GREER® Laboratories, Inc. Presents U.S. Grass Pollen Exposure Study Data at the 2015 AAAAI Annual Meeting

U.S. Region Specific Analysis of Grass Pollen Exposure, Species Prevalence and Population Patterns to be Featured

2015 AAAAI Annual Meeting

LENOIR, N.C.--()--GREER® Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced a poster presentation to take place during the American Academy of Allergy, Asthma & Immunology (AAAAI) 2015 Annual Meeting being held February 20-24 in Houston, Texas. The presentation will feature data from a GREER study examining the prevalence of four key allergenic temperate grass species across regions of the U.S. as well as the population of each region that may be exposed to pollens from the three most prevalent temperate grass species. Grass allergies are the most common seasonal allergy in the United States1,2 and most people are allergic to more than one type of grass.3

Although most of the U.S. population is exposed to multiple grass species, there have been no recent updates on population exposure by species across the continental United States. GREER researchers analyzed U.S. Census data showing the population of every county in the country and data from the U.S. Department of Agriculture (USDA) Plants Database, which provided county-level statistics on prevalence of the grass species studied. Plant prevalence and population data were correlated to project the potential exposure of people to four allergenic grass species. Researchers determined that 84 percent of the U.S. population is potentially exposed to perennial rye grass (Lolium perenne), 75 percent to orchard grass (Dactylis glomerata), 69 percent to timothy grass (Phleum pratense), and 68 percent to Kentucky bluegrass (Poa pratensis). Additionally, geographic regions showed distinct exposure patterns. For example, across the Southeast region, perennial rye dominates with 81 percent of the population potentially exposed, followed by 43 percent potentially exposed to orchard grass.

“We are pleased to be able to share this important data with allergy specialists and the allergy community,” said Rick Russell, GREER president and CEO. “Our goal is that this research will provide allergy specialists with important insights into the regional patterns that their grass allergic patients are exposed to, which will help with interpreting patient history and creating effective treatment plans. It also illustrates GREER’s ongoing commitment to equipping allergy specialists with the educational materials and tools needed to help treat people who suffer from allergies.”

The research also reaffirms the role of using multiple grass allergenic extracts to treat patients, specific to the variety of grasses they are exposed to in their geographic region including allergy immunotherapy injections and ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use. ORALAIR is the first and only sublingual grass allergy tablet with a mixed pollens allergen extract from 5 grasses 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 pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.

ORALAIR is taken for about four months before the expected start of the grass pollen season and is continued throughout the grass pollen season. ORALAIR is a tablet that dissolves under the tongue. The first dose is taken in the allergy specialist’s office under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. The patient will be observed for at least 30 minutes for symptoms of serious allergic reactions. If the patient tolerates the first dose, the remaining doses are administered once a day by the patient or the patient’s caregiver.

In clinical trials, ORALAIR reduced grass allergy symptoms for patients within the first allergy season. ORALAIR is not indicated for the immediate relief of allergy symptoms. In a five-year, multicenter clinical trial of 426 adults in 10 European countries, efficacy was sustained during three years of discontinuous pre- and co-seasonal treatment (Year 1 to Year 3) and ORALAIR significantly reduced daily Combined Score (CS) compared with placebo during every year of treatment. Participants then entered two years of immunotherapy-free follow up (Year 4 and Year 5). Data were insufficient to demonstrate efficacy for one or two years after discontinuation of ORALAIR.

The prescribing information for ORALAIR includes a Boxed Warning regarding the potential severe allergic reactions. Please see below for a summary of the Boxed Warning and additional important safety information. For the full Boxed Warning and additional important safety information, please see the full Prescribing Information at http://oralair.com/docs/ORALAIR%20Prescribing%20Information-Med%20Guide.pdf and the Medication Guide at http://oralair.com/docs/ORALAIR%20Med%20Guide.pdf.

The ORALAIR clinical program was based on results from an extensive set of clinical trials which included, in both the United States and Europe, about 2,500 adults and children. ORALAIR 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 relies on a network of specialty pharmacies that fulfill ORALAIR prescriptions and mail the medication directly to patients. GREER® Rx AssistSM is available for assistance with benefits investigations and specialty pharmacy ordering. To participate in GREER Rx Assist, simply fax your ORALAIR Specialty Pharmacy Enrollment Form to 1.844.708.0058.

GREER holds exclusive U.S. commercialization rights to ORALAIR through its partnership with STALLERGENES, developer and manufacturer of the product.

For more information on ORALAIR, visit www.ORALAIR.com.

About ORALAIR®

ORALAIR was originally approved in Europe in 2008 and is currently authorized in 31 countries around the world including most European countries, U.S., Canada, Australia, and Russia for the treatment of grass pollen allergy. In Canada, ORALAIR® was launched in 2012, making it the first allergy immunotherapy tablet to be registered and marketed in North America. World-wide post-marketing experience with ORALAIR® includes more than 33 million doses given to more than 183,000 patients.

ORALAIR has been approved based on results from an extensive clinical development program. ORALAIR® has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in about 2,500 adults and children. ORALAIR demonstrated that pre-seasonal and co-seasonal treatment with grass allergy immunotherapy reduces patients’ allergy symptoms and their need for symptom-relieving medication.

Important Safety Information

WARNING: SEVERE ALLERGIC REACTIONS

ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema. Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

ORALAIR is contraindicated in patients with severe, unstable or uncontrolled asthma, patients with a history of any severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy or of eosinophilic esophagitis, or patients who are hypersensitive to any of the inactive ingredients.

ORALAIR can cause systemic allergic reactions, including anaphylaxis, and severe local reactions, including laryngopharyngeal swelling, which may be life-threatening. Severe and serious allergic reactions may require treatment with epinephrine. Patients who have a systemic allergic reaction to ORALAIR should stop taking the product. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ORALAIR in patients with persistent symptoms of eosinophilic esophagitis, including dysphagia or chest pain. ORALAIR treatment should be withheld if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.

In case of oral inflammation or wounds, such as following oral surgery or dental extraction, ORALAIR treatment should be discontinued to allow complete healing of the oral cavity. The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.

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. Patients who have escalating or persistent local reactions to ORALAIR should be reevaluated and considered for discontinuation of ORALAIR.

ORALAIR should be used during pregnancy or breastfeeding only if clearly needed.

About STALLERGENES

STALLERGENES is a global healthcare company specialized in the diagnosis and treatment of allergies. For more than 50 years, it has been continuously expanding the existing frontiers of science in order to provide allergy patients with more effective long lasting therapeutic options. Thanks to its innovation strategy, fuelled by investments amounting to around 20% of total annual revenues as well as external collaborations, STALLERGENES is able to provide targeted allergen immunotherapy-based allergy solutions that significantly improve the lives of allergy patients around the world.

STALLERGENES operates in 21 countries and employs over 1,000 people. In 2013, the Company generated total revenues of €248 million, and more than 500,000 patients were treated with STALLERGENES products.

 

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Additional information is available at http://www.stallergenes.com

About GREER®

GREER® is a leading developer and provider of allergy immunotherapy products and services for treating humans and animals. As part of its commitment to allergy immunotherapy innovation, GREER’s clinical development programs are focused on sublingual allergy immunotherapy liquid (SAIL)™. GREER markets ORALAIR® in the United States through its partnership with STALLERGENES. Sublingual immunotherapy is an extension of GREER’s allergy immunotherapy products and provides another treatment option for allergy specialists to offer patients.

GREER was founded in 1904 and is located in Lenoir, North Carolina. For more information, visit www.greerlabs.com.

MPN021615H1500

1 Salo PM, Calatroni A, Gergen PJ, et al. Allergy-related outcomes in relation to serum IgE: results from the National Health and Nutrition Examination Survey 2005-2006. J Allergy Clin Immunol. 2011;127(5):1226-1235.

2 Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005;116(2):377-383.

3 Esch RE. Grass pollen allergens. In: Lockey RF, Bukantz SC, eds. Allergens and Allergen Immunotherapy. 2nd ed. New York, NY: Marcel Dekker; 1999:103-120.

Contacts

For GREER
Andrea Moody, 919-457-0743
andrea.moody@fleishman.com

Contacts

For GREER
Andrea Moody, 919-457-0743
andrea.moody@fleishman.com