KENILWORTH, N.J., Jan. 17 Schering-PloughCorporation (NYSE: SGP) announced that Nippon Organon K.K., now part ofSchering-Plough, has filed a New Drug Application with the Japanese Ministryof Health, Labour and Welfare (MHLW) seeking marketing approval for its novelselective relaxant binding agent (SRBA), sugammadex.
Sugammadex is specifically designed to rapidly reverse to rapidly reversethe effects of certain muscle relaxants, rocuronium bromide (marketed in theU.S. as ZEMURON(R) and in Japan as ESLAX(R)), as well as vecuronium bromide(marketed in Japan as MUSCULAX(R)). Muscle relaxants are used as part ofgeneral anesthesia during surgical procedures.
The company announced on January 2, 2008, that the U.S. Food and DrugAdministration (FDA) has assigned priority review status to the New DrugApplication (NDA) filing for sugammadex. Additionally, the MarketingAuthorization Application for sugammadex was accepted for review by theEuropean Medicines Agency (EMEA) in July 2007.
Schering-Plough acquired sugammadex through its combination with OrganonBioSciences on November 19, 2007.
Sugammadex is a novel selective relaxant binding agent (SRBA) underdevelopment by Organon, a part of Schering-Plough Corporation. Sugammadex wasdesigned to reverse the effects of rocuronium bromide or vecuronium bromide,muscle relaxants commonly used during surgeries that require profound musclerelaxation. Anesthesiologists use muscle relaxation to improve surgicalconditions, to facilitate intubation and mechanical ventilation, and to reducethe chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability torapidly reverse shallow and profound depths of rocuronium-inducedneuromuscular blockade (NMB), thereby enabling control of the onset and offsetof skeletal muscle relaxation through the use of both drugs. Sugammadex alsohas demonstrated the ability to reverse the effects of NMB induced byvecuronium bromide. In a phase III clinical trial, the most frequentlyreported adverse events associated with sugammadex regardless of relationshipto the study drug were procedural pain and nausea.
ESLAX (rocuronium bromide), marketed in the U.S. as ZEMURON, is a non-depolarizing muscle relaxant. It was introduced in the United States in 1994and is one of the most widely used muscle relaxants in the United States,Canada and many European countries (where it is marketed under the brand nameESMERON(R)). It was approved for use in Japan on July 31, 2007, under thebrand name ESLAX. To date, it has been used in over 140 million patientsworldwide, including an estimated 20 million patients in 2006.
Important Safety Information
There have been rare reports of severe anaphylactic reactions to ZEMURON(rocuronium bromide) Injection, including some that have been lifethreatening. Clinicians should be prepared for the possibility of thesereactions and take the necessary precautions, including the immediateavailability of emergency treatment. ZEMURON Injection should be administeredby experienced clinicians who are familiar with the drug's actions and thepossible complications of its use. For Full Prescribing Information please goto www.zemuron.com or www.esmeron.com.
Schering-Plough is an innovation-driven, science-centered global healthcare company. Through its own biopharmaceutical research and collaborationswith partners, Schering-Plough creates therapies that help save and improvelives around the world. The company applies its research-and-developmentplatform to human prescription and consumer products as well as to animalhealth products. In November 2007, Schering-Plough acquired OrganonBioSciences, with its Organon human health and Intervet animal healthbusinesses, marking a pivotal step in the company