The Burrill Report


Investors focused on the missed secondary endpoints and sank Tesaro's shares 23 percent even though the biotech reported positive results from two late-stage trials of its oral cancer drug rolapitant for the prevention of chemotherapy-induced nausea and vomiting, which met the primary endpoints. In the first randomized double-blind trial of 1,369 patients received moderately nausea-producing chemotherapy, the primary endpoint of complete response, defined as no vomiting and no use of rescue medication, in the delayed phase—the 24 to 120 hour period following initiation of chemotherapy. While a greater proportion of patients treated with rolapitant in this trial achieved a complete response in the acute and overall phases and experienced no significant nausea compared to the control arm, statistical significance was not met for these secondary endpoints. Similar results were achieved in a second trial of 555 patients receiving highly nausea-producing chemotherapy, where oral rolapitant was administered with a control anti-nausea medication. Tesaro said the results were good enough to proceed with enrollment in a third and final late-stage trial of patients receiving highly nausea-producing chemotherapy. The biotech is also moving forward with plans to submit a New Drug Application to the U.S. Food and Drug Administration in mid-2014. Tesaro acquired rolapitant from Opko Health in 2010.

Merck issued a voluntary recall of one lot of Gardasil HPV vaccine due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. The vaccine is typically given to children 11 to 12 years old for the prevention of HPV infection, which is known to be a risk factor for cervical cancer. There were 743,360 vials in the affected lot. Merck estimates that approximately ten of those vials could have glass particles in them. Vaccines from the affected lot were distributed between August 20, 2013, and October 9, 2013 and the company said no other lots were affected. Merck said there was little likelihood that if a patient had received a dose of contaminated vaccine, they had only a small risk of experiencing a reaction at the injection site. The efficacy of the vaccine would not be affected.

Actavis said the U.S. Food and Drug Administration denied its New Drug Application for a progestin-only transdermal contraceptive patch for use by women to prevent pregnancy. The company stated that it intends to work closely with the FDA to address its concerns, which primarily related to questions regarding the difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation. Data submitted to the FDA in support of approval came from a 12-month, multicenter, open-label clinical trial conducted in the United States. Actavis submitted the NDA to the FDA on February 26, 2013.

Takeda Pharmaceutical will voluntarily terminate the development of fasiglifam, an investigational treatment for type 2 diabetes, due to concerns about liver safety. The Japanese pharmaceutical was working with three safety monitoring committees to ensure patient safety in a late-stage clinical study. After careful consideration of the data emerging from all the clinical trials and in consultation with these panels, the company reached the conclusion that, on balance, the benefits of treating patients with fasiglifam did not outweigh the potential risks.

December 27, 2013
http://www.burrillreport.com/article-tesaro_reports_positive_results_but_not_good_enough_as_investors_sink_shares.html