Industry Watch  [to 1 March 2014]
Selected media releases and other selected content from industry.

:: Gardasil: New 2-dose Schedule Granted Positive CHMP Opinion for Europe’s Leading HPV Vaccine
Press release | 27 February 2014
Sanofi Pasteur MSD announced today that its quadrivalent HPV vaccine, Gardasil® has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of a two-dose schedule in 9 to and including 13 year old adolescent girls and boys.

:: Novartis provides second US university with Bexsero to help protect students and staff against potentially deadly meningitis B disease
– FDA granted special use of Bexsero for nearly 20,000 UCSB students and staff in response to outbreak; the vaccine is licensed in Europe, Australia and Canada
– Novartis is pursuing a US license that would allow immediate public health response to outbreaks and make Bexsero available to American families
– MenB is an unpredictable disease, easily misdiagnosed, can kill within 24 hours and leaves those affected with serious lifelong disabilities
http://www.prnewswire.com/news-releases/novartis-provides-second-us-university-with-bexsero-to-help-protect-students-and-staff-against-potentially-deadly-meningitis-b-disease-246858901.html\
CAMBRIDGE, Mass., Feb. 24, 2014 /PRNewswire/ — Novartis announced today that its meningococcal serogroup B (MenB) vaccine, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), will be used as part of a vaccination program at the University of California Santa Barbara (UCSB) that began today and will end on March 7. In the last three months, the Food and Drug Administration (FDA) has approved the use of Bexsero twice in response to MenB outbreaks at US college campuses1. More than 5,000 students were vaccinated at Princeton University and 20,000 students will be offered vaccination at UCSB2.
Bexsero is the only licensed broad coverage vaccine approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. It was approved for use in the US under a treatment Investigational New Drug (IND) designation…

:: Pfizer Announces Positive Top-Line Results Of Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13
Data to Be Presented at 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) on March 12, 2014
February 24, 2014 07:00 AM Eastern Standard Time
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives. CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.
“We are pleased with the outcome of the CAPiTA study, which demonstrated that Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia in adults”
The primary objective of the study was to demonstrate efficacy of Prevenar 13 against a first episode of vaccine-type community-acquired pneumonia (CAP). The CAPiTA study also met both secondary objectives, which were efficacy against (i) a first episode of non-bacteremic/non-invasive vaccine-type CAP and (ii) a first episode of vaccine-type invasive pneumococcal disease (IPD).
Vaccine-type CAP (VT-CAP) was defined as CAP caused by any S. pneumoniae serotype included in the vaccine. Non-bacteremic/non-invasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.
http://www.businesswire.com/news/home/20140224005899/en/Pfizer-Announces-Positive-Top-Line-Results-Landmark-Community-Acquired#.UxJGFYUt6F8