The top 10 best-selling diabetes drugs of 2013

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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

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

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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