Samsung Bioepis And Teva Enter Into A Strategic Partnership For Commercialization Of EPYSQLI® (Eculizumab-Aagh) In The United States

• Marks a step forward in broadening treatment options for patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in the U.S.
• Partnership supports Teva's Pivot to Growth strategy and adds to its broad biosimilar portfolio

INCHEON, Korea and TEL AVIV, Israel, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced today that the companies have entered into a license, development and commercialization agreement for EPYSQLI® (eculizumab-aagh), Samsung Bioepis' biosimilar to Soliris®i (eculizumab-aagh) in the United States (U.S.).

Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, manufacture and supply of the product, while Teva will be responsible for commercialization of the product in the U.S. The financial terms of the agreement remain confidential.

EPYSQLI is a complement inhibitor indicated for the treatment of rare disease patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

“We are excited to announce this new strategic partnership for a biosimilar which has a significant potential to increase access for rare disease patients, who are suffering from the high-cost and the limited availability of the treatment. Rare diseases such as PNH, aHUS and gMG, pose many but unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases,” said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis.“This collaboration is a testament of our long-term commitment in the biosimilars business, as a leading biopharmaceutical company with a mission to innovate access to treatments for healthcare systems, payers, providers, and patients. We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the U.S.”

Chris Fox, Executive Vice President, U.S. Commercial at Teva, said,“We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients. The collaboration enables us to leverage our extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options.”

In the U.S., EPYSQLI (eculizumab-aagh) was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris® (eculizumab) in July 2024 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. In Europe, EPYSQLI was approved by the European Commission (EC) in May 2023, and by Korea's Ministry of Food and Drug Safety (MFDS) in January 2024 as a biosimilar to Soliris®. EPYSQLI has been commercially available since July 2023 in Europe and April 2024 in Korea.

This agreement is a testament to both Samsung Bioepis' and Teva's strong track record in the field of biosimilars and the potential value that these biosimilars could deliver to patients and healthcare systems. Since the first biosimilar launch in 2015, Samsung Bioepis' biosimilars portfolio has grown to nine biosimilars available across over 40 countries covering therapeutic areas of immunology, oncology, ophthalmology, hematology, and nephrology.ii Teva has a broad biosimilar portfolio, with this agreement expanding its pipeline to 18 assets across multiple therapeutic areas.

About EPYSQLI ® ( eculizumab- aagh ) injection, for intravenous use

EPYSQLI is a complement inhibitor indicated for the treatment of patients with:

• paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy

Limitation of Use: EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

• generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive
  

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

EPYSQLI is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

Eculizumab products, complement inhibitors, increase a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EPYSQLI treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection.

Complete or update meningococcal vaccination (for serogroups A, C, W, Y, and B) at least 2 weeks prior to administration of the first dose of EPYSQLI, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations, considering the duration of therapy with EPYSQLI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EPYSQLI therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including eculizumab products. The benefits and risks of treatment with EPYSQLI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.

Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Meningococcal infection may become rapidly life- threatening or fatal if not recognized and treated early. Consider interruption of EPYSQLI in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated.

EPYSQLI is available only through a restricted program under a REMS called EPYSQLI REMS, because of the risk of serious meningococcal infections.

Other Infections

Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Eculizumab products block terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after EPYSQLI Discontinuation

Treatment Discontinuation for PNH
Monitor patients after discontinuing EPYSQLI for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS
After discontinuing EPYSQLI, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued eculizumab treatment. TMA complications occurred following a missed dose in 5 patients, and eculizumab was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during EPYSQLI treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during EPYSQLI treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during EPYSQLI treatment.

If TMA complications occur after EPYSQLI discontinuation, consider reinstitution of EPYSQLI treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt EPYSQLI infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

ADVERSE REACTIONS

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

Please see the accompanying full Prescribing Information and Medication Guide for EPYSQLI , including BOXED WARNING regarding serious and life-threatening meningococcal infections.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: and follow us on social media – X , LinkedIn .

MEDIA CONTACT

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Teva 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: our ability to successfully execute the license, development and commercialization agreement with Samsung Bioepis and to commercialize EPYSQLI (eculizumab-aagh) in the U.S. for the treatment of the rare diseases: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG); our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, 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 Soliris is a trademark of Alexion Pharmaceuticals, Inc.

ii Samsung Bioepis data on file. The availability of products differs by countries and regions.

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