Have J&J's Approval Hopes Vanished?

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Acute coronary syndrome might not be the biggest market for Johnson & Johnson's (NYSE: JNJ  ) Xarelto -- the blood thinner is already approved to prevent blood clots after surgery and to treat atrial fibrillation, a type of irregular heart beat -- but it could be the most important.

Xarelto is likely to see competition from Bristol-Myers Squibb (NYSE: BMY  ) and Pfizer's (NYSE: PFE  ) blood thinner called Eliquis, which most people view as the best drug for atrial fibrillation. But in acute coronary syndrome, bleeding caused by Eliquis trumped any efficacy benefit, leaving room for Xarelto to move in.

A decision on Eliquis in atrial fibrillation is expected on June 28. A day later, the Food and Drug Administration is expected to make a decision about Xarelto in acute coronary syndrome. Unfortunately it looks as if Johnson & Johnson might have a hard time sidestepping the competition into the new indication.

An advisory panel voted 6-4 with one abstention on Wednesday recommending that the drug not be given an expanded label. That's good news for AstraZeneca's (NYSE: AZN  ) Brilinta and Eli Lilly's (NYSE: LLY  ) Effient, which both treat acute coronary syndrome patients.

The panel of outside experts was worried about the large number of patients in the trial that were lost to follow-up. In a trial that spans multiple years, it's reasonable to expect that patients will drop out for reasons not related to the efficacy and safety of the drug, but it does confound the analysis.

The FDA rarely goes against an advisory committee's negative recommendation -- overruling a positive recommendation is much more common -- but this is one of the atypical times when I wouldn't be shocked to see the agency ignore the panel's negative advice. While the FDA pointed out the missing data in its briefing documents for the panel, the FDA reviewer ultimately said the drug looked approvable.

If the agency does reject the expanded indication, Johnson & Johnson and its partner Bayer will be left in a tight spot. They might be able to expend energy in tracking down the missing patients, but running another multiyear trial would be costly and might result in the same issue with a high level of dropouts.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Pfizer and Johnson & Johnson. Motley Fool newsletter services have recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

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  • Report this Comment On May 26, 2012, at 9:27 AM, talan123 wrote:

    Considering they have another recall that just went out, I don't know how anybody can invest in this company.

    Here are the recalls in the last few years...

    In February, J&J pulled about 574,000 one-ounce bottles of grape-flavored liquid infant Tylenol after receiving a small number of complaints that the dosing system was difficult to use.

    In December, J&J recalled about 12 million bottles of Motrin brand painkillers because some pills may not dissolve quickly, delaying pain relief.

    In September, J&J pulled about 200,000 syringes of its Eprex anemia drug at the wholesale and pharmacy level because some batches of the drug might not have been sufficiently potent.

    In August, J&J said it was recalling from wholesalers and stores almost 2.5 million packages of Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps due to higher-than-expected levels of a certain compound.

    In late June, McNeil Consumer Healthcare division said it was pulling one lot, or 60,912 bottles, of Extra-Strength Tylenol in the U.S. following “a small number of odor reports.” The smell has been linked to trace amounts of a chemical that’s a byproduct of a preservative sometimes applied to wooden pallets used in storage and transportation. It’s not toxic but can cause GI upset.

    In mid-June J&J pulled 16,000 bottles of Risperdal due to the same odor issues.

    J&J said in May it would pull an estimated 2,000 bottles of Prezista in four European countries due to odor.

    In April J&J recalled about 57,000 bottles of Topamax because of the smell.

    In late March, McNeil Consumer Healthcare pulled about 34,000 bottles of Tylenol 8-Hour Extended Release caplets because of a musty odor. Separately, it widened a wholesale-level recall of Tylenol, Benadryl and Sudafed products.

    Also in March, J&J’s Ethicon unit recalled about 360,000 units of surgical-wound draining products on concerns that the package’s sterility could be compromised.

    Earlier that month, J&J’s Animas unit recalled more than 384,000 insulin-pump cartridges in the U.S. and France, saying they have the potential to leak and give a too-low dose.

    J&J’s Ethicon unit issued a late-December alert in the U.K. that it was recalling about 585,000 surgical sutures. The sutures were mostly sold in Europe.

    In late February, J&J recalled more than 667,000 Sudafed packages at the wholesale level after a typo on the packaging (“do not not divide, crush, chew, or dissolve the tablet”) was discovered.

    Earlier in February, J&J said it was pulling at least 395 injection pens preloaded with rheumatoid-arthritis drug Simponi because they may not deliver a full dose of the drug.

    Days before, we reported that the company’s Ethicon unit recently recalled 700,000 vials of a liquid wound sealant and also a hernia-treatment product.

    Earlier that same week, J&J said it was recalling 70,000 syringes preloaded with its Invega injectable anti-psychotic drug because cracks have been found in the syringes that could theoretically lead to infections or under-dosing in users.

    In January 2011, J&J said it would pull 43 million bottles of certain Tylenol, Benadryl, Sinutab and Sudafed products because they were made at the company’s Ft. Washington, Pa., plant at a time when equipment may not have been properly cleaned. J&J also said it would pull almost 4 million units of Rolaids due to a labeling problem.

    In December 2010 the company said it was recalling all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews following consumer reports of foreign-particle contamination.

    A few weeks earlier J&J recalled a dozen different Mylanta liquid products and one AlternaGEL product because they were mislabeled to omit the presence of small amount of alcohol. (Consumers don’t need to stop using the products or return them to stores.) And it separately widened a recall of daily-use contact lenses in Japan and elsewhere due to traces of an acid that can cause stinging.

    In November 2010 the company recalled three Tylenol Cold Multi-Symptom products, also pulled from retailers and wholesalers due to an alcohol labeling issue. Consumers can keep taking the meds, J&J says.

    Also in November the company also recalled children’s Benadryl and Motrin products. Again, J&J said they weren’t dangerous and consumers didn’t have to stop taking them.

    In October 2010, there was a recall of 127,000 bottles of Tylenol 8-Hour caplets due to a musty odor.

    In August 2010, J&J’s DePuy Orthopedics unit pulled two hip implants off the market because of an unusually high rate of replacement surgeries.

    Also in August there was a recall — later widened — of about 100,000 boxes of 1-Day Acuvue TruEye contact lenses.

    Some OTC medicines were pulled in July 2010, including varieties of Benadryl, Tylenol and Motrin. This was a follow-up to a recall of musty-smelling products made at a plant in Puerto Rico.

    In June 2010, the company widened the recall of drugs made at the Puerto Rican plant by five lots.

    The largest batch of children’s medicines were pulled in the spring of 2010.

    In late 2009 there were recalls of Tylenol Arthritis Pain Caplets due to that musty odor issue.

    J&J officially recalled batches of Motrin in July 2009, but has come under fire for an earlier so-called “phantom recall” of the product.

  • Report this Comment On May 26, 2012, at 9:14 PM, SammyP1 wrote:

    It's "atrial fibrillation," not "arterial fibrillation."

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