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Sanofi US Release: Football Legend Jerome Bettis and Cookbook Guru Robin Miller Kick-off Auvi-Q™ Anaphylaxis Awareness Campaign


1/29/2013 9:34:53 AM

BRIDGEWATER, N.J., Jan. 29, 2013 /PRNewswire/ -- Jerome Bettis and Robin Miller are teaming up with Sanofi US to raise awareness of life-threatening allergic reactions (anaphylaxis) and spread the word that Auvi-Q (epinephrine injection, USP) is now available by prescription in pharmacies nationwide. Bettis, who is allergic to shellfish, and Miller, who is allergic to eggs, hope to help educate adults and caregivers of children at risk for severe allergic reactions.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/59439-auvi-q-epinephrine-injection-usp-now-available-by-prescription-in-u-s

(Photo: http://photos.prnewswire.com/prnh/20130129/MM45075)

"My mantra is 'the best defense is a good offense,' so when I found out about Auvi-Q, I wanted to make sure that people with severe, life-threatening allergies like me know their 'plays' namely, avoid your allergens and always carry an epinephrine auto-injector just in case of accidental exposure," said Bettis. "Auvi-Q fits easily into my pocket, and I can take it with me wherever I go."

"I'm allergic to peanuts and shellfish, so it's crucial for me to always carry an epinephrine auto-injector and know how to respond quickly in an emergency," said Dr. Vivian Hernandez-Trujillo, a pediatric allergist, national expert in anaphylaxis and consultant to Sanofi US. "My nephew is also at risk for anaphylaxis and I know the feeling of panic that can happen when an allergic reaction begins. As much as I always want to be by his side with an epinephrine auto-injector close at hand, I know I can't. I have to rely on others to be able to administer it to him, if necessary. The availability of Auvi-Q is great news for adults and caregivers of children at risk for anaphylaxis."

Auvi-Q is the first-and-only epinephrine auto-injector with audio and visual cues for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.The size and shape of a credit card and the thickness of a smart phone, Auvi-Q is a breakthrough in epinephrine auto-injector design that talks patients and caregivers step-by-step through the injection process.

Bettis and Miller are among the up to six million Americans who may be at risk for anaphylaxis, although the precise incidence is unknown and likely underreported.Food is the most commonly identified anaphylaxis trigger and accounts for 30 percent of all anaphylaxis fatalities. It is estimated that an emergency room visit caused by food-related anaphylaxis occurs in the United States about every 18 minutes. While guidelines emphasize the importance of the life-saving role of epinephrine, two large surveys (n= 600 and n=651) show that two-thirds of patients and caregivers do not carry their epinephrine auto-injectors as recommended, and nearly half worry that others will not know how to use their or their child's epinephrine auto-injector correctly during an emergency.Multiple studies have found an association between delay in epinephrine administration and death from anaphylaxis.

Life-threatening allergic reactions may occur as a result of exposure to allergens including foods such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings; latex and medication, among other allergens and causes.Serious allergic reactions can be unexpected. In fact, most allergic reactions to foods occur to items that were thought to be safe, and an insect sting is unpredictable. So, it's important to always be prepared.

Jerome Bettis' and Robin Miller's Tips for Big Game Party Hosts

"Jerome and I enjoy Big Game parties, but they can be stressful for those of us, young and old, with food allergies," said Miller. "Even the smallest amount of an ingredient or cross-contamination in food can trigger a severe allergic reaction. That's why avoidance is key. To keep the stress on the game and not on the party, I'm sharing some of my favorite, allergy-friendly recipes that are delicious and easy to prepare, so we can all enjoy the Big Game!"

Party hosts have an important role to play in keeping Big Game festivities and other social gatherings fun and allergy-friendly. For allergy-friendly Big Game party recipes, visit http://auvi-q.com/tools-and-downloads. For Jerome's and Robin's allergy-friendly entertaining tips, visit http://www.multivu.com/assets/59439/documents/59439-allergy-friendly-entertaining-tips-original.pdf.

About Auvi-Q

Auvi-Q 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 to help prevent accidental needle sticks.

Available in two different 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 devices - containing one dose of epinephrine each - and a non-active training device.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 Intelliject, Inc., developed Auvi-Q with a team of world class engineers and scientists. The development process incorporated real-world experiences and feedback from patients and caregivers. Sanofi US licensed the North America commercialization rights to Auvi-Q from Intelliject, Inc., which has retained commercialization rights for the rest of the world.

Auvi-Q has been named an International CES Innovations 2013 Design and Engineering Awards Honoree.The prestigious Innovations Design and Engineering Awards are sponsored by the Consumer Electronics Association (CEA)®, the producer of the International CES and the world's largest consumer technology tradeshow. http://www.cesweb.org/Awards/CES-Innovations-Awards/2013.aspx?category=HealthandWellness

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

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 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.

About Anaphylaxis
The signs and symptoms of anaphylaxis can vary from person to person and from one episode to the next.Some people may have hives/itching, facial or tongue swelling, which makes it difficult to breathe or swallow, while others may experience nausea and vomiting.These symptoms may begin within seconds, minutes or hours after exposure to the allergen.The best prevention method for anaphylaxis is avoidance of the specific allergen(s).

When a severe, life-threatening allergic reaction occurs, epinephrine should be administered immediately and patients and caregivers should seek immediate medical attention.Patients and caregivers should always carry and know how to use an epinephrine auto-injector to treat emergency allergic reactions.Without treatment, anaphylaxis can result in death within a matter of minutes.

About Jerome Bettis

The former Pittsburgh Steelers Running Back is one of the best all-time running backs in the NFL (6th overall in rushing). Jerome Bettis is also the 2001 recipient of the Walter Payton Man of the Year Award, and has been a finalist on the Hall of Fame list over the last three years. "The Bus" finished his NFL career in January 2006 after 13 seasons, retiring immediately following the Pittsburgh Steelers' 21-10 win over the Seattle Seahawks in Super Bowl XL in his hometown of Detroit. Bettis was selected to the Pro Bowl six times, including his rookie season. Bettis finished his college career at Notre Dame averaging 5.7 yards per carry and was drafted by the Los Angeles Rams 10th overall in 1993. He was named NFL Co-Rookie of the Year and also earned Sporting News Rookie of the Year and Rams MVP honors. In 1996, Jerome was traded from the Rams to the Steelers. Bettis is also severely allergic to shellfish. Bettis established "The Bus Stops Here Foundation" in 1996 to help improve the quality of life for disadvantaged and underprivileged children. In 2002, he was named the NFL Walter Payton Man of the Year for his community involvement and work by his foundation. Bettis and his wife Trameka live in Atlanta, Ga. with their daughter Jada and son Jerome. The Bettis' also maintain a home in Pittsburgh, Pa.

About Robin Miller

Robin has more than 20 years of experience as a food writer and nutritionist and is the author of the bestselling cookbook Quick Fix Meals and Robin Takes 5. Her popular show, Quick Fix Meals with Robin Miller, aired on Food Network for five years and she has weekly blogs, Robin's Healthy Take, on http://blog.foodnetwork.com/healthyeats/. Robin's recipes and nutrition features can be seen regularly in Cooking Light, Health, Shape, Parade, Woman's Day, Men's Fitness, and Fitness magazines. Currently, she appears on local, network and cable television. Programs of particular interest include: The Early Show (CBS), Regis & Kelly, The View, The Today Show (NBC), Good Morning America (ABC), CNN, Fox News Channel, Food Network, Discovery Channel, the Hallmark Channel and HGTV. She has written ten books: The Robin Takes 5 Cookbook for Busy Families, Robin Takes 5,Robin Rescues Dinner, Robin to the Rescue, Quick Fix Meals with Robin Miller, Picnics, Verdure, The Newlywed Cookbook, The Daily Soup, and Jane Fonda, Cooking for Healthy Living. Robin is severely allergic to eggs.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi US


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