patrick Ross has no financial relationship with Pinnacle Biologics. Dr. Ross has been a paid consultant to Axcan Pharma, Inc. on behalf of PHOTOFRIN® in the past.)

CONTACT:

Guillermo Herrera

Executive Chairman

Pinnacle Biologics, Inc.

2801 Lakeside Dr - Suite 209

Bannockburn, IL 60015

P: 1.847.283.7690

F: 1.847.283.7695

www.pinnaclebiologics.com

www.photofrin.com

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