Schering-Plough Announces NDA for Sugammadex Assigned Priority Review Status by U.S. FDA
KENILWORTH, N.J., Jan 02, 2008 -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the company's New Drug Application (NDA) for sugammadex.
Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive.
"Organon, now part of Schering-Plough Corporation, has had a strong presence in the anesthesia market for over 35 years," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "The development of sugammadex is an exciting advance for the practice of anesthesia. This novel drug has the potential to change the way doctors practice anesthesia as it will allow anesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents."
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide (ZEMURON/ESMERON(R)/ESLAX(R)) or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced neuromuscular blockade (NMB), thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex also has demonstrated the ability to reverse the effects of NMB induced by vecuronium bromide. In a phase III clinical trial, the most frequently reported adverse events associated with sugammadex regardless of relationship to the study drug were procedural pain and nausea.
ZEMURON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in the United States in 1994 and 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 name ESMERON). It was approved for use in Japan on July 31, 2007, under the brand name ESLAX. To date, it has been used in over 140 million patients worldwide, 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 life threatening. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment. ZEMURON Injection should be administered by experienced clinicians who are familiar with the drug's actions and the possible complications of its use. For Full Prescribing Information please go to www.zemuron.com or www.esmeron.com.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the development of, and potential market for, sugammadex. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward- looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in the company's third quarter 2007 10-Q.