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Portfolio versus pathogens
July 2013
by Jeffrey Bouley  |  Email the author


  LONDON—GlaxoSmithKline PLC found itself on the receiving end of a "first-of-its-kind public-private partnership" with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS), with a potential $200 million coming in to GSK to support the development of drugs to fight antibiotic resistance and bioterrorism.  
On the face of it, the deal might not sound so one-of-a-kind, since this isn't the first time HHS or other government agencies have gone to the private sector for help on antibiotics and anti-bioterrorism. What is special about this go-round, though, is that the deal with GSK marks the first time that HHS has taken a "portfolio approach" to funding drug development with a private-sector company instead of contracting to develop a single medical countermeasure, such as a drug, vaccine, diagnostic or medical tool.  
As described by GSK, "This unique collaboration provides flexibility to move funding around GSK's antibacterial portfolio, rather than focusing on just one drug candidate, and allow medicines to be studied for the potential treatment of both conventional and biothreat pathogens."  
According to BARDA Director Dr. Robin Robinson, "Working as strategic partners with a portfolio approach offers a new way to move forward in developing a robust pipeline of novel antibiotics that address gaps in our nation's preparedness as well as the evolving threat of antibiotic resistance."  
For now, GSK will see $40 million to fund an initial 18-month agreement; the rest of the money, totaling as much as $160 million more, would come into play if the agreement is renewed over five years.  
The work under this novel agreement with HHS will be governed by a BARDA-GSK joint oversight committee that will monitor progress, make decisions on the allocation of funds and decide on the addition or removal of drug candidates from the portfolio. The committee will conduct semiannual reviews to do this. Under the agreement, GSK researchers will conduct safety and toxicology testing, clinical pharmacology studies, clinical studies and non-clinical studies to support approval to treat illnesses caused by bioterrorism agents like anthrax, plague and tularemia, as well as address antibiotic resistance.  
GSK has been through this kind of thing before, having forged past government research collaborations and contracts with BARDA and other agencies for vaccines and antibiotics development. In fact, as noted by David Payne, head of GSK's Antibacterial Discovery Performance Unit, GSK and the Texas A&M University System in March received U.S. government approval to establish an influenza vaccine facility in Texas.  
GSK also notes that as "one of the few large pharmaceutical companies still pursuing antibacterial research," the company also has creative collaborations and funding partnerships with other companies, academia and funding bodies, such as the Innovative Medicines Initiative, reportedly Europe's largest public-private initiative, and the Defense Threat Reduction Agency, which is part of the U.S. Department of Defense. Drug-resistant bacterial infections are poised to become a "global crisis," Payne points out, thanks to the "scarcity of new antibiotics in the pharmaceutical industry's pipeline and a decrease in investment in research and development."  
Many companies have in recent years withdrawn from antibacterial R&D due to the scientific challenges and a lower return on investment, he adds, which adversely affects the ability of healthcare professionals to treat bacterial infections and compromises preparedness to tackle biothreat pathogens.
"There is an urgent need to address antibiotic resistance and new models are needed to deal with this challenging area of drug development," Payne says. "We strongly believe that innovative public-private partnerships such as this are integral to solving this critical healthcare issue and we are delighted to work with BARDA in a more strategic way."  
As BARDA's Robinson notes, the cost-sharing approach of this deal balances the business risk for the federal government and GSK, as supporting development of multiple drug candidates simultaneously increases the likelihood that one or more of them will move on to a point at which GSK could apply for U.S. Food and Drug Administration approval.  
Also, as noted in the BARDA news release about the deal, "These novel antibiotics may become available in the commercial marketplace, which diminishes the federal government's need to stockpile as much of these medical countermeasures for biodefense. Reducing the need to stockpile drugs reduces taxpayer costs."  
One of the antibiotics to be developed under this agreement is GSK- 944, a first-in-class drug that targets bacterial DNA replication in what BARDA simply calls "a unique fashion." GSK has conducted studies in which GSK-944 reportedly protected or successfully treated animals suffering from anthrax, plague and tularemia.  
Under the BARDA-funded program, additional data will be generated to support use of GSK-944 for the treatment of anthrax, plague and tularemia. In addition, GSK will pursue development of the use of GSK-944 to treat hospital- and community-acquired drug-resistant bacterial infections, addressing public health needs.  
Additional antibiotic candidates are expected to be incorporated into the program during the first 18 months of the GSK-BARDA program.  

GSK boosts vaccine business with $325-million Okairos acquisition
LONDON—GlaxoSmithKline PLC (GSK) also announced last month that it has acquired Okairos AG, a specialist developer of vaccine platform technologies based in Switzerland, for $325 million in cash.  
Privately held Okairos has developed a novel vaccine platform technology that GSK says will play an important role in GSK's development of new prophylactic vaccines (designed to prevent infection), as well as new classes of therapeutic vaccines (designed to treat infection or disease). Okairos' technology complements GSK's existing vaccine technology and expertise and will enable GSK to continue its work developing the next generation of vaccines, the pharma said. The deal also includes a small number of early-stage assets.  
Under the terms of the transaction, GSK will take full ownership of the company and assume ownership of early-stage assets for diseases such as respiratory syncytial virus (RSV), hepatitis C virus (HCV), malaria, tuberculosis, ebola and HIV.  
"This is a fantastic opportunity for patients and our research organization, as it is expected to contribute to the development efforts for an exciting new generation of vaccines, building on the excellent science and expertise of both companies," said Christophe Weber, president of GSK Vaccines, in a statement.  
Code: E071303



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