Walgreens and Kaléo Expand Retail Pharmacy Collaboration to Include AUVI-q® (epinephrine injection, USP) 0.1 mg, the Only FDA-Approved Epinephrine Auto-Injector for Infants and Toddlers, 16.5 – 33 lbs | kaléo

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July 11, 2019


Walgreens and Kaléo Expand Retail Pharmacy Collaboration to Include AUVI-q® (epinephrine injection, USP) 0.1 mg, the Only FDA-Approved Epinephrine Auto-Injector for Infants and Toddlers, 16.5 – 33 lbs

Full AUVI-Q product line available at Walgreens locations nationwide at no cost to eligible commercially insured patients and those who are eligible for kaleo’s patient support programs

For patients who are unable to fill their current epinephrine auto-injector prescription, Walgreens pharmacists will work with their healthcare providers to determine if AUVI-Q is right for them

Deerfield, Ill. & Richmond, Va. (July 10, 2019) – Walgreens and kaléo, a privately-held pharmaceutical company, today announced AUVI-q® (epinephrine injection, USP) 0.1 mg auto-injector is available at Walgreens locations nationwide. AUVI-q 0.1 mg is the first and only epinephrine auto-injector (EAI) approved by the U.S. Food and Drug Administration (FDA) for infants and toddlers weighing 16.5 to 33 pounds (7.5 to 15 kilograms). Through this collaboration, Walgreens is the first national retail pharmacy to offer the entire AUVI-Q auto-injector product line, which also includes AUVI-Q 0.3 mg and 0.15 mg doses.

An estimated 7.6 percent of U.S. children aged 17 years or younger were found to have a food-specific allergy based on survey data from 38,408 children. The same study also found that 42.3 percent of children with a food allergy have a history of at least one severe food allergic reaction.1

“With the addition of an AUVI-q auto-injector for infants and toddlers at Walgreens pharmacies nationwide, we can help ensure families and children facing life-threatening allergies have convenient and affordable access to the medicines they need,” said Rina Shah, PharmD, group vice president of specialty and retail pharmacy at Walgreens. “Expanding our agreement with kaléo is one more way that Walgreens is helping lower costs for patients, increasing accessibility to care and creating a seamless experience for our customers and patients.”

All eligible patients with commercial insurance, even those with high-deductible plans, can obtain AUVI- Q at no cost. For eligible patients who do not have insurance or prescription drug coverage, kaléo may be able to support through the kaléo Cares Patient Assistance Program. Please see additional information on patient eligibility and the terms and conditions at www.auvi-q.com/get-auvi-q/.

As supply issues related to epinephrine auto-injector products by other manufacturers continue, this collaboration aims to broaden access to an available treatment option for patients with life-threatening allergies, especially as families prepare for back-to-school season.

“With approximately one in 13 children in the U.S. living with life-threatening food allergies,2 it is critically important that parents and caregivers be able to access an epinephrine auto-injector,” said Phil Rackliffe, general manager of Allergy and Pediatrics at kaléo. “Families can get AUVI-Q 0.3 mg, 0.15 mg, and now, 0.1 mg, with a prescription, on-site at Walgreens locations nationwide.”

AUVI-Q features a voice instruction system that helps guide users step-by-step through the injection process, as well as a needle that automatically retracts following administration. It is about the size of a credit card and thickness of a cell phone, and fits in most pockets. AUVI-Q is available in three doses – AUVI-Q 0.3 mg for those weighing 66 pounds (30 kilograms) or more, AUVI-Q 0.15 mg for children weighing between 33 and 66 pounds (15 to 30 kilograms) and AUVI-q 0.1 mg for infants and toddlers 16.5 to 33 pounds (7.5 to 15 kilograms).

AUVI-Q is a prescription medicine approved by the FDA to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. Anaphylaxis is a serious allergic reaction that can happen quickly and may cause death.2 Anaphylaxis can occur from exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.3-5 AUVI-Q does not take the place of emergency medical care. Patients need to seek immediate medical treatment after using AUVI-Q.

To learn more about AUVI-Q, please visit www.auvi-q.com.

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References

  1. Gupta, R. et al. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics (2018). 142. e20181235. 10.1542/peds.2018-1235.
  2. Food Allergy Research and “Facts and Statistics” https://www.foodallergy.org/life- with-food-allergies/food-allergy-101/facts-and-statistics. Accessed July 2019.
  3. Gupta RS, Warren CM, Smith BM, et Prevalence and severity of food allergies among US adults. JAMA Netw Open. 2019 Jan 4;2(1):e185630.
  4. Golden Stinging insect allergy. Am Fam Physician. 2003;67(12):2541-2546.
  5. Kelly K, Kurup V, Reijula The diagnosis of natural rubber latex allergy. J Allergy Clin Immunol. 1994;93(5):813-816.

Indication

AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic 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 using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and the Patient Information at www.auvi-q.com.

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.

About Walgreens

Walgreens (walgreens.com), one of the nation’s largest drugstore chains, is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (NASDAQ: WBA), the first global pharmacy-led, health and wellbeing enterprise. Approximately 8 million customers interact with Walgreens in stores and online each day, using the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice. As of June 28, 2018, Walgreens operates approximately 9,800 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands, along with its omnichannel business, Walgreens.com. Approximately 400 Walgreens stores offer Healthcare Clinic or other provider retail clinic services.

About kaléo (kuh-LAY-oh)

Kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleo.com.

About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)

AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat emergency allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a first-line treatment for allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it, incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg) visit www.auvi-q.com.

Forward-Looking Statements

All statements in this release that are not historical are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future performance and involve risks, assumptions and uncertainties, including, but not limited to, those related to the timing and effectiveness of collaboration plans, the ability to realize the anticipated benefits of the collaboration, competitive actions in the marketplace, and the ability to achieve anticipated financial and operating results in the amounts and at the times anticipated, as well as those described in Item 1A (Risk Factors) of Walgreens Boots Alliance, Inc.’s Form 10-K for its fiscal year ended August 31, 2018 and Form 10-Q for its fiscal quarter ended February 28, 2019, Bausch Health’s Form 10-K for its fiscal year ended December 31, 2018, and subsequent documents that Walgreens Boots Alliance, Inc. and Bausch Health file or furnish with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially. These forward-looking statements speak only as of the date they are made. Except to the extent required by law, each of Walgreens Boots Alliance, Inc., Walgreens and Bausch Health do not undertake, and expressly disclaim, any duty or obligation to update publicly any forward-looking statement after the date of this release, whether as a result of new information, future events, changes in assumptions or otherwise.

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