Royally Kranked

Monday, June 19, 2006

Genentech's Crocodile Tears

Sick, evil, greedy, thieving bastards, it just doesn't get much more anger inducing than this

Let's give some background here

Genentech: Calm And Cool Under Fire

Just about every drug company in the world is now gunning for Genentech and its breakthrough cancer-drug, Avastin.


Genentech is hoping Avastin, already a top-selling colon cancer treatment, will be approved for lung cancer and breast cancer by next October and November, respectively.


Sutent, like Avastin, targets angiogenesis or the growth of tumor-supplying blood vessels, as does Wyeth's Temsirolimus, an experimental kidney-cancer treatment.

In fact, things are going so gangbusters for Genentech, Fortune declared it "The Best Company To Work For in 2006", and a more fawning piece of rhetoric would be hard to find anywhere

Genentech: The best place to work now

Wanted: Brainiacs with passion for science and contempt for business-speak.

But fawning in this case actually presents a ruthless portrait of the place called "The Best Company To Work For", and if anything, Genetech's passion for science is now viewed as less important than "business speak", as becomes obvious with CEO Art Levinson's mindset

At Genentech, every milestone calls for a party and a commemorative T-shirt -- and on very big occasions, very big celebrity bands. A year and a half ago, after an unusual run of FDA approvals, the parking lot in front of Building 9 became the site of a rock concert featuring Elton John, Mary J. Blige, and Matchbox 20.

All this would be way too dot-com to make business sense if it weren't for another performer who took the stage that day -- and who got about as much applause as the bands. That would be Art Levinson, Genentech's impish, brilliant scientist CEO, dressed for the occasion in tennis shoes and a black CLONE OR DIE T-shirt. The 55-year-old Levinson, who once bet his colleagues that five of them could fit inside an ice machine (they did), has made mostly right bets for the company ever since he took the helm in 1995 -- championing its science, creating a stream of new drugs, and winning over employees by making clear to all that there would be no butt-covering culture at Genentech.(Fortune)

Actually, the culture Levinson's enthralled by is much more focused on the color of money, but blatant hypocrisy bears large on Genentech's other uses regarding Avastin

Drugs firm blocks cheap blindness cure

Company will only seek licence for medicine that costs 100 times more


Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients.

But Genentech, the company that invented Avastin, does not want it used in this way. Instead it is applying to license a fragment of Avastin, called Lucentis, which is packaged in the tiny quantities suitable for eyes at a higher cost. Speculation in the US suggests it could cost £1,000 per dose instead of less than £10. The company says Lucentis is specifically designed for eyes, with modifications over Avastin, and has been through 10 years of testing to prove it is safe.(G.U.)

In Britain, there's a bureaucratic loophole that allows Genentech to add even more leverage to jacking up the price to even more ungodly levels

Unless Avastin is approved in the UK by the National Institute for Clinical Excellence (Nice) it will not be universally available within the NHS. But because Genentech declines to apply for a licence for this use of Avastin, Nice cannot consider it. In spite of the growing drugs bill of the NHS, it will appraise, and probably approve, Lucentis next year.

Although Nice's role is to look at cost-effectiveness, it says it cannot appraise a drug and pass it for use in the NHS unless the drug is referred to it by the Department of Health. The department says its hands are tied.(G.U.)

And why is Avastin so important to those afflicted with WMD?

With Avastin, many patients get their sight back with just one or two injections.(G.U.)

And ironically enough, it wasn't even an employee for Genentech who started it's usage for those suffering with WMD

Avastin was first used on human eyes by Philip Rosenfeld, an ophthalmologist in the US, who was aware of animal studies carried out by Genentech that showed potential in eye conditions. This unlicensed use of Avastin has spread across continents entirely by word of mouth from one doctor to another. It has now been injected into 7,000 eyes, with considerable success.

Professor Rosenfeld has published his results and a website has been launched in the US to collate the experiences of doctors from around the world. But although the evidence is good, regulators require randomised controlled trials before they grant licences, which generally only the drug companies can afford to carry out.(G.U.)

True innovation takes guts. Industry-wide, new drugs on average cost about $800 million and take up to 12 years to develop. More than 90 percent of the drugs in clinical development never reach the market, including half of those that make it to late-stage clinical trials. That's why so many big drug companies are running out of new drugs. For a long time it was easier and lucrative enough to pursue what Vishva Dixit, vice president of research, calls the "detergent" strategy -- creating me-too drugs in big established markets as if they were laundry soap, and then spending big bucks on marketing to steal share from rival pharmas.(Fortune)

Sorry, but as we see shortly, Genentech is about the last group that can or should get to play the "Oh poor us, it's so expensive" card

From Genentech's 2005 Annual Report

In terms of our financial performance in 2005, we continued to deliver strong top- and bottom-line growth over 2004, including: a 44 percent increase in total operating revenues, a 55 percent increase in non-GAAP² net income, and a 54 percent increase in non-GAAP² earnings per share compared to 2004. We also set record sales across our product portfolio in 2005, with all of our products showing an increase in sales and total U.S. product sales growing to more than $5 billion. In particular, we are very pleased with the performance of Avastin® (bevacizumab) — sales topped $1 billion in 2005 — and with its future potential.


In the intellectual property arena, we are committed to protecting the significant investments we make in novel research and development technologies, and our efforts continue to serve us well. Our patents relate to all aspects of our technologies, including products and product candidates, therapeutic targets, methods of making products and methods of treatment. We currently have approximately 5,500 non-expired patents worldwide and approximately the same number of patent applications pending.(GAR)

And there's something even more interesting in the part of that paragraph not shown, detailed shortly as 415 Cabilly

And just to give a better look at the finances

But there's plenty else to like about this low-key, high-tech biotech located just north of San Francisco International Airport. For starters, 29-yearold Genentech is not just the very first biotech; it's the brightest star in a promising industry that has chronically under-delivered. The company's yearend revenues should come to $6.6 billion, according to Wall Street estimates, triple what Genentech pulled in four years ago. Its stock price has doubled in the past year, to $95 a share. At one point in December it had a market cap of $102 billion, making it the 20th-most-valuable company in the U.S., ahead of Merck, Lilly, and every other pharmaceutical company except Johnson & Johnson and Pfizer. "There is only one drug company that has really come from nowhere to be a major force in this industry, and that is Genentech," says Peter Tollman, a senior vice president and biopharmaceutical expert at Boston Consulting Group. "It is the only drug company in the world that has created that much value without a merger."(Fortune)

Since it's obviously not the finances that Genentech can spin regarding the off-label use for Avastin, then the next scenario involves "consumer/patient safety", and this is a charge Genentech is least entitled to play ethically or logically or in any other manner of defending itself

About 20,000 people are diagnosed with age-related macular degeneration in the UK each year. "From the patient's point of view, if they have an eye condition that deteriorates very quickly, there is no question of waiting," said Professor Wong. "We're talking about days and weeks, rather than months. The question is should we do nothing and say there is no randomised controlled trial to prove Avastin is of value?" He called for primary care trusts to agree to pay for the planned phasing-in of new drugs for the condition.

Last night Genentech said its main concern over the use of Avastin to treat eye conditions was patient safety. "While there are some small, single-centre, uncontrolled studies of Avastin being performed, safety data on patients who are treated with Avastin off-label is not being collected in a standard or organised fashion," said a spokeswoman for the company.(G.U.)

Well, there is some legitimacy to Genentech's knowledge of off-label use of medications not officially cleared by the Govt itself

Drug firm served subpoena

Analysts said it's possible that investigators are looking into whether Genentech improperly touted Rituxan for so-called off label uses that haven't been approved by the Food and Drug Administration. Although doctors are free to prescribe drugs for any purpose that might help a patient, drug companies are required to limit their marketing to the uses approved by the government.

In 1999, Genentech agreed to pay $50 million to settle an FDA probe into allegations that it improperly encouraged doctors to proscribe a growth hormone drug, Protopin, for short children who didn't qualify for the narrow, official use of the drug.


It's unclear whether the U.S. attorney contacted Genentech as part of a broad industry sweep or is acting on evidence that the company violated the law. It's also possible that federal investigators are looking into some other type of violation, such as exaggerating the drug's effectiveness or underplaying its dangers.


In the case of Rituxan, Genentech acknowledged Tuesday that doctors commonly prescribe the drug to cancer patients in ways that haven't officially been approved by the FDA.

For instance, the drug is supposed to be used for only for one form of cancer, called indolent non-Hodgkin's lymphoma, after chemotherapy and other treatment methods have failed.

But Genentech says some doctors recommend the drug as a frontline defense, before chemotherapy. The company is negotiating with the FDA to get the drug approved for this purpose.

In addition, some doctors also prescribe the drug for other forms of cancer, including a type of leukemia and a more aggressive form of non- Hodgkin's lymphoma. Genentech plans to ask the FDA next year to approve the drug for use with the more aggressive form of non-Hodgkin's.

Genentech has also sponsored studies showing the drug has potential to treat rheumatoid arthritis, but the company said it hasn't tracked whether physicians are already prescribing the drug for that purpose.

Hmmmm, maybe patient safety isn't the card to play when regarding the off-label usage of Avastin after all, not when such claims were used and endorsed by Genentech itself in the very recent past

And then there's always the altruism-rather a strange sentiment for such an organization that's seeking to suddenly eliminate a very cheap and effective treatment for a form of blindness

In addition to remaining a great place to work, we are committed to ensuring patient access to our products and to playing a positive role in our communities. In 2005, we donated drugs with a total market value of approximately $200 million to more than 18,000 uninsured patients as part of our Access to Care Foundation. To further support patient access to therapies for various diseases, we donated more than $21 million to various independent public charities that offer co-pay assistance to eligible patients. In addition, we provided approximately $15 million in financial support to a variety of nonprofit organizations in our local communities. Through philanthropic support, as well as through Genentech employee volunteerism, we worked to help improve health science education and strengthen many other educational, civic and community-based groups located in South San Francisco, Vacaville, and Oceanside, California, as well as Porriño, Spain. Finally, given the magnitude of Hurricane Katrina, Genentech and the Genentech Foundation donated in excess of $2.5 million toward relief and long-term recovery efforts.(G.A.R.)

Sorry Levinson, there's no way for Genentech to positively or logically push their spin regarding why they don't want Avastin used as a cheap form of treatment for WMD

See, as it turns out, one of the ways all the pharmceuticals make money on their products is to extend, whenever possible, the life of their patents so only that company can make and market a certain drug, with no worry about a cheaper, generic version being available

And wouldn't you know it?

Genentech provides such a perfect example of extending the almost officially expired patent for another double-digit number of years

415 Cabilly

For background, on March 25, 1983, Celltech filed in the United Kingdom a patent application directed to methods of making recombinant antibodies and antibody fragments, together with vectors and host cells useful in these processes. Celltech filed a related patent application in the United States, which issued as U.S. Patent No. 4,816,397 ("the Boss Patent"). On April 8, 1983, about two weeks after Celltech’s original U.K. filing, Genentech filed a United States patent application directed to similar technology, which issued as U.S. Patent No. 4,816,567 ("the Cabilly Patent"). The Boss Patent and the Cabilly Patent issued on the same day, and both were scheduled to expire on March 28, 2006.

The USPTO ultimately revoked the Boss Patent and issued a new United States patent, U.S. Patent No. 6,331,415 to Genentech ("the New Cabilly Patent"). All the claims originally issued in the revoked Boss Patent subsequently issued in the New Cabilly Patent. As a result, while the disputed invention was originally scheduled to pass into the public domain in 2006 upon expiration of the Boss Patent, it is now owned exclusively by Genentech until 2018, which is when the New Cabilly Patent is scheduled to expire.

A 12 year extension on a patent that was to expire earlier this year, not a bady day's work at all

The only motive that fits Genentech's sudden desire to play by the "clinical trials" rules it's ignored in the recent past and keep Avastin's off-label use from being used to help people at a cheap price is a financial component

At Genentech, using market data or return-on-investment analysis to drive the science is strictly taboo. "At the end of the day, we want to make drugs that really matter," says Levinson. "That's the transcendent issue."(Fortune)

Yeah, you wouldn't want to focus on finances more than medicines like THIS CEO did here

Levinson's words completely undercut any altruism Genentech tries to spin to offset the bad image people will have of trying to kill off-label usage of Avastin as it relates to cheaply treating Wet Macular Degeneration

Apparently for Genentech, true altruism comes with a pricetag

Part II Next-More About Levinson and the Genetech Corp Culture


Post a Comment

<< Home