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Late-Breaking oral presentation shows that cenerimod for the treatment of moderate to severe systemic lupus erythematosus (SLE) in Japanese patients can be considered safe and well-tolerated Data shows a clinically meaningful improvement in disease activity consistent with results from other global Phase 2 studies of cenerimod PITTSBURGH, Aug. 23, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, presented today the results of one of its Phase 2 studies* of cenerimod (ACT-333441). The ACT-333441 study was accepted as a late-breaking abstract and was presented during an oral presentation at the 26th Asia-Pacific League of Associations for Rheumatology (APLAR) Annual Congress. The congress is being held August 21-25, 2024, in Suntec, Singapore. The ACT-333441 study was a randomized, double-blind, parallel-group, multicenter, Phase 2 study that was conducted in Japan and evaluated the safety, pharmacodynamics (PD), and efficacy of cenerimod, a selective S1P1 receptor modulator, in 17 Japanese patients with moderate to severe systemic lupus erythematosus (SLE). Adult patients receiving SLE background treatment were randomized equally to either 2 mg or 4 mg cenerimod (once-daily, oral dosing). The primary endpoint of the study measured safety and tolerability, and the secondary endpoint measured a change in total lymphocyte count and the efficacy was assessed using a modified SLEDAI-2K (mSLEDAI-2K) score. Both cenerimod doses were considered safe and well-tolerated. A decrease in lymphocyte counts was observed in both the 2 mg and 4 mg doses as expected per the mechanism of action of cenerimod and was reversible upon treatment discontinuation. Both doses showed a clinically meaningful improvement in disease activity, as measured by mSLEDAI-2K, which persisted long after the treatment was discontinued and was higher with the 4 mg dose. These results are generally consistent with the global Phase 2 CARE study*. Visit Viatris at APLAR at Booth #21-23 to learn more about the study and how the company continues to support the needs of the SLE community. The data was presented during the following oral presentation: Cenerimod in Japanese patients with moderate to severe systemic lupus erythematosus (SLE): A Phase 2, randomized, double-blind trial Speaker: Sharavan Kanagaratnam August 23, 3:00 - 4:15 p.m. GMT+8 Abstract session 3: Late-breaking abstracts: Systemic lupus erythematosus Further details on the APLAR program can be accessed online here. About SLE Systemic lupus erythematosus (SLE), the most common form of lupus, is an autoimmune disease. While the cause of SLE is not fully known, T and B lymphocytes are considered the key immune cells that play a role in the development of SLE. In individuals with SLE, both T and B cells become overactive, infiltrate different tissues, and produce autoantibodies, leading to inflammation and organ damage. About cenerimod Cenerimod is an investigational drug, a highly selective S1P1 receptor modulator given as an oral once-daily tablet. Cenerimod is an investigational drug that potentially offers a novel approach for the treatment of SLE, a disease with a significant impact on patients and limited treatment options. In December 2022, the Oral S1P1 receptor ModUlation in SLE (OPUS) program was initiated, which consists of two multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy, safety, and tolerability of cenerimod in adult patients with moderate-to-severe SLE on top of background therapy. The main objectives of the program are to evaluate the effectiveness of cenerimod 4 mg in reducing disease activity, as well as controlling the disease, compared to placebo. The primary endpoint is response on SRI-4 at month 12 compared to baseline. Secondary endpoints include response on BICLA at month 12 compared to baseline and measures of sustained disease control: time to first confirmed 4-month sustained mSLEDAI-2K response and time to first confirmed 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers). The investigation of cenerimod for the treatment of SLE has received Fast-Track designation from the U.S. Food and Drug administration (FDA). This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. *About the CARE study: CARE was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE). Patients with SLE, mSLEDAI-2K ≥6 and history or presence of positive ANA or anti-dsDNA were randomized to daily oral cenerimod (0.5, 1, 2 or 4 mg) or PBO. Background SLE medication had to be stable for ≥30 days pre-randomization (corticosteroids ≥15 days). Study duration was 18 months (M), two 6M treatment periods and a 6M follow-up. After the first 6M, patients on cenerimod 4 mg were rerandomized to cenerimod 2 mg or PBO to assess reversibility of lymphopenia and potential withdrawal effects. Of 427 randomized patients, 339 completed 12M of treatment. The primary endpoint was change from baseline (BL) to M6 in mSLEDAI-2K. Secondary endpoints were SLE Responder Index SRI-4 and BILAG-2004 improvement. Safety endpoints included adverse events (AEs) and AEs of special interest (AESI). About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding the outcomes of clinical trials; that late-breaking oral presentation shows that cenerimod for the treatment of moderate to severe systemic lupus erythematosus (SLE) in Japanese patients can be considered safe and well-tolerated; that data shows a clinically meaningful improvement in disease activity consistent with results from other global Phase 2 studies of cenerimod; that both cenerimod doses were considered safe and well-tolerated; that a decrease in lymphocyte counts was observed in both the 2 mg and 4 mg doses as expected per the mechanism of action of cenerimod and was reversible upon treatment discontinuation; and that both doses showed a clinically meaningful improvement in disease activity, as measured by mSLEDAI-2K, which persisted long after the treatment was discontinued and was higher with the 4 mg dose. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc.

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2022 /PRNewswire/ -- RemeGen Co., Ltd., a leading biopharmaceutical company with fully integrated capabilities in research and discovery, clinical development, manufacturing, and commercialization of biologic drugs, will join the event of the American College of Rheumatology (ACR) 2022, hosted from November 10th to 14th. This event will present Telitacicept phase III clinical trial data on Systematic lupus erythematosus (SLE) and data from the phase II clinical trial for Sjorgren's syndrome. About Telitacicept Continue Reading Telitacicept is a novel fusion protein composed of a transmembrane activator and CAML interactor (TACI) and the Fc portion of IgG, which targets and neutralizes B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). BLyS and APRIL are both involved in the development of B cells from pre-B lymphocytes to mature B cells and ultimately to plasma cells, the professional cells producing antibodies, as well as in the co-stimulation of T-cell proliferation under certain conditions. Telitacicept blocks BLyS and APRIL from binding to BAFF-R, BCMA, and TACI receptors expressed on the B-cell surface, suppressing the BLyS and APRIL signaling, and inhibiting the development and survival of mature B cells and plasma cells. Systemic lupus erythematosus (SLE) is the principal indication of Telitacicept. Through priority review, Telitacicept was approved by China National Medical Products Administration (NMPA) and is included in the National Reimbursement Drug List (NRDL). Telitacicept also received FDA Fast Track Designation as a treatment for SLE with an ongoing global Phase III study. In addition to SLE, the company is actively developing Telitacicept for six other B cell-mediated autoimmune diseases and refractory autoimmune diseases with unmet clinical needs in China, including Neuromyelitis optica spectrum disease, rheumatoid arthritis, IgA nephropathy, primary Sjogren's syndrome, relapsing-remitting multiple sclerosis, and systemic myasthenia gravis. Telitacicept for Systematic Lupus Erythematosus, data from phase III trial This is a 52-week, randomized, double-blind, placebo-controlled, phase III clinical trial (NCT04082416). SLE patients aged 18 to 65 years with positive ANA and/or anti-dsDNA and a SELENA-SLEDAI score ≥8 were randomized 1:1 to receive either Telitacicept 160 mg or placebo subcutaneously once weekly in combination with standard therapy for 52 weeks. A total of 335 patients were randomized to receive Telitacicept 160 mg (n=167) or placebo (n=168). Of the randomized patients, 236 (70.4%) completed 52 weeks of treatment. The primary endpoint at week 52 revealed a significant proportion of patients in the Telitacicept 160 mg group achieving SRI4 response compared with the placebo group (82.6% vs. 38.1%, p< 0.001). The SRI4 response was significantly greater in the Telitacicept group compared with the placebo group as early as Week 4, and the differences sustained between the 2 groups until week 52 (p < 0.01 for all time points) Regarding safety, 91.6% of subjects in the Telitacicept group and 84.5% in the placebo group had treatment-emergent adverse events (TEAEs). There were 17 serious adverse events (SAEs) in 12 subjects (7.2%) treated with Telitacicept and 36 SAEs in 24 subjects (14.3%) treated with placebo. The most common AEs (≥10%) with Telitacicept were upper respiratory tract infection, decreased IgG and IgM, injection site reactions, and urinary tract infection. No death occurred during the study. Telitacicept for Sjogren's Syndrome, data from phase II trial The upcoming event will also present data to evaluate the efficacy and safety of Telitacicept in adult patients with primary Sjogren's syndrome (pSS) in phase II randomized, double-blind, placebo-controlled trial. A total of 42 patients with pSS with positive anti-SSA antibody and ESSDAI≥ 5 were randomly assigned, in a 1:1:1 ratio, to receive weekly subcutaneous Telitacicept 240 mg, 160 mg, or placebo for 24 weeks. Thirty patients who completed their 24 weeks visit were included in the per-protocol set (PPS) (Telitacicept 240 mg, n=8; Telitacicept, 160 mg; n=12; placebo, n=10). The primary endpoint was the change from baseline in the ESSDAI at week 24. Results from the trial revealed that Telitacicept 160 mg showed a significant reduction in ESSDAI score from baseline to week 12 and week 24 compared with placebo (p< 0.05); Telitacicept 240 mg resulted in a considerable decrease in ESSDAI score from baseline to week 24 compared with placebo in the PPS population (p< 0.05). For the secondary endpoint, Telitacicept can significantly reduce from baseline in MFI-20 in weeks 12 and 24. No serious adverse events were observed in the Telitacicept treating group. About RemeGen RemeGen, Ltd. ("RemeGen") is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Since its inception in 2008, RemeGen has created more than 10 novel drug molecules in various clinical development stages. Currently, there are two products in late-stage clinical development to treat autoimmune and oncology indications. Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing and California. For more information about RemeGen, please visit: For those attending ACR, please come and visit us at our booth #2357 SOURCE RemeGen

June 9, 2022 12:00 UTC New blood tests aid in diagnosing systemic sclerosis and systemic lupus erythematosus PORTAGE, Mich.--(BUSINESS WIRE)-- Thermo Fisher Scientific EliA RNA Pol III and EliA Rib-P tests have been cleared by the U.S. Food & Drug Administration (FDA) for aiding in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE). With these new tests, the EliA portfolio provides a more robust clinical offering through a comprehensive menu of automated connective tissue disease tests. “Autoimmune diseases can be a challenge to diagnose. Reliable and accurate laboratory tests that provide clinical clarity are essential tools for clinicians managing these patients,” said Dr. Henry Homburger, Professor Emeritus of Laboratory Medicine at Mayo Clinic College of Medicine, and laboratory director, Thermo Fisher Phadia Immunology Reference Laboratory. “The addition of RNA Polymerase III and Ribosomal P to the EliA connective tissue disease test menu will add considerable value to the diagnosis of SSc and SLE.” RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value.[1, 2] Additionally, in patients who are positive for RNA Polymerase III, up to 70% may have no other SSc associated antibodies present.[2] The EliA RNA Pol III test completes a criteria based EliA SSc panel and is the first fully automated RNA Polymerase test available in the U.S. A subset of SLE patients present with monospecific Ribosomal P antibodies.[3] Detection of these autoantibodies via indirect immunofluorescence has been shown to be an unreliable method, which if used solely, could result in delayed diagnosis and treatment.[4] The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA negative patients. [3, 4] “The availability of a strong CTD test menu on a fully automated instrument could improve the efficiency and productivity of diagnostic laboratories,” added Homburger. “The new EliA RNA Pol III and EliA Rib-P tests have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases. Targeting existing diagnostic care gaps can potentially lead to earlier and more accurate diagnosis and ultimately improve clinical outcomes for patients.” For more information on the Thermo Scientific EliA™ RNA Pol III and EliA Rib-P tests, please visit . About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . References 1. Van Den Hoogen, F., et al., 2013 Classification Criteria for Systemic Sclerosis: An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis & Rheumatism, 2013. 65(11): p. 2737-2747. 2. Wielosz, E., M. Dryglewska, and M. Majdan, Clinical consequences of the presence of anti-RNA Pol III antibodies in systemic sclerosis. Advances in Dermatology and Allergology, 2020. 37(6): p. 909-914. 3. Carmona-Fernandes, D., et al., Anti-ribosomal P protein IgG autoantibodies in patients with systemic lupus erythematosus: diagnostic performance and clinical profile. BMC Medicine, 2013. 11(1): p. 98. 4. Choi, M.Y., et al., A review and meta-analysis of anti-ribosomal P autoantibodies in systemic lupus erythematosus. Autoimmunity Reviews, 2020. 19(3): p. 102463.