December 13, 2017 11:59 PM ET

Pharmaceuticals

Company Overview of Shionogi Inc.

Company Overview

Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs. The company’s portfolio includes products for pain, pediatric conditions, infectious diseases, cardiovascular diseases, diabetes, and women's health. It offers products in the form of injections, chewable and oral tablets, capsules, and oral suspensions. The company also focuses on developing products for allergies, oncology, infections, and HIV. It distributes its products in the United States. The company was founded in 2010 and is based in Florham Park, New Jersey. Shionogi Inc. operates as a subsidiary of Shionogi & Co., Ltd.

300 Campus Drive

Florham Park, NJ 07932

United States

Founded in 2010

Phone:

973-966-6900

Fax:

973-966-2820

Key Executives for Shionogi Inc.

Chief Executive Officer, President and Director
Age: 52
Chief Financial Officer and Executive Vice President
Chief Transformation Officer & Human Resources Officer and Executive Vice President
Chief Compliance Officer, Executive Vice President of Legal & Compliance and Corporate Secretary
Age: 54
Compensation as of Fiscal Year 2017.

Shionogi Inc. Key Developments

Shionogi Inc. and Purdue Pharma L.P. Announce U.S. Availability of Symproic® (naldemedine) for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain

Shionogi Inc. and Purdue Pharma L.P. announced that Symproic® (naldemedine) 0.2 mg tablets are now available throughout the United States. The U.S. Food and Drug Administration (FDA) approved Symproic as a once-daily oral tablet for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Symproic is a peripherally-acting mu-opioid receptor antagonist (PAMORA). Symproic comes as a 0.2 mg once-daily oral tablet and may be taken at any time of day, with or without food, and with or without laxatives. Alteration of analgesic dosing regimen prior to initiating Symproic is not required. Patients receiving opioids for less than 4 weeks may be less responsive to Symproic. Treatment with Symproic should be discontinued if treatment with the opioid medicine is also discontinued. The FDA approval of Symproic was based on data from the global Phase 3 COMPOSE clinical trial program, which enrolled 2346 patients with OIC and chronic non-cancer pain. It was comprised of three studies: COMPOSE 1, COMPOSE 2 and COMPOSE 3. COMPOSE 1 and 2 were two replicate, 12-week, randomized, double-blind, placebo-controlled trials, while COMPOSE 3 was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study. For the primary endpoint, the proportion of responders was significantly higher with Symproic versus placebo in COMPOSE 1 (48%; n = 273 versus 35%; n = 272, p=0.0020) and COMPOSE 2 (53%; n = 276 versus 34%; n = 274, p<0.0001).

Shionogi Inc. and Purdue Pharma L.P. Announces U.S. Food and Drug Administration Approves Symproic® (naldemedine) Once-Daily Tablets C-II for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain

Shionogi Inc. and Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) approved Symproic® (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration (DEA), which is currently under evaluation. Symproic will be jointly launched and commercialized in the U.S. with Purdue Pharma and is expected to be commercially available mid-summer. The FDA approval of Symproic was based on data from the COMPOSE program. It was comprised of three studies: COMPOSE I, COMPOSE II and COMPOSE III. COMPOSE I and II were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, while COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study.

Shionogi and Purdue Pharma Establish Alliance for Joint U.S. Commercialization of Naldemedine

Shionogi & Co., Ltd. and its wholly-owned U.S. subsidiary, Shionogi Inc., and Purdue Pharma L.P. announced the establishment of an alliance for the joint U.S. launch and commercialization of Symproic® (naldemedine). Symproic®, a novel peripherally-acting mu opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, is currently under review at the U.S. Food & Drug Administration (FDA). The target action date for Symproic® under the Prescription Drug User Fee Act (PDUFA) is Mar. 23, 2017. In this alliance, Purdue’s expertise in the care of patients with pain will be combined with Shionogi’s knowledge as the inventor and global developer of naldemedine. Purdue and Shionogi will jointly launch and commercialize Symproic®, including a comprehensive collaboration on all aspects of strategy, sales, and other activities.

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