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Kaiser Permanente study showed patients in home-based cardiac rehabilitation had fewer hospitalizations than those in center-based cardiac rehabilitation PASADENA, Calif., Aug. 25, 2022 /PRNewswire/ -- Patients who participated in in-home cardiac rehabilitation had fewer hospitalizations over 12 months than patients who participated in center-based cardiac rehabilitation, according to a Kaiser Permanente study published August 25, 2022, in JAMA Network Open. "The remarkable thing we found in this study of more than 2,500 diverse patients was that health advantages of home-based cardiac rehabilitation applied to both patients with low and moderate risk, as well as those with higher risk due to poor health, age, or chronic health conditions," said lead author Chileshe Nkonde-Price, MD, a cardiologist at the Kaiser Permanente West Los Angeles Medical Center, a clinician investigator with the Kaiser Permanente Southern California Department of Research & Evaluation, and an assistant professor at the Kaiser Permanente Bernard J. Tyson School of Medicine. Cardiac rehabilitation in a hospital-based setting is a well-studied, effective way to improve health after cardiac issues such as heart attacks, cardiac surgery, and stable angina. Despite this knowledge, many people don't take advantage of rehabilitation, especially women, members of certain racial and ethnic groups, and individuals with multiple chronic illnesses. Home-based cardiac rehabilitation was developed to increase the diversity of participants by improving accessibility. Kaiser Permanente's 8-week home-based program in Southern California includes weekly nurse calls, education, and unsupervised exercise monitored with a smart watch. Prior studies have suggested that participation in home-based and center-based cardiac rehabilitation results in similar clinical outcomes in patients with low-to-moderate risk. However, outcomes from demographically diverse populations and patients who had other chronic illnesses and other medical complexities had not been studied. This study tracked 2,556 patients who participated in cardiac rehabilitation from April 1, 2018, to April 30, 2019. The patients had a mean age of 67 and were about 30% women and 45% nonwhite, and 47% had a combination of health factors that would put them in a medically high-risk category. In the study, 48.5% of patients participated in home-based cardiac rehabilitation and 51.5% participated in center-based cardiac rehabilitation. Patients who participated in home-based cardiac rehabilitation had a 21% less chance of experiencing a hospitalization in the 12 months after cardiac rehab compared to patients who participated in center-based rehabilitation, but similar: Adherence to beta blockers and statins Control of blood pressure Low-density lipoprotein LDL-cholesterol Hemoglobin HbA1c Patients who participated in home-based cardiac rehabilitation typically lived farther from their nearest available center-based rehabilitation center. Patients who participated in home-based cardiac rehabilitation were more likely to complete their program. Study senior author Tad Funahashi, MD, who is Kaiser Permanente's chief innovation officer for Southern California, led the development of the in-home cardiac rehabilitation program, collaborating with a technology company to develop the app for a customized smart watch. "The success of this home-based program demonstrates that healthy behaviors begin where patients live, work, and play. Our technology-enabled care solutions in combination with our integrated delivery system can keep track of the patients, almost as though somebody's calling them every day, all the time, to see what's going on," Dr. Funahashi said. "If a patient isn't exercising or is failing to meet other expectations of the program, health care providers can follow up in person or over the phone. Importantly, these care solutions help provide equitable, convenient, and quality care to all patients over challenges they may have with in-person visits." Doctors or nurses can review data, including step counts and heart rate to check exertion, through a dashboard on Kaiser Permanente's electronic health record system, and adjust the patient's rehabilitation program as needed. About Kaiser Permanente Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve approximately 12.6 million members in 8 states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists, and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery, and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations clinical research, health education, and the support of community health. For more information, go to about.kp.org. For more information, contact: Lauren Davitt, [email protected], 212-886-2228 Terry Kanakri, [email protected], 626-405-2652 SOURCE Kaiser Permanente

– MOMENTUM data demonstrate potential use of momelotinib in myelofibrosis patients who are symptomatic and anemic – – Additional data highlight improved transfusion independence, symptoms and spleen volume of cytopenic myelofibrosis patients – SAN MATEO, Calif.--(BUSINESS WIRE)-- Sierra Oncology Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, today announced two abstracts have been accepted into the program for the Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 3-7, 2022, in Chicago and online. An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for an oral presentation on June 7. An additional subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation. “Receiving an oral presentation at ASCO for our pivotal Phase 3 study data—which demonstrated that momelotinib achieved statistically significant and clinically important efficacy across all prespecified and key secondary endpoints—is truly a momentous occasion for Sierra Oncology. Further, we are excited to present a subset analysis in a poster presentation examining the use of momelotinib in thrombocytopenic patients with platelet counts as low as 25 x 109/L,” said Barbara Klencke, MD, Chief Medical Officer at Sierra Oncology. “Together, these abstracts demonstrate the true potential use of momelotinib as the treatment of choice across a range of myelofibrosis patients who are symptomatic and cytopenic, including those with anemia and thrombocytopenia.” Abstract: 7002: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will be presented in an oral presentation by Ruben Mesa, MD, co-Principal Investigator of the study. Key data to be presented include: Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095) Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority) Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006) SRR of >25% was 40% in the MMB arm and 6% in the control arm A trend toward improved overall survival is demonstrated in the MMB arm based on data up to Week 24 (p=0.0719) and overall (p=0.3510) The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm. The most frequent non-hematologic adverse events were diarrhea, nausea, asthenia, pruritis and increased blood creatinine Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L Abstract 7061: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM] Abstract 7061 will highlight an analysis of MOMENTUM patients with baseline platelet counts as low as 25 x 109/L on study endpoints, including Week 24 TSS reduction of >50% from baseline, transfusion independence rates, and SRR of >35% from baseline. Results to be presented include: Of the 195 patients enrolled in the MOMENTUM study, 124, 100 and 31 patients had baseline platelet counts of less than 150, 100, and 50 x 109/L, respectively. In patients with baseline platelets <100 x 109/L (MMB: n=66; DAN: n=34): TSS responder proportion was 29% in the MMB arm and 15% in the control arm; TI response proportion was 27% in the MMB arm and 21% in the control arm; SRR was 20% in the MMB arm and 6% in the control arm In patients with baseline platelets <50 x 109/L (MMB: n=18; DAN: n=13): TSS responder proportion was 22% in the MMB arm and 8% in the control arm; TI response proportion was 17% in the MMB arm and 15% in the control arm; SRR was 22% in the MMB arm and 0% in the control arm The broader thrombocytopenic subgroup with baseline platelets <150 x 109/L demonstrated similar efficacy and safety as described in the published abstract In patients with baseline platelets below 50 x 109/L, mean platelet levels remained stable over time in both the MMB and control arms Overall Survival directionally favored the MMB arm, consistent with the survival results in the intent-to-treat population The proportion of patients who experience Grade 3 or higher treatment-emergent adverse events were comparable between the study arms Mean baseline characteristics for patients with baseline platelets <100 x 109/L included TSS of 28 and 25 and Hgb of 8.1 and 7.8 g/dL for the MMB and control arms, respectively. In thrombocytopenic, symptomatic and anemic patients with myelofibrosis, including those with platelets as low as 25 x 109/L, momelotinib was administered safely and demonstrated improvements in symptom responses, transfusion independence rates and spleen responses as compared to danazol. Consistent with the overall intent-to-treat MOMENTUM population, platelets levels remained stable over time, survival favored momelotinib versus danazol, and the safety pro generally maintained in thrombocytopenic myelofibrosis patients receiving momelotinib. Presentation Details Abstract 7002 Title: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor Presenter: Ruben Mesa, MD, FACP, Executive Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center Session Title: Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Presentation Date and Time: Tuesday, June 7, 2022, 10:33 am CT Abstract 7061 Title: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM] Presenter: Aaron Gerds, MD, MS, Taussig Cancer Institute, Cleveland Clinic Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Session Date and Time: Saturday, June 4, 2022, 8:00 am – 11:00 am CT About Momelotinib Momelotinib is a potent, selective and orally bioavailable ACVR1 / ALK2, JAK1, JAK2 inhibitor under investigation for the treatment of myelofibrosis in symptomatic, anemic patients previously treated with an approved JAK inhibitor. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including approximately 1,000 patients treated for myelofibrosis, several of whom remain on treatment for over 11 years. Momelotinib is the first and only JAK inhibitor to demonstrate positive data for all key hallmarks of the disease—symptoms, splenic response and anemia. About Myelofibrosis Myelofibrosis is a rare blood cancer that results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia. From prior studies with momelotinib, we know approximately half of myelofibrosis patients are moderately to severely anemic when eligible for JAK inhibitor treatment. Furthermore, currently approved JAK inhibitors only address symptoms and splenomegaly and are myelosuppressive. This can lead to worsening anemia, resulting in dose reductions that potentially reduce treatment effect. About the Pivotal MOMENTUM Clinical Trial MOMENTUM is a global, randomized, double-blind Phase 3 clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anemic, and had been previously treated with an FDA-approved JAK inhibitor. The study was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and splenomegaly (enlarged spleen). The primary endpoint of the study is Total Symptom Score (TSS) reduction of >50% over the 28 days immediately prior to the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form (MFSAF). Secondary endpoints included Transfusion Independence (TI) rate for >12 weeks immediately prior to the end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate (SRR) based on splenic volume reduction of >35% at Week 24. The study enrolled 195 patients based on a planned 180 patients across 21 countries. Danazol was selected as the treatment comparator given its use to ameliorate anemia in patients with myelofibrosis, as recommended by National Comprehensive Cancer Network (NCCN) and European Society of Medical Oncology (ESMO) guidelines. Patients were randomized 2:1 (MMB n = 130 and DAN n = 65) to receive either momelotinib or danazol. After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib. Early cross-over to momelotinib was available for confirmed symptomatic splenic progression. About Sierra Oncology Sierra Oncology is a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer. We harness our deep scientific expertise to identify compounds that target the root cause of disease to advance targeted therapies with assets on the leading edge of cancer biology. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. Together we are transforming promise into patient impact. For more information, visit . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations regarding the potential and future success of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology may be unable to successfully commercialize momelotinib, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) and AstraZeneca (NYSE: AZN - News) today announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZA™ (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program. The Committee unanimously recommended that the Sponsors perform a post-marketing trial to confirm the cardiovascular pro ONGLYZA. Bristol-Myers Squibb and AstraZeneca are working on a series of Phase IIIb and IV studies, including a large, controlled, randomized, post-marketing trial, to further characterize the long-term clinical effectiveness as well as the cardiovascular pro ONGLYZA. The companies will now work with the FDA to finalize the post-marketing trial design. “Bristol-Myers Squibb and AstraZeneca are encouraged by the Committee’s recommendation. We will work closely with the FDA to support the review of ONGLYZA,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. ONGLYZA is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The ONGLYZA application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise, use in combination with three types of commonly used oral anti-diabetic (OAD) medications - metformin, thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not provide adequate glycemic control, as an adjunct to diet and exercise – and use in initial combination therapy with metformin, as an adjunct to diet and exercise. The FDA Endocrinologic and Metabolic Drugs Advisory Committee based its recommendation on review of data from the comprehensive ONGLYZA clinical development program, which included more than 5,000 individuals, more than 4,000 of whom were given ONGLYZA. Data presented included safety and efficacy results from six pivotal Phase III trials, in addition to comprehensive post hoc pooled analyses evaluating cardiovascular risk in the Phase IIb and Phase III studies, which included individuals followed for up to 2.5 years and more than 3,700 person-years of exposure to ONGLYZA. The post hoc pooled analyses did not show evidence of a cardiovascular safety signal in individuals taking ONGLYZA. The FDA is not bound by the Advisory Committee’s recommendations, but takes its advice into consideration when reviewing new drug applications. Bristol-Myers Squibb and AstraZeneca will review the information leading to the Committee’s decision and continue to work closely with the FDA to support the review of ONGLYZA. The new drug application for ONGLYZA was submitted to the FDA on June 30, 2008, and has an action date of April 30, 2009. ONGLYZA, an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes, was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. ONGLYZA is being studied in ongoing and further planned clinical trials. About DPP-4 Inhibitors DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body’s utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose. About Type 2 Diabetes Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage. There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), or the cells ignore the insulin (insulin resistance). Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms. Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterized with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C (“good”) cholesterol levels and high triglyceride levels and hypertension. Type 2 diabetes accounts for approximately 90 to 95 percent of all diabetes. This equates to roughly 221 million people with type 2 diabetes globally, and 21.2 million people in the U.S. alone. The American Diabetes Association recommends a hemoglobin A1C measurement of less than 7 percent for most people with type 2 diabetes. Hemoglobin A1C is a measurement of a person’s average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person’s blood glucose after at least eight hours of fasting and postprandial glucose, a measure of a person’s blood glucose after a meal. Bristol-Myers Squibb and AstraZeneca Partnership Bristol-Myers Squibb and AstraZeneca entered into collaboration in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes – saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information visit About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: Bristol-Myers Squibb Forward-Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval. There can be no assurance that if approved, the product will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. AstraZeneca Forward-Looking Statement The statement contained herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report/Form 20-F for 2008. Nothing contained herein should be construed as a profit forecast. ONGLYZA™ is a trademark of the Bristol-Myers Squibb Company. Contact: Media: Bristol-Myers Squibb Ken Dominski, 609-252-5251 ken.dominski@bms.com or AstraZeneca Neil McCrae, +44 207 304 5045 neil.mccrae@astrazeneca.com or Investors US: Bristol-Myers Squibb John Elicker, 609-252-4611 john.elicker@bms.com or AstraZeneca Edward Seage, 302-886-4065 edward.seage@astrazeneca.com or Jorgen Winroth, 212-579-0506 jorgen.winroth@astrazeneca.com or Investors EU: AstraZeneca Jonathan Hunt, +44 207 304 5087 jonathan.hunt@astrazeneca.com or Karl Hard, +44 207 304 5322 karl.j.hard@astrazeneca.com or James Mead, +44 207 304 5062 james.mead@astrazeneca.com