Navigation Links
Schering-Plough Announces Sugammadex New Drug Application Filed in Japan
Date:1/17/2008

KENILWORTH, N.J., Jan. 17 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) announced that Nippon Organon K.K., now part of Schering-Plough, has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its novel selective relaxant binding agent (SRBA), sugammadex.

Sugammadex is specifically designed to rapidly reverse to rapidly reverse the effects of certain muscle relaxants, rocuronium bromide (marketed in the U.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 of general anesthesia during surgical procedures.

The company announced on January 2, 2008, that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the New Drug Application (NDA) filing for sugammadex. Additionally, the Marketing Authorization Application for sugammadex was accepted for review by the European Medicines Agency (EMEA) in July 2007.

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 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.

About ESLAX/ZEMURON.ESMERON

ESLAX (rocuronium bromide), marketed in the U.S. as ZEMURON, 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(R)). 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 http://www.zemuron.com or http://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 approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://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 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.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
2. Schering-Plough Announces Pricing of Senior Notes Offering
3. Schering-Plough to Webcast Presentation at Merrill Lynch Global Pharmaceutical, Biotech & Medtech Conference
4. Schering-Plough Receives Approval from European Commission for Planned Acquisition of Organon BioSciences N.V.
5. Schering-Plough Completes Acquisition of Organon BioSciences
6. Schering-Plough Wins Three of Scrips Top Pharma Industry Awards
7. Schering-Plough Schedules Conference Call and Webcast for 2007 Fourth Quarter, Full-Year Financial Result
8. Schering-Plough to Webcast Presentation at Morgan Stanley Pharmaceutical CEOs Unplugged Conference
9. Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA
10. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
11. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... ... April 27, 2016 , ... Cambridge Semantics, the ... technology, today announced that it has been named to The Silicon Review’s “20 Fastest ... and other markets, Cambridge Semantics serves the needs of end users facing some of ...
(Date:4/27/2016)... and RESEARCH TRIANGLE PARK, N.C. , ... UTHR ) announced today that Martine Rothblatt ... Therapeutics will provide an overview and update on the ... Annual Health Care Conference. The presentation will ... a.m. Eastern Time, and can be accessed via a ...
(Date:4/27/2016)... ... April 27, 2016 , ... Global Stem Cells Group CEO ... is the founder of GSCG affiliate Kimera Labs in Miami. , In 2004, Ross ... stem cell transplantation for hematologic disorders and the suppression of graft vs. host disease ...
(Date:4/26/2016)... (PRWEB) , ... April 26, 2016 , ... ... today announced that Ardy Arianpour has joined the company as Chief Business Officer. ... experience bringing innovative genomic technologies to market, was most recently Chief Commercial Officer ...
Breaking Biology Technology:
(Date:4/13/2016)... CHICAGO , April 13, 2016  IMPOWER physicians ... are setting a new clinical standard in telehealth ... By leveraging the higi platform, IMPOWER patients can ... weight, pulse and body mass index, and, when they ... quick and convenient visit to a local retail location ...
(Date:3/22/2016)... 2016 According to ... for Consumer Industry by Type (Image, Motion, Pressure, ... & IT, Entertainment, Home Appliances, & Wearable ... 2022", published by MarketsandMarkets, the market for ... USD 26.76 Billion by 2022, at a ...
(Date:3/15/2016)... 15, 2016 --> ... Transparency Market Research "Digital Door Lock Systems Market - Global ... 2023," the global digital door lock systems market in terms ... and is forecast to grow at a CAGR of 31.8% ... and medium enterprises (MSMEs) across the world and high industrial ...
Breaking Biology News(10 mins):