The US Food and Drug Administration (FDA) approved MSD’s (known as Merck & Co. in North America) drug Ragwitek - containing an extract of Ragweed - to treat hay fever with or without conjunctivitis last week, becoming the third allergen extract drug administered sublingually to be approved.
Earlier this month MSD's sublingual treatment of grass pollen-induced allergic rhinitis Grastek was approved, two weeks after Stallergenes’ drug Oralair received the thumbs up.
The clinical batches of both Ragwitek and Grastek were manufactured for MSD by Catalent from its Swindon, UK facility and, according to MSD spokesman Robert Consalvo, the contract development and manufacturing organisation (CDMO) will continue to make and package the drugs for commercial use.
“Catalent packages the tablets in blister cards of ten tablets each,” Consalvo told Outsourcing-Pharma.com, which are then “bulk shipped to Merck’s manufacturing facility in the US, where the blisters are packaged into trade boxes for sale to wholesalers.”
MSD has been undergoing a global manufacturing network review since it merged with Schering-Plough in 2009, which has included the wind down of operations at a number of plants – Swords, Ireland and two sites in Puerto Rico being the most recent.
However, Consalvo told us this contract with Catalent was not indicative of the pharma giant moving towards a wholly outsourcing approach for the manufacture of its products.
“Merck continues its own manufacturing operations worldwide, but also works with third-party suppliers on a case by case basis as part of its global manufacturing and supply strategy,” he said.
Consalvo would not reveal details of any other partnerships MSD has with Catalent but did express the CDMO had been selected due to its “expertise in making sublingual tablets” and its “proprietary Zydis technology that allows for the Grastek and Ragwitek tablets for sublingual use to rapidly dissolve under the tongue.”
The formulation technology is a freeze-dried oral solid dosage form that disperses instantly in the mouth, requiring no water, and according to Catalent, is used in over 20 products approved worldwide, including Eli Lilly’s bipolar drug Zyprexa.
However, in 2012 a "reduced customer forecast" for Zydis led to a cut in staff at the Swindon facility, though more recently Zydis was named a driving force in Catalent’s $35m (€26m), 80,000 sq ft expansion at its Winchester, Kentucky facility, the firm told this publication last year.