Herceptin

ASCO already churning out news

Tracy Staton — Fri, 30 May 2008 11:06:50 -0400

Today marks the start of the annual American Society of Clinical Oncology meeting, always a big news generator in the pharma biz. We'll let our sister pub FierceBiotech keep you up to date on the in-development drugs, while we look at studies of existing meds--and so far, we've picked up a few interesting tidbits:

Analysts are hyped about Celgene, whose Revlimid blood cancer drug performed well as a first-line treatment for multiple myeloma in combo with Millennium's Velcade. Data on Revlimid as a non-Hodgkin's lymphoma treatment looks promising, too, one Wall Street type says.
New data on Avastin, Genentech's multitalented cancer drug, is expected at the conference, including results from a late-stage trial in breast cancer, for which the drug was approved in February. (One closely watched stat is sure to be dosing levels; we'll be looking to see whether low doses work as well as higher ones, because if they do, that could pressure Avastin sales.) Data on the drug as an add-on in early colon cancer is also expected. A third Avastin study on the docket: a mid-stagter in glioblastoma multiforme, the type of advanced brain cancer recently identified in Sen. Edward Kennedy.
Roche is already touting data on Herceptin, saying that two new studies show women with breast cancer should start with the drug and stay with it -- provided they test positive for a protein known as HER-2
In the anxiously awaited category: Lung cancer survival improvement data on Erbitux, the ImClone/Merck KGaA/Bristol-Myers Squibb med that's said to have met the main goal of a big trial, though no specific data has yet been released.

There's sure to be more as the weekend progresses, so check in Monday for an update.

- see the Associated Press ASCO round-up
- find the advance info from CNN Money
- read the Herceptin story at MarketWatch

Pro/Con on FDA off-label proposal

Mon, 28 Apr 2008 06:59:54 -0400

One of the things media love to do is get two people to go head-to-head on an issue. Today's topic: Allowing drugmakers to distribute peer-reviewed journal articles in support of off-label uses for their products. On the pro side is Scott Gottlieb (photo), an ex-FDA deputy commissioner who's now at the conservative American Enterprise Institute. Former New England Journal of Medicine editor Jerome Kassirer is on the con side.

Gottlieb argues that allowing distribution of peer-reviewed articles would set a "measured standard as to what information could help better inform decisions that doctors make with their patients." Using the cancer med Herceptin as an example, Gottlieb says an "information gap" kept doctors from prescribing the med to women who could benefit from the drug. Government-funded studies in 2005 showed Herceptin could help cut the risk of relapse; it was approved for breast cancer use two years later.

Kassirer, however, says that peer review isn't enough of a guarantee. Not all peer review is equally stringent, for one thing; articles rejected by top journals often find a place at lesser pubs with less-exacting standards. Also, some studies are designed just to raise questions for further research. "The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking," Kassirer contends. The proposed practice would simply lead to more inappropriate drug use and "more adverse consequences," he states.

- see the item at the Wall Street Journal Health Blog
- check out Pharmalot's coverage
- get the full commentary at Health Affairs

ALSO: What does a bioethicist think about the ghostwriting scandal that erupted a couple of weeks ago? "All papers must originate with a scientist or scientific author who's done the study," Art Caplan of the University of Pennsylvania told Pharmalot. But, he said, he thinks there's probably a role for third-party writing help--after the first draft. Report

Pfizer, Roche suffer as big drugs falter

Thu, 17 Apr 2008 06:59:57 -0400

Today's earnings roundup is a snapshot of pharma's challenges--generic competition, safety problems--and opportunities, namely biotech meds. Big-selling drugs lost ground, bringing their makers down with them. Safety-related charges depressed earnings. Read on, and you'll see.

Pfizer saw first-quarter net income drop by 18 percent as sales of its linchpin med Lipitor fell--and it hasn't even gone off patent yet. Generic competition for the allergy drug Zyrtec cut its sales by 75 percent. Growing drugs included Celebrex, whose sales rose 2.2 percent, and Chantix, which gained 71 percent. Overall, revenues fell by 5 percent to $11.85 billion.
Roche suffered as demand for the cancer med Herceptin slowed and sales of the antiviral drug Tamiflu sank. The flu drug lost 64 percent of its revenues, compared with last year's first quarter, when governments were actively stockpiling for a potential pandemic. Demand for Avastin leapt by 35 percent, offsetting the Herceptin losses. The declining dollar didn't help, either. Overall, revenues declined by 4 percent to $10.4 billion.
Baxter International managed to eke out a 6.5 percent increase in earnings despite two safety-related charges, one of $45 million on its withdrawn Colleague infusion pump and another of $11 million to cover the cost of its heparin recall. Revenues rose 7.6 percent to $2.88 billion. The company boosted its R&D spend to $190 million, a 19 percent increase.
The news from big biotech Gilead Sciences is rosier: The HIV specialist "trounced" Wall Street targets with earnings of $522.1 million, up from $447.6 million first-quarter 2007. Revenues jumped by 22 percent to $1.26 billion as the antiretroviral Truvada bought in $479.4 million, beating analysts' expectations.
Meanwhile, device maker St. Jude Medical reported a 27 percent hike in net income on strong sales of defibrillators. The company posted $184.8 million in profits on sales of $1.01 billion.

- read the Pfizer earnings in the Wall Street Journal
- check out the BBC's take on Roche
- see MarketWatch's Roche coverage
- find the Baxter story in the Chicago Tribune
- get the Gilead news from TheStreet
- check St. Jude's numbers in the WSJ

High-priced meds spur dosing debate

Mon, 17 Mar 2008 07:59:54 -0400

What's a drug worth? In the case of Cerezyme, a remedy for a rare inherited enzyme deficiency known as Gaucher disease, the answer is $300,000 a year. But experts are questioning whether lower doses of the med would work as well--besides saving some $200,000 per year per patient.

Pharma companies have faced complaints about prices for years, including accusations that they inflate the required doses to boost sales. When those drugs are super-expensive, like Cerezyme, the debate becomes highly fraught. When a study showed that a half-dose of Genentech's Avastin--which runs $100,000 a year--might be as effective in lung cancer as a full one, some doctors switched. Genentech maintains that doses were set for maximum cancer-fighting.

- read the New York Times article

Related Articles:
Drug makers jack prices up 7.8%. Report
Expensive Herceptin draws fire in UK. Report
Doctors fret about long-term impact of expensive drugs. Report

SPOTLIGHT: NIH starts Tykerb vs. Herceptin bout

Fri, 29 Feb 2008 06:59:52 -0500

It's a head-to-head matchup. The National Institutes of Health has launched an 8,000-patient trial pitting GlaxoSmithKline's Tykerb against Genentech's Herceptin in aggressive breast cancer. Meanwhile, GSK is poised to launch its med in the U.K. as Tyverb. Report | Report

SPOTLIGHT: NZ Activists challenge Herceptin denial

Mon, 11 Feb 2008 06:59:52 -0500

Breast Cancer survivors in New Zealand won a small victory in their challenge to the government's decision not to fund a full course of Herceptin treatment; the women have won the right to see behind-the-scenes documents detailing just how the drug-buying agency made its decision. Report

Roche sales surpass Novartis'

Wed, 30 Jan 2008 06:59:56 -0500

Eat dust, Novartis. Roche just posted sales of $42.2 billion, $2.4 billion more than its Swiss rival's $39.8 billion. Strong sales of its cancer drugs helped boost profits by 25 percent to $10.48 billion. The rheumatoid arthritis and lymphoma treatment Rituxan alone delivered revenues of $5 billion, becoming the company's best-selling drug ahead of cancer meds Herceptin and Avastin.

The outlook for 2008 isn't all rosy, however. Tamiflu sales, which dropped 19 percent to $1.9 billion in 2007, will continue to fall off, and Herceptin growth is expected to slow, too. Overall, sales growth will drop to the single digits--and this after seven consecutive years of double-digit increases.

It's flush with cash, though, which it plans to use to accelerate R&D spending and to acquire small to medium-sized companies; it's looking primarily in the diagnostics area, but also would consider small pharma deals. Mega-mergers, however, aren't in the cards, CEO Franz Humer said. Of course, Roche has its Ventana deal to wrap up by the second half of 2008.

- see the release from Roche
- read the article in the Financial Times
- check out CNBC's report
- read the news on cash spending at CNN Money

Related Articles:
Roche invests $387M in biotech. Report
Roche to boost R&D spend, reorganize research. Report
Roche shakes up R&D, eyes new buyouts. Report
Big Ventana owners could nix deal. Report

Breast cancer diagnostics often wrong

Fri, 04 Jan 2008 06:59:54 -0500

So far, personalized medicine isn't perfectly personalized. New data shows that diagnostic tests to determine whether women should take certain breast cancer drugs have a failure rate of up to one-quarter. So women who should be using Genentech's Herceptin, GlaxoSmithKline's Tykerb, and anti-hormone meds like AstraZeneca's Arimidex and Faslodex, aren't given the chance. Likewise, women with the sort of tumors that don't respond to those drugs are taking them, thinking that they're bound to work.

The problem is that those tests aren't clear-cut, yes-or-no diagnostics like pregnancy tests. They rely on individual pathologists' subjective judgment. And patients are more likely to get a false negative than a false positive, so more patients aren't getting the drugs they need than vice versa. Said one pathologist, "If we tried to market pregnancy tests with this rate of inaccuracy, they would be taken off the market."

- read the report in the Wall Street Journal

Related Article:
Is Tykerb GSK's cancer breakthrough? Report
Genetic test seen as big step to personalized meds. Report

Expensive Herceptin draws fire in UK

Fri, 30 Nov 2007 06:59:54 -0500

Roche's drug Herceptin has become a lightning rod for debate over cancer treatment in England. Radiotherapists--including the specialty's chief at the National Health Service--are saying that cancer treatment is weighted too heavily toward expensive drugs and not enough toward more cost-effective radiation treatments.

The NHS spent some $206 million on Herceptin last year, and only 500 patients benefited from that chemotherapy, Dr. Peter Kirkbride told the BBC. Spending that kind of money on drugs means the NHS can't invest as much in radiation machines. For the same amount, Kirkbride said, he could have treated 30,000 cancer patients with radiation.

Predictably, radiation-machine manufacturers aren't pleased, either; a trade group spokesman says there's been a "collapse in critical investment." How much of this debate is evidence-based outrage and how much sour grapes? We'll let the NHS decide.

- read the BBC's report

Related Articles:
Roche's Herceptin KO's tumors. Report
UK accepts J&J's money-back guarantee. Report
Roche cuts UK price on cancer drug. Report

Genentech, Roche rise on cancer sales

Tue, 16 Oct 2007 06:59:54 -0400

Here's Exhibit Z in the long list of reasons why Big Pharma wants to make deals with biotech--and why speculation about Biogen and Genzyme is running so high. Roche and Genentech are both reaping a big harvest from their joint cancer drugs this quarter.

Genentech's profit skyrocketed by 21 percent on better-than-expected sales of Avastin, which jumped 37 percent to $597 million. Roche's strong cancer-med growth--including its share of Avastin and Herceptin--made up for a shortfall in Tamiflu sales, pushing the company's third-quarter revenues up by 6 percent to $28.7 billion.

- see Genentech's release from Genentech
- check out this news release from Roche
- read the NYT report on Genentech's earnings
- read the article about Roche's results from the International Herald Tribune

Related Articles:
Moody's downgrades pharma industry. Report
Should Pharma take the M&A cure? Report
M&A activity heats up as biotech IPOs struggle. Report
MAbs are hottest segment of biotech industry. Report

Read more on: Genentech | Roche | Avastin

Antibody sales growing fastest

Fri, 12 Oct 2007 06:59:54 -0400

Looking for pharma growth? Here it is--in monoclonal antibodies. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry.

It's easy to see why, when you recite a list of drugs that fall under this umbrella: Avastin, Herceptin, Remicade, Humira and Rituxan. Monoclonal antibodies sell at the rate of $20 billion annually; by 2009, Datamonitor predicts, that figure will be $34 billion. The only caveat? The "big five" drugs mentioned above will still account for most of the market--some 70 percent in 2012.

- check out the Datamonitor report for more

Related Articles:
FDA approves Rituxan for rheumatoid arthritis. Report
FDA approves Avastin for lung cancer. Report
Remicade approved for psoriatic arthritis. Report
FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

Roche's Herceptin KO's tumors

Wed, 26 Sep 2007 06:59:55 -0400

Fast-growing tumors keel over in the face of Herceptin combined with chemotherapy--sometimes so completely that mastectomy wasn't necessary. Such are the late-stage study results that Roche proudly announced today. Tumors disappeared completely in 55 percent of the study patients, and from the breast and lymph nodes in 48 percent.

No specifics on side effects, just the standard assurance that treatment was "well tolerated," with an addendum that cardiac safety was "acceptable." We'll have to wait until the study wraps to find out more.

- see Roche's release on Herceptin

Related Articles:
Roche files for expanded use of Herceptin. Report
Genentech wins approval for new Herceptin indication. Report
Blocking enzyme effective in preventing breast cancer. Report
JCO warns on radiation, Herceptin. Report