Acquisition Provides Pfizer with a Preclinical CMV Vaccine Candidate
January 05, 2015 07:30 AM Eastern Standard Time
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today announced that it has acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. This transaction provides access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program.
"We are working to bring innovative vaccines to market that prevent and treat serious diseases"
The CMV vaccine program will complement Pfizer's robust research portfolio of high-quality and life-saving investigational vaccines and place Pfizer among the leaders in CMV research and development. CMV is a herpes virus, infecting 50-90% of the adult population, with a majority remaining asymptomatic. A large segment of young adults, especially women of childbearing age who remain CMV negative, are at high risk of CMV infection during pregnancy and of passing the infection on to the unborn child (congenital infection). 1,2 There are potentially serious and lifelong consequences for babies born with the disease. One out of every five children born with CMV infection may experience hearing loss and severe neurologic disorders.3 More children have disabilities due to congenital CMV than other well-known infections and syndromes, including Down syndrome, fetal alcohol syndrome, spina bifida, and pediatric HIV/AIDS.4
"We are working to bring innovative vaccines to market that prevent and treat serious diseases," said Kathrin U. Jansen, Ph.D., senior vice president & CSO Vaccine Research & Early Development for Pfizer. "Through the acquisition of the Redvax innovative CMV vaccine platform and expertise we will seek to develop a vaccine to prevent a difficult disease that can have a devastating and lifelong impact on young children."
The U.S. Centers for Disease Control and Prevention (CDC) estimate that, in the U.S., approximately 5,000 children each year develop lasting health problems caused by CMV such as hearing or vision loss, and mental disability.5 The Institute of Medicine (IOM) has ranked the development of a CMV vaccine as a highest priority because of the lives it would save and the disabilities it would prevent.5 The estimated costs associated with CMV disease for the U.S. health care system amounts to at least $1.86 billion annually. CMV expenses can run more than $300,000 per child.6
Christian Schaub, CEO of Redbiotec and Managing Director of Redvax commented, "We are pleased to have completed this deal with Pfizer, a global leader in vaccines. This represents an important step toward the development of a much needed vaccine for CMV, a disease that has a devastating impact on children and families. We believe that combining Redvax's assets with Pfizer's commitment, expertise and resources will significantly enhance the potential of developing this important vaccine."
About Pfizer Inc.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About Redvax GmbH
Redvax is a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. Redvax is a preclinical stage company. The company develops multi-component virus-like particles (VLPs) and other protein assemblies for vaccine development in the field of CMV and a further undisclosed field.
The information contained in this release is as of January 5, 2015. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a preclinical CMV vaccine candidate and the acquisition by Pfizer of a controlling interest in Redvax GmbH, including the potential benefits thereof, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated pre-clinical and clinical study commencement and completion dates as well as the possibility of unfavorable study results; whether and when biologics license applications may be filed in any jurisdictions for the CMV vaccine candidate; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the CMV vaccine candidate; the ability to realize the anticipated benefits of the acquisition; other business effects, including the effects of industry, economic, political or regulatory conditions; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
1 CDC website: http://www.cdc.gov/cmv/overview.html ; accessed October 28, 2014
2 Mocarski ES, Shenk T, Griffiths P, Pass RF (2013). Fields Virology (6th ed.)Lippincott Williams & Wilkins.
3 Manicklal, S. et. al., The "Silent" Global Burden of Congenital Cytomegalovirus, Clin. Microbiol. Rev. January 2013
vol. 26 no. 1 86-102
4 Cannon, MJ. et. al., Washing our Hands of the Congenital Cytomegalovirus Disease Epidemic, BMC Public Health.,
5 CDC website: http://www.cdc.gov/features/cytomegalovirus; accessed October 28, 2014
6 Arvin, A. et. al., Vaccine Development to Prevent Cytomegalovirus Disease: Report from the National Vaccine Advisory Committee, Clinical Infectious Diseases 2004; 39:233–9