Washington Editor

WASHINGTON - The federal government awarded a $56.9 million contract to the research and development organization SRI International Inc. for preclinical services on anti-infective therapeutics, representing the latest in a string of carrots to increase the number of products against bioterrorism, drug-resistant pathogens and infectious diseases.

The resource contract comes from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to support investigators already funded by the government. For example, more than $150 million has been awarded to various biotech firms in the fairly recent past to help advance their products to address pressing microbial threats.

An NIAID spokesperson told BioWorld Today that such research "remains a high public health priority," and the latest contract was driven by a need to support the preclinical development of "promising therapeutic candidates." In essence, the agreement allows the government to help certain products traverse the so-called valley of death.

Over the next five years, the NIAID will direct the biosciences division at SRI, a nonprofit group based in Menlo Park, Calif., on a range of activities for therapeutic agents identified through NIAID-funded grants and contracts, the private sector or other sources. Those include drugs and antibodies for avian influenza, severe acute respiratory syndrome, West Nile virus and hepatitis, as well as biodefense pathogens and toxins.

"Very often, these investigators hold grants, such as individuals at universities, or small companies with an SBIR grant, and need these translational medicine services to move something from the discovery stage into the clinic," explained Jon Mirsalis, SRI's director of preclinical development and the principal investigator for this contract. "Our contract covers everything from late-stage discovery - lead optimization and screening assays - all the way through investigational new drug applications."

SRI's work will include medicinal chemistry, custom drug synthesis, formulation, analytical chemistry, clinical manufacturing, microbiology and virology screening, pharmacokinetics, safety testing and preparing INDs for the FDA. Initial efforts will focus on manufacturing clinical supplies for an upcoming study of a product to treat an undisclosed, rare fungal disease, and additional near-term work will center on a monoclonal antibody for botulinim toxin.

"We're going to cover the gamut," Mirsalis told BioWorld Today. "There will be a lot of variety, but I can't tell you what we'll be doing a year from now, because with this contract, we can move very quickly with changing times."

SRI was chosen for this anti-infective contract after responding to a request for proposal issued a year ago by the NIAID, a process that allows for open competition. Mirsalis noted that other bidders offered to subcontract most of the work to additional parties, whereas SRI offered a "one-stop shop" for those preclinical activities. SRI, which he called "the largest preclinical development contractor to the NIH," will outsource very little of this work.

The funding does not come from Project Bioshield.

In the past, SRI has worked with NIAID's AIDS group on safety, formulation and clinical manufacturing projects, as well as with its biodefense programs on safety, vaccines and screening. To date, SRI has developed nine drugs internally that have entered clinical trials, with several more currently in preclinical evaluation. Additionally, working with government and industry partners, SRI has helped advance more than 100 drugs into clinical trials and more than 30 onto the market.

Among biotech companies recently receiving NIAID funds as part of this broad effort are MacroGenics Inc. in Rockville, Md., with a $50 million contract for a monoclonal antibody for West Nile virus; San Diego-based NexBio Inc.'s $49.8 million contract for DAS 181 (Fludase) as a broad-spectrum therapeutic for all annual and pandemic variations of the flu; Alnylam Pharmaceuticals Inc., of Cambridge, Mass., through a $23 million contract for an Ebola antiviral; New York-based SIGA Technologies Inc.'s $16.5 million contract for the smallpox compound SIGA-246; and a $16 million contract to XOMA LLC, of Berkeley, Calif., for monoclonal antibodies for botulism.

InterMune Settles Fine With Feds

InterMune Inc. recently agreed to pay $36.9 million, plus 5 percent interest over five years, to resolve a government investigation into promotional activities for Actimmune (interferon gamma-1b).

The drug is indicated for chronic granulomatous disease and severe, malignant osteopetrosis, but was sold off label for idiopathic pulmonary fibrosis. That's not illegal, but federal prosecutors charged that such use was driven by unlawful sales tactics from former employees during a period that ended in June 2003. Actimmune generated $22.5 million in revenue for the quarter ended Sept. 30.

No criminal sanctions are involved for the company, of Brisbane, Calif. In addition, InterMune also entered corporate integrity and deferred prosecution agreements with the government. The first annual installment of $5 million will be paid this year.

InterMune and its settlement call to mind last year's $704 million agreement between the government and Serono SA around charges that the Geneva-based company improperly promoted Serostim (somatropin [rDNA origin] for injection).

FDA Adds Generic Policy Adviser

The FDA named Stephen Mason a senior adviser in its Office of Legislation. A former director of government relations at the Generic Pharmaceutical Association (GPhA) in Arlington, Va., he will work on a variety of issues pending before Congress, most notably generic drug legislation.