September 01, 2014 4:10 AM ET

Pharmaceuticals

Company Overview of Greer Laboratories, Inc.

Company Overview

Greer Laboratories, Inc. provides allergy immunotherapy products and services for the healthcare industry. It offers human and veterinary allergy products, including pollen, fungi and smuts, antigens, standardized, and custom mixture, as well as epithelia, insect, and miscellaneous inhalant extracts; and sterile diluting fluids, sterile empty vials and caps, safety syringes, syringes and syringe trays, vial trays and racks, and skin testing devices. The company also provides custom vialing and lyophilization of client-supplied products; analytical testing services for protein, moisture, and specific allergen contents; and specialty services, such as custom antibody production, lyophilized ex...

639 Nuway Circle NE

Lenoir, NC 28645

United States

Founded in 1904

Phone:

828-754-5327

Fax:

828-754-5320

Key Executives for Greer Laboratories, Inc.

Chief Executive Officer and President
Chief Financial Officer and Vice President
Vice President of Operations
Executive Vice President of Sales & Marketing and Executive Vice President of Commercial Operations
Executive Vice President of Research & Development
Compensation as of Fiscal Year 2014.

Greer Laboratories, Inc. Key Developments

GREER(R) Laboratories, Inc. Announces FDA Approval of ORALAIR(R)

GREER(R) Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ORALAIR(R) (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet. ORALAIR(R) is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. ORALAIR(R) is approved for use in persons 10 through 65 years of age. Allergy immunotherapy in the United States has traditionally been administered via a series of subcutaneous injections in the allergy specialist's office. The approval of ORALAIR(R) provides an additional option for allergy specialists and patients to consider for treating grass allergies. Grass allergies are the most common seasonal allergy in the United States(1,2) and most people are allergic to more than one type of grass.(3) ORALAIR(R) is the only FDA approved oral allergy immunotherapy tablet that includes a five grass, mixed pollens allergen extract. These five grasses provide a wide range of grass allergy coverage in the United States. ORALAIR(R) is a tablet that dissolves under the tongue. The first dose is taken in the doctor's office under medical supervision, and subsequent doses are administered once a day by the patient or the patient's caregiver. ORALAIR(R) should be started four months before the expected onset of each grass pollen season and treatment continued throughout the season. ORALAIR(R) may reduce grass allergy symptoms for patients within the first allergy season that it is taken. The ORALAIR(R) clinical program was based on safety, efficacy and tolerability results from an extensive set of clinical trials which included, in both the United States and Europe, over 2,500 adults and children. ORALAIR(R) was generally well tolerated and the most common adverse events (reported in >=5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. GREER holds exclusive U.S. commercialization rights to ORALAIR(R) through its partnership with STALLERGENES, developer and manufacturer of the product.

GREER Announces Data from its Pivotal Phase III Investigational Clinical Trial for GREER Sublingual Allergy Immunotherapy Liquid

GREER announced that data from its pivotal Phase III investigational clinical trial for GREER(R) Sublingual Allergy Immunotherapy Liquid (SAIL)(TM) is published in the March issue of the Journal of Allergy and Clinical Immunology. The study marks the first successful North American Phase III clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract. The objective of the study was to determine the efficacy and tolerability of GREER(R) SAIL(TM) Standardized Short Ragweed extract in subjects with ragweed-related allergic rhinoconjunctivitis. The randomized, multi-center, double-blind, placebo-controlled, parallel group Phase III trial included 429 participants, ages 18-55 years, across 26 centers in North America. Participants had a minimum 2-year history of moderate to severe allergic rhinoconjunctivitis attributable to ragweed pollen that normally required anti-allergy medications. During the entire season, there was a 43% decrease in the total combined (symptom + medication use) score (TCS) relative to placebo (p=0.0005). Similar decreases were observed in the secondary endpoints in TCS between the two groups during peak season (42%) and in daily symptom scores during the entire (42%) and peak (41%) seasons.

Greer Laboratories, Inc. Announces U.S. Food and Drug Administration Supports Approval of ORALAIR for the Treatment of Grass Pollen Allergy

Greer Laboratories, Inc. announced that the Allergenic Products Advisory Committee (APAC) of the U.S. Food and Drug Administration (FDA) voted that the available data support approval of the Biologic License Application (BLA) for ORALAIR for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species included in the product. GREER holds exclusive U.S. commercialization rights to ORALAIR through its partnership with STALLERGENES, developer and manufacturer of the product. ORALAIR is an investigational sublingual immunotherapy tablet that includes a five grass mixed pollens allergen extract from Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Grass allergies are the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. The five grasses included in ORALAIR, if approved, would provide a wide range of grass allergy coverage in the United States. The FDA advisory committee supports the approval of ORALAIR based on safety, efficacy and tolerability results from an extensive clinical development program which includes, in both the United States and Europe, over 2,500 adults and children. ORALAIR was generally well tolerated and the most common treatment-emergent adverse events (greater than 10%) were application site reactions including oral pruritus and throat irritation. The FDA will likely consider the recommendations from the FDA advisory committee in its review of ORALAIR but is not required to follow them. In October, GREER and STALLERGENES announced the signing of an exclusive agreement for the United States commercialization rights to ORALAIR. Under the terms of the agreement, GREER would be responsible for the sales and marketing efforts for ORALAIR in the United States and STALLERGENES would be responsible for the manufacturing and supply of the product.

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