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Myriad Genetics and Clovis Oncology Sign Agreement for Use of FDA-Approved BRACAnalysis CDx® Test to Identify Patients with Germline BRCA Mutations for Rubraca® (rucaparib) Treatment

On April 27, 2017 Myriad Genetics, Inc. (NASDAQ: MYGN) and Clovis Oncology, Inc. (NASDAQ:CLVS) reported a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis’ PARP inhibitor, Rubraca. Financial terms of the deal were not disclosed (Press release, Clovis Oncology, APR 27, 2017, View Source [SID1234518706]).

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Under the agreement, Myriad will submit a supplementary premarket approval (sPMA) application under its existing PMA for BRACAnalysis CDx to include Rubraca. The Myriad sPMA submission will fulfill a post-approval regulatory commitment by Clovis Oncology to the Food and Drug Administration (FDA) for Rubraca. In December 2016, Rubraca was approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation as identified by an FDA-approved companion diagnostic test. The companion diagnostic test approved with Rubraca does not discriminate between germline and somatic mutations. Knowledge of germline status is important to provide patients appropriate counseling.

"BRACAnalysis CDx is the only germline companion diagnostic test approved by the FDA to identify patients with BRCA1/2 mutations, and we are excited to support Clovis’ clinical development program and help identify patients who are most likely to benefit from rucaparib," said Mark C. Capone, president and CEO, Myriad Genetics. "This agreement further solidifies Myriad’s leadership role in developing best-in-class companion diagnostics for use with PARP inhibitors and supports our goal of being the worldwide leader in personalized medicine.""This partnership with Myriad Genetics not only enables us to fulfill our post-marketing commitment to the FDA, but will enhance the companion diagnostic information already available to physicians and patients, providing a robust toolkit for personalizing treatment of patients with BRCA1/2 mutations," said Patrick J. Mahaffy, president and CEO, Clovis Oncology.

About Rubraca (rucaparib)
Rubraca is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program based on objective response rate and duration of response, and is based on results from two multicenter, single-arm, open-label clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Please visit rubraca.com for more information.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. BRACAnalysis CDx was reviewed and approved by the FDA in December 2014 for use as a companion diagnostic to aid in identifying ovarian cancer patients eligible for treatment with AstraZeneca’s PARP inhibitor, olaparib. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

Agios and Aurigene Enter into Exclusive License Agreement for Novel Small Molecules for Cancer Metabolism Target

On April 27, 2017 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) and Aurigene Discovery Technologies Limited reported a global license agreement to research, develop and commercialize small molecule inhibitors of an undisclosed cancer metabolism target (Press release, Agios Pharmaceuticals, APR 27, 2017, View Source [SID1234518702]).

Under the terms of the agreement, Aurigene will provide Agios exclusive rights to its portfolio of novel small molecules for the undisclosed target. Financial terms of the agreement include a $3 million upfront payment and potential future milestone payments of up to $17 million per licensed product if certain development and regulatory milestones are achieved by Agios. Aurigene is also eligible to receive low single-digit royalties on product sales. Agios will conduct preclinical studies and, if successful, fund further global research and development, as well as regulatory and commercial activities.

Acceleron Provides Clinical Development Updates on Luspatercept Program

On April 27, 2017 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, reported updates on the luspatercept clinical programs under its collaboration with Celgene (Press release, Acceleron Pharma, APR 27, 2017, View Source [SID1234518699]). Luspatercept is an investigational compound being evaluated in two pivotal Phase 3 trials for the treatment of myelodysplastic syndromes (MDS) and beta-thalassemia.

"Our pivotal luspatercept studies continue to gain momentum as enrollment nears completion, and new clinical data support the drug’s expanded development in patient groups in need of more treatment options," commented Habib Dable, President and Chief Executive Officer of Acceleron. "We now look forward to reporting topline results from the MEDALIST and BELIEVE Phase 3 studies in mid-2018 as we work together with Celgene to evaluate the full clinical potential of luspatercept."

Updated Phase 3 Clinical Trials Enrollment Guidance

Acceleron and Celgene provided updated guidance on the anticipated completion of patient enrollment for the MEDALIST and BELIEVE Phase 3 studies of luspatercept in MDS and beta-thalassemia, respectively. Based on accelerating rates of patient recruitment, the companies expect to achieve full enrollment of both studies in the second quarter of 2017, versus previous guidance of the second half of 2017.

New Phase 3 Clinical Trial

Acceleron and Celgene also plan to initiate a third Phase 3 trial of luspatercept. The new Phase 3 trial, expected to be initiated in early 2018, will evaluate luspatercept treatment versus standard-of-care in the first-line treatment setting for MDS patients. Current first-line, standard-of-care treatment for lower-risk MDS patients includes erythropoiesis-stimulating agents (ESAs) and/or regular red blood cell transfusions. The ongoing MEDALIST Phase 3 trial is evaluating luspatercept in ESA-refractory or -ineligible MDS patients.

Luspatercept Data at the Upcoming MDS Symposium

Acceleron and Celgene plan to report updated Phase 2 data on luspatercept in first-line, lower-risk MDS patients in an oral presentation at the 14th International Symposium on MDS on Saturday, May 6, 2017, in Valencia, Spain.

About Luspatercept

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-beta) superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Acceleron and Celgene are enrolling Phase 3 clinical trials that are designed to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the "MEDALIST" study) and in patients with beta-thalassemia (the "BELIEVE" study). For more information, please visit www.clinicaltrials.gov.

Luspatercept is an investigational product that is not approved for use in any country.

Bristol-Myers Squibb Reports First Quarter Financial Results

On APRIL 27, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the first quarter of 2017, which were highlighted by strong sales for key products Opdivo and Eliquis , regulatory approval for Opdivo in advanced bladder cancer in the U.S., positive opinions from the Committee for Medicinal Products for Human Use (CHMP) for advanced bladder and head and neck cancers in Europe, and strategic transactions in oncology that further strengthened the company’s pipeline (Press release, Bristol-Myers Squibb, APR 27, 2017, View Source [SID1234518703]).

"During the first quarter we delivered strong sales and earnings growth, achieved important regulatory milestones for Opdivo in the U.S. and Europe and presented important new data across our Immuno-Oncology and fibrosis portfolios," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "Building on this strong start to the year, we will continue to drive commercial performance in the short-term while advancing important opportunities to broaden our approach in Immuno-Oncology and progressing our early specialty portfolio."

First Quarter
$ amounts in millions, except per share amounts
2017
2016
Change
Total Revenues $4,929 $4,391 12%
GAAP Diluted EPS 0.94 0.71 32%
Non-GAAP Diluted EPS 0.84 0.74 14%

FIRST QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted first quarter 2017 revenues of $4.9 billion, an increase of 12% compared to the same period a year ago. Revenues increased 13% when adjusted for foreign exchange impact.
U.S. revenues increased 8% to $2.7 billion in the quarter compared to the same period a year ago. International revenues increased 18%. When adjusted for foreign exchange impact, international revenues increased 20%.
Gross margin as a percentage of revenue decreased from 76.0% to 74.5% in the quarter primarily due to product mix.
Marketing, selling and administrative expenses increased 1% to $1.1 billion in the quarter.
Research and development expenses increased 13% to $1.3 billion in the quarter.
The effective tax rate was 21.9% in the quarter, compared to 27.1% in the first quarter last year.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.6 billion, or $0.94 per share, in the first quarter compared to net earnings of $1.2 billion, or $0.71 per share, for the same period in 2016. The results for the first quarter of 2017 included Bristol-Myers Squibb’s share of a patent-infringement litigation settlement related to Merck’s PD-1 antibody Keytruda that contributed $0.18 per share.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.4 billion, or $0.84 per share, in the first quarter, compared to $1.2 billion, or $0.74 per share, for the same period in 2016. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable securities were $8.8 billion, with a net cash position of $360 million, as of March 31, 2017.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

The increase in global revenues for the first quarter of 2017, compared to the first quarter of 2016, was driven by:

Product
Growth %

Opdivo 60%
Eliquis 50%
Yervoy
25%
Sprycel
14%
Orencia
13%

Opdivo

Regulatory

In April, the company announced the CHMP recommended the approval of Opdivo for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing chemotherapy. The CHMP recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
In April, the company announced the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application seeking to extend the use of Opdivo to patients with mismatch repair deficient or microsatellite instability high metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The FDA granted the application priority review and the FDA action date is August 2, 2017.
In April, the FDA approved an updated indication for Opdivo for the treatment of adult patients with Classical Hodgkin lymphoma that have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In March, the company announced the CHMP recommended the approval of Opdivo as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy. The CHMP recommendation will be reviewed by the EC.
In March, the company and its partner Ono Pharmaceutical Co. announced the approval of Opdivo as monotherapy for the treatment of recurrent or metastatic head and neck cancer in Japan.
In February, the company announced the FDA provided accelerated approval for Opdivo for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Clinical

In April, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the company announced new data and analysis from studies evaluating Opdivo and the Opdivo + Yervoy regimen:
First overall survival results from CheckMate -067, a Phase 3 trial of Opdivo and the Opdivo + Yervoy regimen versus Yervoy alone in patients with previously untreated advanced melanoma. More detail of the study results is included in the original press release (link).
The first report of five-year overall survival data from the Phase 1 dose-ranging study CA209-003 evaluating Opdivo in patients with previously treated advanced non-small cell lung cancer. More detail of the study results is included in the original press release (link).
In April, the company announced CheckMate -143, a randomized Phase 3 clinical trial evaluating the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme did not meet its primary endpoint of improved overall survival over bevacizumab monotherapy.
Sprycel

In February, the company announced the European Patent Office (EPO) upheld a decision finding European Patent No. 1169038 (the ‘038 patent), the Composition of Matter patent covering dasatinib, the active ingredient in Sprycel, to be invalid. The decision does not impact patents outside of the EU or other Sprycel-related patents. Additionally in February, the EPO Board of Appeal reversed and remanded an invalidity decision on European Patent No. 1610780 and its claim to the use of dasatinib to treat chronic myeloid leukemia (CML), which the EPO’s Opposition Division had revoked in October 2012. The company intends to take appropriate legal actions to protect Sprycel.
Eliquis

In March, at the American College of Cardiology’s (ACC) Annual Scientific Session, the company and its partner Pfizer Inc. announced findings from a real-world data analysis of the U.S. Medicare database comparing the risk of stroke or systemic embolism and rate of major bleeding among patients with non-valvular atrial fibrillation who were treated with direct oral anticoagulants Eliquis, dabigatran or rivaroxaban versus warfarin. More detail of the analysis is included in the original press release (link).
Fibrosis

In April, at EASL: The International Liver Congress, the company announced data from a Phase 2 study of BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH ) (F1-F3). The study achieved its primary endpoint of significant reduction in liver fat versus placebo, and also showed improvement in markers of liver injury and fibrosis.
FIRST QUARTER BUSINESS DEVELOPMENT UPDATE

In April, the company and Transgene announced a clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Opdivo + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.
In April, the company and Apexigen, Inc. announced a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Apexigen’s APX005M with Opdivo in patients with second-line metastatic NSCLC who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior Immuno-Oncology (I-O) therapy.
In April, the company and Nordic Bioscience announced a collaboration to develop biomarker technology to potentially aid in the diagnosis and monitoring of fibrotic diseases including NASH.
In April, the company announced it entered into two separate agreements to outlicense BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy, to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy, to Roche. The company will receive upfront payments of $300 million from Biogen and $170 million from Roche, along with potential milestone payments and royalties from each company.
In April, the company and Incyte Corporation announced an agreement to advance their clinical development program evaluating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Opdivo into Phase 3 registrational studies in first-line NSCLC across the spectrum of PD-L1 expression and first-line head and neck cancer. Additionally, the companies are expanding the ECHO-204 Phase 1/2 study, established under a collaboration between the companies in 2014, to include anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts.
In March, the company and Foundation Medicine announced a collaboration to leverage Foundation Medicine’s comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden and Microsatellite Instability in patients enrolled across clinical trials investigating Bristol-Myers Squibb’s cancer immunotherapies.
In March, the company, the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute (CRI) announced a multi-year collaboration agreement to coordinate and rapidly initiate clinical I-O studies across the Parker Institute and CRI networks.
In March, the company and CytomX Therapeutics, Inc. announced an expansion of their collaboration to discover novel therapies against multiple I-O targets using CytomX’s proprietary Probody Platform, expanding the number of targets from four to twelve.
In March, the company announced an equity investment and plans for a research collaboration with GRAIL Inc. that grants the company early access to GRAIL’s comprehensive clinical trial databases that may help improve understanding of tumor genomics. Additionally, Bristol-Myers Squibb will utilize GRAIL’s analytics tools to inform research, advance diagnostics and improve patient outcomes.
In February, the company and Exelixis, Inc. announced a clinical development collaboration to evaluate Cabometyx (cabozantinib), Exelixis’ small molecule inhibitor of receptor tyrosine kinases, with Opdivo, either alone or in combination with Yervoy. The agreement is expected to include a Phase 3 pivotal trial in first-line renal cell carcinoma, with additional trials planned in bladder cancer, hepatocellular carcinoma (HCC), and potentially other tumor types.
In February, the company announced an expansion of the five-year old International Immuno-Oncology Network (II-ON) with the addition of Columbia University Medical Center and Peter MacCallum Cancer Centre (Peter Mac). II-ON is a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance I-O science and translational medicine to improve patient outcomes.
SHARE REPURCHASE

In February, the company executed accelerated share repurchase (ASR) agreements to repurchase, in aggregate, $2 billion of the company’s common stock. The ASR was funded through a combination of debt and cash and is part of the company’s existing share repurchase authorization. Approximately 80 percent of the shares to be repurchased under the transaction were received by the company on February 28, 2017 and the company anticipates that all repurchases under the ASR will be completed by the end of the second quarter of 2017.

The decision reflects the company’s strong financial position and its balanced approach to capital allocation, including a commitment to its dividend and a disciplined approach to business development.

2017 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2017 GAAP EPS guidance range from $2.47- $2.67 to $2.72 – $2.87 and is increasing its non-GAAP EPS guidance range from $2.70 – $2.90 to $2.85 – $3.00. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2017 GAAP and non-GAAP line-item guidance assumptions are:

Worldwide revenues increasing in the mid-single digits.
Research and development expenses increasing in the high-teens digit range for GAAP and increasing in the low-double digits range for non-GAAP.
An effective tax rate of approximately 22% for GAAP with non-GAAP remaining at approximately 21%.
The financial guidance excludes the impact of any potential future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The non-GAAP guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling GAAP amounts to non-GAAP amounts, with non-GAAP reflecting specified items are provided in supplemental materials attached to this press release and available on the company’s website.

Keytruda is a trademark of Merck & Co., Inc.
Probody Platform is a trademark of CytomX Therapeutics, Inc.
Cabometyx is a trademark of Exelixis, Inc.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information, that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third party intellectual property rights, divestiture gains or losses, upfront payments from out licensed assets, pension charges, legal and other contractual settlements and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate", "estimates", "should", "expect", "guidance", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

AbbVie Reports First-Quarter 2017 Financial Results

On April 27, 2017 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2017 (Press release, AbbVie, APR 27, 2017, View Source [SID1234518701]).

"AbbVie delivered strong first quarter results, with double-digit EPS and operational revenue growth, exceeding our guidance for the quarter," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "As we look ahead to the remainder of the year we expect continued strong commercial execution and significant pipeline progress. This includes a dozen pivotal trial read-outs and several regulatory submissions and approvals, further supporting our ability to drive top-tier performance over the long term. 2017 is an important year for AbbVie and we are off to an excellent start."

First-Quarter Results

Worldwide GAAP net revenues were $6.538 billion in the first quarter, increasing 10.1 percent, excluding a 0.4 percent unfavorable impact from foreign exchange.
Global HUMIRA sales increased 15.1 percent on a reported basis, or 15.8 percent operationally, excluding a 0.7 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 22.8 percent in the quarter. Internationally, HUMIRA sales grew 4.6 percent, excluding a 1.7 percent unfavorable impact from foreign exchange.
First-quarter global IMBRUVICA net revenues were $551 million, with U.S. sales of $457 million and international profit sharing of $94 million for the quarter, reflecting growth of 44.7 percent.
On a GAAP basis, the gross margin ratio in the first quarter was 75.3 percent. The adjusted gross margin ratio was 79.9 percent.
On a GAAP basis, selling, general and administrative expense was 20.9 percent of net revenues. The adjusted SG&A expense was 20.7 percent of net revenues.
On a GAAP basis, research and development expense was 17.4 percent of net revenues. The adjusted R&D expense was 16.9 percent, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the first quarter was 37.0 percent. The adjusted operating margin was 42.3 percent.
On a GAAP basis, net interest expense was $247 million. On a GAAP basis, the tax rate in the quarter was 18.0 percent. The adjusted tax rate was 18.2 percent.
Diluted EPS in the first quarter was $1.06 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.28, up 11.3 percent.
Key Events from the First Quarter

AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application for IMBRUVICA in chronic graft-versus-host-disease (cGVHD), after failure of one or more lines of systemic therapy. cGVHD is a serious and debilitating complication of stem cell or bone marrow transplant. If approved, IMBRUVICA will be the first therapy specifically approved to treat this condition. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.
AbbVie announced that the U.S. FDA approved IMBRUVICA to treat patients with marginal zone lymphoma (MZL), an indolent form of non-Hodgkin’s lymphoma (NHL). There are currently no other approved treatments specifically indicated for patients with MZL. This approval marks the fifth unique type of blood cancer indication for IMBRUVICA.
AbbVie announced that its Phase 3 studies of veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, in patients with squamous non-small cell lung cancer (NSCLC) and triple-negative breast cancer did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel. Based on these Phase 3 data, AbbVie will not continue development in these indications. Studies of veliparib in non-squamous NSCLC, BRCA1/2 breast cancer and ovarian cancer are ongoing.
AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced detailed results from a Phase 2b clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo in women with uterine fibroids. The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo. Uninterrupted treatment with elagolix was associated with decreased symptom severity and improved quality of life. Phase 3 trials evaluating elagolix as a potential treatment for uterine fibroids are ongoing. Additionally, the Phase 3 program in endometreosis is nearing completion, with regulatory submission planned for later this year.
AbbVie announced that the U.S. FDA accepted its New Drug Application and granted priority review for its investigational, pan-genotypic, once-daily, ribavirin-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). Additionally, AbbVie announced that its marketing authorization application was validated and is under accelerated assessment by the European Medicines Agency (EMA), and that priority review was granted by the Japanese Ministry of Health, Labour and Welfare. The company anticipates commercialization of the next-generation combination in 2017.
AbbVie recently presented data on G/P from the Phase 3 EXPEDITION-1 study and the Phase 3 ENDURANCE-3 study at the International Liver Conference for the European Association for the Study of the Liver. The EXPEDITION-1 study results demonstrated that 99 percent of chronic HCV infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis achieved sustained virologic response at 12 weeks post-treatment (SVR12). The ENDURANCE-3 study results demonstrated that 95 percent of patients infected with genotype 3 chronic HCV, without cirrhosis and who are new to treatment, achieved SVR12 following 8 weeks of treatment. Together with previously reported data, these new study results reinforce G/P’s potential to provide a faster path to cure for the majority of patients living with HCV across all genotypes, as well as offer a potential cure to patients with specific treatment challenges.
AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the EMA granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV and minimal to moderate fibrosis. VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
AbbVie announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer’s disease and progressive supranuclear palsy (PSP). In recognition of the lack of treatment options available to patients with PSP, the U.S. FDA granted Fast Track Designation to ABBV-8E12. The FDA and EMA also granted Orphan Drug Designations to ABBV-8E12 for PSP.
Full-Year 2017 Outlook

AbbVie is confirming its GAAP diluted EPS guidance for the full-year 2017 of $4.55 to $4.65. AbbVie expects to deliver adjusted diluted EPS for the full-year 2017 of $5.44 to $5.54, representing growth of 13.9 percent at the mid-point. The company’s 2017 adjusted diluted EPS guidance excludes $0.89 per share of intangible asset amortization expense and other specified items.