Companies to optimize manufacturing process using GE FlexFactory
CHALFONT ST. GILES, UK and KINGSTON, ONTARIO, CANADA – 8 June 2016 – PnuVax Incorporated (PnuVax), a vaccine and biopharmaceutical company, and GE Healthcare’s Life Sciences business (NYSE: GE) announced today that they have entered an agreement under which PnuVax can acquire GE Healthcare’s intellectual property (IP) relating to an inactivated yellow fever vaccine. Under the terms of the agreement, PnuVax will purchase a GE Healthcare Life Sciences FlexFactory™ biomanufacturing platform and the two companies plan a collaboration to optimize the manufacturing process for the new vaccine. Financial terms were not disclosed.
Yellow fever is an acute viral hemorrhagic disease transmitted by mosquitoes and is endemic in tropical Africa and Central and South America. The World Health Organization estimated the burden of yellow fever during 2013 was 84 000–170 000 severe cases and 29 000–60 000 deaths worldwide (1). The WHO and the Centers for Disease Control and Prevention (CDC) in the US have advised that yellow fever vaccine supplies are constrained at this time (2). Currently, immunization against yellow fever is carried out using a live vaccine, 17D.
While generally regarded as safe and highly effective, the live vaccine can cause serious side effects in certain groups of people such as the elderly, people with severe immunodeficiency and people with a severe egg allergy (3). These side effects have driven research efforts to develop an inactivated non-replicating vaccine, with the aim of allowing more people to be safely vaccinated against yellow fever.
GE Healthcare Life Sciences acquired the IP to the inactivated cell-culture based vaccine, XRX 001, which may reduce the incidence of serious side effects associated with the live vaccine, as a part of the acquisition of Xcellerex Inc. in 2012. In 2011, positive results of a Phase 1 clinical trial (4) were announced for the vaccine, which demonstrated a 100% seroconversion rate. GE Healthcare has continued to optimize the manufacturing process for the vaccine.
Donald Gerson CEO, PnuVax Incorporated, said: “Yellow fever remains a significant and persistent public health problem in Africa and South America. Increased worldwide travel and expanding mosquito populations further exacerbate the risk of yellow fever outbreaks, as seen in the current outbreak in Africa(5). Management of the disease depends on preventive vaccination to protect residents and travelers who may be exposed to the virus. PnuVax is committed to ensuring global access to high-quality, safe, effective and low-cost vaccines."
"We believe the benefits of the single-use based FlexFactory system will allow localization of Yellow Fever Vaccine production to endemic areas Yellow Fever Vaccine production to endemic areas and will provide a platform for manufacturing other similar vaccines to respond to emerging pathogens in the future.”
GE Healthcare’s FlexFactory is a start-to-finish biomanufacturing platform based on single-use technologies that increases productivity by simplifying and accelerating bioprocessing and reducing time-consuming routines, such as cleaning and sterilization. It also provides flexibility to modify the manufacturing processes when production needs change or even to develop a completely new production line. It is designed to help manufacturers such as PnuVax to rapidly respond to local healthcare needs and to support significant demand in an epidemic situation.
Parrish Galliher, Chief Technology Officer, Upstream BioProcess, GE Healthcare Life Sciences, added: “We are delighted PnuVax will be continuing the development of XRX 001 and that they have chosen GE Healthcare to help design and optimize the manufacturing process for this vaccine. We look forward to working with the talented team at PnuVax to help bring better health to more people.”
(1) WHO: Yellow Fever – Link: http://www.who.int/mediacentre/factsheets/fs100/en/
(2) US CDC: Yellow Fever – Link: http://wwwnc.cdc.gov/travel/news-announcements/yellow-fever-vaccine-shortage-2016;
WHO: Yellow Fever – Link: http://www.who.int/mediacentre/commentaries/yellow-fever/en/
(3) WHO: Yellow Fever – Link: http://www.who.int/mediacentre/factsheets/fs100/en/
(5) N Engl J Med 2011;364:1326-33
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
About PnuVax Incorporated
PnuVax Incorporated is dedicated to the production of high quality vaccines and biopharmaceuticals for the promotion of public health worldwide. PnuVax uses the best available technologies to manufacture vaccines that are affordable for the children of lower income nations. For more information about Pnuvax, visit our website at www.pnuvax.com.
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