Roche Diagnostics Acquires Broad Human Papillomavirus --HPV-- Patent Portfolio From the Institut Pasteur.

Business Editors & Health/Medical Writers

BASEL, Switzerland--(BW HealthWire)--June 6, 2002

Roche Diagnostics and the Institut Pasteur (Pasteur) today announced that Pasteur has assigned a broad portfolio of patents pertaining to the Human Papillomavirus (HPV) to Roche for an undisclosed sum. As part of the transaction, Institut Pasteur has assigned to Roche its rights to all cross license agreements concerning other HPV patents owned by others. With these assignments, Roche now has access to one of the most extensive range of HPV subtypes in the diagnostic industry. This provides Roche with a strong basis to develop and commercialize molecular diagnostic products for the early detection of HPV, the leading cause of cervical cancer that affects more than 500,000 women worldwide every year.(1)

Scientists have identified more than 100 subtypes of HPV. Approximately one-third of HPV subtypes are spread through sexual contact, making it one of the most common sexually transmitted infections (STDs). There is the potential for HPV molecular tests to be used as the primary screen for cervical cancer detection, replacing traditional Pap smear testing. In 2001, worldwide HPV molecular diagnostic sales were approximately US $21 million. The total market potential for HPV molecular tests, if adopted as a primary screening test, is estimated to exceed US $600 million annually by year 2010.

"This agreement will truly strengthen our position as the global leader in molecular diagnostics and further our efforts to provide an integrated approach to both the manufacture and distribution of tests which are critical to women's healthcare," said Heino von Prondzynski, member of the Executive Committee of Roche and head of the Roche Diagnostics Division. "HPV represents the next significant molecular target for us after our involvement in the blood screening market. The unique association of HPV with cervical cancer, combined with the benefits of screening, early intervention and available treatments, make this an ideal product for the diagnostics market."

"We are delighted to be entering into this arrangement with Roche," commented Philippe Kourilsky, executive president, Institut Pasteur. "It is clear to us that Roche has made a long-term commitment to advancing the state of testing not only for this highly prevalent sexually transmitted disease, but overall in the field of molecular infectious disease diagnostics. This is of great importance for Institut Pasteur since we are committed to contributing to the improvement of public health worldwide."

Since the correlation between cervical cancer and HPV has been validated in key studies, many clinicians and government authorities are now recognizing the utility of HPV DNA testing in the early detection of cervical cancer.(2) The new standard of care, now stated in both the 2001 Consensus Guidelines recently published in JAMA (April 24, 2002) and the ESIDOG guidelines (European Society for Infectious Diseases in Obstetrics and Gynaecology), is to test borderline or equivocal Pap smears with an HPV DNA test (triage) to rule out approximately 50 percent of tests that are negative. The remaining 50 percent that are positive progress to more invasive and expensive diagnostic procedures, including colposcopy and biopsy. This new algorithm of care significantly improves the cost effectiveness of care and appeals to all target audiences -- payers, clinicians, labs and patients.

Roche, headquartered in Basel, Switzerland, is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's products and services address prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide. Roche Molecular Diagnostics, a business area of Roche Diagnostics, has made the polymerase chain reaction (PCR) the leading nucleic acid amplification technology (NAT) in the world. PCR technology allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, thereby facilitating detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed.

The Institut Pasteur is a private foundation in the service of public health. It aims to contribute to preventing and combating disease in France and abroad through scientific and medical research, teaching and public health services. Twelve scientific departments bring together 130 research teams totaling 2500 people. Research on infectious diseases represents about half of the scientific work carried out at the Institut Pasteur. Biomedical research is also focused on non-infectious diseases: allergies, genetic diseases, brain disorders and some cancers. The international network of the Institut Pasteur and associated institutes has 21 members spread over the five continents.

All trademarks used or mentioned in this release are legally protected.

(1) Soler ME, Blumenthal PD. Curr Opin Oncol 2000, 12(5): 460-465.

(2) Walboomers JMM, et al. J Pathol 1999 Sep; 189(1): 12-19.