Top 10 rheumatoid arthritis drugs 2013

Humira is the world's best-selling drug, bringing in $9.6 billion last year. The way drug information specialist EvaluatePharma sees it, AbbVie's ($ABBV) gem is going to remain the world's best selling drug for the next 5 years. That is despite the fact that its patent expires in 2016. According to EvaluatePharma's "World Preview 2013, Outlook to 2018," sales of Humira should grow 56.5% through 2018, when it is forecast to have sales of $12.8 billion. And if it is the world's best-selling drug that year, then it obviously will be the world's best-selling rheumatoid arthritis (RA) drug in 2018. In fact, it is expected to dominate that market in 2018, holding 23.5% share.

What EvaluatePharma defines as the anti-rheumatics market currently makes up the second largest treatment area by sales, with worldwide revenues of $41.1 billion. Now that is quite a bit smaller than the oncology category, which last year racked up $68 billion in revenues, but still very significant and growing. Anti-rheumatics will remain strong over the next 5 years, despite expected biosimilar competition. The market is forecast to churn out a compound annual growth rate of 4% and reach $52.1 billion in revenues in 2018. It will be outpaced by anti-diabetics, which should have $60.6 billion in sales by then, and oncology treatments, which are projected at $114.4 billion. But it will remain one of the most lucrative markets for the drugmakers that target it.

It will hold that position in part because of some of the current best-sellers in the category that are expected to remain strong sellers through 2018. The three current best-sellers, based on IMS Health figures, are Humira; Enbrel, which Amgen ($AMGN) and Pfizer ($PFE) share; and Remicade, the drug that Johnson & Johnson ($JNJ), Merck ($MRK) and Mitsubishi Tanabe are partnered on. These three are forecast to hold the same top spots in 2018 as well.

Some newcomers will be creeping up the list, however, including Xeljanz, the new drug from Pfizer; it's expected to be the fourth-best-selling drug in the category by 2018 with projected sales of $2.7 billion. It was approved in November 2012 and earned $30.6 million in a couple of months. The drug is an entirely new type of RA drug--a Janus kinase inhibitor, or JAK inhibitor. It's approved for patients who can't tolerate treatment with methotrexate, or haven't fully responded to it. There were big expectations for this one when it was building to a launch, given its novel approach to treating the condition and the fact that it is a twice-daily pill instead of an injection. A Pfizer exec has acknowledged the drug isn't exactly tearing up the category so far, but it is a category with a lot of established players, and so it may just take time. Analysts have predicted it could reach peak sales of $3 billion.

That is all looking forward, however. What about the here-and-now? Of course, Humira is the top dog, and as I mentioned, Enbrel and Remicade round out the top 3. We give you the rest of the top 10 in this report, as well. Take note, the list is based on sales for rheumatoid arthritis for the 12 months ended June 30, as determined by IMS Health, the healthcare technology and information company. The time period chosen is to give you the most current data. But some of the drugs on the list are approved for a variety of treatment areas and so their RA sales make up just a portion of the the total revenues they generate. I also want to mention a couple of drugs that IMS did not include on its list, which through the power of social media, were pointed out when we first went live with this report. Because of the way IMS has some drugs classified, Roche's ($RHHBY)  Rituxan was not included. It gets by far the largest part of its revenues from treating cancer, but also had RA sales during the June to June period of $1.2 billion. Roche's Actemra and RoActemra, which IMS did not include, had sales during that period of $1 billion. So factor those in.

And while this report is about the top branded RA drugs, I would be remiss in not also mentioning methotrexate. Why? Because the generic is usually the first med doctors turn to for RA patients. Total sales of methotrexate for RA were $130 million in the 12-month period, IMS Health says. That is way more than the final three drugs on the list earned individually and very nearly as much as the combined sales for those three.

So please read the report that follows and let us know what your thoughts are. Also, you can join our LinkedIn group and expound there as well. -- Eric Palmer (email | Twitter)

1. Humira, AbbVie
$5 billion in RA sales

What can you say about Humira? It is not only the best-selling arthritis drug; it is also the best-selling drug in the world right now. And it is the backbone of AbbVie ($ABBV), the newest member of Big Pharma, which was spun off from Abbott Laboratories ($ABT) January 1. The drug is approved for a long list of indications in the U.S. and Europe and had 2012 global sales of $9.6 billion, with about half of that in rheumatoid arthritis. In the second quarter of the year, Humira sales were up 12% to $2.6 billion, indicating the company continues to gain ground with the treatment. AbbVie has other drugs in its pipeline, but Humira makes up about half its revenues. And the drugmaker needs to milk that as much as it can, while it can, because Humira's patent expires in 2016 and it has a target on its back. Because it is the world's best-selling drug, there are plenty of companies focusing on it as part of their biosimilar plans.

2. Enbrel, Amgen
$4.6 billion in RA sales

Amgen's Enbrel is the second best-selling RA drug in the world behind Humira. It also is the second best-selling drug in the world behind Humira. Last year, it brought in $8.37 billion in revenue for Amgen ($AMGN). The company also pulled off a coup of sorts with the multifaceted drug. It was set to lose its U.S. patent protection in October 2012, but Amgen won a new patent that could shield the drug for another 17 years. That news led Merck ($MRK), which was developing an Enbrel biosimilar, to drop its own program and join up with partners instead. While a huge deal for Enbrel, Merck's decision has not stopped all plans for cheaper versions of the drug. India's Cipla has announced the launch of an Enbrel biosimilar, which it is selling in the Indian market at a 30% discount to Enbrel.

3. Remicade, Janssen (Johnson & Johnson)
$4 billion RA sales

Remicade is Johnson & Johnson's ($JNJ) best-selling drug, but it is one whose spoils it must share with others. In fact, it was the subject of a custody battle between J&J and Merck that finally got resolved in 2011. J&J argued that the Merck/Schering-Plough tie-up amounted to a "change in control" and that it should get full rights to Remicade, as well as sibling Simponi. In the final shakeout, the two got joint custody, with Merck ponying up $500 million and giving up some territories, retaining marketing rights in Europe, Russia and Turkey. Mitsubishi Tanabe sells it in Japan, and the rest of the world, including the U.S., belongs to J&J.

Getting more control of Remicade has been good for J&J. Last year, the drug's $6.1 billion in total sales made up 9.1% of J&J revenues. Merck still saw more than $2 billion in Remicade sales last year, but they are on the decline with its whittled-down share. Since the two share profits 50-50 in those markets, what happens there is of equal importance, and what is happening is not looking good for the two. The European Medicines Agency (EMA) gave a positive nod to two biosimilars of the drug, one from South Korean biotech Celltrion and one from U.S.-based Hospira ($HSP) for a variety of conditions, including rheumatoid arthritis.

4. Celebrex, Pfizer
$2.1 billion in RA sales

Celebrex has been a big seller for Pfizer ($PFE) for some time and has been used to treat a lot of patients for arthritis and pain. It generated $2.7 billion in total sales for the company last year, ranking it among its top 5 best sellers. But Pfizer's handling of it has created a certain amount of discomfort of its own. In 2008, the company paid close to a billion dollars to settle suits alleging personal injuries from taking Celebrex and Bextra, another Pfizer painkiller that was pulled from the market. For years, the company has been fighting investors who contend that shares dropped after it was learned that it cherry-picked data about its advantages over competitors' products.

Pfizer has defended its practices, saying the fact that doctors continue to prescribe the drug to millions of patients is proof of its effectiveness. Pfizer also has successfully fought for its patents. The drug was scheduled to lose market exclusivity on May 30, 2014, but this year the patent office awarded the company an extra 18 months of exclusivity to the end of 2015. If courts agree, it should mean a billion dollars in extra sales for one of the best-selling RA drugs on the market.

5. Orencia, Bristol-Myers Squibb
$902.5 million in RA sales

Orencia has always been a solid performer for Bristol-Myers Squibb ($BMY) but didn't rank among its top 5 in sales last year. Still, a couple of new approvals in the last two years are kicking up its performance. In late 2011, the company got an FDA nod for Orencia SC, a subcutaneous formulation. That tacked $201 million in revenue onto the drug in 2012, lifting the franchise to $1.176 billion, a 28% jump over the previous year. Then, in December 2012, it got something it had been seeking for 5 years: approval by regulators in the U.K. as a second-line drug for patients who've failed on so-called DMARDs (disease-modifying anti-rheumatic drugs). Its key competitors -- Abbott Laboratories ($ABT) (Humira), Amgen ($AMGN) (Enbrel) and Johnson & Johnson ($JNJ) (Remicade) -- had won that indication in 2007. To win over the National Institute for Health and Care Excellence (NICE), BMS came up with an unspecified discount that helped convince the cost watchdog that approving Orencia was a cost-effective use of its money.

6. Cimzia, UCB
$491.2 million in RA sales

A few years ago, Roch Doliveux, CEO of Belgian drugmaker UCB, told Reuters he was confident that Cimzia's sales would hit the $2 billion mark before 2020. He said he was unconcerned about competitor drugs like Pfizer's Xeljanz, which at that point had yet to be approved by the FDA. The potential concern was that a drug like Xeljanz, which can be taken orally, would steal market share from drugs like Cimzia that are injected. Last year, Cimzia was at about a third of its goal and Pfizer got Xeljanz approved, setting up the situation to see if Doliveux will be right on either prediction.  

7. Simponi, Johnson & Johnson
$378.6 million in RA sales

Simponi, approved by the FDA in 2009 for RA and other conditions, was developed as a follow-up to Remicade. Remicade is an IV drug. Simponi is a subcutaneous treatment. J&J's ($JNJ) Janssen unit in July obtained approval for Simponi Aria, an infusion version to be used in combination with methotrexate to treat moderately to severely active rheumatoid arthritis. When Simponi was approved, there was some talk of it hitting a couple of billion dollars in sales in the first couple of years, but last year it sold just short of $1 billion for J&J and Merck, who are partnered on the product. It did get approval earlier this year for treating ulcerative colitis, and analysts think that with that indication it could hit $1.2 billion in sales for J&J in 2016.

8. Arthrotec, Pfizer
$60 million in RA sales

9. Vimovo, AstraZeneca
$36.8 million in RA sales

10. Kineret, Biovitrum (licenses it exclusively from Amgen)
$35.1 million in RA sales

The three drugs that round out the top 10 are small players in the rheumatoid arthritis market. Their combined sales in that category, according to IMS, don't reach even half of the RA sales for number 7 on the list. There is Pfizer's ($PFE) Arthrotec, as well as Vimovo, both gastrointestinal protectants that combine a nonsteroidal anti-inflammatory drug with an ingredient that protects against ulcers. In the case of Vimovo, that is the active ingredient from AstraZeneca's blockbuster stomach drug Nexium. Kineret is an anti-TNF drug that Sweden's Biovitrum has licensed from Amgen since 2008.

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