MIAMI, January 20, 2016 (BUSINESS WIRE)– NextSource Biotechnology, LLC announced today that Gleostine® (lomustine) 5 mg capsules has been approved by the U.S. Food and Drug Administration (FDA) and is now commercially available in the United States. Gleostine® is approved for use as a single agent treatment or in combination with other approved chemotherapeutic agents. Gleostine® is indicated to treat brain tumors – both primary and metastatic, as well as Hodgkin’s disease.
“We believe that expanding our oncology product line will allow us to drive change in how cancer may be treated”
Robert DiCrisci, President, CEO NextSource Biotechnology
“This approval adds a fourth dosage strength to the Gleostine® product line-up that now includes 5, 10, 40 and 100 mg strengths, offering physicians a wider selection of dosage options to help best tailor medical treatments to the unique needs of each patient. This latest approval offers physicians more precise dosing options in treating patients afflicted with cancer,” said Robert DiCrisci, Founder and CEO of NextSource Biotechnology (NSB). “We believe that expanding our oncology product line will allow us to drive change in how cancer may be treated.” Gleostine® is a sole source FDA approved product, which is also accessible through NextSource CARES®,
NSB’s patient assistance program. As a result of the company’s extensive patient access efforts, the continued use of unregulated compounded products or any other unapproved version of Gleostine® is no longer necessary or permitted by the FDA.
NextSource Biotechnology is committed to providing the highest quality products to consistently meet patient demands.
About NextSource Biotechnology:
Established in 2010, NextSource Biotechnology is a privately held pharmaceutical manufacturer. Its mission is to ensure the availability and consistent supply of pharmaceutical products that have experienced frequent market shortages.
NextSource utilizes a network of leading Contract Manufacturers to successfully deliver these medically critical products, providing the treatments necessary to enhance the lives of patients suffering from unmet medical needs.
About our Partner CordenPharma:
CordenPharma is an expert Contract Manufacturing partner helping leading pharmaceutical and biotechnology companies link their requirements for product success with their patients’ healthier lives.
Formed as a pharmaceutical branch of International Chemical Investors Group in 2006, CordenPharma provides specialized technologies that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services.
About ICI Group
International Chemical Investors Group is a privately owned industrial holding company focusing on mid-sized chemicals and pharmaceutical businesses. Since inception in 2004, ICIG has acquired 19 independent chemicals and pharmaceutical businesses with total sales of approximately EUR 800 million.
All of ICIG’s businesses and employees have origins in major global chemicals or pharmaceutical corporations and while we actively exchange best practice throughout most functions of our different businesses, all of our companies are independently financed and managed.
The focus is exclusively on the chemicals and pharmaceutical industries, preferably subsidiaries of large corporations operating in competitive environments, which were considered non-core and acquired at attractive valuations.
The operating plants are well invested in favorable locations with an international orientation and leading positions in niche markets. ICIG companies presently employ more than 3500 employees and operate 19 manufacturing plants, six in Germany, three in the United States, three in France, four in Italy, one in Ireland, one in Poland and one in Switzerland. The Group has sales or research and development offices in Germany, the United States, Switzerland, Italy, Spain, the United Kingdom, Ireland and China.