NIH Tech Transfer and 1998 Approved Drugs

Technology transfer from government labs to pharmaceutical companies is picking up. In his Internet Patent Newsletter publisher Greg Aharonian reports that in 1998, the US Food and Drug Administration approved six drugs for commercial sales that were originally licensed from the National Institutes of Health. Since the FDA doesn't approve many new drugs each year, this is a worthy accomplishment. The drugs were:

Synagis (non-exclusively licensed to Medimmune from NIAID)—a monoclonal antibody used to prevent and treat serious lower respiratory tract disease by respiratory syncytial virus (RSV). RSV is the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Synagis is the world's first monoclonal antibody licensed by the FDA for any infectious disease.

Certiva (exclusively licensed to North American Vaccine from NICHD)—a combined diphtheria, tetanus, and accellular pertussis vaccine for use in infants and children. A special process that reduces local and systemic adverse events commonly associated with traditional whole-cell PDT vaccine administration has detoxified the acellular pertussis component of this vaccine. Certiva is the first pediatric vaccine introduced into the US market by a new independent vaccine producer in over ten years.

Vitravene (non-exclusively licensed to Isis Pharmaceuticals from NCI)—a phosphorothioate oligonucleotide that inhibits cytomegalovirus (CMV) infections in the eye. Such infections more commonly occur in immunocompromised patients with resultant damage to the retina. Vitravene is the first antisense therapeutic approved for use in humans.

RotaShield (exclusively licensed to Wyeth Laboratories from NIAID)—a live oral vaccine for the prevention of rotavirus gastroenteritis in infants. Rotavirus is the single most important case of epidemic severe acute gastroenteritis (diarrhea and vomiting) in infants and young children in both developed and developing countries. RotaShield is the first rotavirus vaccine approved for use in humans.

AcuTect (exclusively licensed to Diatide from NIDCR)—a synthetic peptide radiopharmaceutical used for the detection of acute deep venous thrombosis (DVT). DVT affects an estimated 5 million individuals in the US each year and is the most common source of pulmonary embolism. AcuTect is the first in-vivo imaging agent to target acute DVT in the lower extermities.

Thyrogen (exclusively licensed to Genzyme from NIDDK)—a recombinant form of human thyroid stimulating hormone (TSH) for use in follow-up screening of patients who have been treated for thyroid cancer. Thyrogen permits these patients to avoid the debilitating effects of thyroid hormone withdrawal while undergoing standard diagnostic procedures such as serum thyroglobulin testing and radioiodine imaging.