Bromocriptine Mesylate

This first-to-market launch showcases Teva’s proven strengths in complex generic formulations and enhances Teva’s strategic goal of sustaining a generic powerhouse.Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of the first and only generic version of Sandostatin®1 LAR Depot, in the United States. Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. Please see the below for more information. “With today’s launch of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot), Teva is providing patients a new option for this important treatment,” said Ernie Richardsen, SVP U.S. Commercial Generics.” He continued, “This first-to-market launch showcases Teva’s expertise in bringing complex generic formulations to market and demonstrates once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and healthcare systems.” Sandostatin® LAR Depot had annual sales of $826 million as of July 2024, according to IQVIA data. What is octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for: Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined. IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? Treatment with octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.What should I tell my doctor before taking octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.What are the possible side effects of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see the full Prescribing Information. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit 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 launch and commercial success of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot); our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; delays in launches of new generic products; our ability to develop and commercialize biopharmaceutical products; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second 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. 1 Sandostatin® LAR Depot is a registered trademark of Novartis AG. IR ContactsUnited StatesRan Meir(215) 591-8912 Sanjeev Sharma(973) 658 2700 PR ContactsUnited StatesKelley Dougherty(973) 658-0237 Yonatan Beker(973) 264 7378 IsraelEden Klein972 (3) 906-2645

• Results presented from a large, pooled database from three Phase 3 clinical trials evaluating MYCAPSSA (octreotide) for the treatment of people living with acromegaly • Additional presentations provide insights into the validation of the Lipodystrophy Severity Scoring tool and the Chiesi Management of Acromegaly (MACRO) registry BOSTON, June 14, 2024 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced updates from their rare endocrine disease portfolio with two late-breaking poster presentations and one oral presentation during the Endocrine Society’s ENDO 2024 Meeting that was held June 1-4, 2024, in Boston, Massachusetts. Presentations included a post hoc analysis of three Phase 3 clinical trials (CH-ACM-01, OPTIMAL, MPOWERED) studying MYCAPSSA (octreotide) as well as real-world MYCAPSSA use data from the Chiesi Management of Acromegaly (MACRO) registry and presentation of the Lipodystrophy Severity Scoring tool designed to assess the disease burden of lipodystrophy. "We're thrilled to support this community of people living with burdensome rare endocrine diseases through the innovation of new resources and validated medicines to aid in disease management," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "As we approach the four-year anniversary of MYCAPSSA being on the market later this month, our commitment remains steadfast to commercializing solutions for the acromegaly and lipodystrophy patient communities.” Oral PresentationTitle: Biochemical Response, Symptom Control, and Safety of Oral Octreotide Capsules Treatment in Acromegaly: A Post Hoc Analysis of a Large Pooled Database from Three Phase 3 Clinical Trials2Key Highlights: MYCAPSSA demonstrated a 72% response rate in patients entering the studies with IGF-I values of ≤ 1x the upper limit of normal. A patient’s prior dose level of injectable medication did not significantly impact response rates.In this post-hoc analysis, symptom improvement was notable with significant reductions in joint pain (36% to 22%) and swelling (15% to 10%) in patients responding to MYCAPSSA. Median decrease of one symptom per patient and a mean decrease of 0.8 in Acromegaly Index of Severity (AIS) further underscored symptom improvement.Safety analysis revealed gastrointestinal issues as the most common adverse events with a median duration and time to onset of roughly two weeks for the first occurrence and a low rate of discontinuation. Late-Breaker Poster PresentationsTitle: Real-world Biochemical And Symptoms Outcomes With Oral Octreotide: Management Of Acromegaly (MACRO) Registry Experience3Key Highlights: Of the 230 patients participating in Chiesi Management of Acromegaly (MACRO) registry, 32 (14%) received MYCAPSSA at baseline, with an additional 26 (11%) initiating post-baseline. Common reasons for initiation included patient preference and lack of symptom or biochemical control.The mean time on OOC was 19.7 months, with the majority receiving treatment for at least 6 months. Most patients remained well-controlled biochemically and symptomatically, with 87% biochemically controlled and 71% symptomatically controlled at the last follow-up.The discontinuation rate was 33% and in cases attributed to a lack of biochemical or symptom control, dose titration to 80mg/day was not implemented in many cases.Overall, OOC demonstrated efficacy in maintaining or achieving biochemical control with the majority of newly-initiated patients reporting well-controlled symptoms. Title: Lipodystrophy Severity Score: Validation Of A Tool To Assess Disease Burden In Lipodystrophy4Key Highlights: The lipodystrophy severity score (LDS) is a validated tool that captures severity in patients with diverse manifestations of lipodystrophy. The LDS allows comparisons among patient groups and changes within patients over time.The LDS is a tool designed to quantify the diverse complications of lipodystrophy, a group of rare, potentially life-threatening disorders that affect how the body accumulates and stores fat.The LDSs showed high reliability and strong correlation with the Clinical Global Impression (CGI) of severity, effectively capturing the severity of lipodystrophy and changes over time. This tool is intended to compare patient groups, and monitor individual progress with future analysis involving in real-world data sets.Development into an online platform enhances functionality – a versatile and valuable resource for the lipodystrophy community.Future work will assess the LDS using real-world datasets. MYCAPSSA IMPORTANT SAFETY INFORAMATION INDICATION AND USAGE MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. CONTRAINDICATIONS Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected. Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly. Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted. ADVERSE REACTIONS The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis. DRUG INTERACTIONS The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA. Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA. PREGNANCY Advise premenopausal females of the potential for an unintended pregnancy. Please contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About AcromegalyAcromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision, and enlargement of the hands, feet, tongue, and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders, and cardiac and cerebrovascular disease. Acromegaly affects over 25,000 people in the United States alone with roughly 8,000 being treated with injectable somatostatin receptor ligands (iSRLs). A significant percentage of these people experience burdens associated with receiving iSRLs including prolonged injection-related pain and poorly-controlled symptoms. About LipodystrophyLipodystrophy syndromes are a heterogeneous group of rare, potentially life-threatening disorders that affect how the body accumulates and stores fat. These syndromes are categorized into two main forms: generalized lipodystrophy, characterized by the near-complete absence or progressive loss of fat (adipose) tissue, and partial lipodystrophy, where the tissue loss is more limited, typically impacting areas like limbs or upper body. Lipodystrophy is also categorized by etiology with inherited and acquired forms1. About Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information visit www.chiesirarediseases.com. About Chiesi GroupChiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com Garg A. Acquired and inherited lipodystrophies. N Engl J Med. 2004 Mar 18;350(12):1220-34. Doi: 10.1056/NEJMra025261. PMID: 15028826.Fleseriu M, et al. Biochemical Response, Symptom Control, and Safety of Oral Octreotide Capsules Treatment in Acromegaly: A Post Hoc Analysis of a Large Pooled Database from Three Phase 3 Clinical Trials. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts.Yuen K, et al. Real-world Biochemical And Symptoms Outcomes With Oral Octreotide: Management Of Acromegaly (MACRO) Registry Experience. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts.Brown R, et al. Lipodystrophy Severity Score: Validation Of A Tool To Assess Disease Burden In Lipodystrophy. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts. Chiesi Group Media ContactChiara TravaginRare Communication ManagerTel: +39 348 8818985Email c.travagin@chiesi.com Sky Striar LifeSci CommunicationsTel: 617-797-6672Email sstriar@lifescicomms.com