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)

• Non-interventional study analysis found no evidence of safety concerns with infants of mothers with multiple sclerosis (MS) who were breastfeeding and undergoing glatiramer acetate (GA) treatment
• Maternal breastfeeding exposure to GA 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)–The COBRA study, a new real world evidence study undertaken by Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St. Josef Hospital (Bochum, Germany), was presented today at EAN congress and provided new insight on the use of COPAXONE® (glatiramer acetate or GA) by mothers with multiple sclerosis (MS) who are breastfeeding.

The study, which represents the largest analysis of child outcomes breastfed by mothers under GA, assessed 120 mothers with MS and their infants. It concluded that no evidence exists to suggest that infants were adversely affected by maternal exposure to glatiramer acetate while breastfeeding with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life¹.

“The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, so it is imperative to provide clinical evidence on safety of disease modifying therapies (DMTs), so mothers with MS will no longer need to give up breastfeeding while on treatment ” said Professor Kerstin Hellwig, Principal Study Investigator, Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany .

“Against the backdrop of the global COVID-19 pandemic, our analysis, which included 60 offsprings in the glatiramer acetate group and 60 in a control group (offspring of mothers with MS not treated with any disease-modifying treatment during breastfeeding), is an important contribution to this significant unmet medical need. There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS. We found no evidence of developmental delay, body growth issues or increased hospitalisation and antibiotic use in group of infants from the glatiramer acetate cohort in comparison with controls.

The COBRA study used data from the National German Multiple Sclerosis and Pregnancy Registry 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: “We are hugely grateful to this study for its work. According to data available, every third woman with MS may experience disease reactivation after childbirth ². Slowing disease progression, control of relapses and breastfeeding are priorities for many patients, especially in this particularly fragile period. Our mission at Teva is to improve the lives of patients. That includes helping to benefit from important medicines throughout life’s stages, and during family planning in particular.”

The data presentation follows extensive ongoing study of glatiramer acetate in a variety of real-world settings. For the past years, studies and leading MS experts have generally advised against the use of DMTs while breastfeeding infants and the postponing of breastfeeding for three months following the last dose of any disease-modifying drug³.

About the 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 GA-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 between cohorts, offspring frequency and incidence of hospitalisations. 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. The use of COPAXONE® during breastfeeding should be decided by weighing the benefit of breastfeeding for the child and the benefit of therapy for the woman. See additional important information at: 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. Important factors that could cause or contribute to such differences include risks relating to:

• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; 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, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; 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;
• the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
• compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2021 and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” 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.

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.

Contacts

Media Enquiries
Fiona Cohen, Teva Europe

+ 31 6 2008 2545

[email protected]

PR contact
Con Franklin, Ketchum UK

+44 (0) 7974 434 151

[email protected]