Eli Lilly Canada, Inc.

EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease, provides new evidence for patients commonly seen in clinical practice1,2,3 Phase III trial also demonstrated a 14% statistically significant reduction in hospitalization for any cause1,2 BURLINGTON, ON and TORONTO, Nov. 4, 2022 /CNW/ - EMPA-KIDNEY Phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for people living with chronic kidney disease (CKD).1,2 When treated with empagliflozin, the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.001).1,2 The results were announced today during the American Society of Nephrology (ASN)'s Kidney Week 2022 by the Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford which designed, conducted and analyzed EMPA-KIDNEY, in scientific collaboration with Boehringer Ingelheim, and Eli Lilly and Company (NYSE: LLY). The results were also published simultaneously in The New England Journal of Medicine.2 EMPA-KIDNEY is the first SGLT2 inhibitor trial in CKD to demonstrate a 14% significant reduction in all-cause hospitalizations (HR; 0.86; 95% CI 0.78 to 0.95; P=0.0025) vs. placebo as a pre-specified key secondary confirmatory endpoint.1,2 CKD doubles a person's risk for hospitalization4 and is the tenth leading cause of death in Canada.5 The overall safety data were generally consistent with previous findings, confirming the well-established safety pro empagliflozin. "The EMPA-KIDNEY trial results provide new evidence to help treat people with chronic kidney disease who are commonly seen in clinical care but who have been under-represented in previous clinical trials – especially those with lower kidney function and lower urine albumin excretion," says Dr. David Cherney, EMPA-KIDNEY Steering Committee Member and Senior Scientist at Toronto General Hospital Research Institute. "Today's positive trial results across a broad chronic kidney disease patient population demonstrate that empagliflozin may benefit adults at risk of progression, including those with and without diabetes, and across a wide range of kidney function." EMPA-KIDNEY is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk in people living with CKD. The EMPA-KIDNEY trial is the largest and broadest dedicated SGLT2 inhibitor trial to date in chronic kidney disease.3 It included 6,609 participants across a wide range of people living with CKD, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. The trial assessed both kidney and cardiovascular outcomes in people across the spectrum of CKD severity.6 One in 10 Canadians are living with kidney disease,7 and more than 50,000 are being treated for kidney failure symptoms.7 The leading cause of kidney disease in Canada is diabetes.8 Up to one-half of people living with diabetes demonstrate signs of renal damage in their lifetime.8 "The Boehringer Ingelheim and Lilly Alliance is incredibly proud that EMPA-KIDNEY has provided another pivotal moment for empagliflozin," said Carinne Brouillon, Head of Human Pharma and Member of the Board of Managing Directors, Boehringer Ingelheim. "Today's data adds to the body of evidence from our clinical program which includes more than 700,000 adults with cardiovascular, kidney and metabolic conditions. EMPA-KIDNEY reinforces the potential role of empagliflozin in changing the way these interconnected conditions may be managed." "Today's EMPA-KIDNEY trial results will be welcomed by people living with CKD and the medical community. We are also encouraged by the risk reduction for hospitalization after just two years, as this finding is in line with the significant reductions seen in prior empagliflozin cardiovascular outcomes trials," says Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "The Alliance looks forward to discussing plans for marketing authorization for CKD with regulators worldwide in due course." Notes to editors Kidney disease progression: Defined as end-stage kidney disease (the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decline in estimated glomerular filtration rate (eGFR) to below 10 mL/min/1.73 m2, kidney death or a sustained decline of at least 40 percent in eGFR from randomization). End stage kidney disease: Includes initiation of maintenance dialysis or receipt of a kidney transplant About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin in people living with CKD1,2,3 EMPA-KIDNEY (NCT03594110) is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk in people living with CKD. The primary outcome is defined as time to a first event of either cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as dialysis or kidney transplantation), a sustained decline in eGFR to <10 mL/min/1.73 m2, kidney death, or a sustained decline of ≥40 percent in eGFR from randomization. Key secondary outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality. EMPA-KIDNEY includes 6,609 adults randomized from eight countries with established CKD both with and without diabetes, as well as with and without albuminuria, receiving either empagliflozin 10 mg or placebo, on top of current standard of care. About the Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford The MRC PHRU at the University of Oxford, part of Oxford Population Health, improves the treatment and prevention of chronic diseases, particularly cardiovascular disease and metabolic disease (such as diabetes mellitus and CKD), which collectively account for a large proportion of premature adult deaths and the burden of disability worldwide. MRC PHRU is led by EMPA-KIDNEY Steering Committee co-chair Professor Colin Baigent. MRC PHRU coordinates innovative clinical trials and meta-analyses that have a major impact on health. Other major studies include the ground-breaking Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial which is co-led by EMPA-KIDNEY Steering Committee co-chair, Professor Sir Martin Landray. MRC PHRU's worldwide approach, involving the study of large numbers of people, provides reliable information about the causes of disease and the effects of treatments, and has had a major impact on global health. About the EMPOWER program The Boehringer Ingelheim and Lilly Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and kidney outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.9 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-kidney-metabolic conditions. With more than 700,000 adults enrolled worldwide, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.10 About empagliflozin Empagliflozin (marketed as Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first treatment to include cardiovascular death risk reduction data in people living with type 2 diabetes and established cardiovascular disease in its label in several countries.11,12,13 Empagliflozin is the first and only approved treatment to improve outcomes of people living with heart failure regardless of ejection fraction.14 Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. About Boehringer Ingelheim (Canada) Ltd. Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at . About Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism. Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at . For our perspective on issues in healthcare and innovation, follow us on Twitter @LillyPadCA and @LillyMedicalCA. CONTACTS: Anne Coffey Specialist, Brand Communications Boehringer Ingelheim (Canada) Ltd. Email: anne.coffey@boehringer-ingelheim.com Amanda Meek Stakeholder Engagement Manager Lilly Canada Email: meek_amanda@lilly.com References SOURCE Boehringer Ingelheim (Canada) Ltd.

Results from the Phase III EMPEROR-Preserved trial were presented August 27 at the European Society of Cardiology Congress 20211 and published in The New England Journal of Medicine2 In this clinical first for adults with heart failure with preserved ejection fraction, empagliflozin demonstrated a 21 per cent relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization2 Approximately 670,000 Canadians are living with heart failure, with nearly 93,000 new diagnoses expected each year3 Empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 per cent and significantly slowed kidney function decline2 The EMPEROR-Preserved trial included 34 study sites across Canada BURLINGTON, ON and TORONTO, Aug. 30, 2021 /CNW/ - Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed a 21 per cent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo.2 The benefit was independent of ejection fraction or diabetes status,2 establishing empagliflozin as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients. The results were presented on August 27, at the European Society of Cardiology (ESC) Congress 20211 and published in The New England Journal of Medicine,2 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 per cent and significantly slowed kidney function decline.2 "Until now, there have been no clinically proven treatment options for patients who have heart failure with a preserved ejection fraction," said Dr. Shelley Zieroth, cardiologist and director of St. Boniface Hospital Heart Failure and Transplant Clinics, in Winnipeg, MB, and a clinical investigator for the EMPEROR-Preserved trial. "Results from the study show that empagliflozin is effective in not only treating heart failure with preserved ejection fraction, but also keeping patients out of hospital and slowing kidney decline – which are key factors for prolonging life and allowing my patients to continue to live well. These findings not only give me hope as a clinician but for my patients who at present have limited options available to them." Heart failure affects more than 60 million people worldwide.4 In Canada, approximately 670,000 Canadians are currently living with heart failure and nearly 93,000 new cases are diagnosed each year.3 HFpEF, which is also known as diastolic heart failure, comprises half of all heart failure cases.5 HFpEF has been described as the single largest unmet need in cardiovascular medicine based on its prevalence, high morbidity and mortality, and the absence of clinically proven therapies to date.6,7 "Heart failure is a complex, serious health issue and a leading cause of hospitalization," said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. "The risk of death in people with heart failure rises with each hospital admission and with kidney function decline. The landmark EMPEROR-Preserved trial shows that empagliflozin brings significant benefit, which is incredibly exciting and welcome news for both the medical and patient communities." "These impressive results will bring hope for the millions of people who currently have limited therapeutic options for a very serious, life-threatening condition," said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "Now there is a light at the end of the tunnel. If approved, empagliflozin would become the first clinically proven therapy across the full heart failure spectrum. The results of EMPEROR-Preserved offer an opportunity to fundamentally change the future for people with heart failure." EMPEROR-Preserved included 5,988 people with heart failure.2 Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50 per cent or above and 1,983 had a LVEF between 40 and 50 per cent.2 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.2 The overall safety data was consistent with previous findings, confirming the well-established safety pro empagliflozin.8 The benefits demonstrated in the EMPEROR-Preserved trial are similar to those in the EMPEROR-Reduced trial, where empagliflozin significantly reduced the relative risk of the composite endpoint of cardiovascular death or hospitalization for heart failure by 25 per cent, compared with placebo, in adults with heart failure with reduced ejection fraction (HFrEF).9 Together, these studies demonstrate the benefits of empagliflozin for patients across the full heart failure spectrum. About the EMPEROR heart failure studies10,11 The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies were two Phase III, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes: EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic HFrEF. Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure Number of patients: 3,730; which included 36 study sites in Canada Completion: 2020 EMPEROR-Preserved [NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF. Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure Number of patients: 5,988; which included 34 study sites in Canada Completion: 2021 Link to lay summary About the EMPOWER program The Boehringer Ingelheim and Lilly Diabetes Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.12 Through the EMPOWER program, the Alliance is working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 400,000 adults enrolled worldwide in clinical studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date. About heart failure Heart failure is a serious condition, that occurs when the heart cannot keep up with its workload, and the body may not get the oxygen that it needs. As the left and right sides of the heart fail, fluid may build up in the lungs, abdomen, or legs.13,14 It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.4,5 In Canada, approximately 670,000 people are living with heart failure.3 Heart failure is twice as common in people with diabetes.15 There are different types of heart failure. People with left-sided heart failure have either a reduced or a preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction.16 When the heart relaxes, the ventricle refills with blood. Heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out to the body.16 Heart failure with reduced ejection fraction occurs when the left ventricle of the heart is not able to contract effectively, which means that the heart cannot pump with enough force, so less blood is pushed out to the body.16 People with heart failure often experience shortness of breath and fatigue, which can severely impact their quality of life.17 Individuals with heart failure often also have impaired kidney function, which can further worsen patient outcomes and quality of life.18 About cardio-renal-metabolic conditions Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.4,12 Through our research and treatments, our goal is to support people's health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps. About empagliflozin Empagliflozin (marketed as Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.19,20,21,22 Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.19,20,21 Additionally, empagliflozin is approved for the treatment of adults with HFrEF in the European Union and the U.S.19,23 Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure.24 Empagliflozin is also currently being investigated in chronic kidney disease.25 Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease. About Boehringer Ingelheim (Canada) Ltd. Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Approximately 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada. Learn more at . About Eli Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism. Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at . For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA. References SOURCE Boehringer Ingelheim (Canada) Ltd. Company Codes: NYSE:LLY

TORONTO, Feb. 25, 2021 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines. i This is the second indication for Emgality, making it the first and only calcitonin gene-related peptide (CGRP) binding monoclonal antibody approved in Canada to reduce the frequency of episodic cluster headache attacks that is also approved for the prevention of migraine in adults who have at least 4 migraine days per month.ii "This is good news for patients living with episodic cluster headache who have had an inadequate response to conventional preventive therapies. Cluster headache attacks are the worst pain known to humanity. Enduring many of these attacks every day, often waking you from sleep, is extremely disruptive. A new treatment that could rapidly decrease the frequency of attacks would be life-changing," says Dr. Elizabeth Leroux, Headache Neurologist in Montreal and President of the Canadian Headache Society. "The approval provides physicians with an additional treatment option to help these patients who suffer from extreme pain." Episodic cluster headache is a devastating primary headache disorder characterized by the abrupt onset of attacks of severe- to very severe pain on one side of the head, occurring in cluster periods lasting typically two weeks to three months.iii Most patients (90%) with cluster headache suffer from the episodic form, meaning they have remissions (with no attacks) of more than 3 months and the cluster periods do not last more than 1 year.iv Pain is felt around or above the eye and/or temple and can be accompanied by symptoms on the same side of the body: eye redness, tearing, nasal congestion, runny nose, forehead and facial sweating, constriction of the pupil, drooping eyelid and/or swollen eyelid, and/or restlessness or agitation.v These attacks last 15 to 180 minutes when untreated and can occur from once every other day to eight times per day.vi Cluster headaches can be so painful that sufferers are unable to follow their normal routine and activities.vii While episodic cluster headache is not as common as migraine, it does impair life for thousands of Canadians.viii About 1 in 1,000 adults have episodic cluster headache, with men affected 3:1 compared to women.ix About Emgalityx Emgality is a humanized IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) and prevents its biological activity. Emgality targets CGRP with high affinity (KD = 31 pM) and does not bind to the CGRP receptor or related peptides adrenomedullin, amylin, calcitonin and intermedin. Emgality is administered subcutaneously through a single-use prefilled syringe or a prefilled pen and is intended for patient self-administration. For the prevention of migraine, Emgality is available in pre-filled syringes and prefilled pens.xi For episodic cluster headache, Emgality is available in 100 mg/mL prefilled syringes. The recommended dose of Emgality for episodic cluster headache is 300 mg once a month (administered as three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Treatment benefit should be assessed within 3 weeks of the initiation of treatment. In patients with no improvement within this time, any further decisions for continuation of the treatment should be carefully considered based on individual patient basis and clinical judgement.xii The science of Emgality for episodic cluster headachexiii The safety and efficacy of Emgality (300 mg once a month) for episodic cluster headache was evaluated in adult patients with episodic cluster headache in a placebo-controlled clinical trial that included 106 patients. CGAL was a randomized, multicenter double-blind placebo-controlled study in adults who met diagnostic criteria for episodic cluster headache and had a prior history of a cluster period lasting 6 weeks or longer. In CGAL, patients were randomized at the initiation of phase 3 (1:1) to receive subcutaneous injections of either Emgality 300 mg once a month or placebo once a month, over an 8-week treatment period. During the prospective 7-day baseline assessment, patients were required to have a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks. The primary efficacy endpoint was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3, with baseline defined as 7 consecutive days from the daily ePRO diary during the prospective baseline assessment. The key secondary endpoint was the proportion of patients achieving response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3. The primary endpoint (Weeks 1-3) and gated secondary endpoint (at Week 3) of Study CGAL measured the effect of only one dose of Emgality. In the CGAL studyxiv the prospective baseline weekly frequency of episodic cluster attacks was 17.8 for participants who received Emgality 300 mg, and 17.3 for patients who received placebo. The patients who received Emgality experienced a mean reduction from baseline in the weekly frequency of their cluster headache attacks of -8.7 (N=49) versus -5.2 (N=57) in patients receiving placebo. More than two thirds of patients achieved at least a 50% reduction in the frequency of their weekly cluster headache attacks at week 3: 71.4% (N=49) for Emgality 300 mg compared to 52.6% (N=57) for placebo. In the CGAL study, injection site pain was the most frequently reported adverse event (8%). The majority of injection site reactions, including pain, were reported within 1 day and most resolved within a few days. Most events were mild to moderate and did not lead to discontinuation of Emgality. For full prescribing information, including Patient Information, please refer to the Canadian Product Monograph for Emgality, available at . About Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism. Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at . For our perspective on issues in healthcare and innovation, follow us on Twitter @LillyPadCA Lilly Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Emgality (galcanezumab) as a treatment for patients with episodic cluster headache and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Emgality will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References SOURCE Eli Lilly Canada