New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis

Rhea-AI Summary

Teva Pharmaceuticals presented new analyses from the COBRA study at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The study, which included data from 99 mothers with multiple sclerosis treated with COPAXONE® (glatiramer acetate) during pregnancy and breastfeeding, found no safety concerns for infants. Specifically, there were no adverse effects on hospitalizations, antibiotic treatments, developmental delays, or growth during the first 18 months. This research addresses significant medical needs concerning treatment safety for women with MS.

Positive

• Study concluded no evidence of safety concerns for infants exposed to glatiramer acetate treatment during pregnancy and breastfeeding.
• No adverse effects were noted regarding hospitalization and antibiotic treatments or developmental delays in infants.

Negative

• None.

COBRA study subgroups results presented at the

37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

• Non-interventional study analysis found no evidence of safety concerns with infants of mothers with multiple sclerosis (MS) who were exposed to glatiramer acetate (GA) treatment during pregnancy and breastfeeding
• Maternal pregnancy and breastfeeding exposure to GA in this study did not adversely affect offspring with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life

AMSTERDAM--(BUSINESS WIRE)--

Teva Pharmaceuticals Europe BV, a European affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St. Josef Hospital – Katholisches Klinikum Bochum (Bochum, Germany), presented today at ECTRIMS congress new analyses of the COBRA study, a real-world evidence study on the safety of COPAXONE® (glatiramer acetate or GA) used by mothers with multiple sclerosis (MS) during pregnancy and breastfeeding.

The new analysis of COBRA study, which currently represents the largest dataset of child outcomes breastfed by mothers treated with GA, assessed 99 mothers with MS and their infants. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during pregnancy and breastfeeding with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life¹.

Professor Kerstin Hellwig, Principal Study Investigator, Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany noted:

“Our new analysis, which included 50 offspring in the GA group and 50 in a control group (offspring of mothers with MS not treated with any disease-modifying treatment during pregnancy and breastfeeding), is an important contribution to the significant unmet medical need. There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS including during the pregnancy period. We found no evidence that GA exposure was associated with developmental delay, body growth issues or increased hospitalisation and antibiotic use in group of infants from the GA cohort in comparison with controls.

“Half of all MS pregnancies are unplanned, so a woman is on average exposed to disease modifying therapies (DMTs) in the first 30 days of her child’s development until she discovers her pregnancy and the treatment can be discontinued. While re-staring DMT during breastfeeding, a mother has concerns whether her exposure to DMT during pregnancy and breastfeeding may harm her child. Our new analyses of the COBRA study provide data that cumulative maternal exposure to GA during pregnancy and breastfeeding did not adversely affect the babies regarding the parameters studied within the first 18 months after birth”

The COBRA study used data from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) from 2011 to 2020. Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT treatment.

Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals comments: “The onset of multiple sclerosis (MS) occurs in women between the ages of 20 and 40 years old; therefore, MS affects women during a key moment in their lives when they’re thinking of having children. This is one of the reasons why family planning, is such an important aspect of MS care in women. Our mission at Teva is to improve the lives of patients, supporting them with important medicines throughout life’s stages, and during family planning in particular.”

The data presentation follows extensive ongoing study of COPAXONE® in a variety of real-world settings that seek to improve treatment decision making. Modern approaches in the care of women with MS after child birth nowadays include that physicians inform them about the benefits of breastfeeding for both the mother with MS and her offspring; encourage the mother to breastfeed if possible; and finally support the patient and her decision. ”

References

1. A. Ciplea et. Al, Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis; presented at EAN 2021.
2. Saneea Almas, Jesse Vance, Teresa Baker, and Thomas Hale, Management of Multiple Sclerosis in the Breastfeeding Mother, Multiple Sclerosis International Volume 2016, Article ID 6527458, http://dx.doi.org/10.1155/2016/6527458
3. Pakpoor J, Disanto G, Lacey MV, Hellwig K, Giovannoni G, Ramagopalan, Breastfeeding and multiple sclerosis relapses: a meta-analysis. SVJ Neurol. 2012 Oct; 259(10):2246-8.

About the Study

“Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) pAtients” (COBRA study) is a retrospective data analysis using data of the German Multiple Sclerosis and Pregnancy Registry. In new subgroup analyses, 50 offspring from the glatiramer acetate (GA) cohort (49 pregnancies; 49 women) and 50 from the control (50 pregnancies; 50 women) were included. Maternal demographics and RMS prognostic factors were descriptively comparable between cohorts. “Cumulative” maternal GA-exposure was higher in the GA cohort vs control, because 100% of offspring’s mothers received GA also at some point during pregnancy (vs 26%).

Safety outcomes in ≤18 months of postpartum follow up showed similar results between cohorts, offspring frequency and incidence of hospitalisations. Annualized number of hospitalisations was 0.22 [95% confidence interval {CI}=0.09–0.35] in the GA cohort vs the control (0.26 [95% CI=0.12–0.40]). 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 of the other five time points studied. Paediatrician check-ups until 12 months identified 2 offspring with developmental delays; all in the control cohort (4%, n=50; [95% CI=0.49–13.71]).

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. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Copaxone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE^® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

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 its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, 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, 2020, 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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Media Enquiries

Fiona Cohen, Teva Europe

+ 31 6 2008 2545

Fiona.cohen@tevaeu.com

Source: Teva Pharmaceutical Industries Limited

FAQ

What did the COBRA study presented by Teva at ECTRIMS find about glatiramer acetate?

The COBRA study found no evidence of safety concerns for infants of mothers with MS exposed to glatiramer acetate during pregnancy and breastfeeding.

How many mothers and infants were included in the COBRA study analysis?

The COBRA study analyzed 99 mothers with MS and their infants.

What were the main outcomes assessed in the COBRA study?

The study assessed hospitalization rates, antibiotic treatments, developmental delay, and growth of infants in the first 18 months.

Where was the COBRA study presented?

The COBRA study results were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

What is COPAXONE® used for?

COPAXONE® (glatiramer acetate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

What does the new data from the COBRA study mean for mothers with MS?

The new data provides reassurance that maternal exposure to glatiramer acetate during pregnancy and breastfeeding did not adversely affect child development or health.