The top 10 best-selling diabetes drugs of 2013

Everybody knows that diabetes is an epidemic in this country that is costing lives and money. New stats from the U.S. Centers for Disease Control and Prevention (CDC) peg at 29.1 million the number of people in the U.S. who have either Type 1 or Type 2 diabetes, with roughly 9 million of those undiagnosed. Most have Type 2 diabetes, which is more prevalent among minorities. On the other hand, a study found that non-Hispanic white children are diagnosed more often with Type 1 diabetes than other groups. And that is just in the U.S. The rest of the world also is developing diabetes at what many see as alarming rates.

Pharma, seeing opportunity, has responded. There are pills as well as injected drugs. Many are incretin mimetics. There are now 12 classes of drugs, including the GLP-1 class drugs like AstraZeneca's ($AZN) Byetta and Novo Nordisk's ($NVO) blockbuster Victoza, and DPP-4 inhibitors like Merck's ($MRK) Januvia, Eli Lilly ($LLY) and Boehringer Ingelheim's Tradjenta/Trajenta and AstraZeneca's Onglyza.

These widely used drugs, some of which are on this list, have stirred safety concerns. The FDA and European regulators announced in February that a new round of safety reviews found little evidence that they cause pancreatitis or pancreatic cancer, as some have suggested. But criticism persists, and this month consumer advocacy group Public Citizen again asked the FDA to pull Victoza from the market, saying the FDA's review of adverse reports was not as extensive as its own.

What is perhaps becoming a bigger deal for Big Pharma, however, is that with so many treatment options, and more coming, the market has gotten crowded and doctors and patients a bit confused. That has led to some studies to sort out which drugs work the best, and that in turn has led some researchers to suggest that for all of the extra money U.S. patients are paying for new treatments, little benefit is being seen. A Yale study, recently cited by Bloomberg, says that many patients have made the switch to analogs and are now spending much more on them than older drugs. But it found little change in the number of episodes of low blood sugar at night, one of the conditions doctors most want to control.

Dr. Silvio E. Inzucchi, director of the Yale Diabetes Center, speaking to The New York Times, asked rhetorically whether patients are any better off with all of the new drugs, then answered his own question this way: "You can control glucose with generics for $4 a month or some new ones that are $8 or $9 per pill. Some medicines are 100 times more expensive, but they're certainly not 100 times as effective. In fact, they're probably equal for most people."

On this list of the best sellers, you will find a mix of the old and new. According to data from EvaluatePharma, one of the big dogs of big pharma data, these top 10 drugs had more than $28 billion in sales last year. All of them, even number 10, were blockbusters. King Lantus alone turned in $7.6 billion in revenue, more than the next two drugs combined and still selling strong. Revenues grew about 20% each of the last two years. Sanofi ($SNY) has been able to be aggressive with its pricing, particularly with the FDA decision to delay approval of potential rival Tresiba pending more safety data.

After you read the report below, please share your thoughts with us, by email or Twitter, or jump into the FiercePharma LinkedIn group and start a discussion thread.

-- Eric Palmer (email | Twitter), Carly Helfand (email | Twitter), Justin Heifetz (email | Twitter)

1. Lantus
2. Januvia
3. NovoLog/NovoRapid
4. Humalog
5. Victoza
6. Levemir
7. Human insulin and devices
8. Janumet
9. NovoMix 30
10. Humulin R

1. Lantus

$7.592 billion

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Lantus is not only the top-selling diabetes drug--it's also the No. 5 best-selling drug worldwide. And as its market gets bigger, its sales have, too, expanding by 20% between 2012 and 2013 and by 19.3% the year prior.

The ranks of Sanofi's ($SNY) rivals have been growing also. The French drugmaker caught a big break when the FDA delayed Novo Nordisk's ($NVO) Tresiba, a would-be competitor, although EU regulators approved it. But Sanofi has also been making some of its own moves to defend its crown, including working to penetrate emerging markets like China, where the company has long been positioned. Last year saw Sanofi open some plants there, as well as start work on a plant in Vietnam and initiate commercial production at a Russian insulin pen plant. The company has also raised Lantus prices 160% since 2007, and it is developing a successor drug--known as U300--that has so far impressed in the clinic.

Most recently, Sanofi used the legal system to fend off a Lantus challenger from Eli Lilly ($LLY), suing the Indiana company over patent infringement claims on four patents. The lawsuit jump-started a 30-month stay of approval by the FDA, which will keep Lilly's biosimilar off the U.S. market until mid-2016 at the earliest. -- Carly Helfand (email | Twitter)

For more:
Special Report: The top 10 best-selling drugs of 2013 - Lantus | 10 big brands keep pumping out big bucks, with a little help from price hikes - Lantus
Sanofi wards off Lilly's Lantus challenger with infringement lawsuit
Sanofi has Lantus for now but says its successor is looking good
Easing U.S. drug spending gives Sanofi, Novo room to raise insulin prices
Sanofi uses multi-pronged strategy to defend its place in diabetes market

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2. Januvia

$4.013 billion

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Januvia's 2013 was less than stellar. The drug's sales fell 2% short of the $4.09 billion it put up the year prior, and it had lower U.S. sales to thank for the dip. While Merck ($MRK) did report increased volume in Japan, that could change this year, with all drugs in Januvia's class subject to repricing in the country. On the bright side for Merck, worldwide sales of Janumet--which combines Januvia with metformin in a single tablet--rose by 10% to $1.8 billion.

Safety worries have continued to plague Januvia and other meds of its kind. The FDA last summer said it wasn't worried about a study linking Januvia and other incretin mimetics with pancreatitis, but that doesn't mean critics have stopped making noise about potential risks. The U.S. regulator and its European counterpart have said they have "not reached a final conclusion" and will continue investigating.

Meanwhile, Januvia is up against some new competition now that SGLT2 inhibitors have arrived on the scene. Instead of affecting insulin like Januvia does, the drugs work by helping the body eliminate sugar through the urine. The FDA approved Johnson & Johnson's ($JNJ) Invokana last March, and nods for AstraZeneca's ($AZN) Forxiga and Eli Lilly ($LLY) and Boehringer Ingelheim's Jardiance have since followed. -- Carly Helfand (email | Twitter)

For more:
FDA clears Merck's Januvia, sister meds of new pancreatitis worries
FDA-nixed diabetes drug from Lilly, Boehringer could face rough path to stardom
Group again petitions FDA to ban Novo Nordisk's Victoza

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3. NovoLog/NovoRapid

$3.001 billion

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NovoLog, named NovoRapid outside of the U.S., is Novo Nordisk's ($NVO) fast-acting insulin used before eating to control blood sugar. Sales rose from $2.8 billion in 2012, and the company says sales were strong in North America and China. Novo has 48% of the total insulin market and 46% of the market for modern insulin and new-generation insulin, the latter being 78% of all of the company's insulin sales. Novo sells prefilled cartridges that allow users to dial in a dose and discreetly take their shots, making the insulin easy to use. In September last year, Novo took a major blow when it lost its supply contract with Express Scripts ($ESRX), along with that for Victoza, after the pharmacy benefits manager went with an insulin from Eli Lilly ($LLY). -- Justin Heifetz (email | Twitter)

For more:
Novo Nordisk loses big U.S. contracts; Victoza, NovoLog sales to suffer

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4. Humalog

$2.611 billion

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Humalog may have lost patent protection in May of last year, but as a biologic, it didn't have generics waiting at the ready to cannibalize its sales. On the contrary, sales of the injectable insulin increased 9% on the year. Sales increased 6% outside U.S. on increased volume, and they grew 11% in Eli Lilly's ($LLY) home country thanks to wholesaler buying patterns, increased demand and higher prices. (The cost of 1 milliliter of the drug has soared 111% since 2007, according to data provider DRX.)

Lilly expects Humalog's revenue gains to continue this year. That's an especially good thing for the Indianapolis-based drugmaker considering the "rapid and severe decline" in U.S. sales it expects for newly off-patent Evista and Cymbalta, once its top-seller. But that won't last forever: The company says it's aware that biosimilars manufacturers have Humalog copies under development. -- Carly Helfand (email | Twitter)

For more:
Eli Lilly's diabetes strategy doesn't include big staff-up in sales

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5. Victoza

$2.072 billion

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Worldwide sales of Novo's ($NVO) Victoza grew 27% last year, but the drug had some hurdles to overcome--and there could be more down the road. For one, the drug faced safety scrutiny in March, when a debate emerged over the safety of incretin mimetics and whether they increased side effects in the pancreas. Though the FDA and EMA cleared the class last summer, the agencies have said they're still investigating, and one advocacy group, Public Citizen, is still petitioning the FDA to ban the drug based on pancreatitis worries.

In October, Novo also got some bad news on the reimbursement front, with Express Scripts announcing it would remove Victoza, as well as the Danish company's NovoLog, from its national formulary for 2014. Analysts have estimated that the PBM accounted for 15% to 20% of Victoza's sales, and Novo's loss of its business is expected to cut into 2014 earnings by anywhere from 1.8% to 3%.

But Novo could boost Victoza's patient pool with a little help from regulators. Last year, the drugmaker filed a 3-mg dose of the drug's active substance, liraglutide, with both U.S. and EU regulators as a potential new treatment for obesity. -- Carly Helfand (email | Twitter)

For more:
Group again petitions FDA to ban Novo Nordisk's Victoza
Express Scripts stops covering key Big Pharma drugs on clinical, cost-effectiveness grounds

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6. Levemir

$2.057 billion

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Levemir is one of Novo Nordisk's ($NVO) workhorse insulins, a steady performer that it often points to as providing a significant part of its growth. After generating more than $2 billion in sales last year, Novo reported a 27% jump in the first quarter of this year, to $570.2 million. That was driven by a 41% jump in sales in North America. Some of that is plain marketing and sales. The Danish drugmaker expanded its sales team last year in anticipation the FDA would approve its new, long-acting insulin Tresiba, which it did not. After getting over the shock of Tresiba's denial, Novo decided it needed more reps to market its existing products, like Levemir, even harder. The long-acting insulin is approved for children and adults with Type 1 diabetes and adults with Type 2.

The FDA last year approved its use in Novo's prefilled FlexTouch pen, a 300-unit device. Novo says that once in use it is good for up to 42 days, 50% longer than Lantus. Perhaps that is not much of an edge over Sanofi's ($SNY) juggernaut, but it provides a selling point. The two companies have had a running verbal battle for years over the two drugs, even getting into a lawsuit. Novo put out a flyer in Germany saying Lantus was more disposed to cause weight gain than Levemir, a legal fight Novo won last year. -- Eric Palmer (email | Twitter)

For more: 
New chief expands Novo team for stepped-up assault on U.S. diabetes market
Premium pricing for Novo's Tresiba in EU, a tiny bit of good news
Novo, Sanofi duke it out in diabetes market

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7. Human insulin and devices

$1.936 billion

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Doctors and patients prefer synthetic insulins, or insulin analogs, because they work faster, absorb at a predictable rate and don't have the same kind of peak effect seen in human insulin. That said, emerging markets and what Novo ($NVO) refers to as "frontier markets" can't afford the analogs, and so human insulins, which it has sold since 1987, are the mainstay.

To some degree, the company says, its approach in these markets is a form of philanthropy. It ships human insulins to the 49 poorest countries at no more than 20% of their cost in mature markets, which works out to about 2 cents per patient per day. "So we help these countries build healthcare capacity and know-how and allow them to buy our products at cost," CEO Lars Rebien Sørensen told The Telegraph last year.

And we don't discontinue production of the cheapest drugs. Novo lumps sales of these insulins, and the devices it sells for their use, as a combined group. Sales of human insulin, however, have fallen in the last year, reflecting growing sales of other insulin products in markets like China. -- Eric Palmer (email | Twitter)

For more:
Special Report: Top 10 Drugmakers in Emerging Markets - Novo Nordisk

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8. Janumet

$1.829 billion

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Janumet, which helps lower blood sugar, follows Januvia, Merck's ($MRK) major blockbuster for Type 2 diabetes. The drug is a combination of Januvia and metformin, a generic drug often used for the disease. Merck developed the drug duo to reduce the hassle of having to take multiple medications. Merck says that sales of the drug were thanks to a major pickup in Europe, and the drug netted $1.6 billion in the fourth quarter last year alone--a 2% increase from the year before. Still, Janumet does not generate nearly the same revenue as Januvia. Merck found itself defending Janumet sales when Indian drugmaker Aprica Pharmaceuticals sought to bring out a generic version. Merck's Indian unit foiled that plan when it was able to secure an injunction against Aprica. -- Justin Heifetz (email | Twitter)

For more:
Merck wins Indian injunction against Januvia copycats

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9. NovoMix 30

$1.738 billion

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As the largest producer of insulin products, Novo Nordisk ($NVO) has an insulin for just about every need. NovoMix 30 is an intermediate-acting insulin. It takes a little longer to start working than rapid-acting insulins but lasts longer in controlling blood sugar. The combo drug comprises 30% soluble insulin aspart and 70% insulin aspart crystallized with protamine. While the Danish drugmaker has few manufacturing issues, it had to recall 33 batches of NovoMix FlexPen and Penfill cartridges in the U.K. in October because a manufacturing problem led to a small number of them having a large disparity--between 50% and 150%--in their insulin fills. -- Eric Palmer (email | Twitter)

For more:
Manufacturing glitch leaves Novo insulin cartridges with bad fills

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10. Humulin R

$1.316 billion

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Eli Lilly ($LLY) has two Humulin R products: U-100 and U-500, the latter of which is 5 times more concentrated. The more potent form is advised for Type 2 diabetes sufferers who have developed insulin resistance to the point that they are injecting more than 200 units of it per day. The concentrated U-500 allows them to inject smaller amounts, and in some cases take fewer injections a day. But because it is concentrated, it is more dangerous, and overdose errors have been an issue, according to the Institute for Safe Medication Practices, as patients struggle with conversions with their syringes. A Lilly spokeswoman said the company is developing both a Humulin R U-500 insulin delivery device and dedicated syringe but can't speculate as to how soon it will be done and approved: "These dedicated devices, if approved, will allow administration of Humulin R U-500 in actual units without dose conversion to non-dedicated syringe unit markings." -- Eric Palmer (email | Twitter)

For more:
Eli Lilly, Insulet to develop Humulin-specific OmniPod

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