FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First...

FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the
First and Only Selective Relaxant Binding Agent
Committee Recommends FDA Approve Novel Anesthesia Drug to Reverse Muscle
relaxation within Minutes

KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough
(NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA)
Advisory Committee on Anesthetics and Life Support has recommended sugammadex
for approval. After reviewing data on the safety and efficacy of the
medication, the committee unanimously recommended approval of the company's
application for marketing.
The FDA is not bound by the committee's recommendations; however, they
usually are considered carefully before a final decision on approval is made.
Upon FDA approval, sugammadex will be the first and only selective
relaxant binding agent (SRBA) and will give anesthesiologists the ability to
rapidly and predictably reverse any depth of muscle relaxation induced by
rocuronium and vecuronium within minutes. Sugammadex allows for flexible
dosing of muscle relaxation agents enabling anesthesiologists to maintain
optimal block through the end of the procedure.
"We are very pleased with the outcome of today's advisory committee
meeting and appreciate the panel's careful consideration of the data on
sugammadex," said Robert J. Spiegel, M.D., Chief Medical Officer and Senior
Vice President, Schering-Plough Research Institute. "Sugammadex has the
potential to transform the practice of anesthesia through improved management
of muscle relaxation in the millions of surgeries where these agents are used.
We will continue to work with FDA to bring sugammadex to the U.S. market as
soon as possible so that anesthesiologists and their patients can benefit from
this innovative product."
Earlier this year, Schering-Plough announced that the FDA assigned
priority review status to the company's New Drug Application (NDA) for
sugammadex. In the U.S., priority review is granted to drugs that FDA
believes will provide meaningful benefit over existing treatment options.
Sugammadex is specifically designed to reverse the effects of certain
widely used 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. Sugammadex works in an
entirely novel way to encapsulate the muscle relaxant molecule and restore
muscle function so that patients can breathe on their own again. Reversal
with sugammadex is generally rapid and can even be used in emergency
situations when immediate reversal of rocuronium is needed.
Schering-Plough acquired sugammadex through its combination with Organon
BioSciences on November 19, 2007.
About Sugammadex
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 muscle
relaxation, thereby enabling control of the onset and offset of skeletal
muscle relaxation through the use of both drugs(1). Sugammadex also has
demonstrated the ability to reverse the effects of muscle relaxation induced
by vecuronium bromide. The most common adverse reactions (incidence >5%) seen
with sugammadex in clinical trials were anesthetic complications generally due
to restoration of muscle function (8.0%) and dysgeusia (12.6%).
About ZEMURON
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 About ZEMURON
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.
About Schering-Plough
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 colleagues 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 plans for, the potential of and the 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 Schering-Plough's 2007 10-K/A.
Reference:
(1) Jones K et al. Faster Reversal of Profound Rocuronium-Induced
Neuromuscular Blockade with Sugammadex vs. Neostigmine.
Anesthesiology 2007; 107: A1577.

SOURCE Schering-Plough

Mary-Fran Faraji, Cell, +1-908-432-2404, or Rosemarie Yancosek, Cell,
+1-908-208-4848, or Investors, Alex Kelly or Robyn Brown, +1-908-298-7436