Navigation Links
Schering-Plough Announces European Filing of SYCREST(R) (asenapine) for the Treatment of Schizophrenia and Bipolar I Disorder
Date:6/2/2009

KENILWORTH, N.J., June 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for SYCREST(R) (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

The MAA for SYCREST includes data from the asenapine clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.

"We highlighted asenapine as one of the Five Stars in our late-stage research and development pipeline at our R&D Update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009," noted Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "I am pleased that we met this important milestone for asenapine within the first half of 2009."

In the United States, a New Drug Application (NDA) for asenapine, under the brand name SAPHRIS(R), is currently under review by the U.S. Food and Drug Administration (FDA) for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

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, animal health and consumer health care products. 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 clinical development of, the commercial plans for and the potential market for SAPHRIS/SYCREST. 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 uncertainties in the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. "Risk Factors" in the Company's first quarter 2009 10-Q, filed May 1, 2009.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Valeant Grants Schering-Plough Exclusive Option in Japan for Taribavirin in Exchange for Release of Last Right of Refusal
2. Johnson & Johnson Files Arbitration Demand Against Schering-Plough to Resolve Dispute Over Agreements for REMICADE(R) and SIMPONI(TM)
3. Video: Schering-Plough Introduces TINACTIN(R) CHILL, a Line of Antifungal Products Geared Specifically to Young Males
4. Schering-Plough Starts Patient Enrollment in Phase 3 Trial for Acadesine, an Investigational Agent Being Studied for Prevention of Complications From Cardiac Surgery
5. Schering-Plough Flips the Switch on 1.7 MW Rooftop Solar Panel System, One of the Largest in N.J., North America
6. J&J, Schering-Plough, Novartis, Bayer vie for Top Honors at the Premier OTC / Healthcare Ad Awards
7. Schering-Plough Reports Financial Results for 2009 First Quarter
8. EPA Names Schering-Plough 2009 EPA ENERGY STAR(R) Partner of the Year
9. Settlement Hearing on Schering-Plough Corporation Securities Litigation to be Held on June 1, 2009 at 2:00 P.M.
10. Schering-Plough Withdraws From Barclays Capital Global Healthcare Conference
11. Schering-Plough Declares Quarterly Dividends on Common Shares and Mandatory Convertible Preferred Stock
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... USA; and SHANGHAI, China – , ... ... -- Global public health organization NSF International has certified the ... to NSF/ANSI 53: Drinking Water Treatment Units – Health Effects, ... certification verifies that MicroCeramics’ NanoNose Pitcher Filter System filters the ...
(Date:1/18/2017)... ... January 18, 2017 , ... A Palm Beach doctor plans ... Train, an international charity that provides free surgery to poor children suffering from cleft ... the past I have run to support the efforts of the American Heart Association ...
(Date:1/18/2017)... , ... January 18, 2017 , ... ... asset protection and financial planning services to families and business owners in the ... aimed at supporting children with developmental disabilities. , The Lakemary Center is a ...
(Date:1/18/2017)... ... January 18, 2017 , ... Catalent ... for drugs, biologics and consumer health products, today announced that Mr. Michael Merges, ... upcoming WCBP Conference, to be held at the Mayflower Hotel, Washington DC, on ...
(Date:1/18/2017)... (PRWEB) , ... January 18, 2017 , ... ... of the revolutionary Active Brake Technology (ABT), an innovative braking system that allows ... Active Brake Technology addresses one of the biggest concerns of beginner and intermediate ...
Breaking Medicine News(10 mins):
(Date:1/18/2017)... Jan. 18, 2017  Dermata Therapeutics, LLC, a ... treat a variety of dermatological diseases, announces dosing ... in a Phase 2 acne rosacea study. DMT210 ... the proinflammatory cytokines in the skin responsible for ... This clinical trial, DMT210-003, is ...
(Date:1/18/2017)... , January 18, 2017 The report " Automated Breast ... Breast Volume Scanner), By End User (Hospitals, Diagnostic Imaging Centers), Industry Analysis Report, ... Argentina , Germany , UK, ... Russia , China , Japan ... Thailand , Saudi Arabia , UAE, ...
(Date:1/18/2017)... , Jan. 18, 2017  Tarix Orphan LLC today ... granted a Rare Pediatric Disease (RPD) designation for the ... Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder. ... treatment is limited to supportive care. "The ... Drug Designation previously granted by the FDA in this ...
Breaking Medicine Technology: