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

:: Novartis announces divestiture of influenza vaccines business to CSL for USD 275 million
CSL to acquire Novartis influenza vaccines business, including development pipeline, for USD 275 million
Basel, Switzerland, October 26, 2014 – Novartis today announced it has entered into a definitive agreement to divest its influenza vaccines business to CSL Limited (CSL) for an agreed price of USD 275 million. This transaction requires regulatory approvals and is expected to close in the second half of 2015.
CSL has more than 40 years of experience in the influenza vaccines business and operates in 27 countries with more than 13,000 employees worldwide. In addition to vaccines, CSL has established businesses in plasma-driven therapies, pharmaceuticals, antivenoms and immunohemotology. The Novartis influenza vaccines unit will be combined with CSL’s subsidiary, bioCSL.
“In CSL, we have found not only an owner for the influenza business that shares our commitment to protecting public health, but also a strong growth platform for the business and our associates,” said Joseph Jimenez, CEO of Novartis.
The Novartis influenza vaccines business has a strong track record of delivering almost 1 billion doses of seasonal and pandemic influenza vaccines globally over the last 30 years. The company was the first and only manufacturer with the flexibility of two production technologies – egg-based vaccines for seasonal, pandemic and pre-pandemic, and cell-culture-based vaccines for antibiotic-free production with the potential for rapid scale-up to protect against pandemic threats. The business also benefits from access to a proprietary adjuvant platform and leadership in pandemic preparedness.
Novartis remains fully committed to the influenza business during the transition period to closing, including honoring agreements with customers, research and development for influenza vaccines and product launches
:: Pfizer Receives FDA Accelerated Approval for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults
October 29, 2014
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TRUMENBA® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains.
TRUMENBA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs…

:: Profectus BioSciences Receives $9.5 Million Department of Defense Funding to Manufacture Trivalent VesiculoVax™-Vectored Vaccine to Protect Against all Ebola and Marburg Viruses – Funding to support GMP manufacture of VesiculoVax™-vectored vaccines for Zaire-Ebola virus, Sudan-Ebola virus, and Angola-Marburg virus that will be blended into a single formulation; rapid follow-up Phase 1 clinical trial planned –
BALTIMORE, Md., Oct. 31, 2014 /PRNewswire/ — Profectus BioSciences, Inc., a clinical-stage vaccine company developing novel vaccines for the treatment and prevention of infectious diseases, announced today that the Department of Defense (DoD) through the Medical Countermeasure Systems-Joint Vaccine Acquisition Program (MCS-JVAP), a subordinate command of the Joint Program Executive Office for Chemical and Biological Defense, Edgewood, MD, has contracted the manufacture and IND-enabling preclinical testing of the Profectus trivalent Ebola/Marburg vaccine. In addition, the USACC has contracted for clinical evaluation of the VesiculoVax™ Zaire-Ebola virus vaccine to meet the current outbreak in West Africa…