Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Blockbusters Do Better, with One Newcomer Reaching #2 in its First Year
Bad press didn’t hurt Sovaldi™ (sofosbuvir) after all. The Hepatitis C virus (HCV) treatment drew the wrath of three members of Congress, who demanded that developer Gilead Sciences justify its $84,000 price for a full 12-week treatment course of Sovaldi. The company offered its justification and didn’t have to worry about too much fallout from the criticism, since its three Congressional critics were top Democrats in the Republican-majority House of Representatives.
Even better for Gilead, which barely began marketing Sovaldi at the end of 2013, sales of the HCV treatment zoomed into eight figures—high enough to place near the top of GEN’s latest version of its List of Top 25 Best-Selling Drugs, reflecting drug sales reported for 2014.
Unlike last year’s Top 25 Best-Selling Drugs of 2013, this year’s list had only 24 drugs generating total sales of $3 billion or more. That allowed the 25th best-selling drug of 2014 to make this year’s list (it appeared in GEN’s Top 20 Best-Selling Drugs list in 2012 but missed 2013), despite sales in only the high-$2 billion range.
Biopharma is in a transition period as the blockbusters of the past decade fade. They have either fallen off the proverbial patent cliff (Novartis’ Diovan, which lost US exclusivity in 2012) or succumbed to a stronger U.S. dollar against European and Asian currencies despite rising sales (Novo Nordisk’s NovoLog, which also missed this year’s list). At the same time, the next generation of multi-billion-dollar drugs takes time to build the billions in sales needed to make the best-seller list—but can be expected to do so starting next year.
At the top, last year’s winner finished #1 again, and with higher sales than 2013. Indeed more than half (16) of the Top 25 best-selling drugs did better in 2014 than the previous year. Among the top three disease categories, six best-selling drugs have indications for forms of cancer, and five for arthritis. Five indications—asthma/COPD, diabetes, heart disease, HIV, and multiple sclerosis—are each represented on the list by two best sellers.
One likely top-seller of 2014 not on the list is Boehringer Ingelheim’s Spiriva, which racked up €3.552 billion ($4.019 billion) in 2013. However, BI will not release full-year 2014 data until April 22, just as it waited until April 2014 to release 2013 data, explaining its absence from GEN’s list.
Top-selling drugs are ranked based on sales or revenue reported for 2014 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), diseases indicated, 2014 sales, 2013 sales, and the percentage change between both years.
Indication(s): Osteoarthritis; rheumatoid arthritis; juvenile Rheumatoid Arthritis in patients two years and older; ankylosing spondylitis; acute pain; primary dysmenorrhea
2014 sales: $2.699 billion
2013 sales: $2.918 billion
% Change: (7.5%)
Sponsor(s): Biogen Idec
Indication(s): Relapsing forms of MS, to slow accumulation of physical disability and decrease frequency of clinical exacerbations
2014 sales: $3.013.1 billion
2013 sales: $3.005.5 billion
% Change: 0.3%
#23. Truvada (emtricitabine and tenofovir disoproxil fumarate)
Sponsor(s): Gilead Sciences
Indication(s): HIV-1 infection in adults and pediatric patients 12 years of age and older (with other antiretroviral agents); pre-exposure prophylaxis to reduce risk of sexually-acquired HIV-1 in high-risk adults (with safer sex practices)
2014 sales: $3.340 billion
2013 sales: $3.136 billion
% Change: 6.5%
#22. Atripla (efavirenz, emtricitabine, and tenofovir)
Sponsor(s): Gilead Sciences and Bristol-Myers Squibb1
Indication(s): HIV-1 infection in adults and children 12 years and older, alone or with other antiretroviral agents
2014 sales: $3.470 billion1
2013 sales: $3.648 billion1
% Change: (4.9%)
#21. Nexium (esomeprazole)
Indication(s): Gastroesophageal reflux disease (GERD); Risk reduction of NSAID-associated gastric ulcers in at-risk patients; H.pylori eradication to reduce the risk of duodenal ulcer recurrence; pathological hypersecretory conditions, including Zollinger-Ellison syndrome
2014 sales: $3.655 billion
2013 sales: $3.872 billion
% Change: (5.6%)
#20. Symbicort (budesonide and formoterol)
Indication(s): Asthma in patients aged 12+; maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema
2014 sales: $3.801 billion
2013 sales: $3.483 billion
% Change: 9.1%
#19. Januvia (sitagliptin)
Sponsor(s): Merck & Co.
Indication(s): Type 2 diabetes in adults
2014 sales: $3.931 billion
2013 sales: $4.004 billion
% Change: (1.8%)
#18. Zetia / Vytorin (ezetimibe)
Sponsor(s): Merck & Co.
Indication(s): Adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin); Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate; Reduce elevated total-C and LDL-C in patients with homozygous familial ypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin; Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia)
2014 sales: $4.166 billion
2013 sales: $4.300 billion
% Change: (3.1%)
#17. Copaxone (glatiramer)
Sponsor(s): Teva Pharmaceutical Industries
Indication(s): Relapsing forms of multiple sclerosis
2014 sales: $4.237 billion
2013 sales: $4.328 billion
% Change: (2.1%)
#16. Prevnar family2
Indication(s): Prevention of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in children ages six weeks through 17 years; prevention of otitis media caused by strains 4, 6B, 9V, 14, 18C, 19F, and 23F in children six weeks through five years; prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains in adults ages 50 and older
2014 sales: $4.464 billion
2013 sales: $3.974 billion
% Change: 12.3%
#15. Gleevec (also sold as Glivec, imatinib mesylate)
Indication(s): Newly-diagnosed adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase; patients with Ph+ CML in blast crisis, accelerated phase; adults with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL); pediatric patients with newly-diagnosed PH= ALL in combination with chemotherapy; adults with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adults with aggressive systemic mastocytosis without the D816V c-KIT mutation or with c-KIT mutational status unknown; adults with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown; adults with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans; patients with KIT (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GISTs); adjuvant treatment of adults following resection of KIT (CD117)-positive GIST
2014 sales: $4.746 billion
2013 sales: $4.693 billion
% Change: 1.1%
#14. Revlimid (lenalidomide)
Indication(s): Multiple myeloma (with dexamethasone) for patients with at least one prior therapy; 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
2014 sales: $4.980 billion
2013 sales: $4.280 billion
% Change: 16.4%
#13. Abilify (aripiprazole)
Sponsor(s): Otsuka Pharmaceutical and Bristol-Myers Squibb3
Indication(s): Oral form indicated for schizophrenia; acute treatment of manic and mixed episodes associated with Bipolar I; adjunctive treatment of major depressive disorder; irritability associated with autistic disorder; Tourette’s disorder. Injection is indicated for agitation associated with schizophrenia or bipolar mania
2014 sales: $5.269 billion (¥627.3 billion)3
2013 sales: $4.910 billion (¥584.5 billion)3,4
% Change: 7.3%
#12. Lyrica (pregabalin)
Indication(s): Neuropathic 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
2014 sales: $5.168 billion
2013 sales: $4.595 billion
% Change: 12.5%
#11. Neulasta / Neupogen (pegfilgrastim, also sold as Peglasta / filgrastim, also sold as Gran)
Sponsor(s): Amgen and Kyowa Hakko Kirin5
Indication(s): For both, decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 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; and 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
2014 sales: $5.857 billion [$5.755 billion Amgen + 0.102 billion [¥12.2 billion] Kyowa Hakko Kirin5
2013 sales: $5.866 billion [$5.790 billion Amgen + 0.076 billion [¥9.0 billion] Kyowa Hakko Kirin5,6
% Change: (0.2%)
#10. Crestor (rosuvastatin calcium)
Sponsor(s): AstraZeneca and Shionogi
Indication(s): Primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet; hypertriglyceridemia as an adjunct to diet; primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; homozygous familial hypercholesterolemia (HoFH); slowing the progression of atherosclerosis as part of a treatment strategy as an adjunct to diet; pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy; risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors
2014 sales: $5.869 billion ($5.512 billion AstraZeneca + $0.357 billion [¥42.0 billion] Shionogi)
2013 sales: $5.946 billion ($5.622 billion AstraZeneca + $0.324 billion [¥38.1 billion] Shionogi)7
% Change: (1.3%)
#9. Advair (fluticasone and salmeterol; sold in some countries as Seretide)
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
2014 sales: $6.431 billion (£4.229 billion)
2013 sales: $8.020 billion (£5.274 billion)8
% Change: (19.8%)
#8. Herceptin (trastuzumab)
Indication(s): HER2 overexpressing breast cancer; HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
2014 sales: $6.793 billion (CHF 6.275 billion)
2013 sales: $6.375 billion (CHF 5.889 billion)9
% Change: 6.6%
#7. Avastin (bevacizumab)
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 rogressed on a first-line Avastin-containing regimen; Non-squamous non-small cell lung cancer, with arboplatin and paclitaxel for firstline 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; platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan
2014 sales: $6.957 billion (CHF 6.417 billion)
2013 sales: $6.777 billion (CHF 6.254 billion)10
% Change: 2.7%
#6. Lantus (insulin glargine)
Indication(s): Once-daily treatment for diabetes
2014 sales: $7.279 billion (€6.344 billion)
2013 sales: $6.557 billion (€5.715 billion)11
% Change: 11.0%
#5. Enbrel (etanercept)
Sponsor(s): Amgen and Pfizer
Indication(s): Rheumatoid arthritis (RA); polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis
Moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis
2014 sales: $8.538 billion ($4.688 Amgen + $3.850 billion Pfizer)
2013 sales: $8.325 billion ($4.551 Amgen + $3.774 billion Pfizer)
% Change: 2.6%
#4. Rituxan (rituximab, MabThera)
Sponsor(s): Roche (Genentech) and Biogen Idec
Indication(s): Non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis 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.
2014 sales: $8.678 billion ($7.478 billion [CHF 6.900 billion] Roche + $1.2 billion Biogen Idec)12,13
2013 sales: $8.631 billion ($7.531 billion [CHF 6.951 billion] Roche + $1.1 billion Biogen Idec)12,13
% Change: 0.5%
#3. Remicade (infliximab)
Sponsor(s): Johnson & Johnson and Merck & Co.
Indication(s): Moderately to severely active rheumatoid arthritis in adults (with methotrexate); pediatric patients with moderately to severely active Crohn's disease; adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; 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; moderately to severely active ulcerative colitis in children and adults who have had an inadequate response to conventional therapy
2014 sales: $9.240 billion ($6.868 billion J&J + $2.372 billion Merck & Co.)
2013 sales: $8.944 billion ($6.673 billion J&J + $2.271 billion Merck & Co.)
% Change: 3.3%
#2. Sovaldi (sofosbuvir)
Sponsor(s): Gilead Sciences
Indication(s): Chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen
2014 sales: $10.283 billion
2013 sales: $0.139 billion
% Change: 7,298%
#1. Humira (adalimumab)
Indication(s): Moderate to severely active rheumatoid arthritis; moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate; 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 had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP); ankylosing spondylitis; psoriatic arthritis; moderate to severely active polyarticular juvenile idiopathic arthritis
2014 sales: $12.543 billion
2013 sales: $10.659 billion
% Change: 17.7%
1 Does not include sales from Bristol-Myers Squibb, since BMS combines sales of bulk efavirenz used in Atripla with sales of BMS’ Sustiva in a reporting category called “Sustiva franchise.” BMS reported full-year 2014 “Sustiva franchise” sales of $1.444 billion, down 11% over 2013.
2 “Prevnar family” consists of Prevnar 13/Prevenar 13 and Prevnar/Prevenar (7-valent), Pfizer’s pneumococcal conjugate vaccines for the prevention of various syndromes of pneumococcal disease.
3 Otsuka records net sales and then pays a portion of that as a fee to BMS, as detailed under the companies’ development and commercialization agreement covering the U.S. That portion was 51.5% beginning in 2012 and 50% beginning in 2013 “through the expected loss of U.S. exclusivity in 2015,” according to an extension of the agreement announced in 2009. See: http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announces-extension-us-agreement-abilify-and-estab. During 2014, BMS recorded $2.020 billion in worldwide revenues for Abilify, down 11.8% from $2.289 billion in 2013.
4 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Abilify as generating $5.265 billion for Otsuka.
5 Effective January 1, 2014, Amgen acquired rights to pegfilgrastim and filgrastim from Roche. Roche had held those rights under license from Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. See Amgen announcement of October 22, 2013: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1866783. 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.”
6 In 2013, pegfilgrastim and filgrastim were sold by Roche in 100 markets under the brands Neulastim and Neupogen, respectively. Roche did not disclose sales figures on either drug for 2013.
7 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Crestor as generating $0.372 billion for Shionogi, and $5.994 billion for both Shiopnogi and AstraZeneca combined.
8 A decline in the U.K. pound since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Advair as generating $8.783 billion.
9 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Herceptin as generating $6.839 billion.
10 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Avastin as generating $7.037 billion.
11 A decline in the Euro since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Lantus as generating $7.849 billion.
12 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Rituxan as generating $8.920 billion ($7.820 billion [CHF 6.951 billion] Roche + $1.1 billion Biogen Idec)
13 Biogen Idec figures include sales from a next-generation version of Rituxan, Gazyva (obinutuzumab), which launched in November 2013.