Kids With Food Allergies (KFA) is sharing this press release from Sandoz Inc. (a Novartis division) to bring you the latest news and research quickly. SYMJEPI epinephrine injection joins the options for injectable epinephrine available in the U.S. but it is not an auto-injector device.

PRESS RELEASE

Sandoz extends SYMJEPI™ (epinephrine) Injection launch to US pharmacies to help improve patient access to life-saving medicine

• 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 shortages² for 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, July 9, 2019 – 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.

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.

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our broad portfolio, covering all major therapeutic areas, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.

Media Contact:
Sandoz US Communications Leslie Pott
+1 609 627 5287 leslie.pott@sandoz.com

References
1. SYMJEPI. Prescribing Information. Available at: https://dailymed.nlm.nih.gov/d...9f-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...ates-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/fir.../basics/art-20056608. Accessed June 18, 2019.
5. Food Allergy Research & Education. Facts and Statistics. Available at: https://www.foodallergy.org/li...facts-and-statistics. Accessed May 1, 2019.