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TRIALS AND TRIBULATIONS

J&J; Terminates Trial of Investigational Skin Disorder Drug

The weekly round-up of failed trials, missed targets, and other business mishaps.

J&J; Terminates Trial of Investigational Skin Disorder Drug

The Burrill Report

Johnson & Johnson terminated a clinical trial of an experimental drug, JNJ-3975897, for a skin disorder after two patients in Japan encountered a substantial drop in their white blood cell count. The company also cancelled two planned trials to test the same drug as a treatment for rheumatoid arthritis and asthma. The mid-stage trial for skin disorder was testing the drug at two different dosage levels in adult Japanese patients that develop scaly and itchy rashes on the skin. A Johnson & Johnson spokesman said that the two patients had fully recovered from the drops in white blood cells but the company declined to disclose any further details on the mechanism of action of the drug, or why it may have caused the adverse event.

A panel of outside advisors for the U.S. Food and Drug Administration voted 5-3 to recommend the rejection of Cornerstone Therapeutics’ experimental drug for the treatment of low sodium in patients who have a condition that causes the body to retain excess water. The drug, lixivaptan, was also rejected as a potential treatment for heart failure patients with low sodium. Most panel members determined that the drug’s risks outweighed its benefit of raising sodium levels. In the clinical trial for heart failure patients, lixivaptan was linked to more deaths than the placebo, though it was unclear if the drug directly caused the deaths. The panelists called for more clinical trials to see if lixivaptan actually improves patients’ symptoms or helps them live longer.

Weekly prescriptions for Merck’s asthma and allergy treatment Singulair dropped nearly 90 percent since generic competitors entered the market at the beginning of August. Adam Schechter, president of Merck’s global human-health unit, said during a presentation at a Morgan Stanley conference that Singulair weekly prescriptions had declined 87 percent within four weeks of losing its U.S. patent protection. Though Merck had anticipated a significant decline in prescriptions of its blockbuster drug, it had not anticipated such a rapid decline, Schechter told analysts. Based on historical valuations, the company had predicted it would take Singulair two months to lose 90 percent of its U.S. market share. Singulair had long been Merck’s top selling drug, generating $5.5 billion in revenue in 2011.

Navidea said it received a complete response letter from the U.S. Food and Drug Administration after the regulatory agency denied Navidea’s application for its radioactive cancer imaging agent, Lymphoseek. Navidea has said that the FDA rejected its application because of problems with a third-party manufacturer. “We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review,” Mark Pykett, CEO of Navidea said. “We remain confident that our clinical data clearly demonstrate the value of Lymphoseek.” Investor’s, however, responded by selling shares of the company. Navidea’s stock plunged more than 37 percent in aftermarket trading on the day of the announcement.

Lundbeck said it plans to discontinue its leukemia treatment, Elspar, globally because of manufacturing and supply difficulties. “[We] are no longer in a position to guarantee a future supply [of Elspar],” said Roger Keding, vice president of supply chain management. “Lundbeck has concluded that continuing to manufacture and distribute Elspar is not a sustainable business going forward.” The company pointed out that the decision to discontinue the drug had nothing to do with safety or efficacy issues, but, rather, that it been challenging to find a new supply chain for it. The company would have had to make additional investments and changes to certain processes to maintain long-term sourcing of the drug, and it believed that those changes would unlikely be accepted by health regulators. Elspar had accounted for 1 percent of Lundbeck’s U.S. sales.



September 14, 2012
http://www.burrillreport.com/article-jj_terminates_trial_of_investigational_skin_disorder_drug.html

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