Johnson & Johnson

J&J taps surgical chief to lead pharma

Tracy Staton — Fri, 10 Oct 2008 10:19:48 -0400

Another woman will take the mantle from Johnson & Johnson's "most powerful woman in pharma." Veteran J&Jer Sheri McCoy (photo) has been tapped to lead the company's pharmaceuticals division, replacing Christine Poon (photo), who's retiring in March. Now chairman of J&J's surgical products unit, McCoy is a chemical engineer by training; she's served as head of the company's medical devices division in Latin America and as chief of J&J's Ethicon business. Alex Gorsky (photo), who joined J&J back in February after leaving Novartis, will take McCoy's slot as surgical chief.

McCoy will be charged with the difficult task of boosting growth at J&J's pharma unit, which has been struggling of late; last quarter, it posted a 3.1 percent hike in revenue on the back of foreign exchange gains, but without the currency boost, sales would have dropped by 1.3 percent. As you know, J&J recently lost patent protection on its blockbuster antipsychotic Risperdal, and the faces all the same pressures that are plaguing Big Pharma everywhere.

CEO Bill Weldon (photo) cited McCoy's "breadth of business experience" as a big asset. Writing to the Wall Street Journal Health Blog, Weldon said, "Sheri has a strong history of success leading R&D organizations as well as businesses in our consumer and medical devices areas." We'll see how she does at leading the pharma biz.

- check out J&J's release
- read the item at the Health Blog
- see Business Week's coverage

J&J win in patent suit

Christe Bruderlin-Nelson — Wed, 01 Oct 2008 04:14:05 -0400

Johnson and Johnson received some happy news yesterday when a federal judge awarded its cardiac device unit $1.2 billion in a longstanding battle between the megacompany, Boston Scientific and Medtronic over a stent device.

The U.S. District Court in Delaware entered a final judgment benefiting Cordis Corporation, a Johnson & Johnson company, for patent infringements by Boston Scientific and Medtronic from cases from 2000 and 2005 involving the Palmaz balloon expandable stent. In all, the battle has been raging for just over a decade. Previous juries found that Boston Scientific's and Medtronic's stent products and ordered them to pay $703 million and $521 million, respectively.

The final amount includes accrued interest. The best part? The stent the companies were fighting over is no longer on the market.

- read the Wall Street Journal story
- find out more at MSN Money
- see MarketWatch's article

J&J's anemia med linked to stroke deaths

Tracy Staton — Mon, 29 Sep 2008 11:22:32 -0400

The FDA is sifting safety data on Johnson & Johnson's epoetin drug, which has come under a red flag thanks to a German stroke study. The study was testing high doses of Eprex (sold in the U.S. as Procrit) as a treatment for stroke patients. But it turns out that patients taking the J&J anemia drug appeared more likely to die than patients treated with placebo were. Some 14 percent of the Eprex patients died, versus 9 percent of the control group.

J&J took a proactive stance on this data: It notified the FDA of the findings last week. Now, the agency is taking a look at the German trial. It's also going to monitor several other ongoing trials that are testing the neurological effects of epoetin alfa, which also is sold by Amgen under the name Epogen.

As you know, this isn't the first time anemia drugs have come under the safety spotlight. In July, the FDA added warnings to this class of meds, aimed at limiting their use in cancer patients. Studies had shown that the drugs might cause tumors to spread and raise the risk of bleeding, too. Patients whose cancer is curable shouldn't use them, an FDA advisory panel said.

- read the story from US News
- see the Forbes article

Johnson & Johnson - Top 13 Ad Budgets

Maureen Martino — Tue, 23 Sep 2008 16:20:16 -0400

Company: Johnson & Johnson
2007 Ad Spending: $2.409 billion
2006 Ad Spending: $2.401 billion

Breakdown

Magazines: $ 402.1 million
Newspaper: $ 50.9 million
Outdoor: $ 4.8 million
TV: $ 879.4 million
Radio: $ 34.8 million
Internet: $ 49.2 million

Where J&J is spending money: J&J spent $50.2 million promoting its epilepsy drug Topamax. The drug--which was originally scheduled to go off-patent in September--won extended market exclusivity for one year based on a new pediatric indication for the med. The multi-purpose biologic Remicade saw $14.3 in advertising spending. Overall, J&J spent $49.2M on Internet advertising--far more than any other drug company.

Though J&J spent a substantial amount on prescription drugs, consumer product advertising was the name of the game in 2007. Neutrogena ($165 million), Tylenol ($152 million), Aveeno ($126 million), and Listerine ($111 million) made up the company's top four ad campaigns. J&J also spent $80 million on image advertising, though that was down from $100 million in 2006.

J&J boosted it's Internet advertising budget 41 percent in 2007 to 49.1 million. The company also embraced outdoor advertising--that budget increased 470 percent to $4.8 million. National radio spots were up 71.9 percent to 9.2 million. Overall, company sales rose 14.6 percent to $61 million.

Where J&J isn't spending money: None of J&J's top five ad campaigns included spending on prescription drug advertising. Remicade was the only prescription drug that had an increased budget in 2007 (there was no budget for the biologic in 2007). Topamax dropped 16.2 percent and Zyrtec dropped 17.8 percent. Newspaper advertising fell a whopping 98 percent to a paltry $149,000 from 7.4 million.

Amgen defends Enbrel after J&J wins trial

Tracy Staton — Fri, 19 Sep 2008 10:27:29 -0400

A new Johnson & Johnson drug trial has put Amgen on the defensive. According to the 903-patient study, J&J's experimental drug ustekinumab (Stelara) proved more effective at treating psoriasis than Amgen's blockbuster Enbrel was. "We've never really seen clearance [of psoriasis] along the lines of what we've seen with ustekinumab," one of the trial's lead investigators told the Wall Street Journal.

Amgen fired back, saying that the J&J trial only lasted 12 weeks, and so it didn't address the new drug's long-term safety. Enbrel has a "consistent safety profile," an Amgen spokeswoman said, and 16 years of clinical experience. It's true that the FDA is digging into links between the fungal infection histoplasmosis and TNF-alfa meds, but only 17 of the 240 cases occurred among Enbrel patients. Stelara works via a different mode of action than Enbrel does: It's an interleukin inhibitor, rather than a TNF blocker.

Amgen's safety focus may be well targeted. The FDA recently delayed approving the J&J drug for three months, with a decision now expected in December; this after the FDA advisory panel unanimously recommended approval. The expert panel did discuss worries about possible cancer risks with Stelara, and according to the WSJ Health Blog, safety appears to be the FDA's overriding concern. “We have submitted a summary of safety data to the FDA but efficacy will probably not play a major role in the approval," a J&J biologics exec told the blog. We'll have to wait and see what the agency decides.

- read the WSJ story
- check out the article in Forbes

Johnson & Johnson wins reinstatement

Christe Bruderlin-Nelson — Wed, 17 Sep 2008 05:38:20 -0400

In a patent infringement lawsuit over a decade old that has involved multiple trials, Johnson & Johnson's Cordis unit won reinstatement of more than $595 million in damages. The United States District Court in Delaware handed down the decision.

The company went up against Medtronic and Boston Scientific over coronary artery stents. In 2000, the courts told Medtronic to pay $271 million and Boston Scientific to pay $324 million plus interest at the prime rate based on damages after taxes.

Boston Scientific had motioned for a new trial, but the courts denied it and instead ruled favorably on J&J's motion to move toward final judgment, which it will enter on September 30, 2008.

That's not likely to be the end of the story, however, as Boston Scientific says it will appeal the decision.

- view the Boston Scientific release
- check out the Johnson & Johnson release
- read the WSJ Market Watch article

Top-ranked woman to retire from J&J

Tracy Staton — Fri, 12 Sep 2008 10:08:44 -0400

There's another big executive departure coming in the world of Big Pharma: this time it's Christine Poon (photo), vice chairman of Johnson & Johnson and worldwide chair of its pharmaceuticals division. Poon, 56, plans to retire on March 1, J&J announced today, saying that it will announce a succession plan "in a timely fashion."

With 20 years in pharma, 15 of them at Bristol-Myers Squibb before she joined J&J, Poon has been a heavyweight in the industry. She's the top-ranked woman in the drug business, and, according to Forbes, one of the most respected. The magazine ranked her as the 26th most powerful woman in business in 2006.

- see J&J's release
- read the Forbes article
- get more from Pharmalot

Related Article:
J&J reorg anoints growth czar

FDA holds back on J&J schizophrenia drug

Christe Bruderlin-Nelson — Wed, 27 Aug 2008 01:54:43 -0400

Johnson & Johnson will have to provide the FDA with more information about its candidate schizophrenia drug paliperidone palmitate before it gets approval, the company announced yesterday. J&J's Janssen will market the drug. While J&J did not disclose the specifics of the FDA request, the company did say it will not have to perform any additional studies on the drug and that it intends to comply with FDA and provide the requested information. Release

FDA won't expand Doribax use now

Tracy Staton — Fri, 22 Aug 2008 10:56:06 -0400

The FDA hasn't exactly said "no" to Johnson & Johnson's Doribax, but it has definitely said "not yet." J&J had asked the agency to expand the use of the IV antibiotic to hospital-acquired pneumonia; right now, it's only approved for serious abdominal and urinary tract infections. But the FDA said it needs more info before it makes a decision.

As you know, an advisory committee voted narrowly in favor of the new use for Doribax. But lately, the FDA has been going against its expert advice, as the Wall Street Journal Health Blog notes. It rejected Schering-Plough's sugammedex in spite of a unanimous approval rec. And it delayed a decision on J&J's psoriasis med, ustekinumab. That was another unanimous vote in favor.

In Doribax's case, FDA staff had expressed some doubts about the data J&J submitted in support of its pneumonia use, calling the info "flawed." The advisory committee, despite voting in favor of the new indication, questioned the design of the pneumonia trial. J&J hasn't said just what additional info the agency has asked for, and neither has the FDA; we'll have to wait and see whether the agency wants a whole new trial.

- read J&J's press release
- see the Health Blog's take
- check out the coverage in Forbes

Amgen, Schering-Plough most likely to replenish pipeline

Christe Bruderlin-Nelson — Tue, 19 Aug 2008 11:00:01 -0400

AVOS Life Sciences has created a new analysis using a term called a "replacement ratio" that measures how quickly new products replace lost sales from a particular drug company when it goes off patent. AVOS says the replacement ratio is a direct measure of R&D productivity.

According to the analysis, Schering-Plough is most likely to recover quickly with the most potential in the pipeline, despite earlier bad news about its cholesterol drugs, Vytorin and Zetia.

In fact, of the top 14 pharma companies worldwide, only two--Schering-Plough and Amgen--are projected to maintain a positive replacement ratio. On the other hand, the analysis predicts that in 2012, current bigwigs Roche and Sanofi-Aventis will drop to the bottom of the rankings, as there are no known plans on the part of either company to launch a new product before then.

Several major products will drop off patent by 2012, including Merck's Cozaar and Hyzaar, Wyeth's Effexor, Pfizer's Lipitor, J&J's Risperdal and Topamax and Eli Lilly's Zyprexa. AVOS speculates that the result will be that the top 14 drugmakers will see just 26 cents come in for every dollar lost that year, down 65 percent from 77 cents in 2007.

- read the Pharmalot blog post

Pipeline Reports:
The Top 15 R&D Budgets
The next generation of biotech blockbusters
FiercePharma's 2007 trends & 2008 predictions

New Jersey feels pain of pharma employment drop

Christe Bruderlin-Nelson — Tue, 19 Aug 2008 10:49:41 -0400

A survey released yesterday shows a drop in employment of 1 percent in 2007 from the previous year across the 22 members of the HealthCare Institute of New Jersey, which include companies like Merck, Johnson & Johnson, Pfizer and Roche. Pharma layoffs are the reason for the dip.

The decline is small, but significant in light of industry growth overall.

As we all know, many big pharma companies call New Jersey home, and pharma is one of the key industries of state.

According to the survey, the total New Jersey payroll rose to $7.7 billion, an increase of 1.3 percent. Overall, the economic impact to the state increased by 3.8 percent to $27 billion in 2007.

Nevertheless, members of the group say that they are spending more on research and development and working on new products and drugs. Spending increased by $7.9 billion and was up by 5.3 percent. The survey did not account for biotech companies or companies with pharma workers in New Jersey if the company was headquartered elsewhere.

In the meantime, there might be an additional pharma exodus or two planned from New Jersey, depending on current M&A activities, and California seems to be the hot place for big pharma to go. Roche, for one, has said it too will move its headquarters to California if its deal with Genentech goes through.

--read the story at CNN Money
--see what they're saying at NJ.com
--find the Pharmalot blog post

Texas suspends children's drug program

Christe Bruderlin-Nelson — Tue, 19 Aug 2008 03:43:36 -0400

In another whodunit case, the state of Texas is trying to determine if pharma companies paid researchers inappropriate, but legal, fees to get drugs on a list of preferred psychiatric medications for children. Activities under suspicion include granting researchers consulting contracts, speaking fees and providing other gifts and monetary benefits, but involved researchers say that the implications are untrue and that child advocacy is their utmost priority.

Under a program called the Children's Medication Algorithm Project (CAMP), researchers were tasked with determining the most effective psychiatric medications for children, as well as which drugs to try first on children in state-funded mental health facilities, but state regulators have suspended the project.

In fact, no less than four of the projects' developers have received funds from drug companies, either in the form of research funding, consultancy fees or speaker fees, according to published papers and disclosure forms filed with the University of Texas system--and some of the drugs on the list are drugs manufactured by those very same drug companies.

The reason for the suspension remains unclear, but officials are saying the cause is a lawsuit against Johnson & Johnson regarding false advertising and improper influence with the adult protocol under the Texas Medication Algorithm Project. Others suspect that state investigators are searching for information about whether the children's project had similar issues.

Drug companies today provide more grants and consulting fees than the federal government, which previously was the largest research supporter. While many worry that such funding will influence study results, most physicians say that they do not let the funds affect their findings. Still, the few states that require physicians to report financial ties to drug companies have found at least some evidence that funding affects physicians with drug company connections, including writing more children's prescriptions.

--read the full story at The Dallas Morning News
--catch the Pharmalot blog entry

J&J pays up for Pfizer consumer unit error

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:22:19 -0400

In 2006, Johnson and Johnson acquired a plant in Lititz, PA when it bought Pfizer's consumer health care division. Now federal lawmakers contend that the plant violated paperwork regulations for controlled substances in Pennsylvania during the preceding five years, from 2001 to 2005.

Pseudophedrine is the controlled substance under question, and authorities allege that Prizer's consumer unit imported Benadryl-D, which contains pseudophedrine, from Canada without officially notifying the US Drug Enforcement Agency under the Controlled Substances Act. The Act requires companies to provide written notification of importation of any controlled substances.

J&J settled the case; it will pay $511,000 to the federal government because of the error.

- check out the story at CNN Money
- read the Pharmalot blog post
- get more from the Wall Street Journal
- check out the US Department of Justice statement

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Justice probes biliary stent marketing

Tracy Staton — Tue, 05 Aug 2008 10:39:02 -0400

The U.S. Department of Justice has launched a probe of the bile-duct stent market, trying to determine whether companies such as Abbott Laboratories, Boston Scientific and Johnson & Johnson improperly promoted the devices. The U.S. Attorney's Office in Massachusetts has been subpoenaing stentmakers about their marketing practices, according to SEC filings. The companies have reported that Justice wants to know whether they've promoted the biliary stents for other uses, such as propping open leg arteries.

The U.S. Attorney's office wouldn't comment on the investigation, and the companies themselves wouldn't either, beyond saying that they're cooperating.

- read the Dow Jones story at CNN Money

Bid-happy analysts play matchup

Tracy Staton — Mon, 04 Aug 2008 10:20:11 -0400

Analysts just can't get their minds off which drugmakers might make a deal next. The most recent suspects are Bayer and Onyx, which are partnered on the liver and kidney cancer med Nexavar. One industry observer pointed out that both the Roche-Genentech offer and the Bristol-ImClone bid include lucrative cancer meds. And if you're looking at cancer meds, this one naturally comes to mind. Onyx shares leapt accordingly last week.

And then there's Johnson & Johnson and Vertex. They're partners; Vertex is working on a drug for hepatitis C, and J&J doesn't have those U.S. rights. So snapping up the whole company might be attractive. "Not cheap, but look what you get," one analyst wrote to investors.

Meanwhile, Deutsche Bank's Barbara Ryan threw some cold water on speculation that Eli Lilly might buy out Amylin for full access to Byetta, the diabetes med. New scrips for that drug have been flat lately, she said. Plus, Amylin is "a one-product story," whereas Genentech and ImClone have more to offer.

- read the post at the Wall Street Journal Health Blog
- check out the item at Pharmalot

J&J nabs Topamax patent extension

Tracy Staton — Fri, 25 Jul 2008 09:52:25 -0400

Johnson & Johnson's epilepsy med Topamax won't go off patent in September as scheduled because the FDA has extended market exclusivity for one year based on a new pediatric indication for the med. Report

Study links J&J epilepsy med to birth defects

Tracy Staton — Tue, 22 Jul 2008 09:43:55 -0400

Just a week after FDA experts narrowly rejected a new black-box warning on epilepsy drugs, new research shows that one of them, Johnson & Johnson's Topamax, may increase the risk of birth defects. In a small study--203 patients--scientists found a 14-fold increase in the risk of birth defects. The risk appeared to be higher among patients who took Topamax in combination with valproate (Depakote) or other epilepsy meds.

Experts stressed that the results need to be confirmed, because the study was small. And pregnant women with epilepsy should not stop taking the drug, they said, because seizures can cause even greater damage to a fetus. Women using it to prevent migraines should stop if they're pregnant or trying to get pregnant, they said. They didn't mention off-label use of Topamax--sometimes in combination with valproate--for bipolar disorder, but presumably those patients ought to discuss with their doctors, too.

- read the Los Angeles Times story
- see the article in the Washington Post

Panel gives mixed blessing to J&J's Doribax

Tracy Staton — Thu, 17 Jul 2008 10:14:13 -0400

Johnson & Johnson's Doribax squeaked through an FDA advisory panel yesterday, winning its blessing as an effective treatment for hospital-acquired pneumonia on a 7-6 vote. And at least one panelist still had doubts: "I voted yes with great reservation," Dr. James K. Stoller told Dow Jones, citing worries about J&J's supporting studies.

Like FDA staffers, a majority of the expert panelists weren't happy with the studies J&J used as justification for the antibiotic's new use. They voted 9-4 against accepting those trials, saying they weren't statistically rigorous enough to prove Doribax works as well as older drugs for the same use. FDA reviewers said they'd found cases in which "patients with worsening chest X-rays were evaluated as cures." And some panelists thought the drugmaker should have produced evidence that Doribax saved as least as many lives as existing meds. But an AstraZeneca VP on the panel didn't like that idea at all, saying that "practical compromises" are necessary to get new drugs onto the market.

But ultimately, enough of the panels weighed in on the positive side of the ledger to get Doribax its recommendation. The FDA doesn't have to follow that advice, but it usually does. If it rejects Doribax's new indication, analysts said, that could create a high bar for other hospital-acquired pneumonia drugs to clear.

- see J&J's release
- read the story in Forbes
- check out the Dow Jones coverage

Related Articles:
FDA extends Doribax review
Doribax--2007 FDA approvals

J&J's consumer sales drive earnings growth

Tracy Staton — Tue, 15 Jul 2008 10:29:48 -0400

Mixed news on Johnson & Johnson today, too: Reporting its second-quarter results this morning, J&J announced a healthy 8 percent hike in net income on strong sales of its consumer products. The company also boosted its 2008 earnings forecast (for the second time) to $4.50 per share from $4.45. But that good news follows an FDA announcement late yesterday that it has "major concerns" about the company's application for a new indication on its antibiotic Doribax.

Let's look at the earnings first. Profits came in at $3.33 billion, up from $3.08 billion year-over-year; revenues rose 8.7 percent to $16.45 billion. EPS of $1.17 per share handily beat Wall Street estimates of $1.12. It was consumer products, though, that delivered the goods. Newly over-the-counter Zyrtec helped boost those sales by 13.2 percent. But pharma sales themselves only grew by 3.1 percent. The autoimmune drug Remicade saw its sales expand by 2 percent, which, though modest, certainly outclassed Procrit, the anemia drug, which fell by 14 percent. Sales of the antipsychotic Risperdal dropped 16 percent in advance of a quarter's-end generic competitor; we'll have to wait and see how that drug fares with full-on generic competition next quarter.

On Doribax, the FDA had been entertaining the antibiotic as a treatment for ventilator patients with pneumonia. Currently, the drug is OK'd for complicated urinary tract and intra-abdominal infections. The agency said that many patients in the study lacked convincing evidence that they had pneumonia. So, FDA says, it can't properly evaluate the efficacy of the drug for this use. The indication is up for discussion at an FDA advisory panel later this week, so we'll soon see what those experts think.

- read J&J's earnings release
- see the Wall Street Journal's earnings coverage
- find the WSJ's story on Doribax
- check out CNN Money's Doribax article

Amgen, J&J settle sales-discount lawsuit

Tracy Staton — Mon, 14 Jul 2008 10:35:21 -0400

Amgen agreed to pay $200 million to settle an antitrust lawsuit by Johnson & Johnson's Ortho Biotech unit, putting to rest 2½ years of legal wrangling over Amgen's sales of its oncology products Aranesp, Neupogen, and Neulasta. Report