January 30, 2015 3:43 PM ET

Pharmaceuticals

Company Overview of Meritage Pharma, Inc.

Company Overview

Meritage Pharma, Inc. develops prescription products for the treatment of gastrointestinal and atopic diseases. It offers budesonide, an active pharmaceutical ingredient and a glucocorticoid steroid for products that treat pediatric asthma, allergic rhinitis, and Crohn’s disease; and oral budesonide suspension, an oral formulation of budesonide for the potential treatment of adolescents and young adults with eosinophilic esophagitis, an allergic inflammation of the gastrointestinal tract. Meritage Pharma, Inc. was founded in 2008 and is based in San Diego, California.

12555 High Bluff Drive

Suite 385

San Diego, CA 92130

United States

Founded in 2008

Phone:

858-436-1660

Fax:

858-436-1661

Key Executives for Meritage Pharma, Inc.

Co-founder and Chief Scientific Officer
Compensation as of Fiscal Year 2014.

Meritage Pharma, Inc. Key Developments

Meritage Pharma, Inc. Announces Positive Phase 2B Results of Oral Budesonide Suspension for the Treatment of Adolescents and Adults with Eosinophilic Esophagitis

Meritage Pharma, Inc. announced positive Phase 2b results of oral budesonide suspension (OBS) for the treatment of adolescents and adults with eosinophilic esophagitis (EoE), a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophil-predominant inflammation. OBS achieved the co-primary endpoints of reduction in inflammation (p< 0.0001) and symptom of dysphagia (p=0.0096) with statistical significance. In addition, statistical significance was demonstrated for other secondary endpoints including histopathologic score, endoscopic score and physician global impression of disease activity. OBS was well tolerated. The double-blind, randomized, placebo-controlled 16-week study enrolled 119 patients aged 11 to 40 with confirmed EoE and documented problems swallowing food. The trial was conducted at approximately 25 U.S. clinical centers and a 24-week open label extension is ongoing. The effectiveness of OBS versus placebo was measured by a dysphagia symptom score determined from patient daily responses to the electronic Dysphagia Symptom Questionnaire™ (DSQ) tool and by evaluating the change in eosinophilic inflammation in biopsy samples from the esophagus at the beginning and end of treatment. Meritage plans to present the full results at an appropriate medical meeting in the future. The company's initial 12-week Phase 2 placebo-controlled dose-ranging trial evaluating 71 pediatric patients met the combined primary endpoint of reduction of esophageal eosinophilia and improvement in clinical symptom score as assessed by the treating physician. OBS was well tolerated with no serious adverse events. EoE is an emerging disease that has been increasingly recognized by the medical community with a dramatic rise in its incidence and diagnosis. The diagnosed EoE population is approximately 180,000 in the U.S. and is expected to reach 272,000 in the U.S. and 305,000 in the five large European countries by 2018. EoE may be triggered by a variety of stimuli including certain foods and environmental allergens. People with EoE commonly have other allergic conditions such as asthma or eczema and may experience symptoms for months or years prior to the initial diagnosis. Symptoms of EoE vary among age groups. Infants and toddlers experience feeding difficulties and failure to thrive. School-aged children may have nausea, vomiting and stomach pain. Adolescents and adults most often present with symptoms of dysphagia (difficulty swallowing) and food impaction. While eliminating certain foods from diets may help some patients, there are no FDA approved therapies. OBS is a proprietary viscous oral formulation of budesonide that is designed to coat the esophagus where the drug can act locally. Budesonide is the active pharmaceutical ingredient in several products approved by the FDA, including products for the treatment of pediatric asthma, allergic rhinitis and Crohn's disease. Budesonide is a corticosteroid and has an established safety profile in those diseases. The FDA has granted Orphan Drug Status designation to OBS for the treatment of patients with EoE. Orphan drug designation generally provides the developer with market exclusivity for the product for seven years following FDA approval, in addition to other incentives.

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