Pharmos announces results of its Phase 2b Dextofisopam trial

November 16, 2017

Research and development spending for the 2009 third quarter totaled $913 million, a 2 percent increase (4 percent operational increase and 2 percent favorable foreign exchange impact), related to higher spending for clinical trials and related activities, partially offset by the impact of foreign exchange.

Recent Developments

In addition to the regulatory and pipeline advances discussed above, the company also offered the following summary of recent significant developments that have previously been announced, including:

Announced FDA acceptance of a filing for a New Drug Application (NDA) for DULERA, a fixed-dose combination of mometasone furoate and formoterol fumarate, for the maintenance treatment of asthma in patients 12 years of age and older. (Announced July 22)Reported a proposed settlement, subject to Court approval, to resolve litigation seeking to enjoin the planned merger with Merck & Co., Inc., and other forms of relief. The consolidated class action lawsuits were filed in U.S. District Court for the District of New Jersey. (Announced July 24)Announced that SAPHRIS sublingual tablets met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia. (Announced July 24)With sanofi-aventis and Merck & Co., Inc., announced that the companies have signed a definitive agreement under which Merck will sell its 50 percent interest in the companies' animal health joint venture, Merial Limited, to sanofi-aventis. (Announced July 30)With Merck and the companies' cholesterol joint venture, Merck/Schering-Plough Pharmaceuticals, announced agreements to resolve civil class action litigation relating to the purchase or use of VYTORIN and ZETIA. (Announced Aug. 5)Announced results of a special shareholders meeting regarding the proposed merger with Merck. More than 99 percent of votes cast voted to approve the merger agreement, with more than 78 percent of common shares voting. (Announced Aug. 7)Reached agreement with Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc., related to certain generic formulations of CLARINEX (desloratadine). The agreement marks the end of all pending litigations filed and consolidated since 2006 in the U.S. District Court for the District of New Jersey against several generic drug manufacturing companies involving generic solid oral dosage forms of desloratadine. (Announced Aug. 11)Gained U.S. approval for SAPHRIS sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder. (Announced Aug. 14)Reported the European Medicines Agency's acceptance for review of two applications: for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma, and nomegestrol acetate/estradiol, a combined oral contraceptive. (Announced Aug. 26)With Merck, announced that as part of the pending merger the following three Schering-Plough Board members are expected to remain on the Board of the newly combined company upon completion of the merger: C. Robert Kidder, Patricia F. Russo and Craig B. Thompson, M.D. (Announced Sept. 3)Reported final results of a SAPHRIS long-term schizophrenia relapse prevention clinical study, showing that time to relapse or impending relapse, the primary efficacy endpoint, was significantly longer with SAPHRIS than with placebo. (Announced Sept. 14)Reported long-term data with vicriviroc, an investigational CCR5 receptor antagonist, from an ongoing, open-label extension of the Phase II VICTOR-E1 study in treatment-experienced HIV-infected patients. (Announced Sept. 14)Reported the recommended approval by the FDA's Oncologic Drugs Advisory Committee by a vote of six to four for PEGINTRON in the adjuvant treatment of patients with Stage III malignant melanoma. (Announced Oct. 5)With Centocor Ortho Biotech Inc., reported the European Commission approval of SIMPONI as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis, active and progressive psoriatic arthritis and severe, active ankylosing spondylitis. (Announced Oct. 6)Nobilon, Schering-Plough's human vaccine business unit, initiated a clinical Proof of Concept trial with a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use. (Announced Oct. 13)Reported new long-term data from two pivotal, Phase III clinical trials showing that patients with active rheumatoid arthritis receiving SIMPONI every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. (Announced Oct. 19)

Third Quarter 2009 Conference Call and Webcast

Schering-Plough will conduct a conference call today at approximately 7:15 a.m. (EDT) to review results for the 2009 third quarter. To listen live to the call, dial 1-877-565-9664 or 1-706-634-5003 and enter conference ID # 33373738. A replay of the call will be available beginning later on Oct. 22 through 5 p.m. on Thursday, Oct. 29. To listen to the replay, dial 1-800-642-1687 or 1-706-645-9291 and enter the conference ID #33373738. A live audio webcast of the conference call also will be available by going to the Investor Relations section of the Schering-Plough corporate Web site, www.schering-plough, and clicking on the "Presentations/Webcasts" link. A replay of the webcast will be available starting on October 22 through 5 p.m. on November 2.

SOURCE Schering-Plough Corporation