Erbitux

Erbitux growth boosts German Merck

Tracy Staton — Mon, 27 Oct 2008 11:17:06 -0400

If you want more confirmation that drugmakers can grow sales even in this market, look no further than Merck KGaA. The German company expects to grow revenues between 6 percent and 8 percent this year, within its earlier guidance of 5-9 percent. And it's still predicting margins of at least 23 percent on those sales.

For the quarter, Merck reported profits of €200.1 million, or $251.8 million, compared with €36.2 million a year ago (when the company booked a €183 million charge on its buyout of Serono). Revenues for the quarter grew 8.7 percent to €1.89 billion. And unlike U.S. companies, whose sales were often inflated by currency gains, Merck's numbers reflect a "considerable" negative impact from currency, cutting organic sales growth by 4.8 percent.

Digging deeper, Merck's fastest-growing drugs were Erbitux, the cancer treatment marketed in the U.S. by Bristol-Myers Squibb and ImClone Systems, which mushroomed by 13 percent to €134 million. Rebif, Merck's multiple sclerosis treatment, grew by 10 percent to €338 million.

- read the story in the Wall Street Journal

Bristol to get $1B in ImClone deal

Tracy Staton — Tue, 07 Oct 2008 10:13:50 -0400

Carl Icahn may have won the ImClone war, but Bristol-Myers Squibb counts itself among the victors, too. Though Bristol won't get control of ImClone, it will rake in about $1 billion in cash for its 17 percent stake when Eli Lilly forks over the $70 a share buyout price. And Bristol still boasts a share of the cancer drug Erbitux; it will just work with Eli Lilly on marketing the drug. (Ironically, working with Lilly won't be unfamiliar to Bristol CEO Jim Cornelius, because he spent years at the company.)

In fact, Bristol's statement in response to losing ImClone to Eli Lilly was quite upbeat, full of phrases like "pleased," "proud" and "looking ahead." Bristol even seemed to take a share of the credit for bringing ImClone and Lilly together; after all, if BMS hadn't decided to try to buy ImClone, the company might not have been in play.

Bristol's teeth didn't show until the statement's final phrase: "to which Bristol-Myers Squibb holds long-term marketing rights." Those words referred to ImClone's experimental compound IMC-11F8, a potential follow-up/competitor to Erbitux. ImClone appears to dispute those rights; Bristol, not surprisingly, stolidly stands behind its claim. Lilly CEO John Lechleiter (photo) was noncommittal: "We feel good where we are" with the experimental med, he said during a conference call about the deal. And he promised that Lilly and Bristol would hash over the subject soon.

- read Bristol's release
- see the post at the Wall Street Journal Health Blog
- check out the Forbes article

Lilly nabs ImClone in $6.5B deal

Tracy Staton — Mon, 06 Oct 2008 10:05:27 -0400

It's official: Eli Lilly is the highest bidder for ImClone Systems. The drugmaker has agreed to pay $6.5 billion cash for ImClone, outbidding Bristol-Myers Squibb by more than 10 percent. And the $70-a-share price represents a 50 percent premium to ImClone's closing price the day Bristol first announced its interest in a buyout.

Lilly is touting the two-company combo as a "global leader in oncology biopharmaceuticals." The deal amounts to "a very important step forward in addressing the challenges of patent expirations we will face early in the next decade," says Lilly CEO John Lechleiter (photo) in a statement.

The cancer drug ImClone is known for, of course, is Erbitux--a product that it markets in partnership with Bristol. ImClone also has a promising cancer drug candidate that's either a follow-up to or potential competitor for Erbitux, depending on who's talking. Bristol claims that it's a follow-up, which would mean that Bristol gets a piece of the pie. ImClone says no. We'll have to wait and see what Lilly says.

No word yet on how Bristol is reacting to the news that Lilly snatched its buyout target away. But we can bet ImClone Chairman Carl Icahn has a big "I told you so" ready for Bristol's Jim Cornelius.

- see the Lilly release
- read the story in the Star-Ledger

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

Did BMS bid to avoid ImClone dispute?

Tracy Staton — Mon, 11 Aug 2008 10:39:44 -0400

When Bristol-Myers Squibb announced its bid to buy its partner ImClone, a lot of people asked, Why now? ImClone's stock is a lot higher now than it was a couple of years ago. So if BMS didn't make an offer then, why would it pay more today? Apparently, the answer lies in the successor to the partnership's successful cancer med Erbitux--and in some contract language vague enough to give ImClone a claim to full rights to it.

Bristol says it's entitled to a piece of Erbitux the second, known as IMC-11F8. The companies' 2001 agreement stipulates that if this next-generation med was derived in any way from the original Erbitux, or if it's a competing product, BMS gets its share. But ImClone says Bristol's out of the picture (after saying it was in some time back, but you'll have to read the Wall Street Journal's story to get the details).

The disagreement could end up in a years-long slog through arbitration. Or BMS could buy ImClone and avoid all that, hence the $4.5 billion offer for the 83 percent of ImClone that Bristol doesn't already own. But BMS may have to raise its price. The market is still betting on a higher bid; ImClone stock closed Friday at almost $64.

- read the Wall Street Journal story
- see the Health Blog's post

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

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

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

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

ALSO NOTED: Novo Nordisk creating 400 NJ jobs; Schering to sell off animal products;

Thu, 24 Apr 2008 06:59:50 -0400

> GlaxoSmithKline is acquiring Cambridge, MA-based Sirtris Pharmaceuticals for $720 million. GSK will pay $22.50 per share for the company. Report

> Novo Nordisk plans to expand its North American headquarters in New jersey, adding 400 jobs. Report

> Schering-Plough is selling 12 animal health products, including several vaccines, to Pfizer and the French animal health firm Virbac. Release

> Bayer's net income dropped by 73 percent for the first quarter--but before you have a heart attack, realize that last year's figure was inflated by the company's sale of its diagnostic business. Income from continuing operations rose 16 percent, to $1.2 billion, on $13.4 billion in revenues. Report

> ImClone Systems boosted revenues by 15 percent during the first quarter, to $162.6 million, on a 36 percent hike in Erbitux sales, but an $84 million charge took the bottom line into the red by $55.9 million. Report

> Fresenius Kabi offered to buy an additional 20 percent of the family-controlled Indian drug company Dabur Pharma; already Fresenius had agreed to buy the Burman family's 73.3 percent stake. Report

> Nicholas Piramal India saw fourth-quarter profits soar on a 19 percent increase in revenues. Report

> Theravance announced that it is cutting 40 percent of its workforce now that it has finished work on its antibiotic telavancin. Report

> The U.K.'s Acambis has won a $425 million contract to supply the CDC with its smallpox vaccine for 10 years. Report

And Finally... DTC advertising is poised for growth this year, just as regulators and activists are considering reforms. Report

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

Avastin, Erbitux side effects probed

Thu, 13 Mar 2008 07:59:55 -0400

Researchers figured out how two different cancer drugs--Avastin and Erbitux--might lead to side effects. Made by Genentech, Avastin can cause kidney damage in some people. And Erbitux, sold by Bristol-Myers Squibb, causes severe allergic reactions in about 3 percent of patients.

Avastin works by cutting off the blood supply to tumors, inhibiting the growth of blood vessels feeding the cancer. But the medicine can also inhibit growth of tiny blood vessels in the kidney, researchers said. About 1 percent to 2 percent of patients develop serious kidney damage; 21 percent to 64 percent excrete excess protein in their urine, which can be an indicator of damage. The study's lead author said more research needs to be done into just how many patients end up with some level of kidney damage, because as of now, "we don't know."

Meanwhile, the Erbitux reactions may be preventable. The reactions appear to be caused by antibodies patients previously developed, perhaps in reaction to--of all things--tick bites. Researchers saw that the allergic reactions were most common in southeastern states such as Tennessee and North Carolina; there, they saw that patients bitten by multiple ticks developed the sort of antibodies that caused reactions to Erbitux. A test for these antibodies is under development.

- find the study abstract on Avastin in the New England Journal of Medicine
- see the article in the Washington Post
- read the Erbitux abstract in NEJM
- check out this coverage

Related Articles:
FDA approves Avastin for lung cancer. Report
Erbitux clears late-stage hurdle for lung cancer. Report
Erbitux ok'd as front-line colon cancer drug. Report

BMS, AZ, Wyeth report earnings

Thu, 31 Jan 2008 06:59:54 -0500

A handful of drug makers released their earnings, and it's a mixed bag: some up, some down, some hit by one-time charges. Here's a roundup.

Bristol-Myers Squibb reported a fourth-quarter loss of $133 million on revenues of $5.38 billion, profits hampered by a slate of extraordinary charges. Rebounding sales of the clot-buster Plavix, plus rising revenues from cancer-fighter Erbitux and other meds, boosted sales. But BMS isn't as optimistic about 2008 earnings now as it was in December; it downgraded EPS expectations to $1.36 to $1.46 from $1.44 to $1.54.
AstraZeneca met analysts' expectations with a 3 percent downfall in 2007 earnings, citing "challenging" market conditions. Pretax profits were $7.98 billion on a 12 percent hike in sales to $29.56 billion. In 2008, the company faces possible generic competition for its blockbuster heartburn drug Nexium and its schizophrenia drug Seroquel. But, AZ says, its cost-cutting plan--which includes cutting 10 percent of its workforce--will help profits in the coming year.
Wyeth reported a 19 percent increase in fourth-quarter net on strong sales growth of its arthritis, heartburn and antidepressant meds. Income rose to $1.02 billion, or 75 cents per share, on a 10 percent increase in revenues to $5.76 billion. But it's not as optimistic about 2008 as analysts had expected; it projected earnings for the coming year of $3.35 to $3.49 per share, compared with analysts' target of $3.54. One reason: It could face generic competition for its top-selling drug, Effexor, which loses patent protection on its active ingredient this year.

- see the earnings release from BMS
- here's AstraZeneca's earnings release (.pdf)
- see the article on AZ's earnings at CNBC
- check out a more detailed look at AZ's results in the Financial Times
- get the release and find the story on Wyeth's results

ImClone goes long on Erbitux

Tue, 08 Jan 2008 06:59:54 -0500

Is all the Erbitux hype warranted? Some industry analysts say yes, others say they're skeptical. The right answer carries big stakes, because ImClone Systems has all its short-term eggs in that cancer drug's basket.

You'll recall that ImClone is aiming to expand the use of Erbitux beyond its current indications for colorectal cancer and head and neck cancers. The company completed a lung cancer study last year, but so far it's been coy about the results, saying only that they have "positive news." The data is scheduled for release at the June meeting of the American Society of Clinical Oncologists; analysts say the company's recent surge on the stock market has been stoked by anticipation of good news. At least one analyst predicts that Erbitux will hit $4 billion in sales eventually. But others say the company has raised questions by holding back details of that lung cancer study.

Now, Erbitux is ImClone's only product, and it's years away from launching any of its late-stage candidates. Some say that pipeline is strong. For confirmation of that, and for any solid info on the forthcoming data, we'll all have to wait.

- read the report from CNN Money

Related Articles:
Erbitux ok'd as front-line colon cancer drug. Report
Erbitux clears late-stage hurdle for lung cancer. Report
ImClone shares dive after Erbitux fails a Phase III. Report

ALSO NOTED: Erbitux surge doesn't produce ImClone profit; Glenmark to sell MeyerZall drugs in S. Africa;

Thu, 25 Oct 2007 06:59:50 -0400

> Despite rising Erbitux sales, ImClone Systems lost $916,000 in the third quarter; the culprit was higher operating costs, including a $50 million charge for a patent lawsuit settlement. Report

> Indian drug maker Glenmark Pharmaceuticals has inked a deal with South Africa-based MeyerZall Laboratories to market a handful of topical dermatology drugs in that country. Report

> Celgene almost doubled its profits in the third quarter, to $38.8 million from $20.4 million the same period last year; revenues were up by $104 million to $349.9 million. Report

> Belgium-based Galapagos shares shot up 12 percent on news that the company has inked a massive deal with Jassen Pharmaceutica, a division of Johnson & Johnson. Report

> The FDA has issued an approvable letter for Noven Pharmaceutical's Stavzor, a treatment for manic episodes associated with bipolar disorder, an adjunctive therapy in multiple seizure types, and prophylaxis of migraine headaches. Report

And Finally... One way to help wipe out scary drug-resistant staph? Screen patients as they enter the hospital. Report

SPOTLIGHT: Merck KGaA leads team to sell Erbitux in Japan

Wed, 17 Oct 2007 06:59:52 -0400

Merck KGaA leads team to sell Erbitux in Japan
Call it a trifecta: ImClone Systems, Bristol-Myers Squibb and Merck KGaA are joining together to develop and market ImClone's cancer drug Erbitux in Japan, with Merck getting half the proceeds. Report

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

SPOTLIGHT: Erbitux gets first-line status

Wed, 03 Oct 2007 06:59:52 -0400

The cancer drug Erbitux can be marketed as a first-line treatment for colon cancer, now that the FDA has OK'd a label change. The drug is made and marketed by ImClone Systems and Bristol-Myers Squibb. Release

ImClone: Stock buy timing a coincidence

Thu, 13 Sep 2007 06:59:56 -0400

Talk about great timing: new ImClone CEO John Johnson (formerly, yes, of Johnson & Johnson) did his executive duty Friday by buying a half-million shares of the company's stock at $36.74 each. Monday, the stock closed at $37.93. Yesterday, of course, the stock soared to almost $45, on news that ImClone's cancer drug Erbitux showed promise in treating lung cancer patients. Shares are currently trading at $44.62.

Johnson's contract with ImClone required him to buy the 500,000 shares within three months of his August 27 start date. And he has to hold the shares for as long as he's CEO. The company says the timing of his stock purchase was a coincidence; he'd come into some money from J&J and decided to go ahead. But with ImClone's history--former CEO Sam Waksal is in prison for insider tip-offs--it may be a coincidence that attracts SEC scrutiny.

- read the report from Mike Huckman's blog on CNBC.com

Related Articles:
ImClone names new CEO. Report
Icahn takes control of ImClone as CEO departs. Report
Investors cheer positive Erbitux trial. Report
ImClone CEO Lynch resigns. Report