Industry Watch [to 13 December 2014]

:: Sanofi Pasteur Announces FDA Approval of Fluzone® Intradermal Quadrivalent (Influenza Vaccine) for Adults
– The first and only four-strain influenza vaccine option administered intradermally –
– Helps protect adults 18 through 64 years of age against an additional influenza B strain
SWIFTWATER, Pa., Dec. 12, 2014 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus. Fluzone Intradermal Quadrivalent vaccine is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza (“the flu”) caused by influenza A subtype viruses and type B viruses contained in the vaccine.
“Influenza B is a common cause of influenza-related morbidity and mortality across all age groups,” said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. “Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system.”…

:: FDA Approves Merck’s HPV Vaccine, GARDASIL®9, to Prevent Cancers and Other Diseases Caused by Nine HPV types – Including Types that Cause About 90% of Cervical Cancer Cases
GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine
December 11, 2014 05:30 PM Eastern Standard Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is also approved for use in boys 9 to 15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
“With GARDASIL 9, the medical and public health community now has the potential to help prevent 90 percent of cervical cancers caused by HPV,” said Dr. Julie Gerberding, president, Merck Vaccines. “This is an extraordinary opportunity to even further reduce the burden of HPV-related diseases and cancers in males and females.”…

:: Merck Announces Appointment of Dr. Julie Gerberding as Executive Vice President for Strategic Communications, Global Public Policy and Population Health
December 10, 2014 09:30 AM Eastern Standard Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the appointment of Dr. Julie Gerberding, 59, as executive vice president for strategic communications, global public policy and population health, effective Dec. 15. In this newly created Executive Committee position, Gerberding, who most recently served as president of Merck Vaccines, will be responsible for Merck’s global public policy, corporate responsibility and communications functions, as well as the Merck Foundation and the Merck for Mothers program. Gerberding will also lead new partnership initiatives that accelerate Merck’s ability to contribute to improved population health, a measure of impact that is increasingly valued by governments and other global health organizations.
“Julie has been instrumental in making Merck’s vaccines more accessible and affordable, particularly in emerging markets and many of the world’s most resource-limited countries,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “Julie’s leadership of our vaccines business and her exceptional track record in both the public and private sectors make her ideally suited to lead these areas and to advance our engagement with organizations around the world that, like Merck, are working to advance population health.”
Gerberding joined Merck as president of Merck Vaccines in January 2010. Since then, Merck’s vaccines are reaching more people than ever, and Merck became the global leader in the vaccine market based on sales. In addition, the Sanofi Pasteur MSD joint venture in Europe, Merck’s European vaccine business for which Gerberding is the Board co-chair, has improved in both population reach and financial performance. She also helped lead the successful launch in India of the Merck Wellcome Trust non-profit joint venture for vaccine development, the MSD Wellcome Trust Hilleman Laboratories.
Prior to joining Merck, Gerberding served as director of the U.S. Centers for Disease Control and Prevention (CDC) from 2002-2009 and before that served as director of the Division of Healthcare Quality Promotion. Before joining the CDC, Gerberding was a tenured faculty member in Infectious Diseases at the University of California at San Francisco (UCSF). She continues as an Adjunct Associate Clinical Professor of Medicine at UCSF…