Portfolio versus pathogens

LONDON—GlaxoSmithKline PLC found itself on the receiving endof a "first-of-its-kind public-private partnership" with the BiomedicalAdvanced Research and Development Authority (BARDA) of the U.S. Department ofHealth and Human Services (HHS), with a potential $200 million coming in to GSKto support the development of drugs to fight antibiotic resistance andbioterrorism.

On the face of it, the deal might not sound soone-of-a-kind, since this isn't the first time HHS or other government agencieshave 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 marksthe first time that HHS has taken a "portfolio approach" to funding drugdevelopment with a private-sector company instead of contracting to develop asingle medical countermeasure, such as a drug, vaccine, diagnostic or medicaltool.

As described by GSK, "This unique collaboration providesflexibility to move funding around GSK's antibacterial portfolio, rather thanfocusing on just one drug candidate, and allow medicines to be studied for thepotential treatment of both conventional and biothreat pathogens."

According to BARDA Director Dr. Robin Robinson, "Working asstrategic partners with a portfolio approach offers a new way to move forwardin developing a robust pipeline of novel antibiotics that address gaps in ournation's preparedness as well as the evolving threat of antibiotic resistance."

For now, GSK will see $40 million to fund an initial 18-monthagreement; the rest of the money, totaling as much as $160 million more, wouldcome into play if the agreement is renewed over five years.

The work under this novel agreement with HHS will begoverned by a BARDA-GSK joint oversight committee that will monitor progress,make decisions on the allocation of funds and decide on the addition or removalof drug candidates from the portfolio. The committee will conduct semiannualreviews to do this. Under the agreement, GSK researchers will conduct safety andtoxicology testing, clinical pharmacology studies, clinical studies andnon-clinical studies to support approval to treat illnesses caused bybioterrorism agents like anthrax, plague and tularemia, as well as addressantibiotic resistance.

GSK has been through this kind of thing before, havingforged past government research collaborations and contracts with BARDA andother agencies for vaccines and antibiotics development. In fact, as noted byDavid Payne, head of GSK's Antibacterial Discovery Performance Unit, GSK andthe Texas A&M University System in March received U.S. government approvalto establish an influenza vaccine facility in Texas.

GSK also notes that as "one of the few large pharmaceuticalcompanies still pursuing antibacterial research," the company also has creativecollaborations and funding partnerships with other companies, academia andfunding bodies, such as the Innovative Medicines Initiative, reportedlyEurope'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 antibioticsin the pharmaceutical industry's pipeline and a decrease in investment inresearch and development."

Many companies have in recent years withdrawn fromantibacterial R&D due to the scientific challenges and a lower return oninvestment, he adds, which adversely affects the ability of healthcareprofessionals to treat bacterial infections and compromises preparedness totackle biothreat pathogens.

"There is an urgent need to address antibiotic resistanceand new models are needed to deal with this challenging area of drugdevelopment," Payne says. "We strongly believe that innovative public-privatepartnerships such as this are integral to solving this critical healthcareissue and we are delighted to work with BARDA in a more strategic way."

As BARDA's Robinson notes, the cost-sharing approach of thisdeal balances the business risk for the federal government and GSK, assupporting development of multiple drug candidates simultaneously increases thelikelihood that one or more of them will move on to a point at which GSK couldapply 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 thesemedical countermeasures for biodefense. Reducing the need to stockpile drugsreduces taxpayer costs."

One of the antibiotics to be developed under this agreementis GSK-944, a first-in-class drug that targets bacterial DNA replication inwhat BARDA simply calls "a unique fashion." GSK has conducted studies in whichGSK-944 reportedly protected or successfully treated animals suffering fromanthrax, plague and tularemia.

Under the BARDA-funded program, additional data will begenerated to support use of GSK-944 for the treatment of anthrax, plague andtularemia. In addition, GSK will pursue development of the use of GSK-944 totreat hospital- and community-acquired drug-resistant bacterial infections,addressing public health needs.

Additional antibiotic candidates are expected to beincorporated into the program during the first 18 months of the GSK-BARDAprogram.

GSK boosts vaccinebusiness with $325-million Okairos acquisition

LONDON—GlaxoSmithKline PLC (GSK) also announced last monththat it has acquired Okairos AG, a specialist developer of vaccine platformtechnologies based in Switzerland, for $325 million in cash.

Privately held Okairos has developed a novel vaccineplatform technology that GSK says will play an important role in GSK'sdevelopment of new prophylactic vaccines (designed to prevent infection), aswell as new classes of therapeutic vaccines (designed to treat infection ordisease). Okairos' technology complements GSK's existing vaccine technology andexpertise and will enable GSK to continue its work developing the nextgeneration of vaccines, the pharma said. The deal also includes a small numberof early-stage assets.

Under the terms of the transaction, GSK will take fullownership of the company and assume ownership of early-stage assets fordiseases such as respiratory syncytial virus (RSV), hepatitis C virus (HCV),malaria, tuberculosis, ebola and HIV.

"This is a fantastic opportunity for patients and ourresearch organization, as it is expected to contribute to the development effortsfor an exciting new generation of vaccines, building on the excellent scienceand expertise of both companies," said Christophe Weber, president of GSKVaccines, in a statement.