AbbVie 2019: After Humira

 

The world’s leading prescription drug will still bring in plenty of revenue over the next few years, but AbbVie has already begun moving on to what’s next.

 

 

 

 

AbbVie Inc.
1 North Waukegan Road
North Chicago, IL 60064
Telephone: 847-932-7900
Website: abbvie.com

 

Best-Selling Rx Products

Product	2018 Sales	2017 Sales
Humira	$19,936	$18,427
Imbruvica	$3,590	$2,573
Mavyret	$3,438	$490
Creon	$928	$831
Lupron	$892	$829
Synthroid	$776	$781
Synagis	$726	$738

All sales are in millions of dollars.

 

Financial Performance

	2018	2017
Revenue	$32,753	$28,216
Net income	$5,687	$5,309
Diluted EPS	$3.66	$3.30
R&D expense	$10,329	$5,077

All figures are in millions of dollars, except EPS.

	1H 2019	1H 2018
Revenue	$16,083	$16,212
Net income	$3,197	$4,766
Diluted EPS	$2.14	$2.99
R&D expense	$2,580	$2,566

All figures are in millions of dollars, except EPS.

 

Outcomes Creativity Index Score: 7
Manny Awards – 4
Cannes Lions – 3
LIA: Health & Wellness – N/A
Clio Health – N/A
One Show: HW&P – N/A
MM&M Awards – 1
Global Awards – 2
Creative Floor Awards – N/A

 

2018 was the year of peak Humira for AbbVie. The world’s first fully human anti-TNF-α monoclonal antibody placed No. 1 in sales for all pharmaceutical products worldwide for the seventh consecutive year while bringing an impressive $19.94 billion in revenue to the company; including sales reported by partner marketer Eisai, Humira became the first drug ever to pass the $20 billion sales mark in a single year.

But after more than 16 years on the market, the Humira ride is coming to an end. Slowly, of course; while biosimilars have been available in some international markets since October 2018, AbbVie is protected from such competition in the United States until 2023. And published reports suggest that Humira should retain its title as top pharma brand by sales worldwide for at least a few more years; after all, the drug’s sales were more than double those of the second best-selling prescription product, Revlimid, last year. But still, sales of Humira in the first half of 2019 actually declined, an experience that company leaders have never faced before. So AbbVie will have to move on to what is next. And what is next? Imbruvica, Mavyret/Maviret, and a very big acquisition.

“We delivered exceptional performance in 2018, including operational revenue growth of more than 15 percent and EPS growth above 40 percent,” stated AbbVie Chairman and CEO Richard A. Gonzalez at the end of 2018. “We’re entering an important new phase for AbbVie. The continued momentum of our business, combined with the launch and ramp of several new products, will allow us to drive strong earnings growth once again in 2019 and position us for growth over the longer term.”

AbbVie’s top line amounted to $32.75 billion in 2018, an improvement of 16.1 percent over the previous year. Net income was up 7.1 percent to $5.69 billion, and earnings per share rose 36 cents to $3.66. In first-half 2019 the slow decline of Humira began to tell, with total company top-line revenue down by 0.8 percent to $16.08 billion, net income falling nearly a third to about $3.2 billion, and EPS declining 85 cents to $2.14. Both bottom line numbers, though, were impacted by contingent considerations related to the pending Allergan transaction; without all that, operating earnings for first-half 2019 actually rose 13.2 percent. Company leaders are projecting full-year 2019 EPS between $5.69-$5.79.

Allergan acquisition

In June, AbbVie announced that the company would acquire Allergan in a cash and stock deal for a transaction equity value of about $63 billion, based on the closing price of Abb­Vie’s common stock of $78.45 on June 24, 2019. Company leadership expects the transaction to close in early 2020, subject to regulatory and Allergan shareholder approvals.

According to the leadership team, the newly combined company will consist of several attractive franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise and international infrastructure. AbbVie’s enhanced growth platform, comprising growing and durable franchises across highly attractive therapeutic areas, is expected to grow at a high-single digit annual growth rate well into the next decade, from more than $30 billion in 2020. Executives project that the transaction will be 10 percent accretive to adjusted earnings per share over the first full year, with peak accretion of more than 20 percent. ROIC is expected to exceed AbbVie’s cost of capital within the first full year.

Under the terms of the agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share that they hold, for a total consideration of $188.24 per Allergan share. The transaction represents a 45 percent premium to the closing price of Allergan’s shares on June 24, 2019.

AbbVie leaders anticipate that the acquisition will provide annual pre-tax synergies and other cost reductions of at least $2 billion in year three while leaving investments in key growth franchises untouched. The synergies and other cost reductions will be a result of optimizing the research and early stage portfolio, and reducing overlapping R&D resources (about 50 percent), driving efficiencies in SG&A, including sales and marketing and central support function costs (about 40 percent), and eliminating redundancies in manufacturing and supply chain, and leveraging procurement spend (about 10 percent). The synergies estimate excludes any potential revenue synergies.

AbbVie is expected to generate significant annual operating cash flow, which will support a debt reduction target of $15 to $18 billion before the end of 2021, while also enabling a continued commitment to Baa2/BBB or better credit rating and continued dividend growth.

In the announcement of the deal, AbbVie leaders offered an explanation of why they chose to pursue a transaction of such scale. “This transaction is designed to meet a different strategic imperative than smaller bolt-on acquisitions,” they wrote. “Its ability to deliver immediate scale to the AbbVie growth platform with Allergan’s on-market diversified product portfolio meets our strategic goal to reduce reliance on Humira and allows us to continue expanding our focus on high-innovation science throughout the next decade. Smaller bolt-on acquisitions provide opportunities for future growth, but also require significant R&D investment amid scientific and clinical uncertainty. This transaction offers immediate compelling financial and strategic value to our shareholders with a much lower risk profile.”

Other acquisitions and partnerships

In January, AbbVie and privately held immunotherapy company Tizona Therapeutics Inc. entered into a global strategic collaboration to develop and commercialize CD39-targeted therapeutics, including the first-in-class antibody TTX-030 for treating cancer. The ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway. An investigational new drug application for TTX-030 has been accepted by FDA.

Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona is leading clinical development through completion of Phase Ib studies, after which AbbVie has an exclusive option to lead global development and commercial activities. Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

“Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment,” says Mo Trikha, Ph.D., VP, head of Oncology Early Development, AbbVie. “Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody.”

AbbVie entered into a global strategic transaction during February with Teneobio Inc. and affiliate TeneoOne Inc. to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. According to AbbVie leaders, B-cell maturation antigen (BCMA) has emerged as an attractive target for multiple myeloma therapeutics. TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3, utilizing Teneobio’s unique anti-CD3 platform. Through this dual targeting mechanism, TNB-383B is designed to direct the body’s own immune system to target and kill BCMA expressing tumor cells. Teneobio was expected to begin the clinical program for TNB-383B in the first half of 2019.

Under the terms of the agreement, TeneoOne received an upfront payment of $90 million and will continue developing TNB-383B through Phase I. AbbVie will hold the exclusive right to acquire TeneoOne and lead subsequent global development and commercialization of TNB-383B. If AbbVie exercises its right to acquire TeneoOne, the former stockholders of TeneoOne will also be eligible for regulatory and commercial sales milestones.

“Developing novel targeted treatments for patients with cancer continues to be our key priority,” Dr. Trikha says. “Multiple myeloma is one of the most common hematological cancers and an area of significant medical need. Teneobio’s novel approach to T-cell redirection with TNB-383B has the potential to be a treatment option that may offer new hope for myeloma patients.”

Also in February, AbbVie entered into a collaboration with Voyager Therapeutics Inc., a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. The exclusive, global strategic collaboration and option agreement is intended to develop and commercialize vectorized antibodies directed at pathological species of alpha-synuclein for the potential treatment of Parkinson’s disease and other diseases (synucleinopathies) characterized by the abnormal accumulation of misfolded alpha-synuclein protein.

The delivery of sufficient quantities of antibodies across the blood-brain barrier is one of the major limitations of current biologic therapies for neurodegenerative diseases that require frequent systemic injections with large amounts of antibodies. Voyager’s vectorized antibody platform and approach aims to circumvent this limitation by delivering – with a potential, one-time intravenous administration – the genes that encode for the production of therapeutic antibodies utilizing Voyager’s blood-brain barrier penetrant adeno-associated virus capsids. This approach could result in the potential for higher levels of therapeutic antibodies in the brain compared with current systemic administration of antibodies.

Under the terms of the collaboration and option deal, Voyager is performing research and preclinical development work to vectorize antibodies directed against alpha-synuclein that are designated by AbbVie, after which AbbVie may select one or more vectorized antibodies to advance into IND-enabling studies and clinical development. Voyager is responsible for the research, IND-enabling and Phase I activities and costs. Following completion of Phase I development, AbbVie has an option to license the vectorized alpha-synuclein antibody program for further clinical development and global commercialization for indications including Parkinson’s disease and other synucleinopathies.

Voyager received an upfront cash payment of $65 million and has the potential to earn up to $245 million in preclinical and Phase I option payments. Voyager is also eligible to receive up to an additional $728 million in potential development and regulatory milestone payments for each alpha-synuclein vectorized antibody compound. Voyager is eligible to receive tiered royalties on the global commercial net sales of each alphasynuclein vectorized antibody and may also earn up to a total of $500 million in commercial milestones.

In July, AbbVie announced the acquisition of Seattle-based Mavupharma, a privately held biopharma company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer. Financial terms of the transaction were not disclosed. STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients.

“AbbVie’s vision in oncology is to advance breakthrough areas of science leading to a strong pipeline of innovative cancer therapies,” says Steve Davidsen, Ph.D., VP of oncology discovery, AbbVie. “Mavupharma’s platform has the potential to further our immuno-oncology portfolio and assist in the development of transformative medicines for patients.”

Mavupharma’s lead clinical candidate is MAVU-104, a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 activity with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections.

Product performance

Humira continued to be the world’s best-selling prescription product during 2018 with total sales for AbbVie of $19.94 billion, an improvement of 8.2 percent compared with 2017. The autoimmune drug actually represented a little less of AbbVie’s revenue pie than the medicine had in the previous year – 60.9 percent versus 65.3 percent. According to company leaders, Humira sales increases in 2018 and 2017 were driven primarily by market growth across therapeutic categories and geographies as well as favorable pricing in certain geographies. In the United States, Humira sales increased by 11 percent in 2018 and 18 percent during 2017. The sales increases in 2018 and 2017 were driven by market growth across all indications and favorable pricing. Internationally, Humira revenue increased 1 percent in 2018 and 7 percent in 2017. The sales increase in 2018 was driven primarily by market growth across indications partially offset by direct biosimilar competition in Europe following the expiration of the European Union composition of matter patent for adalimumab – which is the active ingredient in Humira – in October 2018. Due to the entry of biosimilar competition, AbbVie leaders expect international Humira sales to decline in 2019. Biosimilar competition for Humira is not expected in the United States until 2023. In the first half of 2019, AbbVie’s Humira sales totaled $9.32 billion, a decline of 5.2 percent compared with the first half of 2018, with international sales declining by 31.3 percent.

Sales of the oncologic Imbruvica rose by more than a billion dollars in 2018, increasing by 39.5 percent to $3.59 billion following 40 percent growth the previous year. According to AbbVie executives, Imbruvica’s impressive performance has come as a result of continued penetration of the product as a first-line treatment for patients with CLL as well as favorable pricing. In January 2019, FDA approved the use of Imbruvica in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. This FDA approval expands the use of Imbruvica, which can already be administered as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients. In the first half of 2019, Imbruvica sales rose another 31.6 percent to $2.12 billion.

Not all of the Imbruvica news has been positive, though. In January AbbVie announced an update on the Phase III RESOLVE trial (PCYC-1137) of Imbruvica plus the chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma. PCYC-1137 evaluated the efficacy of Imbruvica in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer. Patients were randomized 1:1 to receive Imbruvica and nab-paclitaxel and gemcitabine combination treatment arm versus the placebo and nab-paclitaxel and gemcitabine combo treatment arm. At conclusion, the study did not meet the primary endpoint of improving progression-free survival or overall survival benefit among the study population.

The most impressive spike in growth for any product in Abb­Vie’s portfolio in 2018 came from Mavyret. Sales of the company’s hepatitis C drug grew by more than seven times, jumping from $490 million to $3.44 billion. Mavyret was initially approved by the European Commission in July 2017 and by FDA during the following month; according to AbbVie executives, the drug’s spectacular growth was the result of market share gains after these approvals as well as further geographic expansion in 2018. But as is common with hep C drugs after their first year on the market, Mavyret’s growth has recently reversed itself, with sales for the first half of 2019 declining 11.8 percent to $1.57 billion.

During September, Mavyret won FDA marketing clearance as the only 8-week pan-genotypic (GT1-6) treatment option for treatment-naïve chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis. The U.S. marketing approval is supported by an overall 98 percent cure rate across this patient population. The label expansion was based on data from the Phase 3b EXPEDITION-8 trial, a single-arm, open-label study assessing the safety and efficacy of Mavyret in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the clinical trial, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatment (SVR12).

The European Commission granted marketing authorization in August for Maviret to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C patients with genotype 1, 2, 4, 5, and 6 infection. An analysis from the same clinical trial evaluating Maviret as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is under way. Maviret is also approved in the EU as an eight-week, pan-genotypic treatment for treatment-naïve patients without cirrhosis. The marketing authorization was supported by data from the EXPEDITION-8 study.

The exocrine pancreatic insufficiency compound Creon enjoyed a solid year of growth in 2018, with sales rising 11.7 percent to $928 million. According to AbbVie executives, this was due primarily to continued market growth, higher market share and favorable pricing. Creon has maintained market leadership in the pancreatic enzyme market. In first-half 2019, sales of Creon rose another 13.1 percent to $484 million.

In the pipeline

FDA approved during August AbbVie’s Rinvoq (upadacitinib), a 15 milligram, once-daily oral Janus kinase inhibitor for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. FDA approval of Rinvoq was supported by data from the SELECT program, one of the largest registrational Phase III programs in RA with about 4,400 patients evaluated across all treatment arms in five studies. The studies included assessments of efficacy, safety, and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate.

Across the SELECT Phase III studies, Rinvoq met all primary and ranked secondary endpoints. In SELECT-EARLY, 52 percent of MTX-naïve patients treated with Rinvoq 15 milligrams achieved ACR50 versus 28 percent treated with MTX at week 12. In SELECT-MONOTHERAPY, 68 percent of MTX-IR patients treated with Rinvoq 15 milligrams achieved ACR20 versus 41 percent treated with continued MTX at week 14. In SELECT-COMPARE, 71 percent of MTX-IR patients treated with Rinvoq 15 milligrams plus MTX achieved ACR20 versus 36 percent treated with placebo plus MTX at week 12. In SELECT-NEXT, 64 percent of csDMARD-IR patients treated with Rinvoq 15 milligrams plus csDMARDs achieved ACR20 versus 36 percent treated with placebo plus csDMARDs at week 12. And in SELECT-BEYOND, 65 percent of biologic-IR patients treated with Rinvoq 15 milligrams plus csDMARDs achieved ACR20 vs 28 percent treated with placebo plus csDMARDs at week 12.

FDA accepted for priority review AbbVie’s new drug application for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis during February. Upadacitinib is under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is being studied for multiple immune-mediated diseases.

In April, FDA approved the interleukin-23 inhibitor Skyrizi for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In clinical trials, Skyrizi produced high rates of durable skin clearance – most people (82 and 81 percent) treated with Skyrizi achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100). The European Commission also approved Skyrizi in April, after the product was approved in Japan in March.

The approval of Skyrizi was supported by results from Abb­Vie’s global Phase III psoriasis program, which assessed the safety and efficacy of Skyrizi in adults with moderate to severe plaque psoriasis across four randomized, placebo, and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at 16 weeks versus placebo.

In ultIMMa-1 and ultIMMa-2 at 16 weeks, PASI 90 was achieved in 75 percent of people treated with Skyrizi, compared to 5 and 2 percent receiving placebo, respectively. PASI 100 was achieved in 36 and 51 percent of people treated with Skyrizi, compared to 0 and 2 percent receiving placebo, respectively. In ultIMMa-1 and ultIMMa-2 at one year, 82 and 81 percent of people treated with Skyrizi achieved PASI 90, and 56 and 60 percent achieved PASI 100, respectively. Also, an integrated analysis of ultIMMa-1 and ultIMMa-2 showed that most people treated with Skyrizi who achieved PASI 90 and PASI 100 at week 16 maintained this response at one year (88 and 80 percent, respectively).

In May, FDA approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. FDA granted Breakthrough Therapy designation for this combination therapy, and early submission of the data was provided under the Real-Time Oncology Review pilot program, which led to approval in just over two months, following submission of the complete application. Venclexta, an oral B-cell lymphoma-2 inhibitor, has been granted five Breakthrough Therapy designations from FDA; the compound is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States and by AbbVie outside of the United States.

The CLL14 trial demonstrated superior progression-free survival as assessed by an independent review committee (PFS; the time from initiation of treatment until disease progression or death) in patients treated with Venclexta plus obinutuzumab compared to patients who received chlorambucil plus obinutuzumab, a commonly used standard of care. With a median follow-up of 28 months (range: 0.1 to 36 months), Venclexta plus obinutuzumab reduced the risk of progression or death by 67 percent compared with chlorambucil plus obinutuzumab. Median PFS was not reached in either treatment arm. Minimal residual disease negativity (undetectable disease in the blood or bone marrow) was assessed as a secondary endpoint and occurs when less than one CLL cell per 10,000 leukocytes can be detected using sensitive analytical methods. Higher rates of MRD negativity were observed with Venclexta plus obinutuzumab compared to obinutuzumab plus chlorambucil in both bone marrow (57 percent versus 17 percent) and peripheral blood (76 percent versus 35 percent) three months after treatment completion.

Additionally in May, AbbVie announced that the Phase III INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma, whose tumors have EGFR (epidermal growth factor receptor) amplification, showed no survival benefit for patients receiving Depatux-M at an interim analysis. An Independent Data Monitoring Committee recommended the study be stopped due to lack of survival benefit for patients receiving Depatux-M versus placebo when added to the standard regimen of radiation and temozolomide. Enrollment in all Depatux-M studies was halted.

In June, FDA lifted the partial clinical hold placed on CANOVA (M13-494), a Phase III trial evaluating Venclexta for the investigational treatment of relapsed/refractory multiple myeloma. The CANOVA trial evaluates Venclexta in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma positive for the translocation (11;14) abnormality. The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with multiple myeloma.

FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines, and updated futility criteria. Enrollment in the CANOVA trial may resume as determined by each participant site based on the approved protocol. All other clinical trials evaluating Venclexta in patients with multiple myeloma remain on partial clinical hold while next steps continue to be evaluated with the regulatory agency. The partial clinical hold does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia or acute myeloid leukemia. The partial clinical hold, placed in March 2019, followed a review of data from the Phase III BELLINI trial of Venclexta with bortezomib and dexamethasone versus placebo in patients with relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the Venclexta arm compared to the control arm of the trial.

In August, AbbVie and co-developer Neurocrine Biosciences Inc. submitted a new drug application to FDA for the investigational, oral gonadotropin-releasing hormone antagonist elagolix for the management of heavy menstrual bleeding associated with uterine fibroids in women. Uterine fibroids are non-cancerous, hormonally responsive muscle tissue tumors of the uterus that can affect up to 70 percent of Caucasian women and up to 80 percent of African-American women by age 50. Fibroids can be asymptomatic but, in some women, fibroids can cause symptoms, such as heavy menstrual bleeding, vaginal bleeding at times other than menstruation, and anemia.

The NDA was supported by data from the elagolix Phase III uterine fibroid program, which evaluated nearly 800 premenopausal women with HMB associated with uterine fibroids in two pivotal studies (ELARIS UF-I and ELARIS UF-II) at about 100 sites in the U.S. and Canada. The replicate studies evaluated the safety, tolerability, and efficacy of elagolix alone (300 milligrams twice daily, or BID) and in combination with low-dose hormone (add-back) therapy (estradiol 1.0 milligrams/norethindrone acetate 0.5 milligrams) in women with uterine fibroids for six months. An extension study permitted women to be treated for an additional six months. The primary endpoint assessed the reduction in HMB versus placebo as measured by the alkaline hematin method, an objective measurement of total menstrual blood loss based on quantification of menstrual blood collected on sanitary products. In both studies, elagolix in combination with add-back therapy met the primary endpoint.

AbbVie announced in August that MERU, a Phase III trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer, showed no survival benefit at a preplanned interim analysis for patients receiving Rova-T versus placebo. The MERU trial was closed and the Rova-T R&D program was terminated.