Highlights of Commercial Achievement

At URMC, we have a long history of translating discoveries into medical advances that benefit humankind. More than 25 years ago, URMC scientists developed glycoconjugate vaccine technology to protect young children from deadly bacterial infections. The start-up, Praxis Biologics, was founded to commercialize the innovative strategy. Three first-in-class vaccines have resulted from the licensing of this industry-revitalizing technology:

Prevnar® protects against infection due to seven prevalent, antibiotic resistant types of Streptococcus pneumoniae. This agent is the leading bacterial cause of pneumonia, spinal meningitis, blood, and middle ear infections in U.S. children and is a major contributor to infant mortality globally. Pneumococcal pneumonia is a serious threat to the geriatric population as well. Prevnar® was approved for use in 37 countries by 2004, with several more approvals expected in 2005. With annual sales of over $1 billion, Prevnar® is the only vaccine ever to achieve “blockbuster” status. Wyeth is the current licensee of this technology and continues to develop additional glycoconjugate vaccines.

HibTiter® was the first glycoconjugate vaccine approved for use in infants. The target of this vaccine is a group of Haemophilus influenzae type b (Hib) diseases, including pneumonia, spinal meningitis, and middle ear infections. Once prolific killers and disablers of young children, these diseases have been virtually eradicated from the U.S.

Meningitec® prevents group C meningococcal blood infections and spinal meningitis. Currently available in 20 countries, peak sales reached $78 million annually.

Additional, novel vaccine technology developed at URMC is the basis of two cervical cancer vaccines being developed by Merck and Co. and GlaxoSmithKline. More than 10,300 diagnoses of invasive cervical cancer and nearly 4,000 cervical cancer deaths will occur in American women in 2005 alone. The greatest risk factor for developing the disease is prior infection with human papillomavirus (HPV), which also causes warts, including genital warts. Both of these vaccines were developed to prevent infection with several strains of this virus.

Cervarix™, GlaxoSmithKline’s HPV vaccine, addresses the two HPV types associated with 70 percent of cervical cancer in American women. The vaccine is in Phase III efficacy studies. Merck’s formulation addresses the same two HPV types with the addition of two more types associated with 90 percent of genital warts. Phase III efficacy studies completed in 2005 indicate that the Merck product, Gardasil™, is highly effective in preventing cervical cancer and pre-cancerous abnormalities. FDA marketing approval for one or both of these vaccines is expected in 2006.

URMC researchers are quite active in investigations that may lead to improved women’s health. Following additional URMC discoveries, Pfizer Inc. and PharmaNova LLC licensed technology to develop a specific class of nonhormonal drugs for the treatment of hot flashes associated with menopause. Since the revelation that hormone replacement therapy for the treatment of menopausal symptoms carries health risks, the search for nonhormonal treatments has been conducted with elevated urgency.

In 2001, URMC was granted a patent that covers the use of drugs that treat hot flashes by targeting a specific group of cells in the hypothalamus, the brain’s temperature control center. This mode of therapy was first investigated when Neurontin® (gabapentin), an FDA-approved seizure and shingles pain medication was reported to reduce hot flashes in a patient taking the drug. While the mechanism of action of gabapentin on the hypothalamus is not completely clear, it has been proven safe and effective for the treatment of hot flashes in clinical trials.

The Federal Government has also become a licensee of URMC technology. In 2004, the FDA entered an agreement to use COMPAS, or Comprehensive Analysis of Repolarization Signal. COMPAS is a software tool that provides a way to simply and accurately analyze the electrocardiograms (EKGs) of people who volunteer for clinical trials of new drugs.

Comprehensive testing of the heart’s reaction to medications became an FDA requirement in 2002. Of particular concern is the QT interval, or the period between ventricular contraction and muscle repolarization. Alterations in this interval have proven toxic to the heart. COMPAS automates the reading process and accurately identifies EKG abnormalities in clinical trial subjects. URMC hopes to license the copyrighted software to drug companies and other institutions involved in pre-market drug testing.

In recognition of URMC scientists’ ability to advance biomedical discoveries that have potential to lead to new health care products, Johnson & Johnson has partnered with URMC in the establishment of the Discovery Concept Fund. The fund solicits proposals from scientists with the objective of nurturing early-stage research and technologies that have the potential to impact health care in novel and/or significant ways. The Discovery Concept Fund will be jointly administered by Johnson & Johnson and URMC and will be funded on a renewable basis by Johnson & Johnson.