Investigational Sublingual Allergy Immunotherapy Tablet Meets Primary Endpoint In A Study Of Adult Subjects With A History Of Grass Pollen Allergies

Main Category: Allergy
Also Included In: Clinical Trials / Drug Trials
Article Date: 03 Nov 2009 - 1:00 PST

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Schering-Plough Corporation (NYSE: SGP) announced that its investigational sublingual Grass (Phleum Pratense) Allergy Immunotherapy Tablet (AIT) has met the primary endpoint in a Phase III study of adult subjects in the U.S. with a history of grass pollen induced rhinoconjunctivitis with or without asthma. The investigational Grass AIT treatment is designed to work by inducing a protective immune response against grass pollen allergy and providing sustained prevention of allergy symptoms, treating both the symptoms and the underlying cause of the disease.

The study was a U.S. multicenter, randomized, placebo-controlled, double-blind, parallel-group clinical trial evaluating the efficacy of the grass sublingual tablet versus placebo in the treatment of grass pollen-induced rhinoconjunctivitis based on the combined (sum of) rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire grass pollen season (GPS). In the study 439 adults were randomized to receive either placebo or grass tablet. The study met its primary endpoint. Additionally, the adverse events experienced by subjects receiving the drug in this study were similar to previous studies in adults and include oral itching, with no new or unexpected findings.

These data are planned to be submitted for presentation at a U.S. medical conference in 2010.

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 asenapine. 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 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 third quarter 2009 10-Q, filed October 29, 2009.

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.

Source: Schering-Plough Corporation