Royal DSM’s contract manufacturing arm, DSM Pharmaceutical Products, has signed a three year master supply agreement with the US arm of Japanese drug developer Eisai. The deal, of which financial details were not given, will see DSM manufacture a number of sterile products including the breast cancer vaccine eribulin mesylate, marketed as Halaven.
DSM will shortly begin commercial production at its Greenville, North Carolina facility. In a press statement Shawn Gallagher, President Partnership Management CFU at Eisai said: “This alternate site of manufacturing strengthens the supply reliability of this important product for our patients.”
President of DSM Pharmaceuticals, Laura Parks, added that the company had worked with Eisai from the launch of eribulin mesylate, and “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.”
Keeping Manufacturing Options Open
Quality issues at several manufacturing plants have led to shortages of a number of drugs and some pharma companies are on the lookout for alternative sites to ensure constant supply.
Quality issues caused a shutdown at CMO Ben Venue’s Bedford plant and led to a number of drug shortages including Genzyme’s leukaemia drug Fludara and Janssen’s ovarian cancer drug Doxil.
Janssen is currently hunting out other CMOs to ensure its drug supply remains full and unrestricted in the wake of Ben Venue’s continual problems as lapses in quality and an increase in regulatory pressures is causing drug companies to rethink how their products are manufactured.
Halaven received approval from the FDA (US Food and Drug Administration) in November 2010. Eisai began marketing the agent in the United Kingdom, Germany and other European countries in April 2011.
The drug, derived from marine sponges, is an injectable therapy which inhibits cancer cell growth in breast cancer sufferers.