Lilly 2019: Diabetes-plus

 

The better part of Lilly’s portfolio might still be filled with diabetes products, but there is clearly more to the company than that.

 

 

Eli Lilly and Co.

Lilly Corporate Center
Indianapolis, IN 46285
Telephone: 317-276-2000
Website: lilly.com

 

Best-Selling Products

Product	2018 Sales	2017 Sales
Trulicity	$3,199	$2,030
Humalog	$2,997	$2,865
Alimta	$2,133	$2,063
Cialis	$1,852	$2,323
Forteo	$1,576	$1,749
Humulin	$1,331	$1,335
Taltz	$938	$559
Cyramza	$821	$758
Basaglar	$801	$432
Cymbalta	$708	$757
Jardiance, Glyxambi, Synjardy	$658	$448
Erbitux	$635	$646
Trajenta and Jentadueto	$575	$538

All sales are in millions of dollars.

 

Financial Performance

	2018	2017
Revenue	$24,556	$22,871
Net income	$3,232	$(204)
Diluted EPS	$3.13	$(0.19)
R&D expense	$5,307	$5,357

	1H 2019	1H 2018
Revenue	$10,729	$10,549
Net income	$5,569	$958
Diluted EPS	$5.84	$0.92
R&D expense	$2,633	$2,379

All figures are in millions of dollars, except EPS.

 

Outcomes Creativity Index Score: 89
Manny Awards – 21
Cannes Lions – 16
LIA: Health & Wellness – 2
Clio Health – 14
One Show: HW&P – N/A
MM&M Awards – 17
Global Awards – 15
Creative Floor Awards – 4

 

Eli Lilly and Co. might be typecast as a diabetes company, but the typecast is not far from the truth. The company’s newest sales leader is, you guessed it, a diabetes product, and it took over from, you guessed it, another diabetes product. Lilly’s fastest-growing product last year was, yes, a diabetes product. And two of the company’s top three non-diabetes products had declining sales in 2018, with the third barely moving the needle.

All that said, Lilly is not just a diabetes company. Sales of the oncologic Alimta may have only edged up slightly of late, but the compound earned a new indication in combination with the blockbuster medicine Keytruda for NSCLC in January. And the autoimmune drug Taltz looks to sweep past the blockbuster mark in the current year, with sales growth of two-thirds in 2018 and the first half of 2019. Taltz even outperformed Humira in a head-to-head trial in psoriatic arthritis that reported in June. And Lilly has invested significant M&A dollars in the past year to acquire or license a variety of compounds targeting cancer, autoimmune diseases, and the treatment of chronic pain; several of the top compounds in the company’s pipeline are aimed at similar targets. Lilly may still be known as a diabetes company, but the reality does not quite match the typecast.

“We are continuing to make significant investments in our business to ensure the success of our recent product launches,” says Lilly CEO and Chairman David Ricks. “At the same time, we are expanding investment in our pipeline in order to develop new medicines that have the potential to more effectively treat patients that have diabetes, cancer, autoimmune disorders, and other serious conditions.”

Lilly’s top-line revenue in 2018 was $24.56 billion, an improvement of 7.4 percent compared with 2017. Net income for the year was $3.23 billion and diluted earnings per share were $3.13. GAAP net income and EPS for Lilly in 2017 were negative due to a one-time charge related to U.S. tax reform; excluding that, the company’s income before taxes rose 72.7 percent in 2018 to $3.8 billion.

In the first half of 2019, top-line revenue rose 1.7 percent to $10.73 billion. Net income was up by nearly six times to $5.57 billion, and EPS rose similarly from 92 cents to $5.84. The bottom line, however, was impacted by a one-time gain of about $3.7 billion related to the disposition of the Elanco animal care business in March 2019. Excluding that, net income from continuing operations still more than doubled from $936 million to $1.89 billion for the half. Company executives are estimating that full-year 2019 EPS will fall between $8.58 and $8.68.

Acquisitions and partnerships

In January, Lilly agreed to acquire Loxo Oncology for $235.00 per share in cash, or about $8 billion. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers. The acquisition, company leaders say, broadens the scope of Lilly’s oncology portfolio into precision medicines through the addition of a pipeline of highly selective potential medicines for patients with genomically defined cancers. The deal duly closed the following month.

The acquisition of Loxo Oncology provides Lilly with several investigational medicines, including LOXO-292 and LOXO-305. LOXO-292 is a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by FDA for three indications. LOXO-292 targets cancers with alterations to the rearranged during transfection kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers. LOXO-305 is an oral BTK inhibitor currently in Phase I/II. LOXO-305 targets cancers with alterations to the Bruton’s tyrosine kinase, and is designed to address acquired resistance to currently available BTK inhibitors.

In March, Lilly and ImmuNext Inc. announced a global licensing and research collaboration focused on the study of a preclinical novel target that could lead to potential new medicines for autoimmune diseases by regulating immune cell metabolism. Under the terms of the agreement, ImmuNext received an upfront payment of $40 million, and is eligible to receive up to about $565 million in development and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales. In return, ImmuNext will grant Lilly an exclusive, worldwide license to develop and commercialize the novel immunometabolism target. In addition, Lilly and ImmuNext will establish a three-year research collaboration to support the target’s development.

In April, Lilly and Avidity Biosciences Inc. announced a global licensing and research collaboration focused on the discovery, development, and commercialization of potential new medicines in immunology and other select indications. The companies will utilize Avidity’s technology platform to progress new therapeutic approaches toward clinical development and commercialization. Avidity’s platform seeks to combine the tissue selectivity of monoclonal antibodies and the precision of oligonucleotide-based therapeutics to potentially overcome barriers to the delivery of oligonucleotides and target genetic drivers of disease. Under the terms of the agreement, Avidity received a payment of $20 million, as well as an investment of $15 million. Avidity is also eligible to receive up to about $405 million per target for development, regulatory and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales.

In May, Lilly announced a license agreement to acquire the exclusive worldwide rights for CNTX-0290 from Centrexion Therapeutics Corp., a company focused on developing non-opioid, non-addictive therapeutics for the treatment of chronic pain. CNTX-0290 is a novel, small molecule somatostatin receptor type 4 agonist that is currently being studied in Phase I clinical testing as a potential non-opioid treatment for chronic pain conditions.

Under the terms of the agreement, Centrexion received an upfront payment of $47.5 million and may be eligible for up to $575 million in potential development and regulatory milestones. If CNTX-0290 is successfully commercialized, Centrexion would be eligible for up to $375 million in potential sales milestones and tiered royalties ranging from the high-single to low-double digits. Lilly and Centrexion may also elect at a later date to co-promote CNTX-0290 in the United States.

Product performance

The diabetes product Trulicity leaped to the top of Lilly’s portfolio for the first time in 2018, with sales rising an impressive 57.6 percent to $3.2 billion. According to company executives, this was due to higher demand in the United States and increased volume internationally. In the first half of 2019, Trulicity sales were up another 30.9 percent to $1.91 billion.

In June, Lilly announced that a trial studying higher doses of Trulicity met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes, compared to once-weekly Trulicity 1.5 milligrams after 36 weeks. The trial also met the secondary efficacy endpoint for superiority on weight reduction. AWARD-11 – a Phase III randomized, double-blind, parallel arm study – evaluated the safety and efficacy of dulaglutide 3.0 milligrams and 4.5 milligrams doses in 1,842 participants with type 2 diabetes. The AWARD-11 trial will continue through 52 weeks to evaluate longer-term safety data and is expected to complete in late 2019.

Also in June, Lilly announced that detailed results from REWIND, the Trulicity cardiovascular outcome trial, showed a significant 12 percent reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), non-fatal stroke or CV death. REWIND data showed a consistent MACE 3 effect in people with and without established CV disease. The CV risk reduction was sustained throughout the trial’s duration.

Sales of Humalog rose again in 2018, by 4.6 percent to $3 billion, due to increased demand in the United States and increased volume internationally. In May 2019, though, Lilly announced that Insulin Lispro Injection was available for order in pharmacies for people who use Lilly’s rapid-acting insulin and need a lower-cost option. Lilly’s Insulin Lispro Injection has a 50 percent lower list price than its identical medicine, Humalog U-100 and is available in both a vial and KwikPen. Because they are the same insulin, pharmacists will be able to substitute Insulin Lispro Injection for Humalog. A competitor also launched a similar version of insulin lispro in the United States in the second quarter of 2018. Not surprisingly, Humalog sales in the first half of 2019 declined by 9.9 percent to $1.41 billion, with that figure including Insulin Lispro sales.

The oncology drug Alimta generated $2.13 billion in sales for Lilly in 2018, an improvement of 3.4 percent. According to company leaders, this was due to increased demand and higher realized prices in the United States, offset by lower volume due to competitive pressure internationally and the loss of exclusivity in certain European markets, including Germany. In the first half of 2019, Alimta sales edged up another 2 percent to $1.08 billion.

In January, FDA granted approval for a new indication for Alimta in combination with Merck’s Keytruda, and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations. This indication was approved based on data from Merck’s Phase III KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival and progression-free survival.

The autoimmune product Taltz closed in on blockbuster status in 2018, with sales up 67.8 percent to $938 million, helped along by $126 million in new international revenue from recent launches. In the first half of 2019 Taltz sales rose another 65.1 percent to $606 million, once again driven by recent international launches.

In April, Lilly announced that Taltz met the primary and all major secondary endpoints in COAST-X, a Phase III study evaluating the safety and efficacy of the compound for the treatment of non-radiographic axial spondyloarthritis in patients who are biologic disease-modifying anti-rheumatic drug-naïve. Taltz met the primary endpoint at both week 16 and week 52, demonstrating a statistically significant improvement in the signs and symptoms of nr-axSpA, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 response compared to placebo. Taltz also met the major secondary endpoints at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score, significant improvement in Bath Ankylosing Spondylitis Disease Activity, proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey Physical Component Summary Score.

In June, Lilly announced positive findings from the Phase IIIb/IV SPIRIT-Head-to-Head study in patients with active psoriatic arthritis. The assessor-blinded, randomized, controlled trial is the first H2H study that utilizes on-label dosing for both Taltz and AbbVie’s Humira and allows inclusion of concomitant conventional DMARDs. Topline results from the study, which demonstrated Taltz met the primary and all major secondary endpoints, were announced in December 2018.

In August, FDA approved Taltz injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis. This was the third indication for Taltz, which was first approved by FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by FDA in December 2017 for the treatment of adults with active psoriatic arthritis.

The efficacy and safety of Taltz in AS was demonstrated in two randomized, double-blind, placebo-controlled Phase III studies that included 657 adult patients with active AS: COAST-V in patients who are biologic disease-modifying antirheumatic drug-naïve and COAST-W in patients who previously had an inadequate response or were intolerant to tumor necrosis factor inhibitors. In both studies, the primary efficacy endpoint was the proportion of patients at 16 weeks achieving Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo. The COAST clinical trial program includes the first and only registration trials in AS to achieve ASAS40 response at 16 weeks as a primary endpoint. Results from both studies demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by ASAS40 response, compared to placebo.

Also in August, Lilly announced that Taltz met the primary and all major secondary endpoints up to week 12 in the Phase IV IXORA-R study, which evaluated the efficacy and safety of Taltz versus Tremfya in people living with moderate to severe plaque psoriasis. The IXORA-R trial is the first completed head-to-head trial between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index 100 score as the primary endpoint.

At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to Janssen’s Tremfya as measured by PASI 100. In addition, Taltz met all major secondary endpoints up to week 12, which include superiority over Tremfya in the proportion of patients achieving PASI 75 at Week 2, PASI 90 at Weeks 4 and 8, PASI 100 at Weeks 4 and 8, static Physician’s Global Assessment 0 at Week 12, and PASI 50 at Week 1.

The oncologic Cyramza earned $821 million in sales for Lilly in 2018, an improvement of 8.3 percent over the previous year. In the first half of 2019. Cyramza sales were up another 9.5 percent to $440 million.

In March, Lilly announced that the Phase III RELAY study of Cyramza met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment. The Phase III global, randomized, double-blind trial is evaluating Cyramza in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations.

During May, FDA approved Cyramza, as a single agent, for the treatment of patients with hepatocellular carcinoma who have an alpha-fetoprotein of ≥400 ng/mL and have been treated with sorafenib. Concurrent with this FDA approval – the fifth for Cyramza – FDA also removed the boxed warning from the Cyramza labeling.

The approval was based on the results from the REACH-2 study, the first positive Phase III HCC trial in a biomarker-selected patient population. REACH-2 is a global, randomized, double-blind, placebo-controlled Phase III study of Cyramza compared to placebo in patients with HCC who have been treated with sorafenib and are AFP-High (AFP ≥400 ng/mL).

Sales of Basaglar, a long-acting human insulin analog for the treatment of diabetes, nearly doubled in 2018, from $432 million to $801 million. According to company leaders, this was due to increased demand in the United States and increased volume internationally. Basaglar sales in the first half of 2019 totaled $542 million, an improvement of 47.3 percent over the first half of 2018.

The type 2 diabetes products Jardiance, Glyxambi and Synjardy generated $658 million in combined sales in 2018, up 46.9 percent compared with the previous year. In the first half of 2019, the products accounted for sales growth of 46.3 percent to nearly $436 million.

In June, FDA granted Fast Track designation to Lilly and Boehringer Ingelheim’s Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure. This designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of Jardiance on cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively. The two EMPEROR phase III studies include more than 8,500 people with chronic heart failure and are designed to assess the effect of treatment with Jardiance on cardiovascular death and hospitalization for chronic heart failure as primary endpoints. The EMPEROR studies are part of the Jardiance chronic heart failure program.

Also in June, a new post-hoc analysis of data from the EMPA-REG OUTCOME trial indicated a consistent effect of Jardiance on reducing cardiovascular and renal risk in adults with type 2 diabetes and known cardiovascular disease, who also have a form of chronic kidney disease without overt proteinuria, as well as others in the trial. In this new post-hoc analysis, the effect of Jardiance on reducing risk for cardiovascular and kidney outcomes was consistent between people in the trial who had chronic kidney disease without overt proteinuria and all others in the trial.

Tradjenta and Jentadueto, also for type 2 diabetes, generated $575 million in sales for Lilly in 2018, an improvement of 6.9 percent. In the first half of 2019, the products’ sales were $286 million, 1.1 percent better than the first half of 2018.
In February, Lilly and Boehringer Ingelheim announced that CAROLINA met its primary endpoint, defined as non-inferiority for Tradjenta versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).

CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 inhibitor. The clinical trial evaluated the cardiovascular safety of Tradjenta (5 milligrams once daily) compared with the sulfonylurea glimepiride, on top of standard of care, in 6,033 adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease. The clinical trial also assessed Tradjenta safety over the longest period ever studied in a DPP-4 inhibitor cardiovascular outcome trial, with a median follow-up of more than six years.

In June, Lilly and Boehringer Ingelheim announced detailed findings from the CAROLINA trial demonstrating that Tradjenta did not increase cardiovascular risk compared with glimepiride in adults with type 2 diabetes and cardiovascular risk. The trial met its primary endpoint, defined as non-inferiority for Tradjenta versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, which occurred in 11.8 percent of the Tradjenta group compared with 12.0 percent of the glimepiride group.

In the pipeline

In January, partner developers Lilly and Pfizer Inc. announced positive top-line results from a Phase III study evaluating tanezumab 2.5 milligrams or 5 milligrams in patients with moderate-to-severe osteoarthritis pain. The tanezumab 5 milligrams treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients’ overall assessment of their osteoarthritis compared to those receiving placebo.

The tanezumab 2.5 milligrams treatment arm met two of the three protocol-defined co-primary efficacy endpoints compared to placebo, demonstrating a statistically significant improvement in pain and physical function, while patients’ overall assessment of their osteoarthritis was not statistically different than placebo.

In February, Lilly and partner developer Incyte Corp. announced that Olumiant met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase III studies evaluating the efficacy and safety of the compound as monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis.

In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with Olumiant achieved the primary endpoint at Week 16 defined by the Investigator’s Global Assessment for AD score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.

Also in February, Lilly and Pfizer announced positive top-line results from a Phase III study evaluating tanezumab in patients with moderate-to-severe chronic low back pain. In the study, treatment with tanezumab 10 milligrams met the primary endpoint, a statistically significant improvement in pain at 16 weeks compared to placebo. The tanezumab 5 milligrams arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis.

In April, Lilly and Pfizer announced top-line results from a Phase III study evaluating tanezumab 2.5 milligrams and 5 milligrams. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs in patients with moderate-to-severe osteoarthritis of the hip or knee.
The tanezumab 5 milligrams treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs.

Patients who received tanezumab 2.5 milligrams did not experience a statistically significant improvement in pain, physical function, or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs.

Also in April, Lilly announced that the company was working to facilitate the withdrawal of Lartruvo from the market for the treatment of advanced soft tissue sarcoma. Lilly’s actions to withdraw Lartruvo from the market followed the failure of the Phase III ANNOUNCE clinical trial, in which Lartruvo did not improve survival for patients. Lilly is establishing a program to ensure current patients will have access to Lartruvo with limited interruption after the drug’s market withdrawal.

In May, Lilly announced new data and post-hoc analyses for lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine. The presentations include pooled analyses from the Phase III SAMURAI and SPARTAN studies, as well as interim results from the Phase III, one-year, open-label extension study of lasmiditan (GLADIATOR). Rates of pain relief, and freedom from most bothersome symptom (selected from nausea, photophobia which is sensitivity to light, or phonophobia, which is sensitivity to sound) were both higher and statistically significant starting as early as 30 minutes post-dose in the lasmiditan 100 milligrams and 200 milligrams treated groups when compared with placebo. The 200 milligrams lasmiditan treated group also achieved higher and statistically significant rates of freedom from photophobia and phonophobia than placebo starting as early as 30 minutes post-dose. The primary endpoint of freedom from pain was statistically significant for both the 100 milligrams and 200 milligrams doses starting at 60 minutes.

In June, FDA approved Emgality injection (300 milligrams) for the treatment of episodic cluster headache in adults. Emgality is the first calcitonin gene-related peptide antibody approved by FDA for two distinct headache disorders. Emgality was first approved by FDA in September 2018 for the preventive treatment of migraine in adults.

The efficacy of Emgality was evaluated for the treatment of episodic cluster headache in a randomized, 8-week, double-blind, placebo-controlled study. In the study, 106 patients were randomized 1:1 to receive once-monthly injections of Emgality 300 milligrams or placebo, with a baseline number of weekly cluster headache attacks of 17.8 for Emgality and 17.3 for placebo. Patients on Emgality experienced an average of 8.7 fewer weekly cluster headache attacks over Weeks 1 to 3 versus 5.2 fewer weekly attacks for patients on placebo. With Emgality, 71.4 percent of patients had their weekly cluster headache attacks cut in half or more from baseline at Week 3 versus 52.6 percent of patients with placebo.

Also in June, FDA accepted a New Drug Application for the fixed-dose combination tablet of empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin extended release for the treatment of adults with type 2 diabetes. The NDA was based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and metformin XR fixed-dose combination tablets and their individual components in healthy adults.

Also in June, Lilly announced results from two Phase III studies showing that the company’s ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.

Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day. URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. Lilly has submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later by year-end 2019.

In July, FDA approved Baqsimi nasal powder 3 milligrams for the treatment of severe hypoglycemia in people with diabetes ages 4 years and older. Baqsimi is the first nasally administered glucagon, designed with severe hypoglycemia rescue in mind. The drug is compact, portable, and ready to use (no reconstitution required) in a single, fixed, 3 milligram dose.

Also during July, Verzenio demonstrated a statistically significant improvement in overall survival in the Phase III MONARCH 2 clinical trial. These results were from a pre-planned interim analysis and are definitive. MONARCH 2 evaluated Verzenio in combination with fulvestrant for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer previously treated with endocrine therapy. The study included both pre/peri- and postmenopausal women.

The analysis showed that treatment with Verzenio in combination with fulvestrant met its secondary endpoint of overall survival. The MONARCH 2 study previously demonstrated a statistically significant improvement in progression-free survival, the trial’s primary endpoint which served as the basis for its approval of this regimen in more than 50 countries around the world.

Also in July, Lilly announced the presentation of post-hoc analyses showing improvements in daily functioning and reductions in disability in patients with chronic and episodic migraine treated with Emgality compared to placebo. The analyses are based on data from three double-blind, placebo-controlled, Phase III pivotal studies of Emgality in chronic (REGAIN) and episodic migraine (EVOLVE-1 and EVOLVE-2).

According to the post-hoc analyses, greater and statistically significant proportions of patients treated with Emgality showed reductions in disability due to migraine, as measured by the Migraine Disability Assessment, when compared to placebo. The MIDAS questionnaire measures headache-related disability as lost time due to headache from paid work or school, household work and nonwork activities. The MIDAS disability categories correspond to different levels of limitation and medical need. Also, among patients in the chronic migraine pivotal study, a statistically significant increase of 46.2 percent was seen in the proportion of patients with “little/no disability” after three months of treatment with Emgality compared to placebo (20.3 percent for Emgality versus 13.9 percent for placebo), regardless of baseline disability.

In August, Lilly and Incyte announced that Olumiant met the primary endpoint in BREEZE-AD7, the third pivotal Phase III trial in the BREEZE-AD program to be completed in 2019. BREEZE-AD7, an investigational study evaluating the efficacy and safety of Olumiant to treat moderate-to-severe atopic dermatitis in adults, met its primary endpoint. Adding Olumiant to standard-of-care topical corticosteroids significantly improved disease severity, measured by the Investigator’s Global Assessment score of “clear or almost clear” skin, the primary endpoint of the study at 16 weeks.

Also in August, Lilly announced that Emgality met the primary and all key secondary outcomes in CONQUER, a Phase III study evaluating the compound’s efficacy and safety in the preventive treatment of chronic and episodic migraine in patients with documented previous failures on two to four different standard-of-care migraine preventive medication categories, due to inadequate efficacy or for safety/tolerability reasons. The study met its primary objective of demonstrating superiority of Emgality versus placebo in the overall mean change from baseline in the number of monthly migraine headache days across months one through three. In the study, Emgality treatment reduced monthly migraine headache days by 4.1 days compared with 1 day with placebo. medadnews