DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, today announced the signing of a 3 year master supply agreement with Eisai Inc., based in Woodcliff Lake, NJ, USA, for the production of sterile products. The agreement covers the production of eribulin mesylate as well as other developmental drugs.
Alexander Wessels, President and CEO of DSM Pharmaceutical Products, stated, "We are delighted to be working with Eisai under a long-term agreement to serve markets globally for important human health treatments, bringing our expertise and reliability in sterile injectables and worldwide regulatory record to ensure market supply." DSM will be a supplier for eribulin mesylate to the US market.
Commercial production is anticipated to start in early 2013. Laura Parks, President, DSM Pharmaceuticals, Inc., the finished dosage business of DSM, stated, "It has been an honor to work with Eisai through the launch into commercial supply of eribulin mesylate and to continue to support the development of other products. Combining the expertise of Eisai in developing innovative medicines with DSM's strength in Good Manufacturing Practices (GMP),and supply chain management will provide critical high quality treatments for patients." DSM operates a 1.5 million square foot finished dosage facility in Greenville, North Carolina, USA, with a broad range of capabilities in aseptic filling of liquid and freeze-dried cytotoxic and non-cytotoxic steriles, the manufacture of tablets and capsules, pharmaceutical development services, and clinical trial materials manufacturing for solid and injectable forms, and holds a range of regulatory approvals including the production of scheduled drugs.
Eisai is a research based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. "Eisai appreciates the focus and effort the DSM Pharmaceuticals team in Greenville has provided in support of our commercial and developmental products. We are particularly pleased to have received FDA approval to manufacture eribulin mesylate at DSM for the commercial US market. This alternate site of manufacturing strengthens the supply reliability of this important product for our patients," added Shawn Gallagher, President Partnership Management CFU, Eisai Inc.
No financial details were disclosed.