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January 6, 2014


Intelliject, Inc. announces name change to kaléo

Intelliject, Inc. a pharmaceutical company based in Richmond, VA has announced that its company name has been changed to kaleo, Inc. In normal usage, the company will be known as kaléo.

Announcing the change, Spencer Williamson, President and CEO of kaléo said, “We are excited that our new name, kaléo, will help to communicate our future as a leader in developing a new generation of personal lifesaving medical products. The name kaléo is from the Greek word for “a calling” or “purpose”, and this name speaks to why we do what we do.”

“It is bittersweet to no longer be Intelliject,” Williamson continued, “but our value proposition has expanded to the point where the existing name no longer accurately represents the company’s potential. Our name has changed but our team and focus on patient-led innovation has not.”

Kaléo currently has one FDA approved product, Auvi-Q™ (known as Allerject™ in Canada), which is manufactured and commercialized in North America by Sanofi under a licensing agreement. Kaléo retains rights to the product in all other global markets. Kaléo has a portfolio of other personal lifesaving medical products in various stages of development.

About kaléo

Kaléo is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients’ hands. We believe patients are experts on their medical condition and are an integral part of our product development process. Each kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority, cost effectiveness and patient preference.

Kaléo applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable.

Kaléo is a privately-held company headquartered in Richmond, Virginia.

For online information please visit kaleopharma.com.

About Auvi-Q

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. It is the size and shape of a credit card, the thickness of a cell phone and fits comfortably in a pocket or small purse.

During a life-threatening allergic reaction, it talks the user through each step of the injection process. If the patient or caregiver needs more time, it repeats the step-by-step directions. Alternatively, a patient or caregiver can move at his or her own pace by following the printed instructions on the device.

Auvi-Q provides users with audible and visual cues for correct use – including a five-second injection countdown and an alert light to signal when the injection is complete. In addition to being an auto-injector, it features an automatic retractable needle mechanism to help prevent accidental needle sticks.

Available in two different dosages; the Auvi-Q 0.3mg is intended for patients who weigh 66 pounds or more, and Auvi-Q 0.15mg is intended for patients who weigh 33 – 66 pounds. Auvi-Q was not studied in patients weighing less than 33 pounds. Each Auvi-Q pack contains two products – containing one dose of epinephrine each – and a trainer that contains no needle or epinephrine.

Sanofi has exclusive commercial rights to market Auvi-Q and Allerject in US and Canada, respectively. Kaléo retains rights to the product in all other global markets.


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 accidentaly 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.

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 see www.Auvi-Q.com for full prescribing information.

About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lax-is) is a serious allergic reaction that happens quickly and may cause death. It can occur as a result of exposure to allergens including nuts, shellfish, dairy, eggs, insect bites, latex and medication, among other allergens. Food is the most commonly-identified anaphylaxis trigger and accounts for 30 percent of all anaphylaxis fatalities.

According to the 2010 AAAAI Practice Parameters, up to six million Americans may be at risk for anaphylaxis, although the precise incidence of anaphylaxis is unknown and is likely underreported. Numerous studies indicate that the rate of anaphylaxis has increased in recent years, particularly among those under 20.

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 breath 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 of anaphylaxis is avoidance of the specific allergen(s).

When an 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.

Kaléo Disclaimer

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide kaléo’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. Some of these forward-looking statements may be identified by the use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Kaléo cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and kaléo undertakes no obligations to update or revise these statements, except as may be required by law.