Subscribe to RSS feedGeneric Nexium tentatively approved — what’s the point?
Readers of this blog know that we here at PAL are no fans of Nexium, AstraZeneca’s [NYSE:AZN] blockbuster drug for erosive esophagitis, heartburn and Gastroesophageal Reflux Disease (GERD). Nexium, a so-called “proton pump inhibitor,” is the successor to Prilosec, and is essentially no better than Prilosec. Nexium is the brand name for the chemical known as esomeprazole. It is the “S-enantiomer,” or chemical mirror of Prilosec, or omeprazole. The main difference is that Nexium has three yellow stripes. But it’s more than 8 times more expensive than Prilosec, which is now available Over-the-Counter. (Today, the price on drugstore.com for 30 tablets of Nexium 20 mg was $164.31, and a box of 42 tablets of Prilosec was $26.99 – that’s $5.47 per pill for Nexium, compared to 64 cents a pill for Prilosec, meaning you could get 8.54 Prilosec pills for the same price as one Nexium.)
The bottom line is that millions of people take Nexium, and pay dearly for the privilege, when they would do just as well with a cheaper generic Proton Pump Inhibitor, over-the-counter Prilosec, or another over-the-counter heartburn medication like Pepcid, Zantac or plain ol’ Tums. And why do they take Nexium? Overwhelmingly because of the aggressive marketing that Astra Zeneca pours into it, directed at both consumers (TV ads, magazine ads for “The healing purple pill”) and physicians (through pharmaceutical salespeople).
In 2005, we here at Prescription Access Litigation gave Astra Zeneca one of our Bitter Pill Awards for Nexium, the “The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag.” A number of PAL member are also involved in lawsuits against AstraZeneca for allegedly deceptively marketing Nexium as an improvement over Prilosec.
So we regard last week’s news that Ranbaxy Laboratories got tentative approval from the FDA to market generic Nexium (esomeprazole) with some amazement. Does the world need a generic version of Nexium? If it’s the same as Prilosec, isn’t it unnecessary? Aren’t the seemingly innumerable numbers of heartburn drugs on the market enough, particularly since they don’t differ all that much in terms of how effective they are?
The answer is, that’s beside the point. A generic will be introduced because the market for Nexium is huge — $5.2 billion in annual global sales, according to a Reuters article. If and when generic Nexium comes on the market, there are millions of people with prescriptions for Nexium who will have that prescription automatically substituted with a generic, saving them money, and giving them exactly the same level of relief. So isn’t that a good thing?
Perhaps. Generics are terrific. Consumers should use generics more than they already do. The obstacles that brand-name drug companies put in the way of generics coming to market (frivolous patent lawsuits, frivolous FDA petitions, authorized generics, reverse payment settlements, etc.) should be prohibited. Generic drug companies should challenge bogus patents. While that’s all true, a generic version of a drug that the world never needed in the first place feels like a hollow victory. I’d rather see the pharmaceutical industry focus on genuinely innovative treatments that don’t just duplicate — often exactly — treatments that already exist, or yet another “extended relief”/once a day/once a month version that’s just aimed at preserving market share. Then I’d like to see generic versions of those truly breakthrough treatments become available as soon as valid patents on them expire, without unnecessary interference by the brand-name holder of the patent.
My worries of course are probably premature. The FDA only granted tentative approval, not final approval. Astra Zeneca has no intention of letting its cash cow go without a fight. If and when the FDA grants final approval, you can be sure that Astra Zeneca will sue Ranbaxy for patent infringement before the final approval letter is even out of the envelope. As AZ’s CEO said recently:
“Our position has been we have strong intellectual property and we intend to defend it and stand behind it. Obviously, we have options available to us. We always explore options that are available but it’s clear to us that we have an intellectual property argument to make and we are making it.”
So, dear Readers, what do you think? Does the world need a generic Nexium? Post your thoughts in the comments.
February 19th, 2008 at 2:49 PM
In theory, I appreciate what you are saying about Nexium. However, in real life, my personal experience is different. I have pretty severe acid reflux. Prilosec worked for me for about 5 years, and then stopped working. I switched to Nexium and it’s working again. I have a high Rx copay, so so I’ve tried to switch back to Prilosec a few times, but I cant “stomach it,” so to speak. Also, didn’t the head-to-head clinical trials show Nexium to be twice as effective as Prilosec, but with fewer side effects? I don’t think of them at all as the same drug, based on how they work for me, and how I feel when I take them.
February 19th, 2008 at 3:07 PM
Laura:
The first thing I wonder upon reading your comment is whether you’re comparing apples-to-apples, dosage-wise. Nexium is frequently prescribed at 40 mg, whereas Prilosec OTC is 20 mg. And therein, as they say, lies the rub.
The head-to-head clinical trials that Astra Zeneca lists on Nexium’s FDA approved label tell an interesting tale. For “Sustained Resolution of Heartburn (Erosive Esophagitis
Patients),” Astra Zeneca compared Nexium 40 mg to Nexium 20 mg to Prilosec 20 mg in a number of different trials:
Notice that in the first trial, Nexium 20 mg vs. Prilosec (omeprazole) 20 mg, there was no statistically significant difference between the two. In the 2nd trial, Nexium 40 mg performed slightly better than Prilosec 20 mg, but not a huge improvement: After 4 weeks, 7.6% more patients on Nexium 40 mg had sustained resolution of heartburn than the patients on Prilosec 20 mg. But that’s not surprising: They were getting twice the dosage! But again, Nexium 20 mg was statistically no better than Prilosec 20 mg.
In the third trial, Nexium 40 mg performed statistically no better than Prilosec 20 mg! Only 0.8% more patients on Nexium 40 mg had sustained resolution of heartburn than patients on Nexium 20 mg.
In the fourth trial, Nexium 40 mg did perform slightly better than Prilosec 20 mg (4.3% improvement). But again, that’s twice the dose.
In short, at least for heartburn in people with erosive esophagitis, Nexium’s own FDA approved label shows that Nexium is no better than Prilosec at equivalent doses.
February 19th, 2008 at 5:31 PM
Hi Alex:
I hear and see what you’re saying, but I also tried taking 2 Prilosec’s — to compare it, since that would still be cheaper — but it made me ironically nauseous! I also was getting migraines at that dose. So maybe for milder cases, Prilosec is better. I’d be curious to see what side-effect data they have on Prilosec at higher doses. My sister, by the way, can take Nexium, but not Prilosec (even at 20mg) because it also makes her nauseous. Maybe it’s a genetic thing, but I do see value in Nexium — but I’d also love a cheaper generic.
On a related note, are the mirror images of drugs always the similar in how they behave? I was under the impression that they could sometimes be very different. No?
February 19th, 2008 at 5:39 PM
I defer to the chemists and pharmacologists among us for a response about whether isomers always behave the same as the original molecule or not. My understanding is that it varies.
For any drug, there are going to be people who react differently (better or worse) to one formulation or another. But for the vast majority of patients, Nexium is no improvement over Prilosec, and thus Nexium does not deserve to be a $5 billion+ per year blockbuster drug, but rather a small-niche drug. Overhyping of drugs leads to them being taken, and paid for, inappropriately by millions of people.
March 6th, 2008 at 11:53 AM
pal, little help… I’m doing a 25 minute seminar to my college of pharmacy peers on this topic. where, oh where did you find these nexium v prilosec studies? if you have a link, title, or can in some other way direct me to them i would be forever indebted.
March 6th, 2008 at 12:03 PM
Steph:
They’re in Nexium’s FDA approval label.
http://www1.astrazeneca-us.com/pi/Nexium.pdf
March 10th, 2008 at 2:27 PM
With this post and the intention of AZ to maintain profits, it’s strategy in doing so almost entirely mirrors what Schering did with thier conversion of Claritin to Clarinex. Efficacy and benefits remain the same, along with the cost.