- 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. #19. Januvia (sitagliptin)
Sponsor(s): Merck & Co.Indication(s): Type 2 DIABETES in adults2014 sales: $3.931 billion2013 sales: $4.004 billion% Change: (1.8%)
#12. Lyrica (pregabalin)
Sponsor(s): PfizerIndication(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 injury2014 sales: $5.168 billion2013 sales: $4.595 billion% Change: 12.5%
Notes:
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.
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.
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