The Burrill Report

Pfizer said four patients enrolled in a late-stage clinical trial of its oral rheumatoid arthritis drug tofacitinib died during or after treatment, but that only one death has been linked to the drug, the Wall Street Journal reports. When news of the four deaths broke, shares of Pfizer fell as much as 5 percent and ended the day down 3 percent on a trading volume nearly three times its average volume. The patient whose death was linked to the drug died of respiratory failure. Pfizer says that full results of the ORAL Sync study of tofacitinib will be presented May 27 at a scientific meeting in London.

NicOx withdrew an application seeking marketing authorization for its osteoarthritis candidate naproxcinod in Europe following feedback from the Committee for Medicinal Products for Human Use indicating that it would not recommend approval of the drug because the data NicOx submitted did not demonstrate benefits outweighing its risks. NicOx had submitted its application in December 2009. NicOx is now evaluating its options for the potential further development of naproxcinod in Europe, together with its advisors and with Grupo Ferrer Internacional, which has an option for rights to naproxcinod in certain European countries. Shares of the company plummeted as much as 34 percent on the news, hitting an eight year low. NicOx’s marketing application to the U.S. Food and Drug Administration was denied in July 2010 and the company received a complete response letter, which it is appealing.

Johnson & Johnson’s Janssen Pharmaceutica decided not to exercise its option to continue development of Furiex Pharmaceuticals’ JNJ-Q2, a novel broad-spectrum fluoroquinolone antibiotic. Furiex has now acquired full exclusive license rights to develop and commercialize the compound JNJ-Q2 under their agreement. Furiex has completed a successful mid-study of the JNJ-Q2 for the treatment of acute bacterial skin and skin structure infections and is currently conducting a phase 2 study in patients with community acquired bacterial pneumonia. The company intends to progress development of JNJ-Q2 and may owe royalty and other payments to Janssen based on future regulatory milestones.

Idera Pharmaceuticals will delay initiating its planned phase 2 clinical trial of IMO-2125, a toll-like receptor 9 agonist, based on preliminary data from a 26-week nonclinical toxicology study of IMO-2125 in rodents that showed instances of atypical lymphocytic proliferation. The phase 2 clinical trial involves the evaluation of IMO-2125 plus ribavirin in treatment-naïve, genotype 1 hepatitis C virus patients. Idera is conducting chronic 26-week nonclinical toxicology studies of IMO-2125 in rodents and non-human primates. Idera expects data from the non-human primate study and additional histology data from the rodent study during the second half of 2011.

AstraZeneca is facing a lawsuit that charges its acid reflux drug Nexium caused a 58-year-old Ohio woman’s bones to deteriorate. Ginny Begin, of Toledo, Ohio, suffered serious bone deterioration after taking the drug daily between 2003 and early 2011. In March, the U.S. Food and Drug Administration issued a safety alert stating use of prescription proton-pump inhibitors, including Nexium, results in an increased risk of fractures. In May 2010, the FDA mandated manufacturers of these drugs include safety information and warnings about the increased risk of osteoporosis and fractures associated with them. The lawsuit alleges that studies as early as 2006 found that proton-pump inhibitors interfered with the body’s ability to absorb calcium, thus speeding up bone loss and leading to an increased number of fractures. The lawsuit states that six studies found an increased risk of fracture in women. It also alleges that AstraZeneca knew of these risks but continued to market and sell Nexium without warning consumers. Begin’s law firm says its suit seems to be the first filed against AstraZeneca arising from bone fractures caused by Nexium. The pharmaceutical company earned $5 billion from sales of the drug last year.



April 22, 2011
http://www.burrillreport.com/article-pfizer_says_patient_died_from_experimental_ra_drug.html