Dalton Pharma Services and Zafgen Enter Into Aseptic Fill Services Agreement
Published: May 16, 2011
Dalton Pharma Services will provide aseptic fill/finish services and analytical support under cGMP for Zafgen’s lead obesity treatment.
"Dalton’s expert capabilities in the sterile manufacture of API’s and analysis combined with its strength in aseptic filling solidified the manufacturing agreement," said James Vath, Head of Drug Discovery and Development for Zafgen.
"Adding Zafgen to our growing list of strategic relationships with innovative pharmaceutical clients is an important milestone for Dalton”, said Peter Pekos, President and CEO. “We are thrilled to be working with the Zafgen team and look forward to a successful collaboration as we advance this breakthrough obesity therapy through clinical development.”
Thomas Hughes, CEO of Zafgen, remarked, "The alliance with Dalton is a key part of our success in quickly advancing our first-in-class therapy for severe obesity into the next phase of clinical development. As a virtual company, Zafgen benefits tremendously from having the facilities and technical expertise found at Dalton. The opportunity to partner with a company that provides all aspects of manufacturing including the drug product and analytical services fits perfectly with Zafgen’s capital-efficient business model."
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved contract pharmaceutical manufacturer that supplies chemistry, analytical and formulation development services to the biotechnology and pharmaceutical industries in the areas of chemistry, medicinal chemistry and fine chemical manufacture. Dalton provides cGMP manufacturing of solid dosage forms and aseptic filling services to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its state of the art cGMP facilities, Dalton produces active pharmaceutical ingredients at the gram or kilogram scale. Dalton conducts sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions. In addition, Dalton’s analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients. Further information can be found at http://www.dalton.com.
About Zafgen, Inc.:
Zafgen is pioneering novel obesity therapeutics that directly target fat metabolism to help the body regain and sustain a lean, healthy state. The company’s approach focuses on restoring control of key metabolic processes, releasing stored fat which then is used by the body as fuel. Zafgen’s first generation product, named ZGN-440, has recently successfully completed a Phase 1b clinical trial in obese patients showing unprecedented efficacy and good tolerability. Zafgen's leadership and scientific advisors include leading experts in obesity, metabolic disorders and medicinal chemistry. Founded in 2005, the company is located in Cambridge, Mass. For more information, visit http://www.zafgen.com.
About Obesity and Fat Metabolism:
Obesity continues to be one of the world’s most costly and underserved health issues. As such, there exists a tremendous unmet medical need for effective drug therapies to treat obesity, which has reached epidemic proportions and is growing at an alarming rate. According to the Worldwide Health Organization (WHO), the number of obese adults had increased to at least 400 million worldwide in 2005, with more than 700 million projected by 2015. If current trends continue, 103 million American adults will be considered obese by 2018. The U.S. is expected to spend $344 billion on health care costs attributable to obesity in 2018 if rates continue to increase at their current levels with obesity-related direct expenditures expected to account for more than 21 percent of the nation’s direct health care spending in 2018.
Obesity leads to serious health consequences. As BMI increases, so does one’s risk for chronic diseases such as cardiovascular disease, diabetes, musculoskeletal disorders and some cancers, compounding the urgency for new and effective treatment options. Currently available weight loss treatments function by blocking fat absorption or signaling feelings of fullness or diminished appetite in the brain. These drugs are often associated with undesirable side effects and limited efficacy that fails to provide sustainable weight loss in many patients.
For further information contact:
President & CEO
Dalton Pharma Services Inc.
349 Wildcat Road