COPAXONE ® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

Teva Pharmaceuticals Europe BV confirms that the SmPC for COPAXONE^® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated. The product is now approved by EU health authorities for use in breastfeeding. The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.ⁱⁱ

COBRA, the largest standardized analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life.ⁱⁱⁱ The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.

Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany says: “The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, but historically there has been limited clinical safety data for infants breastfed by mothers undergoing MS treatment. It is now believed breastfeeding could be protective for mothers with MS. The COBRA study results support mothers with MS in their choice to breastfeed without having to preclude MS treatment. This is an important contribution to current significant medical need.”

There are almost half a million women in Europe living with MS¹; it is most common during childbearing age and about half of mothers with MS start their families after diagnosis. The pregnancy rate in MS is constantly increasing^iv and recent research shows pregnancy does not worsen the disease progression (which traditionally has been a concern for patients).^v

However, studies have found an increase in relapse incidence after child birth, in the postpartum period^vi, so MS treatment may need to be resumed. The majority of MS therapies’ labels advise against breastfeeding, so mothers are often faced with a choice to breastfeed their babies or restart their treatment. Given that according to a U.S. study approximately half of women with MS want to breastfeed ^vii, the safety of medications used to treat MS while breastfeeding is of concern to mothers. A further treatment option that can be used during breastfeeding may help address a significant medical need for mothers with MS.

Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals comments: “Our mission at Teva is to improve the lives of patients. This includes addressing gender inequalities in healthcare and understanding the unique challenges that women face during pregnancy and breastfeeding. The COPAXONE^® label change provides breastfeeding patients with MS the choice to breastfeed while on MS treatment.”

Notes to editors

About the COBRA Study

“Real-world safety of COPAXONE^® in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) patients” (COBRA study) was retrospective data analysis using the national German Multiple Sclerosis and Pregnancy Registry. 60 offspring from the Glatiramer Acetate (GA) cohort (59 pregnancies; 58 women) and 60 from the control (60 pregnancies; 60 women) were included. Maternal demographics and RMS prognostic factors were descriptively comparable between cohorts. “Cumulative” maternal COPAXONE^® exposure was higher in the GA cohort vs control, because 86.7% of offspring’s mothers received GA also at some point during pregnancy (vs 25%).

Safety outcomes in ≤18 months of postpartum follow up showed similar frequency and incidence of hospitalisations for both cohorts. Annualized number of hospitalisations was 0.20 [95% confidence interval {CI}=0.09–0.31] in the GA cohort vs the control (0.25 [95% CI=0.12–0.38]). Frequency and incidence of antibiotic use were similar between cohorts. Growth parameters (body weight, body length and head circumference) were also comparable between cohorts at birth as well as at each time point studied. Paediatrician check-ups at 12 months identified 3 (2.5%; N=120 [95% CI=0.52–7.13]) offspring with developmental delays; all in the control cohort (n=60; 5% [95% CI=1.04–13.92]).

About COPAXONE^®

COPAXONE^® (Glatiramer Acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE^® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE^® can be used in breastfeeding. www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. COPAXONE^® is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

About COPAXONE^®label update

In 2021, Teva submitted to German reference health authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and to the rest of the EU competent health authorities a thorough analysis of the scientific data related to COPAXONE^® use in breastfeeding in MS. The scientific assessment of the analysis was performed by BfArM in alignment with the other EU health authorities. Upon conclusion of this assessment, the label for COPAXONE® (Glatiramer Acetate injection) 20 mg/mL and 40 mg/mL was changed.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the commercial success of COPAXONE^®; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO^®, AJOVY^® and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto, our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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ⁱ Pugliatti M et al. The epidemiology of multiple sclerosis in Europe. Eur J Neurol 2006;13(7):700-22.ⁱⁱ Ciplea A, Kurzeja A, Thiel S, Haben S, Alexander J, Adamus E, Hellwig K. Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis. Eur.J.Neurol. 2021; 28(SUPPL 1): 201-202. 10.1111/ene.14973ⁱⁱⁱ Teva Pharmaceutical Industries Limited, 2021. New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN). [online] Available at: https://www.tevapharm.com/news-and-media/latest-news/new-safety-data-on-treatment-with-copaxone-glatiramer-acetate-of-breastfeeding-mothers-who-live-with-r/ [Accessed 1 February 2022].^iv Maria K. Houtchens, MD, Natalie C. Edwards, MSc, Gary Schneider, ScD, Kevin Stern, BA and Amy L. Phillips, Pregnancy rates and outcomes in women with and without MS in the United States, Neurology® 2018;91:e1559-e1569. doi:10.1212/WNL.0000000000006384^v Langer-Gould AM, Multiple Sclerosis & other CNS Inflammatory Diseases p. 773-792 June 2019, Vol.25,No.3,doi: 10.1212/CON.0000000000000745^vi Manson J. European Women With Multiple Sclerosis Feel Unprepared and Uneducated About Family Planning and Their Ability to Have Children – How Do We Improve Patient Education? European Neurological Review. 2018;13(1):21–4 DOI: https://doi.org/10.17925/ENR.2018.13.1.21

^vii Lorifice L, et al. Neurol Ther 2021; doi: 10.1007/s40120-021-00297-6. Online ahead of print.

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Fiona Cohen
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