Company Overview of Oceana Therapeutics, Inc.
Oceana Therapeutics, Inc., a healthcare company, acquires, develops, and commercializes therapeutics with a focus on colorectal, gastroenterology, and urological diseases in the United States and internationally. It provides Deflux that is used for the treatment of Vesicoureteral reflux and other urological conditions; and Solesta, which is used for the treatment of fecal incontinence. The company was founded in 2008 and is headquartered in Edison, New Jersey. Oceana Therapeutics, Inc. operates as a subsidiary of Salix Pharmaceuticals Ltd.
2035 Lincoln Highway
Edison, NJ 08817
Founded in 2008
Key Executives for Oceana Therapeutics, Inc.
Chief Financial Officer and Executive Vice President
Senior Vice President and General Counsel
Compensation as of Fiscal Year 2012.
Oceana Therapeutics, Inc. Key Developments
CuraScript Signs an Agreement with Oceana Therapeutics
Oct 14 11
CuraScript, Inc. is now the exclusive specialty pharmacy for patients using Solesta(R), a product of Oceana Therapeutics, Inc., under an agreement announced October 14, 2011. Part of Express Scripts HealthBridge Pharma & Biotech services, CuraScript SD Specialty Distribution will be one of two national distributors responsible for delivering Solesta to healthcare providers.
Oceana Therapeutics, Inc. Announces U.S. Launch of Solesta(R)
Sep 6 11
Oceana Therapeutics, Inc. announced the U.S. launch of Solesta(R), a significant new treatment option offering patients with fecal (bowel) incontinence an opportunity for restored confidence to pursue a more normalized lifestyle. The Food and Drug Administration (FDA) approved Solesta for the treatment of fecal incontinence in adult patients who fail conservative therapy (e.g., diet, fiber therapy). The administration of Solesta does not involve surgery and can be performed without anesthesia. This is a major treatment innovation for the many underserved patients faced with social embarrassment and the potential need for invasive, surgical therapies. Solesta represents a powerful nonsurgical addition to the treatment arsenal of colorectal surgeons. These specialists are engaged in both noninvasive and surgical treatments of bowel incontinence, and enthusiastically welcome an entirely new treatment regime to fill the wide gap that previously existed between conservative and invasive therapies. Solesta(R) is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed for the treatment of fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for surgery or anesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allow for better sphincter control.
Oceana Therapeutics, Inc. Announces FDA Approves Solesta as Treatment for Fecal (Bowel) Incontinence in Adult Patients
May 31 11
Oceana Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Solesta as a treatment for fecal (bowel) incontinence in adult patients who have failed conservative therapy such as dietary control. The main body of clinical evidence in the Solesta PMA submission involved a multi-center, prospective, randomized, Sham (placebo) controlled study of the product's effectiveness and safety. The study included 206 patients (136 Solesta, 70 Sham) and consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: 1) demonstrating a statistically significant Solesta effect after 6 months of treatment; 2) meeting a pre-defined threshold for clinical significance; and 3) showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met.
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