Genentech’s Two Headed Monster: Lucentis and Avastin
Genentech, the Biotech powerhouse, has a problem. They’re too good at what they do. The company has two drugs that both do a fantastic job treating the same disease - age-related macular degeneration (AMD), the leading cause of vision loss and blindness in Americans age 65 and older.
One drug, Lucentis, received its FDA approval to treat macular degeneration in June 2006. Lucentis costs $2,000 per injection (the drug is injected into the eye). Avastin, the other drug, has been around for a few years to treat various forms of cancer, such as colon cancer, and only costs $20 per injection. While treating age-related macular degeneration is an off-label use for Avastin, doctors who treat the disease believe that both drugs are fairly comparable. And many have used Avastin while waiting for Lucentis to receive approval.
The problem for Genentech? By the time Lucentis was finally approved, so many doctors were using the cheaper off-label Avastin that the drug had significant market share. And what doctor is going to tell an elderly patient with limited savings that they will now be switched to a drug that cost 100 times more than their current drug?
If you were Genentech, which drug would you rather sell? The one that costs as much as a night at the movies with your main squeeze? Or the one that costs an arm and a leg…or an eye??
Again, roll-playing Genentech, imagine that the National Institute of Health announces that for the first time ever they are going to do a head to head comparison of two commercial drugs that treat the same condition. And both drugs are yours! You’re the winner. A trend setter of sorts. Yay! Once and for all it will be proven beyond a reasonable doubt (because there currently is doubt) that your more expensive drug is clearly the superior drug and, therefore, millions of seniors should be lining up around the block to receive their monthly injections. Prepare the cash registers and the Brinks armored trucks.
But wait…Genentech is a no-show to this Lucentis coming out party. They claim the study is a waste of time and money, that public funds could be better spent elsehwere.
The National Eye Institite, a part of the NIH, is leading the study and has, barring any last minute interference by those that shall remain unnamed, the support of the Center for Medicare Services (CMS), which foots the bill for most age-related macular degeneration. This makes sense, given that Medicare represents seniors, and most people who have AMD are over 65, a large and growing population.
What is significant for the Pharma industry is that if this trial goes through, it could lead to more head to head trials between, say two drugs that both treat diabetes, or four that treat heart disease. While every other industry endures similar head to head comparisons, for example, between two compact cars, or two SUVs, Pharma has been insulated from this type of scrutiny. What if the new blockbuster, which took years and billions to develop, is no more efficacious than the generic already on the market? All the direct to consumer advertising can’t help that drug out.
To shed some light on the Lucentis / Avastin trial, I talked to Dr. William Rich, Medical Director for Health Policy, American Academy of Opthalmology, and a no-bullshit straight shooter.
We view this audio interview as a starting point to a discussion. Feel free to leave your comments below. We’d love to hear them.
- Peter
After listening to the interview with Dr. William Rich, it is my belief that it should be transcribed and published!
Irv Arons
http://irvaronsjournal.blogspot.com
Thank you for this site! I will definitely pass this on to my colleagues and friends.
I was very interested to hear Dr. Rich’s interview. Bill is a real voice of integrity in our field. As I listened, I couldn’t help thinking about what seems like a break in logic.
Here are the premises:
1. Genentech’s folks are brilliant and they have made a fantastic drug in Avastin and recreated it in Lucentis. They say that they tested an Avastin precursor before developing Lucentis and it didn’t penetrate monkey retina so they just figured Avastin would never work in the eye. (How convenient)
2. They are very (appropriately) proud of their ability to know EVERYTHING about their drugs and engineer them for optimum patient benefit.
3. Phil Rosenfeld is also a brilliant guy. Unlike these proud and brilliant Genentech guys, he figured out in just a patient or two that Avastin not only works in the eye; it is quite miraculous. This and the safety of Avastin have been corroborated over and over by other brilliant people in peer reviewed reports since then.
Here are the obvious facts:
1. Genentech knew that, in Avastin, they had a true wonder drug for cancer.
2. They knew that it would be priced appropriately for 500 to 1500 mg doses every two weeks, guaranteeing them billions in revenue.
3. They knew or could figure out (hey, it’s simple arithmetic) that IF Avastin would work in the eye, we’d only need 1 mg or so, meaning that, at the pricing they would be stuck with from the cancer indication, they wouldn’t make any money.
4. They knew Novartis was making billions with the pricing precedent they set with Visudyne, and it doesn’t even work that well.
So, here’s the questions:
1. Is it possible that the oncology pricing could have been seen as a problem for ophthalmology marketing?
2. As a for-profit company, what would have been the motivation to even see if Avastin worked for AMD? Might there have been greater motivation to NOT look at Avastin and just extrapolate a conclusion from perfunctory testing of a precursor in order to make some plausible claim that Avastin was worthless for the eye?
3. Would that have cleared the way to take a drug with an active site that they KNEW was good, alter it, give it a new name, and bring it out as “something else”, with, of course, a new price, once again guaranteeing billions more in profit from essentially the same molecular active site?
These are NOT accusations, just musings on the seeming illogic of the brilliant folks at Genentech missing something so obvious, and the odd coincidence that missing this could result in up to 10 billion per year in additional revenue. Boy, I’d give a nickel to see the e-mails at Genentech about ten years ago, just to see what they knew and when.
Wait, 10 Billion with a “B”? Sure. They are projecting 1 billion for ‘07 when 79% of docs use Avastin half as often as Lucentis>> 1 billion X5X2=10 BILLION per year, or about twice the CMS budget for ALL of eye care. Even at only 1 billion per year, it will break the bank for many seniors and I would guess more than a few payers.
Thanks for putting up a great website.
A head to head trial is undoubtedly in order. It must be done for the benefit of our patients, and the field of medicine.
Just wanted to say thank you so much for this valuable information. I am just dumbfounded and apalled at this situation. This is indeed a critical public health issue, due to the ramifications of the study if and when it is completed.