Genentech

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

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

Fortune snubs Big Pharma in employers list

Tracy Staton — Thu, 05 Jun 2008 09:56:34 -0400

Looking for the best employers? Don't look at Big Pharma. The annual Fortune magazine list of the 100 "Best Companies to Work For" contains only one Big Pharma name: AstraZeneca, at No. 83. Genentech, a biotech certainly worthy of the "Big" label, made the top 10 for the third year in a row (this year it's No. 5). But aside from AstraZeneca, none of the traditional pharma biggies got the nod this year. Over the past three years, only Eli Lilly popped onto the list, just once.

Given the fact that the industry has been roiled by layoffs and restructurings, the lack of major drugmakers in a best-employer ranking probably isn't that surprising. People working in fear for their jobs don't generate a lot of, shall we say, positive energy. Morale tends to suffer when the axe falls. So this conspicuous absence is just another sign that pharma is living through some interesting times.

- see the Fortune list
- check out the Pharmalot item

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

Who are pharma's true VIPs?

Tracy Staton — Fri, 23 May 2008 10:57:38 -0400

You mean you don't know? Helpfully, a trade magazine has ranked them for you. The 40 most influential people in pharma--and they're not always the people you'd expect. In fact, FDA Commissioner Andy von Eschenbach didn't make the list. Who did? Carl Icahn, for one. The highest ranking CEO was (drum roll, please) Genentech's Arthur Levinson at the number two spot. GlaxoSmithKline's new CEO Andrew Witty came in came in at number six. Other familiar names include Bill and Melinda Gates (3), Janet Woodcock (18), Warren Buffett (25)and J. Craig Venter (27). You'll have to read the list to get the rest.

- check out the list and article in World Pharmaceuticals (.pdf)
- see the Pharmalot item

Alimta, Nexavar look for ASCO boost

Fri, 16 May 2008 06:59:58 -0400

As always, the American Society of Clinical Oncology's annual meeting is spawning tons of drug news. Only this year, the news is coming ahead of the conference itself, because ASCO released all the studies on the program in one fell swoop last night. Wall Street analysts were planning all-night cram sessions to tease the news out of those reams of data. Here are three big items about already-approved drugs:

Eli Lilly's Alimta delayed lung cancer growth when used soon after a first round of chemotherapy. The study could support broader use of Alimta, the Wall Street Journal reports. Currently, patients do a round of chemo, then stop drug therapy until the cancer grows again, then start a second-line drug like Alimta. The new data suggests Alimta could be used right after that first round to keep tumors at bay.
Bayer and Onyx Pharmaceuticals' Nexavar boosted overall survival by 47.3 percent in patients with advanced liver cancer compared with placebo. The study comprised 226 Asian patients who'd never received systemic therapy for their cancer. Overall survival was 6.5 months on Nexavar compared with 4.2 months on placebo.
Combination therapy with Herceptin and Tykerb delayed the worsening of advanced breast cancer in women who'd stopped responding to other treatments. Patients using the combo survived 12 weeks without their cancer advancing, compared with eight weeks on Tykerb alone. Herceptin is marketed by Genentech and Roche, Tykerb by GlaxoSmithKline.

- see the WSJ's Alimta piece
- check out the Nexavar release
- read the Associated Press combo story

Alimta, Nexavar look for ASCO boost

Fri, 16 May 2008 06:59:58 -0400

Eli Lilly's Alimta delayed lung cancer growth when used soon after a first round of chemotherapy. The study could support broader use of Alimta, the Wall Street Journal reports. Currently, patients do a round of chemo, then stop drug therapy until the cancer grows again, then start a second-line drug like Alimta. The new data suggests Alimta could be used right after that first round to keep tumors at bay.
Bayer and Onyx Pharmaceuticals' Nexavar boosted overall survival by 47.3 percent in patients with advanced liver cancer compared with placebo. The study comprised 226 Asian patients who'd never received systemic therapy for their cancer. Overall survival was 6.5 months on Nexavar compared with 4.2 months on placebo.
Combination therapy with Herceptin and Tykerb delayed the worsening of advanced breast cancer in women who'd stopped responding to other treatments. Patients using the combo survived 12 weeks without their cancer advancing, compared with eight weeks on Tykerb alone. Herceptin is marketed by Genentech and Roche, Tykerb by GlaxoSmithKline.

- see the WSJ's Alimta piece
- check out the Nexavar release
- read the Associated Press combo story

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

ALSO NOTED: Forest takes charge on Azor split; GSK launches Tykerb-Herceptin trials;

Tue, 13 May 2008 06:59:50 -0400

> Forest Laboratories will take a $44.1 million charge on termination of its deal to co-promote the hypertension drug Azor with Daiichi Sankyo. Report

> GlaxoSmithKline launched its large-scale trials pitting Tykerb against Genentech's Herceptin in early-stage breast cancer. Tykerb report

> Worried that antipsychotics are prescribed when they're not needed, Washington State is working on a plan to ensure that the meds are used appropriately in children on Medicaid. Report

> Schering-Plough is getting the country's largest rooftop solar-energy system, according to PPL Renewable Energy, which is installing the panels at Schering's Summit, NJ, campus. Report

> Already a problem in Southeast Asia, counterfeit malaria drugs are flooding African areas already hard hit by the disease, according to a new study. Report

> Daiichi Sankyo posted a 24.3 percent increase in fiscal-year profits to $941.5 million, but revenues fell by 5.3 percent, and it expects smaller profits in the year to come. Report

> Solvay reported a slight rise in first-quarter rise sales and profits. Report

> Following Wal-Mart, Kroger expanded its popular $4 generic drug program. Report

> India's Ranbaxy has flexed its research muscles once again, this time signing a five-year pact with Merck to develop new anti-infectives. Ranbaxy report

> Faced with a patent fight that has frustrated efforts to find a buyer, Trimeris has begun to hand back out $80 million in cash as it winds down its operations. Trimeris report

> Elixir Pharmaceuticals has dropped its bid for an $86 million IPO, saying that market conditions aren't right. At the same time, Aldagen, a small biotech company with 18 employees, is making a bid to raise $80 million in an IPO. IPO report

> Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Report

Emerging Drug Developer: Resolvyx Pharmaceuticals. Profile

And Finally... The Republic Party's new slogan sounds a little familiar to the folks marketing Effexor XR. Report

SPOTLIGHT: Rituxan falls short in lupus trial

Wed, 30 Apr 2008 06:59:52 -0400

In a big disappointment for Genentech and Biogen Idec, Rituxan failed its late-stage test against lupus. Already approved for non-Hodgkins lymphoma and rheumatoid arthritis treatment, Rituxan might have added $1 billion to its $2.3 billion in 2007 sales with a lupus indication. Report