Sandoz Extends SYMJEPI™ (epinephrine) Injection Launch to U.S. Pharmacies to Help Improve Patient Access

• Adult and pediatric doses immediately available as single-dose, pre-filled syringe and device combination for emergency treatment of Type 1 allergic reactions, including anaphylaxis¹

• SYMJEPI will help address critical impact of ongoing epinephrine auto-injector shortages²for the one in 50 Americans at risk for anaphylaxis³

• Sandoz is committed to helping people access high quality healthcare at affordable prices, with strong focus on areas of unmet patient need

Princeton, New Jersey – Sandoz Inc. (Sandoz), a Novartis division, today announced the US retail launch of SYMJEPI™ (epinephrine) 0.3 mg and 0.15 mg Injections, making both the adult and pediatric doses immediately available in local pharmacies across the nation.

SYMJEPI is a small, single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment of allergic reactions (Type 1), including anaphylaxis, a severe reaction that can lead to death if left untreated⁴.

The US Food and Drug Administration (FDA) recently highlighted ongoing shortages of epinephrine auto-injectors from several drug manufacturers²,  which can  put people’s lives in jeopardy if they have a severe allergic reaction and do not have access to this life-saving medicine.

“Patients and health care professionals are trying to navigate this critical shortage of self-injectable epinephrine products, which is why Sandoz is immediately making SYMJEPI available in adult and pediatric doses to patients at their local pharmacies,” said Carol Lynch, President of Sandoz Inc. “Our collaboration with retail partners will enable patients and their caregivers to conveniently access SYMJEPI, a cost-effective treatment option with a compact and user-friendly design.”

Sandoz launched SYMJEPI 0.3 mg Injection in the institutional (hospital) setting earlier this year, and has a certified sales force educating hospital providers on the device, demonstrating its use and advising on how to write a prescription to include epinephrine injections.  Sandoz large wholesaler customers are now fully stocked to supply hospitals and clinics with both SYMJEPI 0.3 mg and 0.15 mg Injections inventory in the US.

Doctors who determine that epinephrine medicine alternatives are appropriate for their patients should write the prescription as “epinephrine injection” rather than “epinephrine auto-injector,” so that pharmacies can ensure patients receive epinephrine medicine alternatives during their first attempt to fill their prescription. In addition to physicians writing the prescription for the greatest access to epinephrine injections, federal and state legislation in 18 states should change to allow for more alternatives such as SYMJEPI by amending the definition of “auto-injectors”. By limiting the definition to only permit the use of auto-injectors, federal and states are inadvertently restricting what schools and other entities could have on hand. These narrowly worded laws will not allow for new products that may be cost efficient and effective to be dispensed. Sandoz, in partnership with other stakeholders, has had early success amending existing legislation in multiple US states.

Epinephrine is a critical medicine for many people nationwide, including the 200,000 people in the US who require emergency medical care for allergic reactions to food each year⁵. The availability of SYMJEPI may provide confidence to patients given its small size and ease of use ⁶ to encourage it being on-person when needed, and confidence in its use.

SYMJEPI 0.3 mg and 0.15 mg Injections are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis. SYMJEPI 0.3 mg and 0.15 mg Injections are intended for immediate administration in patients who weigh approximately 66 pounds or more, and who weigh between 33 and 65 pounds, respectively, who are determined to be at an increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Important Safety Information

CONTRAINDICATIONS 

None

WARNINGS AND PRECAUTIONS

You should get emergency medical care right away after using the product.

You may need to use a second SYMJEPI (epinephrine) injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

SYMJEPI should only be injected into the middle of your outer thigh (upper leg) with the needle facing downwards. Never inject into any other part of the body.  If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. SYMJEPI can be injected through your clothing if needed.

The needle cap on the SYMJEPI prefilled syringe helps to prevent needle sticks and accidental injection of epinephrine. Do not remove the needle cap until you are ready to use it.

Never put your thumb, fingers, or hand over the exposed needle.

If an accidental injection happens, get medical help right away.

Do not drop the carrier case or SYMJEPI prefilled syringe. If the carrier case or prefilled syringe is dropped, check for damage and leakage. Dispose of the prefilled syringe and carrier case, and replace if damage or leakage is noticed or suspected.

Do not place patient information or any other foreign objects in the carrier case with the prefilled syringe, as this may prevent you from removing the prefilled syringe for use.

If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during injection.

Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems or high blood pressure.

have diabetes.

have thyroid problems.

have asthma.

have a history of depression.

have Parkinson’s disease.

are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

ADVERSE REACTIONS

SYMJEPI may cause serious side effects.

Rarely, patients who have used SYMJEPI 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 at an injection site:

redness that does not go away

swelling

tenderness

the area feels warm to the touch

Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during the injection.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your SYMJEPI.

Talk to your healthcare provider about all your medical conditions.

Common side effects of SYMJEPI include:

fast, irregular or “pounding” heartbeat

sweating

headache

weakness

shakiness

paleness

feelings of over excitement, nervousness or anxiety

dizziness

nausea and vomiting

breathing problems

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.

DRUG INTERACTIONS

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider of all known allergies.

Especially tell your healthcare provider if you take certain asthma medicines.

SYMJEPI and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

See full PI for additional safety information available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1c6a201-4f23-4...

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

For more information, visit the SYMJEPI website (https://www.symjepi.com/) and view the instructional video on how to use the injection device.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential launches, marketing approvals, new indications or labeling for SYMJEPI, or regarding potential future revenues from SYMJEPI. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that SYMJEPI will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that SYMJEPI will be commercially successful in the future. In particular, our expectations regarding SYMJEPI could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competitive versions of this product; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political and economic

conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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References

1. SYMJEPI. Prescribing Information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1c6a201-4f23-489f-9fca-f8c82bb9fa58. Accessed June 17, 2019.
2. United States Food and Drug Administration. Extended use dates to assist with EpiPen intermittent supply interruptions. Available at: https://www.fda.gov/drugs/drug-shortages/extended-use-dates-provided-pfizer. Accessed June 6, 2019.
3. Allergy and Asthma Foundation of America. Anaphylaxis in America. Available at: https://www.aafa.org/anaphylaxis-in-america/. Accessed May 8, 2019.
4. Mayo Clinic staff. First aid: Anaphylaxis. Available at: https://www.mayoclinic.org/first-aid/first-aid-anaphylaxis/basics/art-20056608. Accessed June 18, 2019.
5. Food Allergy Research & Education. Facts and Statistics. Available at: https://www.foodallergy.org/life-with-food-allergies/food-allergy-101/facts-and-statistics. Accessed May 1, 2019.

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