NASONEX(R) Now Approved In Japan For The Treatment Of Allergic Rhinitis In Adult Patients

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 18 Jul 2008 - 2:00 PDT

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Schering-Plough Corporation (NYSE: SGP) announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for NASONEX(R) (mometasone furoate monohydrate) Nasal Spray 50mcg for the treatment of allergic rhinitis in adult patients.(1) NASONEX is an intranasal steroid that significantly improves nasal allergy symptoms when taken once each day. NASONEX is the first intranasal steroid to be approved in Japan for once-daily administration. NASONEX is currently approved in over 100 countries worldwide and is anticipated to be available in Japan this fall.

"Allergies are a growing health problem in Japan," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "NASONEX provides physicians with an important treatment option for the relief of nasal allergy symptoms, especially for those patients looking for the convenience of a once-daily treatment."

Allergic rhinitis, which encompasses the outdoor symptoms of seasonal allergic rhinitis (SAR) and the indoor symptoms of perennial allergic rhinitis (PAR), affects an estimated 18 to 23 million people in Japan. Nasal allergy symptoms classically include sneezing, nasal itching, nasal discharge and congestion. Japan is the world's second largest market for prescription and over-the-counter medications for the treatment of allergies.

NASONEX

In the United States, NASONEX is indicated to treat nasal symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age and older, as well as nasal polyps in adults 18 years of age and older.(2) NASONEX is also proven to help prevent most seasonal nasal allergy symptoms in adults and children 12 years of age and older when NASONEX is started 2 to 4 weeks prior to allergy season.(2) NASONEX is nonsedating and not addictive when used as directed.(1) Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds and coughing.(2)

About Schering-Plough Corporation

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. 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 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 potential market for NASONEX. 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 about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2008 Q1 10-Q.

References:

1. NASONEX(R) Package Insert. Schering-Plough K.K.

2. NASONEX(R) (summary of product characteristics). Schering Corporation.

Schering-Plough Corporation
http://www.schering-plough.com

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