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Sanofi (France) (SAN.PA) Donates Record Number Of Epinephrine Auto-Injectors To Help People At Risk For Severe, Life-Threatening Allergic Reactions



5/2/2014 8:45:39 AM

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SANTA BARBARA, Calif.
, May 1, 2014 /PRNewswire-USNewswire/ -- The Sanofi Foundation for North America has donated more than 90,000 Auvi-Q® (epinephrine injection, USP) epinephrine auto-injectors to medical aid organization Direct Relief for distribution to nonprofit health centers, clinics, and allergy camps across the U.S. that care for people at risk of life-threatening allergies.

The donation valued at approximately $30 million (wholesale acquisition cost) is Sanofi's largest single donation of Auvi-Q ever and is part of the company's commitment to helping people with severe allergies live healthier and safer lives through access to treatment. Auvi-Q is the only epinephrine auto-injector with audio and visual cues to help guide the user through the injection process during an anaphylactic reaction.

"Direct Relief is making the donation of Auvi-Q available to its entire network of more than 1,100 nonprofit health centers and clinics across all 50 U.S. states, with a particular focus on school-based health centers and allergy camps to ensure people are prepared when emergencies occur," said Damon Taugher, Director of U.S. Programs at Direct Relief. "We are deeply thankful for the Sanofi Foundation's terrific donation, which is a perfect example of why Direct Relief has built out a national network among nonprofit safety-net health centers and clinics and made the investment to become the only nonprofit to obtain Verified-Accredited Wholesale Distributor status from the National Association of Boards of Pharmacy."

Anaphylaxis is a severe, sudden allergic reaction that typically involves two or more organs, such as the skin, airways, lungs, stomach, heart or blood pressure. Reactions can be deadly. Anaphylaxis is most commonly triggered by allergies to foods, medications, insect bites/stings, latex, and exercise. Symptoms may include: difficulty breathing; rashes, hives or swelling of the lips, tongue or skin; vomiting; loss of blood pressure; or, even loss of consciousness.

"The Sanofi Foundation for North America is pleased to be able to provide Auvi-Q for patients at risk of anaphylaxis. Our goal is to ensure all people at risk for life-threatening allergies have their prescription epinephrine on-hand when allergic reactions occur. Sanofi US is committed to providing access to our drugs to underserved communities, particularly when children are at risk," said John Spinnato, President, Sanofi Foundation for North America and Vice President North America Corporate Social Responsibility.

In October 2013, the Journal of Allergy and Clinical Immunology (JACI) published a landmark survey by the Asthma and Allergy Foundation of America (AAFA), which found that severe life-threatening allergic reactions anaphylaxis are common in the U.S. According to the survey of 1,000 adults, sponsored by Sanofi US, anaphylaxis very likely occurs in nearly 1-in-50 Americans (1.6%), and the rate is probably higher, close to 1-in-20 (5.1%). According to Anaphylaxis in America: The Prevalence and Characteristics of Anaphylaxis in the United States there are alarming patterns of inaction when anaphylaxis occurs: most patients are not getting their prescriptions, not keeping their auto-injectors nearby or not using them during allergic reactions when they should.

There is no cure or preventative treatment for most causes of anaphylaxis, so immediate use of a prescription epinephrine auto-injector at the first sign of a severe allergic reaction is the standard-of-care for adults and children. Patients at-risk for anaphylaxis should be prescribed epinephrine auto-injectors to keep on-hand at all times and ready to use if an emergency occurs.

As the only nonprofit to receive Verified Accredited Wholesale Distributor (VAWD)© certification by the National Association of Boards of Pharmacy, Direct Relief is licensed to distribute prescription drugs in all 50 states and is well-positioned to ensure the people in need and at risk of life-threatening allergies have access to the standard of care treatment.

About Auvi-Q
Auvi-Q (epinephrine injection, USP) provides users with audible and visual cues, including a five-second injection countdown and an alert light to signal when the injection is complete. In addition to being an auto-injector, Auvi-Q features an automatic retractable needle mechanism designed to help prevent accidental needle sticks.

Auvi-Q is available in two dosages. Auvi-Q 0.3mg delivers 0.3mg epinephrine injection and is intended for patients who weigh 66 pounds or more. Auvi-Q 0.15mg delivers 0.15mg epinephrine injection and is intended for patients who weigh 33 66 pounds. Auvi-Q has not been studied in patients weighing less than 33 pounds. Each Auvi-Q pack contains two active devices containing one dose of epinephrine each and a training device that does not contain epinephrine, which is provided for practicing. Auvi-Q received U.S. Food and Drug Administration approval in August 2012.

Eric and Evan Edwards, twin brothers who suffer from life-threatening allergies, and co-founders of Kaléo Pharma (formerly Intelliject, Inc.), developed Auvi-Q with a team of world class engineers and scientists. The development process, based on Human Factors Engineering, incorporated real-world experiences and feedback from patients and caregivers. Sanofi US licensed the North America commercialization rights to Auvi-Q from Kaléo Pharma, which has retained commercialization rights for the rest of the world. The inventors of Auvi-Q received the George DiDomizio Industry Award as part of the 16th annual ISMP Cheers Awards. This award recognizes individuals, organizations, and companies that have set a standard of excellence for others to follow in the prevention of medication errors and adverse drug events.

Indication
Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions.

Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure, and heart disease.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

Talk to your healthcare professional to see if Auvi-Q (epinephrine injection, USP) is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for Full Prescribing Information.

For more information about Auvi-Q visit www.Auvi-Q.com.

About Direct Relief
Direct Relief is a leading medical relief organization, active in all 50 states and in 70 countries and is the only U.S. nonprofit to obtain Verified Accredited Wholesale Distributor (VAWD)© certification by the National Association of Boards of Pharmacy. The organization has been among the world's largest medical suppliers in Haiti after the 2010 earthquake, has top charity ratings, including four-star and "top-notch" rating from Charity Navigator, and a 100% fundraising efficiency rating from Forbes magazine. Among other distinctions, Direct Relief was the 2011 winner of the Peter F. Drucker Award for Nonprofit Innovation and received the 2013 President's Award from ESRI. For more information visit www.DirectRelief.org.

About the Sanofi Foundation for North America

The Sanofi Foundation for North America makes it possible to provide free prescription drugs to patients who do not have insurance coverage and who meet program eligibility requirements. Product is donated to the Foundation by the company for this purpose. The Foundation also provides monetary support and partners with charities and 501(c)(3) organizations and other entities that are strategically aligned with mission particularly access to health care.

CONTACT:
Kerri Murray, (805) 452-7599
kmurray@directrelief.org

SOURCE Direct Relief International



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