HHS forges strategic partnerships

WASHINGTON, D.C.—The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) recently announced two strategic partnerships—one with The Medicines Company headquartered in Parsippany, N.J., and the other with Hoffmann-LaRoche Inc. (Roche), part of the Roche Group headquartered in Basel, Switzerland—to develop innovative products to combat the growing threat of multidrug-resistant bacterial infections.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will manage a portfolio of products with each company. Through the agreements, BARDA will have joint oversight and share the cost of developing a portfolio with each company, helping determine which products to develop and collaborating on decisions about which products enter or leave each partnership’s portfolio.

Under the agreement with The Medicines Company, BARDA will provide more than $32 million over four years and potentially more than $132 million over five years. Under the agreement with Roche, BARDA will provide more than $35 million over two years and potentially more than $151.6 million over five years. Each company also will provide a significant portion of the funding and resources needed to bring their own products to the market.

“Combating the rise of antimicrobial resistant infections requires innovation, nimbleness and collaboration—all of which are components of these new agreements,” said Dr. Richard Hatchett, BARDA acting director. “These partnerships allow BARDA and its partners to respond rapidly to new discoveries, technical developments and strategic priorities by quickly refocusing our portfolios.”

The portfolio with The Medicines Company will continue developing multiple antibiotics including one known as Carbavance, a drug being developed to treat hospital-acquired bacterial pneumonia and ventilator-acquired bacterial pneumonia.

The portfolio with Roche will include continued development of diagnostic tests to detect specific viral and bacterial infections. Armed with such information, physicians and patients can make better decisions about how to treat the illness and avoid unnecessary or inappropriate use of antibiotics.

The portfolio also will include an investigational antibiotic being developed to treat a variety of infections caused by drug-resistant bacteria in combination with another antibiotic, and Roche will continue to review promising products in discovery and nonclinical study phases of development that could be added to this portfolio.

Having products in each portfolio at different stages of maturity helps mitigate the business risk associated with drug development and increases the likelihood that at least one product in each portfolio will succeed, noted the Department of Health and Human Services (HHS).

Rather than a standard contract, HHS entered into the agreements using other transaction authority that was granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. Although not a contract, grant or cooperative agreement, other transaction authority provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development.

The partnerships are the third and fourth ASPR has formed under other transaction authority. All of the partnerships focus on developing new products to address the rising threat of antibiotic-resistant infections. These collaborations directly address the President’s National Strategy and Action Plan for Combating Antibiotic-Resistant Bacteria which called on ASPR to create portfolio partnerships with industry to accelerate the development of new antibacterial drugs.

The partnerships also align with the President’s Executive Order for Combating Antibiotic Resistant Bacteria, which requires certain federal agencies to support the development of new and next-generation countermeasures capable of treating those bacterial threats determined by the U.S. Centers for Disease Control and Prevention as either urgent or serious.

ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to minimize the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to support approval or licensure by the U.S. Food and Drug Administration.