Amgen 2021: Breakaway potential

To keep the company’s pipeline full of promising new treatments over the long term, Amgen continues to invest in building a set of differentiated early research capabilities.

By Andrew Humphreys • [email protected]

 

 

 

 

Amgen

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

Telephone: 805-447-1000

Website: amgen.com

 

OUTCOMES CREATIVITY INDEX SCORE: 13

Manny Awards — 2 

Cannes Lions — N/A

Clio Health — 4

Creative Floor Awards — N/A

MM+M Awards — 7 

One Show — N/A 

 

Financial Performance

(All figures are in millions of dollars, except EPS.)

2020  

Revenue $25,424  

Net income $7,264  

Diluted EPS $12.31  

R&D expense $4,207  

1H 2021 

Revenue $12,427  

Net income $2,110  

Diluted EPS $3.65  

R&D expense $2,049  

 

Best-Selling Products

(All sales are in millions of dollars.)

2020 

Enbrel $4,996  

Prolia $2,763  

Neulasta $2,293  

Otezla $2,195  

Xgeva $1,899  

Aranesp $1,568  

Kyprolis $1,065  

Repatha $887  

Nplate $850  

Vectibix $811  

Mvasi  $798  

Parsabiv $716  

Epogen $598  

Kanjinti $567  

1H 2021  

Enbrel $2,068  

Prolia $1,572  

Otezla $1,010  

Neulasta $968  

Xgeva $956  

Aranesp $722  

Mvasi $588  

Repatha $572  

Kyprolis $531  

Nplate $472  

Vectibix $430  

Kanjinti $317  

Epogen $255 

Evenity $238  

Blincyto $215  

Note: * Otezla was acquired from Bristol Myers Squibb during November 2019, post that company’s acquisition of Celgene.

 

 

Amgen is dedicated to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. According to the company, this approach begins by using tools such as advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

“A belief in the potential of biotechnology inspired Amgen’s founders to create our company more than 40 years ago,” states Robert A. Bradway, chairman and chief executive officer at Amgen. “We are even more convinced today about the potential for biotechnology to make a positive difference in the world than they were then.”

Bradway says by any measure, 2020 was a very successful year for Amgen, and the company’s ability to deliver in the most trying of circumstances gives management confidence for the future. “The pandemic has made it clear that the world needs more innovation, not less, and we at Amgen are determined to provide it.”

Amgen is contributing scientific and manufacturing expertise directly to the fight against COVID-19. “For example, our deCODE Genetics subsidiary has conducted extensive genetic research into how the coronavirus spreads and mutates, with its findings published in The New England Journal of Medicine. Our anti-inflammatory medicine Otezla is being studied as a potential therapy for COVID-19, and our company is collaborating with Eli Lilly and Company to manufacture an antibody that has received emergency use authorization from the U.S. Food and Administration (FDA) for treating patients with mild-to-moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization,” Bradway stated.

Acquisitions, Deals & Partnerships

Between March and July 2021, Amgen announced three company acquisitions. The intended acquisition of TeneoBio was reported in July 2021, with an expected close during second-half 2021. A privately held, clinical-stage biotechnology company, TeneoBio is developing a new class of biologics called Human Heavy-Chain Antibodies. Under the terms of the deal, Amgen will acquire all outstanding shares of TeneoBio at closing in exchange for a $900 million upfront cash payment, and future contingent milestone payments to TeneoBio equity holders potentially worth up to another $1.6 billion in cash.

The acquisition includes TeneoBio’s proprietary bispecific and multispecific antibody technologies, which will allow for significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a broad range of important diseases across Amgen’s core therapeutic areas. These platforms complement Amgen’s existing antibody capabilities with the addition of a heavy-chain only platform that enables a streamlined, sequence-based discovery approach for target binders, as well as TeneoBio’s novel T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s BiTE platform.

“The acquisition of TeneoBio will strengthen our ability to develop innovative medicines to treat patients with serious illnesses and to bring to market best-in-class products, particularly with respect to multispecific and bispecific medicines directed against targets in a wide range of diseases across our core therapeutic areas,” noted David M. Reese, M.D., executive vice president of Amgen’s R&D. “TeneoBio’s antibody platform complements our existing capabilities and could potentially give us a more diverse set of building blocks that can be developed into new multispecific therapeutics. In addition, the availability of TeneoBio’s CD3 engager technology will allow us to broaden our capabilities in generating bispecifics, and with our own technology, enable customization of the T cell engaging domain of the molecules depending on the disease and target.”

The acquisition additionally includes TNB-585, a Phase I bispecific T cell-engager for treating metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes the Phase I candidates acapatamab (formerly AMG 160) and AMG 509. Management says these three investigational therapies use a different approach to treat a highly prevalent disease for which new treatment options are very much needed. 

Amgen successfully completed the tender offer to acquire all outstanding shares of common stock of Five Prime Therapeutics for $38.00 per share in cash on April 16, 2021, for a total equity value of $1.9 billion. The clinical-stage biotechnology company has concentrated on developing immuno-oncology and targeted cancer therapies. 

“Five Prime fits squarely within Amgen’s leading oncology portfolio and includes bemarituzumab, a Phase III trial-ready, first-in-class program for gastric cancer, the third leading cause of cancer mortality worldwide,” according to Bradway. 

An agreement was announced at the end of March 2021 through which Amgen will acquire Rodeo Therapeutics, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Management says Rodeo’s 15-prostaglandin dehydrogenase (15-PGDH) program is a strong strategic fit with Amgen’s inflammation portfolio and efforts to develop first-in-class therapeutics for patients.

Amgen will acquire all outstanding shares of Rodeo in exchange for a $55 million upfront payment and future contingent milestone payments potentially worth up to another $666 million in cash.

Rodeo is developing first-in-class, orally available modulators of prostaglandin biology that play a significant role in tissue regeneration and repair. The company’s lead 15-PGDH modulators have generated compelling data in extensive preclinical studies and have clinical potential in various indications.

Amgen and Kyowa Kirin announced a deal in early June 2021. The companies teamed up for the joint development and commercialization of KHK4083, which is Kyowa Kirin’s potential first-in-class, Phase III-ready anti-OX40 fully human monoclonal antibody in development for treating atopic dermatitis, with potential in other autoimmune diseases. In February 2021, Kyowa Kirin announced positive results from a Phase II trial of KHK4083 in patients with moderate-to-severe atopic dermatitis, which affects almost 30 million people in major global markets.

Kyowa Kirin will jointly promote KHK4083 with Amgen in the United States and has opt-in rights to co-promote KHK4083 in certain other non-U.S. markets, including in Europe and Asia. Amgen will leverage unique data from the company’s deCODE Genetics subsidiary to inform the potential use of KHK4083 in indications beyond atopic dermatitis.

The agreement renews a successful worldwide collaboration that resulted in several groundbreaking therapies in multiple disease areas. During 1984, Amgen and Kirin Holdings, the parent company of Kyowa Kirin, established a 50-50 joint venture to develop and commercialize Epogen (Japanese brand name: Espo), which became the first Amgen medicine approved in the United States in 1989, and became the first Kirin medicine approved in Japan during 1990. The joint venture would expanded to include the development and commercialization of several other products, including Neupogen (Gran in Japan), Neulasta (G-Lasta in Japan), Aranesp (NESP in Japan), and Nplate (Romiplate in Japan). The companies announced during 2017 that the joint venture would become a wholly owned subsidiary of Amgen, with Kyowa Kirin in-licensing certain Amgen medicines in the Asia-Pacific region.

“Kyowa Kirin was one of Amgen’s very first collaborators and we are delighted to be joining forces with them once again to advance this promising late-stage asset to treat atopic dermatitis,” Bradway said. 

Amgen is a worldwide leader in treating inflammatory diseases, with a portfolio of marketed drugs that includes Otezla, Enbrel, Amgevita (a biosimilar to the world’s top-selling medicine Humira), and Avsola (a biosimilar to the blockbuster brand Remicade). The company’s pipeline of investigational therapies includes tezepelumab (filed for U.S. FDA approval during May 2021 as a potential first-in-class treatment for severe asthma), ABP 654 (a biosimilar to the blockbuster product Stelara), and several innovative molecules in Phase IIb development for systemic lupus erythematosus and celiac disease.

Financial & Product Performance

Key results during Amgen’s second-quarter 2021 included total revenue growth of 5 percent to $6.5 billion in comparison to same-time 2020, driven by higher unit demand, partially offset by lower net selling prices.

Product sales rose 3 percent worldwide, fueled by double-digit volume growth across various products including Prolia (denosumab), Repatha (evolocumab) and the biosimilar products Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns). 

Unit volumes improved 8 percent during the 2021 second quarter while net selling price decreased 5 percent. On a sequential basis, product sales rose 9 percent quarter-over-quarter, driven by 6 percent volume growth.

Amgen’s Q2 2021 GAAP earnings per share fell 73 percent year-over-year to 81 cents, driven by the write-off of $1.5 billion in acquired in-process research & development (acquired IPR&D) associated with the acquisition of Five Prime Therapeutics, partially offset by increased revenue. GAAP operating income decreased 64 percent to $0.8 billion and GAAP operating margin declined 25.8 percentage points to 13.5 percent.

Amgen generated $1.7 billion of free cash flow in the second quarter versus $2.7 billion during April-June 2020, driven by a difference in the timing of tax payments.

According to Amgen, “Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Patient visits and lab test procedure trends continued to improve but remained below pre-COVID-19 levels. The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business during the second half of the year.”

For the six-month period ended June 30, 2021, total revenue amounted to $12.43 billion versus $12.37 billion during the same time frame in 2020. Total product sales worldwide came in at $11.71 billion, representing a 1 percent decrease versus the same period in 2020. U.S. product sales fell 5 percent year-over-year, decreasing to $8.28 billion in first-half 2021.

After generating about $5 billion for the company in 2020, Amgen’s top-selling medicine globally during the first half of 2021 continued to be Enbrel (etanercept), coming in at $2.07 billion versus $2.4 billion during the first six months of 2020. The company’s Enbrel sales declined 8 percent year-over-year for the second quarter of 2021, primarily driven by lower net selling price and unfavorable changes in estimated sales deductions. On a year-over-year basis, volumes decreased 1 percent. Going forward, Amgen management expects net selling price to continue to decline year-over-year.

Prolia followed up 2020 global sales growth of 3 percent to $2.76 billion with first-half 2021 sales of $1.57 billion and Q2 sales of $814 million. The product’s sales rose 24 percent year-over-year for the second quarter, spurred by 20 percent volume growth as new and repeat patient volumes continued to recover from the pandemic. With osteoporosis diagnosis rates remaining at 90 percent of pre-COVID-19 levels in the quarter, Amgen is focused on driving patient growth and was optimistic about Prolia’s continued strength during second-half 2021.

Amgen’s third best seller during the 2021 first half was Otezla (apremilast) at $1.01 billion. The drug’s sales declined 5 percent year-over-year for the second quarter, primarily driven by unfavorable changes to estimated sales deductions and lower net selling price, partially offset by 5 percent volume growth. In the United States, Amgen said Otezla continued to maintain first-line share leadership in psoriasis. New-to-brand prescription (NBRx) volumes advanced 10 percent year-over-year, even as patient visits to dermatologists remained 15 percent below pre-pandemic levels, according to the company. The amount of new patients that started treatment with Otezla during the second quarter was near pre-pandemic levels, but those gains were largely offset by a lower percentage of 90-day prescriptions and lower prescription refill rates. 

Management expects that recovery in the dermatology segment will continue to progress during the coming quarters. Looking forward, Amgen is preparing for the anticipated approval of the mild-to-moderate psoriasis indication by the U.S. FDA, and continued geographic expansion, including Otezla’s launch in China.

Xgeva (denosumab) sales for the 2021 second period increased 12 percent to $488 million versus the product’s April-June 2020 performance, driven by volume growth as the segment recovered from the earlier effects of the pandemic. First-half worldwide sales were reported at $956 million.

Sales for Repatha improved 43 percent during Q2 2021 and reached $286 million, driven by 49 percent volume growth. U.S. volumes rose 37 percent year-over-year, and non-U.S. volumes improved 66 percent. Volume growth during the quarter was partially offset by lower net selling price due to an increase in the number of U.S. Medicare Part D patients receiving Repatha and entering the coverage gap. Amgen expects further reduction in the net selling price on a sequential basis as the amount of Medicare Part D patients receiving Repatha increases. Repatha’s first-half 2021 sales totaled $572 million and the medicine has been prescribed for more than 1 million patients.

Mvasi sales increased 71 percent year-over-year for the second quarter of 2021 to $294 million, driven by strong volume growth, partially offset by lower net selling price. In the United States, Mvasi continued to hold leading volume share with 50 percent of the bevacizumab segment in the quarter. Sales were flat quarter-over-quarter as volume growth was offset by unfavorable changes to estimated sales deductions. The drug’s sales for the first six months of 2021 amounted to $588 million. Going forward on a sequential basis, Amgen expects continued worldwide volume growth to be more than offset by declines in net selling price due to increased competition.

Sales for Evenity (romosozumab-aqqg) rose 30 percent in Q2 2021 to $131 million, fueled by 32 percent volume growth. U.S. sales nearly doubled year-over-year, reaching $79 million, driven by 97 percent volume growth as Amgen continued to focus on new patient activation. Rest of world (ROW) sales dropped off 15 percent due in part to the timing of purchases by the company’s partner Astellas Pharma during the first six months of 2020. For first-half 2021, Evenity global sales totaled $138 million.

Second-quarter 2021 Amgevita (adalimumab) sales grew 73 percent to $107 million, primarily driven by volume growth. Amgen says the product continued to be the most prescribed adalimumab biosimilar in Europe. ROW sales amounted to $213 million for first-half 2021.

Amgen’s Kyprolis (carfilzomib) produced Q2 2021 sales growth of 11 percent year-over-year, reaching $280 million, primarily driven by volume growth and net selling price. Having attained blockbuster status in 2020 with sales of $1.07 billion, the product remains on pace to do again in 2021 with a first-half total of $531 million. For the remainder of 2021, the company expects continued growth from Kyprolis use in combination with CD38 antibodies.

Sales for Vectibix (panitumumab) improved 23 percent to $239 million during the second quarter, driven by 20 percent volume growth that benefited from increased shipments to Takeda, the company’s partner in Japan. First-half 2021 sales reached $430 million. Amgen expected lower demand from Takeda in the third quarter.

After generating 2020 sales of $850 million, Nplate (romiplostim) accounted for $472 million in first-half 2021 sales. During the 2021 second quarter, sales rose 27 percent year-over-year to $245 million, driven by 17 percent volume growth and higher inventory levels.

The BiTE immunotherapy Blincyto (blinatumomab) produced first-half 2021 sales of $215 million. Q2 sales of $108 million grew 16 percent versus the 2020 second quarter, driven by 18 percent volume growth as Amgen benefited from broader adoption in the community hospital setting.

First-half 2021 sales for Kanjinti clocked in at $317 million, including U.S. growth of 33 percent to $262 million. The product’s Q2 sales improved 27 percent year-over-year to $156 million, primarily driven by volume growth, partially offset by lower net selling price. Kanjinti continued to hold leading U.S. volume share with 42 percent of the trastuzumab segment in the 2021 second quarter. Sales decreased 3 percent, primarily driven by unfavorable changes to estimated sales deductions. Amgen projected sales to decline sequentially in the second half of 2021, driven by net selling price.

Upon reporting the 2021 first-half results, Amgen’s full-year total revenues guidance was reaffirmed at $25.8-$26.6 billion. EPS guidance was revised to $8.84-$9.90 on a GAAP basis and reaffirmed at $16.00-$17.00 on a non-GAAP basis, with a tax rate in the range of 13.0 percent to 14.5 percent. Previously, Amgen forecasted GAAP EPS in the range of $9.11 to $10.71 and a tax rate in the range of 14.0 percent to 15.5 percent.

Product Approvals & Pipeline Updates

Amgen’s Lumakras (sotorasib) received marketing clearance from the U.S. Food and Drug Administration during May for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Lumakras is the first targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.

The once-daily drug received U.S. accelerated approval based on overall response rate and duration of response. Regulatory reviews are under way in Europe, Japan and other countries.

According to Amgen management, Lumakras has been well received by the oncology community. The medicine was added to the National Comprehensive Cancer Network (NCCN) guidelines and unaided awareness among oncologists has grown significantly since the launch or Lumakras. KRAS testing of patients with metastatic NSCLC stood at 70 percent as of August 2021, driven by increased next-generation sequencing (NGS) utilization and KRAS G12C educational efforts, and 46 of the 50 top testing laboratories were identifying the KRAS G12C mutation as actionable in their lab reports.

Top-line results from the event-driven confirmatory Phase III trial comparing Lumakras to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in first-half 2022. Primary results from the Phase II monotherapy trial in patients with advanced KRAS G12C-mutated colorectal cancer (CRC) were submitted for publication.

Initiation of a Phase II trial for Lumakras was intended for third-quarter 2021 in first-line patients with KRAS G12C mutated NSCLC whose tumors express < 1 percent programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutations. Data from the Phase II monotherapy trial in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are anticipated during the first half of 2022.

Data presented at ESMO 2021 in September support the initiation of a Phase III study of Lumakras plus Vectibix in patients with 3L+ colorectal cancer. The company is leading the largest and most comprehensive clinical development program in patients with the KRAS G12C mutation. In the first combination study results from the Phase Ib/II CodeBreaK 101 trial, Lumakras plus the monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor Vectibix demonstrated encouraging efficacy and safety. 

“Based on these results and the urgent need for new therapies, we are pleased to announce the initiation of a new Phase III trial with Lumakras plus Vectibix in the third-line setting,” Reese stated. “This new trial, along with our doublet and triplet combination trials in colorectal cancer, demonstrates our commitment to delivering a new treatment option for metastatic CRC patients who harbor the KRAS G12C mutation.”

Lumakras showed median overall survival of 12.5 months in patients with previously treated NSCLC, according to data released in June 2021 from the Phase II trial of CodeBreaK 100. Presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in the NEJM, Lumakras is the first KRAS G12C inhibitor with overall survival data.

Amgen initiated discussions with regulators on the Phase III trial design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for treating patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer. Initiation of the registrational program is planned for fourth-quarter 2021.

Bemarituzumab was granted FDA Breakthrough Therapy Designation as a first-line treatment for patients with at least 10 percent FGFR2b overexpression and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). Planning is under way for bemarituzumab clinical trials in other solid tumors, including squamous NSCLC.

The FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma in July 2021. According to Amgen, tezepelumab is the first biologic to consistently and significantly reduce asthma exacerbations in a broad population of patients across Phase II and III clinical studies. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is during first-quarter 2022. Regulatory reviews were additionally being evaluated in the European Union and Japan.

Amgen reported new data from the pivotal NAVIGATOR Phase III study in September 2021 showing that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps. A potential first-in-class treatment, tezepelumab acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and has demonstrated promise in treating a broad population of patients with severe asthma. 

Tezepelumab works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, the investigational monoclonal antibody targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 

“This new analysis from NAVIGATOR is exciting for the up to one in five severe asthma patients who have comorbid nasal polyps,” stated Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital in London, the principal investigator of the study. “The analysis shows tezepelumab’s ability to reduce exacerbations, improve lung function and reduce the symptoms of nasal polyps in this comorbid population who are typically more prone to asthma attacks, have an increased likelihood of airway obstruction, and may have a worse quality of life.” 

In other tezepelumab pipeline news, a Phase III trial was enrolling patients with chronic rhinosinusitis with nasal polyps. Amgen was enrolling patients in a Phase IIb trial for chronic spontaneous urticaria. A Phase II study was enrolling patients for COPD.

Tezepelumab is being developed in collaboration with AstraZeneca via a 2012 agreement that was updated during 2020. Through the amended deal in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab; Amgen will record sales in the United States and AstraZeneca will account for sales in Canada. Outside the United States, Amgen will report sales as collaboration revenue.

Positive data was unveiled by Amgen in September from the HUYGENS Phase III trial. The study demonstrated that Repatha in addition to optimized statin therapy, in comparison with optimized statin therapy alone, significantly improved features of plaque stability in patients with coronary artery disease (CAD). 

Heart attacks often result from vulnerable plaque ruptures. Key features of these plaques are a large lipid core with a thin fibrous cap that serves as a wall or barrier around the plaque to keep it intact. The HUYGENS trial evaluated whether Repatha, in addition to optimized statin therapy, could increase the thickness of the fibrous caps, to ultimately improve a feature of plaque stability. HUYGENS met the study’s primary endpoint.

Stephen J. Nicholls, M.D., Ph.D., professor of Cardiology and director, Monash University Victorian Heart Institute in Melbourne, Australia and first author of HUYGENS, noted “These encouraging results reaffirm the potential of Repatha and highlight the benefits of Repatha in ACS patients who initiated treatment early.”

A Phase III cardiovascular outcomes study (VESALIUS-CV) for Repatha continues to enroll patients at high cardiovascular risk without prior myocardial infarction or stroke.

A human monoclonal antibody, Repatha inhibits proprotein convertase subtilisin/kexin type 9. Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and allowing for LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the amount of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is approved in 76 countries, including the United States, Japan, China and in all 27 European Union countries. Applications in other countries are awaiting approval. 

For the blockbuster brand Otezla, Amgen announced during May that the FDA accepted the supplemental New Drug Application for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla has the potential to be the only approved oral therapy for the mild-to-moderate patient population. FDA regulators assigned a PDUFA action date of Dec. 19, 2021.

Enrollment was halted in the Otezla arms of ongoing platform studies designed to assess the efficacy and safety of potential treatments for patients hospitalized with COVID-19. In the meantime, Phase III planning for Otezla for treating Japanese patients with palmoplantar pustulosis was under way. 

Amgen expects to begin discussions with regulators in the near term for the anti-OX40 monoclonal antibody AMG 451 for the treatment of atopic dermatitis. Phase III development is slated to kick off during H1 2022.

Data from a multicenter, randomized Phase III trial testing the efficacy, safety and tolerability of Blincyto compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia were published in The Journal of the American Medical Association (JAMA) in Q1 2021. The product showed significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) versus chemo.

A Phase IIb study of rozibafusp alfa continues to enroll patients with systemic lupus erythematosus (SLE). The multispecific antibody-peptide conjugate simultaneously blocks inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) activity. 

For Aimovig (erenumab), the Japanese Ministry of Health, Labour and Welfare during June granted marketing approval for the suppression of onset of migraine attacks in adults. Aimovig is the first approved treatment in Japan to block the Calcitonin Gene-Related Peptide Receptor (CGRP-R) that plays a significant role in migraine.

On the biosimilars pipeline front, a Phase III study of ABP 654, a biosimilar candidate to the blockbuster immunosuppressive medicine Stelara (ustekinumab), completed enrollment. A Phase III trial of ABP 938, a biosimilar candidate to the eye medication Eylea (aflibercept), was enrolling patients. A Phase III clinical trial of ABP 959, a biosimilar candidate to the immunosuppressive drug Soliris (eculizumab), is under way.