The NIH Office of Technology Transfer reports that six new products developed from research conducted by NIH scientists were approved by the FDA in 1998.

The six products emanate from five different institutes, and five of them are "firsts" of their kind.

Typically, there have been one or two such approvals yearly, says Steve Ferguson, OTT senior licensing specialist, who notes that the FDA action is the final step in actions initiated by the inventors, institutes, and OTT more than a decade ago, when the OTT was launched in response to changes in the technology transfer law.

"Our investments are starting to pay off now," he observes, and 1998, therefore, may mark the "beginning of an upward trend."

While all the approvals are gratifying, the RotaShield license (see below) is "particularly exciting," says Ferguson, because its history is longest (see "More than Two Decades of Research Culminates in Rotavirus Vaccine"). For more info, contact Ferguson by e-mail or at 496-7057, ext. 266.

Synagis (Medimmune, Inc.)—a monoclonal antibody used for the prevention and treatment of 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. (Nonexclusive Biological Materials License)

NIH Inventors: Robert Chanock, Brian Murphy, Judy Beeler, and Kathleen Coelingh, NIAID; no patent; discovery first published in a scientific journal in 1989.

Certiva (North American Vaccine, Inc.)—a combined diphtheria, tetanus, and acellular pertussis vaccine for use in infants and children. A special process that reduces local and systemic adverse events commonly associated with traditional whole-cell DPT vaccine administration has detoxified the acellular pertussis component of this vaccine. Certiva is the first pediatric vaccine introduced into the U.S. market by a new independent vaccine producer in more than 10 years. (Exclusive Patent License Agreement)

NIH Inventors: Ronald Sekura,Yan-Ling Zhang, and Joseph Shiloach, NICHD; first patent application filed in 1986.

Vitravene (Isis Pharmaceuticals, Inc.)—a phosphorothioate oligonucleotide that inhibits cytomegalovirus 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. (Nonexclusive Patent License Agreement)

NIH Inventors: Jack Cohen, Gerald Zon, Leonard Neckers, Cy Stein, Shee Loke, Kazuo Shinozuka, and Makoto Masukura, NCI; first patent application filed in 1987.

RotaShield (Wyeth Laboratories, Inc.)—a live oral vaccine for the prevention of rotavirus gastroenteritis in infants. Rotavirus is the single most important cause 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. (Exclusive Patent License Agreements)

NIH Inventors: Albert Kapikian, Harry Greenberg, Richard Wyatt, Robert Chanock, Karen Midthun, Jorge Flores, Yasutaka Hoshino, and Anthony Kalica, NIAID; first patent application filed in 1983.

AcuTect (Diatide, Inc.)—a synthetic peptide radiopharmaceutical used for the detection of acute deep venous thrombosis (DVT). DVT affects an estimated 5 million individuals in the United States 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 extremities. (Exclusive Patent License Agreement)

NIH Inventors: Frank Robey, Raymond Fields, and Wolfgang Lindner, NIDCR; patent application filed in 1988.

Thyrogen (Genzyme Corporation)–a recombinant form of human thyroid-stimulating hormone 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. (Exclusive Patent License Agreement)

NIH Inventors: Bruce Weintraub and Fredric Wondisford, NIDDK; first patent application filed in 1989.

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