Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Prospect of Price Curbs May Dent Future Results for Blockbusters

Addressing Congress on Tuesday, President Donald Trump urged lawmakers to “work to bring down the artificially high price of drugs, and bring them down immediately.” Yet even before the speech, Trump’s jawboning about drug costs appears to have rubbed off on the companies that develop prescription treatments.

Already this year, Johnson & Johnson released data showing that it limited its price hikes to below 10% each year since 2012; while AbbVie, Allergan, Novo Nordisk have all said they will do likewise this year. In reining in their price hikes, the companies hope to address public criticism fueled by the actions of other drug sellers—most recently Marathon Pharmaceuticals, which held off on introducing its recently-approved Duchenne muscular dystrophy treatment Deflazacort after it set an eye-popping price of $89,000 for a year’s treatment course. At the same time, presumably, the companies also hope to stave off new laws by President Trump or Congress that would force them to curb how much they charge for prescription treatments.

Whether voluntary or otherwise, smaller price hikes will reduce Biopharma profits, not to mention shrink how much companies generate in sales from their therapies. Below is GEN’s updated list of top-selling prescription drugs, limited this year to a top 15. The top-selling drug last year was the same one that topped GEN’s 2013 list (when it generated $10.659 billion) and GEN’s 2014 list, when it racked up $12.543 billion—which means that its sales have zoomed 28% in the past two years.

Also, interestingly, while 10 of the top 15 selling drugs saw year-over-year sales gains, four of those 10 saw sales rise more than 10%. Another five drugs saw their sales decline last year compared with 2015, most often due to generic competitors.

Just off the top 15, ranking #20 through #16, are treatments that all generated between $3.8 billion and $4.2 billion last year—the AstraZeneca/Shionogi treatment Crestor® (rosuvastatin calcium), Merck’s Januvia® (sitagliptin), Biogen’s Tecfidera® (dimethyl fumarate), Gilead’s Sovaldi® (sofosbuvir), and Teva’s Copaxone® (glatiramer acetate injection).

One top-selling drug could not be ranked and included in this list. Eliquis (apixaban) is co-marketed by Bristol-Myers Squibb (BMS) and Pfizer, but sales figures are only available from BMS ($3.343 billion in 2016). Pfizer combines sales figures for Eliquis and other products co-developed with partner companies in an “Alliance revenues” reporting line that stood at $1.588 billion last year. Pfizer says that line consists “primarily” of Eliquis, without furnishing a specific figure.

Among top disease categories the leader remains cancer, with five of the 15 top sellers. Arthritis accounts for four of the top 15—but those four all rest within the top-five-selling drugs. Hepatitis appears as at least one indication for three top sellers; and Crohn’s disease, two top sellers. While diabetes is an indication for only one of the top 15, two other top sellers list among their indications diabetes-related conditions.

Top-selling drugs are ranked based on sales or revenue reported for 2016 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), diseases indicated, 2016 sales, 2015 sales, and the percentage change between both years.

#15. Advair /Seretide (fluticasone and salmeterol)

Sponsor(s): GlaxoSmithKline

Indication(s): Advair Diskus indicated for asthma in patients aged 4 years and older; maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Advair HFA indicated for asthma in patients aged 12 years and older.

2016 sales: $4.325 billion (£3.485 billion)

2015 sales: $4.568 billion (£3.681 billion)

% Change: (5.3%)

#14. Neulasta / Peglasta (pegfilgrastim) and Neupogen / Gran (filgrastim)

Sponsor(s): Amgen and Kyowa Hakko Kirin1

Indication(s): For both, decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia; and increasing survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome or acute radiation syndrome). For Neupogen, additional indications of reducing time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); reducing the duration of neutropenia and neutropenia-related clinical sequelae (e.g.‚ febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; mobilizing autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; reducing the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

2016 sales: $4.701 billion ($4.648 billion Amgen + $0.053 billion [¥5.9 billion] Kyowa Hakko Kirin

2015 sales: $4.752 billion ($4.715 billion Amgen + $0.037 billion [¥4.1 billion] Kyowa Hakko Kirin

% Change: (1.1%)

#13. Lyrica® (pregabalin)

Sponsor(s): Pfizer

Indication(s): peuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; adjunctive therapy for adult patients with partial onset seizures; fibromyalgia; neuropathic pain associated with spinal cord injury

2016 sales: $4.966 billion 2

2015 sales: $4.838 billion 2

% Change: 2.6%

#12. Eylea (aflibercept)

Sponsor(s): Bayer and Regeneron Pharmaceuticals

Indication(s): novascular (wet) age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular edema (DME); diabetic retinopathy in patients with DME.

2016 sales: $5.045 billion ($1.722 billion [€1.625 billion Bayer + $3.323 billion Regeneron)

2015 sales: $3.977 billion ($1.301 billion [€1.228 billion Bayer + $2.676 billion Regeneron)

% Change: 26.9%

#11. Xarelto™ (rivaroxaban)

Sponsor(s): Bayer and Johnson & Johnson

Indications(s): reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrence of DVT and of PE; prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

2016 sales: $5.390 billion ($3.102 billion [€2.928 billion] Bayer + $2.288 billion J&J)

2015 sales: $4.254 billion ($2.386 billion [€2.252 billion] Bayer + $1.868 billion J&J)

% Change: 26.7%

#10. Prevnar 13® / Prevenar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

Sponsor(s): Pfizer

Indication(s): prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in adults aged 18 and older; prevention of invasive disease caused by the 13 serotypes in children ages 6–17; prevention of invasive disease caused by the 13 serotypes in children ages 6 weeks through 5 years old; prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children ages 6 weeks through 5 years old

2016 sales: $5.718 billion

2015 sales: $6.245 billion

% Change: (8.4%)

#9. Lantus® (insulin glargine)

Sponsor(s): Sanofi

Indication(s): once-daily treatment for improving glycemic control in adults and pediatric patients with type 1 diabetes, and in adults with type 2 diabetes

2016 sales: $6.054 billion (€5.714 billion)

2015 sales: $6.770 billion (€6.390 billion)

% Change: (10.6%)

#8. Herceptin® (trastuzumab)

Sponsor(s): Roche (Genentech)

Indication(s): HER2 overexpressing breast cancer; HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

2016 sales: $6.751 billion (CHF 6.782 billion)

2015 sales: $6.509 billion (CHF 6.538 billion)

% Change: 3.7%

#7. Avastin® (bevacizumab)

Sponsor(s): Roche (Genentech)

Indication(s): metastatic colorectal cancer with intravenous 5-fluorouracil–based chemotherapy for first-or second-line treatment; metastatic colorectal cancer, with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; nonsquamous non-small cell lung cancer, with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease; glioblastoma, as a single agent for adult patients with progressive disease following prior therapy; metastatic renal cell carcinoma with interferon alfa; cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease; recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that is either platinum-resistant, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, or platinum-sensitive, in combination with carboplatin and paclitaxel, or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent.

2016 sales: $6.752 billion (CHF 6.783 billion)

2015 sales: $6.654 billion (CHF 6.684 billion)

% Change: 1.5%

#6. Revlimid® (lenalidomide)

Sponsor(s): Celgene

Indication(s): multiple myeloma, in combination with dexamethasone; multiple myeloma, as a maintenance therapy following autologous hematopoietic stem cell transplantation; transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities; mantle cell lymphoma in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

2016 sales: $6.974 billion

2015 sales: $5.801 billion

% Change: 20.2%

#5. Remicade® (infliximab)

Sponsor(s): Johnson & Johnson and Merck

Indication(s): moderately to severely active Crohn’s disease in adults and children who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adults with fistulizing disease; moderately to severely active ulcerative colitis in adults and children who have had an inadequate response to conventional therapy; moderately to severely active rheumatoid arthritis in adults (with methotrexate); moderate to severely active rheumatoid arthritis; active ankylosing spondylitis; active psoriatic arthritis; chronic, severe (extensive, and/or disabling) plaque psoriasis in adults who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate

2016 sales: $7.829 billion ($6.561 billion J&J + $1.268 billion Merck)

2015 sales: $8.760 billion ($6.966 billion J&J + $1.794 billion Merck)

% Change: (10.6%)

#4. Rituxan® (rituximab, MabThera)

Sponsor(s): Roche (Genentech) and Biogen

Indication(s): non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely active RA who have inadequate response to one or more TNF-antagonist therapies; granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) and microscopic polyangiitis (MPA) in adults in combination with glucocorticoids

2016 sales: $8.583 billion ($7.268 billion [CHF 7.300 billion] Roche + $1.315 billion Biogen)

2015 sales: $8.354 billion ($7.015 billion [CHF 7.045 billion] Roche + $1.339 billion Biogen)

% Change: 2.7%

#3. Enbrel® (etanercept)

Sponsor(s): Amgen and Pfizer

Indication(s): Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis in patients aged 2 years or older; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis in patients aged 4 years or older

2016 sales: $8.874 billion ($5.965 billion Amgen + $2.909 billion Pfizer)

2015 sales: $8.697 billion ($5.364 billion Amgen + $3.333 billion Pfizer)

% Change: 2.0%

#2. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg)

Sponsor(s): Gilead Sciences

Indication(s): indicated with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection

2016 sales: $9.081 billion

2015 sales: $13.864 billion

% Change: (34.5%)

#1. Humira® (adalimumab)

Sponsor(s): AbbVie

Indication(s): moderate to severely active rheumatoid arthritis (RA); moderate to severely active polyarticular juvenile idiopathic arthritis; active psoriatic arthritis in adults; active ankylosing spondylitis in adults; moderate to severely active Crohn’s disease in adults who have had an inadequate response to conventional therapy; moderate to severely active pediatric Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate; moderate to severely active ulcerative colitis in adults who have hepatitis B virus reactivation, demyelinating disease, cytopenias or pancytopenia, heart failure, or lupus-like syndrome

2016 sales: $16.078 billion

2015 sales: $14.012 billion

% Change: 14.7%

1 Effective January 1, 2014, Amgen acquired rights to pegfilgrastim and filgrastim from Roche. Roche had held those rights under license from Kirin-Amgen (a joint venture between Amgen and Kirin Holdings, of Japan), in Eastern Europe, Latin America, Asia, the Middle East, and Africa since 1989. See Amgen announcement of October 22, 2013: Kyowa Hakko Kirin retains rights to pegfilgrastim under the name Peglasta® in Singapore and Thailand, and under the name Neulasta® in Taiwan. Kyowa Hakko Kirin retains rights to filgrastim under the name Gran in China, Japan, South Korea, Malaysia, and Taiwan. Kirin reports sales under the combined listing of “Gran.”
2 Pfizer lists separately the Lyrica revenues generated in all of Europe, Russia, Turkey, Israel, and Central Asia countries ($801 million in 2016, $1.183 billion in 2015). Those revenues are listed by Pfizer’s “Essential Health” operating segment, while its “Innovative Health” segment records Lyrica revenues generated elsewhere in the world, including the U.S. ($4.165 billion in 2016, $3.655 billion in 2015).

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