Avastin

Avastin meets breast cancer goal

Tracy Staton — Mon, 24 Nov 2008 11:17:38 -0500

Roche and Genentech issued exultant press releases Monday to spread the news that Avastin extended breast cancer patients' progression-free survival in a new study. The trial had aimed to prove that Avastin could delay tumor growth, so the drug met its primary endpoint. The result is expected to aid the companies' bid to expand Avastin's use against breast cancer.

Avastin is already provisionally approved by the FDA for treatment of new cases of breast cancer, in combination with the chemo drug paclitaxel. Genentech wants the full-on OK, however, so it's been pursuing more research in support of broader use. This most recent study looked at Avastin as an addition to several chemotherapy drugs, compared with chemo alone. The study used patients who hadn't previously received chemotherapy treatment.

"We look forward to discussing these data with the FDA and are committed to securing full FDA approval of Avastin based on the totality of data in advanced breast cancer," said Chief Medical Officer Dr. Hal Barron in a statement. Stay tuned.

- read the release from Roche
- get Genentech's version
- see the Associated Press news
- check out the Dow Jones story at EasyBourse

Scientists recommend 'black box' for Avastin

Christe Bruderlin-Nelson — Wed, 19 Nov 2008 09:08:40 -0500

A report released in the new issue of the Journal of the American Medical Association said that Genentech's blockbuster cancer drug, Avastin, could raise the risk of blood clots by about 12 percent, which means a risk of blood clots that is about 33 percent higher than that of patients not on the therapy. The increased risk of blood clots is especially problematic for cancer patients, because increased clotting is a major cause if illness--and even death--for them. However, the study found that while 6.3 percent of the clots required treatment, few of the clots were fatal.

Earlier studies were too small to base recommendations upon, but that the new review of 15 studies and close to 8,000 patients is strong, said study author, Shenhong Wu of Stony Brook University in New York.

Approximately 350,000 cancer patients across the globe have been treated with Avastin since it was approved for use in 2004. It can cost as much as $55,000 per year, with sales reaching $2 billion this year alone.

According to the JAMA review, the drug should receive the FDA's strongest warning, but a spokesperson for Genentech said that all cancer patients are at increased risk for blood clots and that the label already warns patients about the risk.

- check out the USA Today report

GlaxoSmithKline does better in Q3

Christe Bruderlin-Nelson — Wed, 22 Oct 2008 10:28:57 -0400

GlaxoSmithKline did better than it expected in the third quarter, showing increases in sales and revenue, despite a drop in net profit.

While profit was down $2.1 billion compared to a year ago, revenue was up 7 percent to $9.6 billion. Per share earnings also went up 6 percent to 41 cents a share.

GSK CEO, Andrew Witty (photo), attributes the positive results to the "considerable transition" occurring in its portfolio, but fluctuation of the British Pound also appeared to play a role. Stronger Advair sales helped during the quarter, as well.

The company has held on fairly well in these tough economic times, but is expecting sales to drop for some of its key products, including Avandia for diabetes, the depression med Wellbutrin and its heart medication, Coreg. Avandia is likely to suffer most, due to a newer FDA black box label warning.

The company will be exploring small-to-medium acquisition opportunities, as well as opportunities to diversify, moving forward.

- see the Associated Press story
- read the Wall Street Journal article

No early break in Avastin trial

Tracy Staton — Tue, 21 Oct 2008 10:01:10 -0400

Hoping to see Avastin hit one out of the park in its latest colon cancer trial? Prepare to be disappointed, at least for now. Researchers took an early look at data from a study of the Genentech drug and found no reason to stop the trial early. As you know, that means Avastin wasn't so obviously successful at its trial goal--preventing a recurrence of colon cancer after surgery--that further study would just deprive the control group of a potentially lifesaving treatment.

Thus the trial will continue till next year as originally planned. And the lack of big news means that Roche's offer for Genentech stands as is, at $89 per share. If the data had shown a clear win for Avastin, that "would likely have led to an immediate increase in the Roche bid," an analyst told the San Francisco Chronicle. That's because even a small improvement in recurrence stats would boost Avastin sales significantly. And Avastin is already a key driver of Genentech's sales.

- check out the Genentech's release
- read the story in the Chronicle

Avastin-Tarceva combo falls short in trial

Tracy Staton — Mon, 06 Oct 2008 11:05:55 -0400

A high-powered drug combo didn't make the grade in a new lung cancer trial. Combining Genentech's Avastin and OSI Pharmaceuticals' Tarceva didn't boost survival for patients who had not responded to chemotherapy, failing the trial's primary endpoint. Release | Report

Erbitux doesn't meet survival time goal

Tracy Staton — Tue, 16 Sep 2008 10:46:05 -0400

Another skirmish in the ongoing cancer-drug competition between upstart Erbitux and heavyweight Avastin. ImClone Systems announced today that colon cancer patients on Erbitux survived 24.9 months, compared with 21 months on chemo alone--provided that the patients lacked the K-Ras gene mutation. Those with the mutated gene, however, survived just 19.9 months on Erbitux versus 18.6 on chemo alone. And in both cases, the difference could have been due to chance. It was statistically insignificant.

Roche shot back, saying that Avastin extends patients' lives regardless of their K-Ras status. Quoting previous studies, the company said Avastin patients survived more than two years if they didn't have the mutation, and a had statistically significant gain in survival whether mutated or not.

Roche needn't have bothered. The media quickly picked up ImClone's release, highlighting the fact that Erbitux didn't meet its survival time endpoint. The word "failed" was used. We'll see how ImClone responds.

- check out the ImClone announcement
- see the Roche release
- read the CNN Money story

Costly Lucentis gets NICE nod

Tracy Staton — Thu, 28 Aug 2008 10:37:49 -0400

As researchers in the U.S. compare Genentech's macular degeneration drug, Lucentis, with Avastin, another Genentech drug used off-label to treat the eye disease, notoriously tight-fisted regulators in the UK are clearing the much more expensive Lucentis for funding by the National Health Service.

As you know, Genentech has run into controversy over Lucentis, which costs $2,000 per treatment, versus $60 per dose for Avastin when used for the eye malady. The company had moved to restrict distribution of Avastin to compounding pharmacies that repackage the drug for ophthalmic use, but the outcry from doctors and patients led Genentech to soften its stance.

Genentech has come in for criticism from the National Eye Institute, which wanted the company to be part of the head-to-head study. Unsurprisingly, the company wasn't eager to sink money into a trial that pitted two of its drugs against each other--but some have read that refusal as evidence of the company's lack of faith that Lucentis will prevail.

Most importantly, though the study results won't be available for a couple of years, folks are already talking about the prospect that, if the drugs prove comparable at treating macular degeneration, Medicare would refuse to pay any more for Lucentis than it does for Avastin.

In the U.K., however, the National Institute for Clinical Excellence has decided to make Lucentis available to NHS patients. The series of 14 injections will run about $18,000 per eye; under its deal with NICE, Novartis, which markets the drug in Europe, will cover any additional injections needed. Even at the $18,000 cost, NICE figures it will save money compared with the cost of patients' vision impairment.

Why didn't NICE recommend Avastin instead? There's no trial data showing the drug's effectiveness against macular degeneration. And there won't be--until the National Eye Institute trial wraps. We'll see how NICE reacts then.

- see the Boston Globe story
- read the news from the Wall Street Journal

NICE rejects four cancer meds

Tracy Staton — Thu, 07 Aug 2008 10:16:02 -0400

The debate over costly oncology meds rages on in the U.K. as the National Institute for Health and Clinical Excellence rejected four high-tech drugs for advanced kidney cancer treatment: Sutent (Pfizer), Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth). NICE acknowledged that the drugs do extend life--by up to six months--but concluded that the money would be better spent on other patients.

The decision drew immediate fire, not only from patient advocates, but from cancer researchers and doctors, too. One doctor said there was no point in accepting referrals for advanced kidney cancer patients without those drugs, because most don't respond to the only other alternative, interferon.

The outcry might actually have some effect: NICE initially rejected Herceptin outright for breast cancer treatment, then relented after receiving an outpouring of complaint. The agency's final kidney cancer treatment guidance will come through in January.

- read the story in the Times
- check out the Telegraph's coverage

Genentech profits clouded by failed trial

Tracy Staton — Tue, 15 Jul 2008 10:11:49 -0400

Yesterday was a good news, bad news sort of day for Genentech. Sales of its cancer blockbusters Avastin and Rituxan drove second-quarter profits up almost 5 percent year-over-year, but the results still didn't meet Wall Street forecasts. And though the company raised its full-year earnings forecast, it had to stop a three clinical trials when the treatment--in combination with Pfizer's Sutent--induced anemia in some patients.

The second-quarter earnings details: Revenues hit $3.24 billion, up from $3 billion a year earlier, and profits ran at $782 million compared with $747 million. Avastin sales reached $650 million for the quarter, up 15 percent year-over-year, and Rituxan sales were up 12 percent to $651 million. The revenue figures satisfied analysts, but at 73 cents, earnings per share disappointed; the Street had expected 86 cents.

Now, about Avastin. Currently FDA-approved for treating breast, lung, and colorectal cancers, Avastin isn't approved for use in combination with Pfizer's Sutent. The company had been running a Phase II trial on the combo. Yesterday, the FDA announced that patients had developed microanegiopathic hemolytic anemia during that study, and Genentech halted it and two others looking at Avastin in combination with Sutent. The anemia cases resolved themselves within three weeks after the patients stopped using both meds.

- find the FDA alert on Avastin
- see the earnings basics in the New York Times
- check out the Wall Street Journal's take
- read the Forbes story

Costs put cancer docs in financial bind

Tracy Staton — Tue, 08 Jul 2008 09:14:54 -0400

Pricey cancer meds aren't just putting the squeeze on patients and insurers. They're putting oncologists in a financial quandary as well. We got an inkling of this recently when the American Society of Clinical Oncology convened a task force to help guide doctors in discussing treatment costs with patients. At the time we saw that rising drug costs were starting to affect treatment decisions; a 2007 survey found that 23 percent always or most always figured cost into those choice, and 86 percent felt it their duty to consider the impact of treatment on a patient's finances.

Perhaps the next survey should measure how many oncologists-in-arrears have had to beg wholesalers to continue sending cancer meds. Or how many are sending patients to nearby hospitals for drug infusions because they can't bear the costs themselves. Or how many are millions of dollars in debt to their drug suppliers.

The problem is obvious: With expensive cancer meds such as Genentech's Avastin and Tarceva, Abraxis's Abraxane, and ImClone's Erbitux, patients have to foot the bill for thousands of dollars in copays over the course of their treatments, and digging up that money isn't easy for some people--so they're slow to pay. Private insurers turn around their reimbursements slowly, say 90 days or so. And after decades of allowing 50 percent markups on some chemo meds, Medicare cut IV drug margins to 6 percent. (FYI, the most expensive drugs were only ever marked up by 10 or 15 percent.)

Now, it's tough to weep for an oncologist whose pay isn't growing when that pay already amounts to an average of $360,000 per year. But with more and more oncology practices deep in debt and many of them forced to dun very sick patients for their payments, treatment can suffer. And the monetary woes of cancer docs just emphasize the fact that the debate over funding healthcare in general and pricey drugs in particular is far from over.

- read the Wall Street Journal article

Is Avastin really worth the cost?

Tracy Staton — Mon, 07 Jul 2008 09:34:40 -0400

Is Avastin an object lesson in weighing the costs of an expensive drug against its benefits? Some experts think so, and the New York Times over the weekend took an extensive look at the controversy. The facts are these, the NYT says: Avastin is expensive, up to $100,000 per year. It's proven only to prolong life by a few months, if that. And it has side effects, some of which are rare but lethal.

According to the newspaper, some pharma insiders worry that the half-dozen or so drugs like Avastin--which are expensive and offer "arguable benefits"--will cause a backlash such as drug-price controls or usage restrictions. Even patient advocates question its use. But because cancer-treatment issues are emotionally touchy, and because Americans are accustomed to treatment whatever the monetary cost, the debate hasn't been very public. And that's what needs to change, some say. "I think of Avastin as a model that is showing us where the problem is," one told the Times.

The issue raises questions about how drugs are priced, too. Genentech and Roche say they spent $2.25 billion developing Avastin and will spend an additional $1 billion on clinical trials. But is this why Avastin is so costly? Yes and no, the experts say. One analyst told the Times, "It's high because Genentech can price it high."

- see the article

Breast-cancer uptake boosts Avastin sales

Tracy Staton — Tue, 01 Jul 2008 09:12:15 -0400

Avastin may have lost its chance to go on the U.K.'s National Health Service formulary, but it's still blowing past sales expectations. Wall Street analysts are saying that faster-than-expected uptake of Avastin in breast cancer--for which it was FDA-approved in February--likely has boosted the Genentech cancer med past second-quarter forecasts. According to investor notes, Avastin sales grew 4.6 percent in May to surpass one analyst's $648 million monthly estimate; another analyst pegs second-quarter sales at $677 million.

Genetech's other two revenue drivers--the rheumatoid arthritis treatment Rituxan and breast-cancer med Herceptin--also appear to be beating their targets.

If Avastin does make a forecast-beating showing when Genentech posts its results July 14, it would be a vindication for the company: When the drug got FDA's blessing for breast-cancer use, some skeptics predicted it wouldn't be adopted quickly. Indeed, an FDA advisory panel voted against approval. In its breast cancer trials, Avastin did slow tumor growth, but didn't help patients live longer. The agency's blessing came despite the committee's doubts, and industry observers said the decision appeared to lower the bar for cancer approvals.

- read the article in Forbes

ALSO: Avastin "significantly" boosted survival in patients with metastatic colorectal cancer whether or not the patients carried a gene mutation that commonly influences the efficacy of cancer drugs, a new study showed. Release

More NICE debate over cancer meds

Tracy Staton — Fri, 27 Jun 2008 09:16:33 -0400

It's not just Roche that refused to fork over cost-effectiveness info on its cancer med to the U.K.'s National Institution for Clinical Health and Excellence. So, too, has Merck Serono. Yesterday, you'll recall, NICE said it was rejecting Roche's Avastin for National Health Service use because it lacked that data. Merck Serono's Erbitux is in the same boat. And given the fact that NICE is increasingly skeptical of high-priced cancer meds, there's likely to be more wrangling among the regulators and pharma.

Merck Serono's U.K. oncology chief Denise Richard maintains that NICE needs to change its criteria and procedures--and needs to speed up its reviews, too. For instance, NICE doesn't allow drugmakers to update their applications even during long appeals, she told the Financial Times, even though efficacy data often changes quickly.

Richard also thinks NICE should change its requirements for cost-effectiveness for patients with late-stage cancer. One of the regulators' gripes is that some of these expensive meds only extend life by months rather than years; Richard says late-stage patients rarely live more than a few months. So that extra time can be precious.

Interestingly, the FT posits that the best value might lie in using these high-tech meds earlier in the cancer-fighting game--but at lower prices, so that drugmakers would make up the price difference by selling a higher volume.

- see the FT article

Roche, NICE in Avastin data standoff

Tracy Staton — Thu, 26 Jun 2008 09:25:16 -0400

It's another blow for Roche's Avastin the U.K. The National Institute for Clinical Health and Excellence shot down the high-tech cancer med as a first-line treatment for lung and breast cancer, meaning the National Health Service won't pay for it. That's the second rejection at NICE for Avastin, which was also denied for colon cancer use.

The negative verdict came after NICE asked Roche for more data on the drug's clinical and cost-effectiveness--and Roche refused, figuring the data would just show that Avastin was too expensive to meet the agency's requirements. With the announcement came the expected rhetorical clash. "Other healthcare systems seem to think it's fairly priced," a Roche spokesman sniffed. NICE's chairman sniped, "Roche would rather not supply the drug in the U.K. than risk a negative opinion."

Avastin's thumbs-down comes at a time when expensive cancer meds are under increasing scrutiny in the U.K. And because NICE tends to be influential in the drug-reimbursement world, that scrutiny could follow cancer treatments to other countries, too.

- check out NICE's statement
- get the news from Interactive Investor
- see the Financial Times story

FDA: Don't blame us for Avastin change

Tracy Staton — Thu, 19 Jun 2008 09:33:36 -0400

Remember last year when Genentech said it wouldn't sell its cancer med Avastin to compounding pharmacies, which repackage it for off-label use in patients with macular degeneration--and then blamed the FDA for the change? Well, Genentech ended up backing down a bit. But it never stopped stressing the fact that the restriction was FDA's fault. The company flatly denied that it was trying to protect Lucentis, its drug approved for use in macular degeneration, which just happens to cost roughly $2,000 per treatment course versus some $50 for repackaged Avastin.

Now, though, a Senate investigation appears to show that Genentech's blame game was unfounded. The company had claimed that agency inspectors were concerned that some batches of Avastin didn't meet standards for ophthalmic use, but the agency says they didn't meet standards, period. Inspectors “identified deficient practices and the lack of of effective processes to know what was in those four lots," the agency wrote Senate investigators. "Consequently, the Agency recommended that those lots should be considered unfit for use for any indication.” Genentech disputes this, saying that the lots were OK for cancer use.

When Genentech started citing FDA for its distribution change, some officials were miffed. "Genentech has found a way to blame FDA for their decision to limit their distribution of Avastin," an official wrote.

Curiouser and curiouser, FDA declined to expressly limit the use of Avastin. When Lucentis was approved, Genentech asked the FDA to change Avastin's label to say that the drug was not for ophthalmic use, according to an internal FDA email obtained by the Senate. The agency concluded there was "no safety-related basis adequately justifying that labeling change."

- read the (lengthy) Wall Street Journal Health Blog post

Erbitux, KRAS gene star at ASCO

Tracy Staton — Mon, 02 Jun 2008 11:26:14 -0400

As expected, headlines have been spewing from the American Society of Clinical Oncology meeting like ash from a volcano. And as promised, we bring you a roundup of the latest and greatest on using existing drugs against cancer. Here goes:

A growing body of evidence suggests that patients with a non-mutant form of the KRAS gene respond better to EGFR inhibitors such as ImClone's Erbitux and Amgen's Vectibix; you can get a link to the 300-odd KRAS hits from an ASCO search at the WSJ Health Blog. (By the way, just yesterday, the E.U.'s drug regulators recommended approval for Erbitux as a first-line colon cancer treatment--but only for those with the non-mutated KRAS gene.)
The Novartis bone drug Zometa surprised folks by helping prevent a recurrence of breast cancer--and not just in cutting spread of the cancer to the bones. Among those who took the drug in addition to chemo, 6 percent died or had a recurrence within five years of treatment, compared with 9 percent who got chemo alone.
A high dose of Pfizer's painkiller Celebrex may help keep smokers from developing lung cancer; Celebrex blocks the COX-2 enzyme that causes inflammation, which besides causing arthritis pain, has also been linked with cancer. Researchers said the findings need to be confirmed with other studies.
Despite all the good news on Erbitux at the meeting, analysts said they don't think growth in that drug will necessarily take away from Genentech's Avastin, which is already entrenched as a first-line treatment. Among the patients most likely to jump at the prospect of Erbitux are lung cancer sufferers who can't take Avastin because of the risk of side effects.

Stay tuned: The meeting goes on through today, so we'll have more updates tomorrow.

- check out the Merck KGaA release
- see the Health Blog KRAS item
- find the WSJ post on Zometa
- read the Celebrex story in the Washington Post
- get the Avastin-Erbitux comparison in the New York Times

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

Avastin-Lucentis trial may reshape pharma

Wed, 14 May 2008 06:59:56 -0400

We thought the head-to-head trial of Avastin and Lucentis for age-related macular degeneration was a big deal for Genentech, which makes both drugs. Now, IMS Health is saying that the trial could be "a Pandora's box" for the entire pharma industry.

Conducted by the National Eye Institute, part of the National Institutes of Health, the trial is designed to see whether the much cheaper Avastin, often used off-label to treat AMD, measures up to the AMD-specific--and very expensive--Lucentis. If Avastin passes muster, then prescribers may desert Lucentis completely. And if docs don't do so voluntarily, then insurers and other payers may nudge, cajole, incentivize, or downright push them to.

And there's the rub, IMS says. By taking the drugmaker out of the testing, this trial could fundamentally reshape relations between payers and pharma. Payers could sponsor comparative drug studies of their own or lobby the government to do so, IMS theorizes, especially as databases make those comparisons easier. There's plenty of time to worry about it, though: The Avastin-Lucentis trial won't wrap till 2010.

- see the story in the Financial Times

BMS swallows Canada's Erbitux price

Tue, 29 Apr 2008 06:59:54 -0400

Call it a new pricing strategy. Bristol-Myers Squibb is preparing to launch the cancer treatment Erbitux in Canada after a two-year wrangle over cost. Approved by Health Canada in September 2005, Erbitux never went on sale because Bristol-Myers and the Patented Medicines Prices Review Board couldn't agree. Now, the drugmaker has acceded to the price the board set. "We think [the price] did not recognize the value of innovation that Erbitux represents," BMS's Marc Osborne said, "but with the overall survival data, we decided it's time to market this drug."

Next, the government has to check out the drug's manufacturing process, and once that's approved, the provinces will decide whether to cover Erbitux. Ontario looks like a safe bet: It currently sends patients to the U.S. for treatment.

- read the story from CBC

Stanley: Erbitux outperformed Avastin

Mon, 21 Apr 2008 06:59:57 -0400

Morgan Stanley got a juicy scoop on the Avastin versus Erbitux boxing match: Genentech's Avastin faces news that as-yet-unpublished data shows Erbitux delivering an "unexpected survival benefit" against metastatic lung cancer. Perhaps not coincidentally, the news comes as Genentech announced that a new trial showed Avastin improving progression-free survival in non-small cell lung cancer but didn't prolong life.

According to CNBC, this scores the match at two Phase III survival benefits for Erbitux, compared with only one for Avastin. Erbitux, as you know, is sold in Europe by Merck KGaA and in the U.S. by Bristol-Myers Squibb; Avastin is marketed by Roche and Genentech.

Morgan Stanley says it won't change its official sales estimates for either drug until it sees this mystery data (which, incidentally, the companies declined to confirm). But the brokerage did make a breathless estimate of €400 million in additional revenue if the rumor proved true.

- see the CNBC story
- get more from Pharmalot

Related Articles:
Erbitux clears late-stage hurdle for lung cancer. Report
FDA approves Avastin for lung cancer. Report