DCVMN / PhRMA / EFPIA / IFPMA / BIO Watch [to 27 June 2015]

:: Pfizer Enters Into Agreement To Acquire Nimenrix And Mencevax From GlaxoSmithKline
June 22, 2015
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130 million (€115 million). This transaction will add two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population…
… “The addition of Nimenrix and Mencevax is an important milestone for Pfizer Vaccines. Adding these two innovative and complementary vaccines to our current portfolio will allow us to more completely respond to meningococcal disease outbreaks as well as proactively address a critical public health need – the prevention of meningococcal disease across all ages,” said Susan Silbermann, President, Pfizer Vaccines. “Acquiring these quadrivalent vaccines will broaden our ability to address the burden of meningococcal meningitis – an uncommon but serious and sometimes fatal disease. This helps us to further fulfill our vision to protect lives with innovative vaccines to fight serious diseases worldwide and gives us even greater capability to meet the needs of the global community we serve.”…

:: U.S. CDC committee recommends physicians make individual decisions on the use of meningococcal group B vaccines
PHILADELPHIA, June 24, 2015 /PRNewswire/ — GlaxoSmithKline (LSE: GSK) announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO® (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18). This recommendation means that the decision to vaccinate against meningococcal group B will be made by qualified healthcare professionals, based on individual patient risk assessment. BEXSERO® was approved by the U.S. Food and Drug Administration (FDA) in January 2015 through an accelerated approval pathway for use in individuals aged 10 through 25 years and acquired by GSK in March 2015 following the closure of the three-part transaction with Novartis.
“GSK welcomes this vote as an important step forward to help protect against meningococcal disease in the U.S.,” said Patrick Desbiens, Senior Vice President, U.S. Vaccines, GSK. “Meningococcal disease is fast-moving, unpredictable and can cause irreversible damage, so vaccination is the best tool to help prevent it. Today’s vote is the latest milestone on a 20-year journey to develop a vaccine in order to help protect individuals from this devastating condition.”…

:: CDC Advisory Committee on Immunization Practices Votes to Recommend Serogroup B Meningococcal Disease Vaccination including TRUMENBA® for Adolescents and Young Adults 16 through 23 Years of Age
Committee’s Recommendation Allows for Individual Clinical Decision
June 24, 2015
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. Specifically, the ACIP voted that a serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age.
“Serogroup B meningococcal disease is an uncommon but serious illness that attacks without warning and may become life-threatening within 24 hours”
Pfizer’s TRUMENBA® (Meningococcal Group B Vaccine) is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
“Healthcare providers should understand the importance of today’s ACIP recommendation to help protect adolescents and young adults,” said Dr. Laura York, Global Medical Lead for Meningococcal Vaccines, Pfizer Vaccines. “This recommendation is an important step forward that provides guidance that serogroup B meningococcal disease vaccination may be administered between the ages of 16 through 23, with preferred timing for vaccination between ages 16 through 18.”…

:: PhRMA Statement on ASCO Value Framework
Washington, D.C. (June 22, 2015) — Pharmaceutical Research and Manufacturers of America (PhRMA) executive vice president, policy and research, Lori Reilly provided the following statement on the American Society of Clinical Oncology’s (ASCO) conceptual framework for assessing the value of new cancer treatment options based on clinical benefit, side effects, and cost.