World’s Top-Selling Drugs: Gilead Sciences, Inc. Sovaldi Closes In On AbbVie Inc Humira

Latest data compiled by GlobalData analysts lists down the world’s 50 top-selling pharmaceutical products. Arthritis drug Humira of AbbVie Inc (NYSE:ABBV) leads the list with $13 billion in global sales reported. Humira was followed closely by Gilead Sciences, Inc.’s (NASDAQ:GILD) star hepatitis C drugs, Sovaldi and Harvoni, which generated combined sales of $12.4 billion last year.

Gilead’s Sovaldi and Harvoni sales posted a staggering 8,828% revenue growth in 2014, as opposed to a 17% year-over-year (YoY) boost seen in Humira sales. Sovaldi was launched in December 2013 as a revolutionary new hepatitis C medicine that served to cut down treatment time from a former 24-48 weeks to only 12 weeks for most patients. It demonstrated cure rates of above 90%, and removed the need for side-effect ridden peginterferon administration. With a price tag amounting to $84,000 for a 12-week regimen, the drug took the market by surprise, immediately putting Gilead on the pharma map as one of the most significant biotech giants.

In the process, Sovaldi helped establish Gilead as the market leader in the hepatitis C space — a disease that affects nearly 3.2 million people in the US and 150 million people worldwide. In October 2014, the company followed up Sovaldi with its advanced combination drug, Harvoni, which further lowered treatment time to eight weeks for 40% of patients (genotype 1). With an even higher price tag of $94,500 for a 12-week course, the drug raked in $1.2 billion in sales in only its first quarter.

Despite intense competition, heavy price discounts, and state pressures, Harvoni managed to bring in another $3.6 billion in the first quarter of 2015. Sovaldi sales, cannibalized in large part by Harvoni, amounted to almost $960 million during the same time period. Although the two drugs’ revenue is expected to rise at a decreasing rate in the coming years, the sales will likely be strong enough to significantly challenge Humira’s lead in the world’s top-selling meds list.

Humira is set to lose its US patent in December 2016 and European patent in April 2018. The drug is a biologic, which is expected to make it harder for a cheaper biosimilar to enter the market. Nonetheless, Deutsche Bank analyst Robyn Karnauskas predicts Humira’s biosimilar to hit the US market by January 2017, while Morgan Stanley analyst David Risinger sets 2018 as the ill-fated date for the drug. Humira also faces imminent challenge from the next-gen arthritis treatments, one of which is currently under development by Belgium-based Galapagos NV (ADR) (NASDAQ:GLPG). Humira accounted for 63% of AbbVie sales in 1QFY15, raking in $3.11 billion.

Remicade
The third lead in the GlobalData list was taken by Johnson and Johnson’s (NYSE:JNJ) autoinflammatory drug Remicade, sales of which grew 3% YoY to reach $10.1 billion in 2014. The drug’s third position, however, may be contested this year as it lost European patent protection in February 2015, and now faces biosimilar competition from Hospira, Inc.’s (NYSE:HSP) Inflectra, which hit the market in the same month. Remicade made around $2 billion annually from Europe alone. Its US patent expiry is scheduled for September 2018. Johnson & Johnson faces litigation against some of Remicade’s remaining patents in the US courts already.

Surprise Entry:Soliris

Alexion Pharmaceuticals, Inc.’s (NASDAQ:ALXN) rare disease drug, Soliris, occupied the 48th position in the top 50 list, with 2014 sales of $2.2 billion at a whopping 44% YoY growth rate. Launched in 2007 as a breakthrough therapy for an extremely rare disorder called paroxysmal nocturnal hemoglobinuria (PNH), the drug managed to convert Alexion overnight into an innovation powerhouse. Soliris was approved for another rare condition called hemolytic uremic syndrome in 2011. The drug carries the honor of being the world’s priciest medicine at a price tag of about $500,000 in the most established markets. Although its combined indications affect less than a few thousand people worldwide, the price tag has placed Soliris on the 2014 top-selling drugs list.

Losing Drugs
Among 2014 losers, in terms of leading drug sales, is GlaxoSmithKline plc (ADR) (NYSE:GSK) with its former blockbuster respiratory med, Advair. The inhaler saw the largest drop in sales among the top ten meds, falling from the fourth lead in 2013 to eighth position in 2014. Advair posted a 20% YoY plunge in sales to $6.7 billion during the year. It lost the US patent protection in 2010, but patent on its Diskus device continues till 2016. However, in 2013, the US Food and Drug Administration passed a ruling making it easier for Advair’s generic copies to reach markets, significantly affecting its sales. The drug also faces competition from rival products such as AstraZeneca plc’s (ADR) (NYSE:AZN) Symbicort.

Other drugs that suffered from patent expiries last year include Eli Lilly and Co’s (NYSE:LLY) antidepressant, Cymbalta, which lost exclusivity in 2014, and dropped from the world’s 11th top-selling med with $5.2 billion revenue in 2013, to off the list altogether in 2014.

Boehringer Ingelheim Pharmaceuticals, Inc.’s heart med, Micardis, also met the same fate as it lost most of its patents over the past year. In 2013, the drug had occupied the 25th lead in the world’s top-selling drugs list with $3.3 billion in sales.

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