Healthcare Industry News: Hexvix
News Release - January 9, 2006
GE Healthcare and PhotoCure Announce Licensing Partnership for the Optical Imaging of Bladder CancerCHALFONT ST GILES, England & OSLO, Norway--(HSMN NewsFeed)--Jan. 9, 2006--GE Healthcare, a unit of General Electric Company (NYSE:GE ), and PhotoCure ASA (OSE:PHO), today announced a licensing agreement that grants GE Healthcare exclusive global rights outside of the US and the Nordic region to market and distribute PhotoCure's product Hexvix® (hexaminolevulinate), an optical molecular imaging agent intended for the diagnosis and monitoring of bladder cancer. PhotoCure will be responsible for manufacturing and Nordic distribution of the product. The agreement includes an exclusive option for GE Healthcare to market and distribute the product in the US.
Hexvix has received approval for the diagnosis of bladder cancer in a large number of European countries through the European mutual recognition procedure with more expected in the near future. This product is not currently approved by the U.S. Food and Drug Administration (FDA). However a New Drug Application (NDA) was submitted in June 2005 in the United States and if approved by the FDA it would be the first optical molecular imaging agent of its kind available to the US market. GE's agreement includes access to other indications for the product currently under evaluation and testing by PhotoCure.
"This is a great match. With its focus, strong market position in imaging and successful track record of launching new products, GE Healthcare is the ideal partner for establishing Hexvix as a tool in the diagnosis of bladder cancer," said Kjetil Hestdal, president and CEO, PhotoCure.
"We believe our partnership with PhotoCure will result in significant patient benefit in the diagnosis and management of bladder cancer," said Daniel L. Peters, president of Medical Diagnostics at GE Healthcare. "This partnership underscores GE Healthcare's commitment to addressing the unmet clinical needs of physician customers and to enhancing the quality of patient care through new approaches to the diagnosis and monitoring of disease."
Optical imaging is an imaging modality with the potential to provide new applications in the prevention and treatment of bladder cancer as well as other diseases. Optical imaging uses light to illuminate superficial tissue -- such as bladder tissue. By combining this technology with an optical molecular imaging agent, tumors might be targeted more accurately. Optical imaging may enhance the diagnostic abilities of urologists and allow for improved patient care.
"GE Healthcare is a leader in the development of innovative diagnostic techniques and the addition of Hexvix to our imaging portfolio will further strengthen our leadership position in molecular imaging," said Peters. "Fluorescent optical imaging is a core GE Healthcare competency and we have several applications of this technology in our Discovery Systems business, including the cellular analysis research tools and pre-clinical imaging systems we provide to our pharmaceutical customers for drug development."
About Bladder Cancer
- Globally, bladder cancer is ranked 4th and 8th in men and women respectively as the most common form of cancer causing mortality. It is expected that the incidence of bladder cancer will continue to increase concurrent with an increase in industrialization, lifestyle factors and an aging population.
- Risk factors for bladder cancer include age, tobacco use, occupation (carcinogens in the workplace), infections, drinking arsenic-contaminated water, Caucasian race, male gender, family history, treatment with chemotherapy or radiation therapy, low fluid consumption and personal history of the disease.
- Over 500,000 people in the United States are survivors of this cancer. It is the fourth most frequent cancer diagnosed in men in the US, and the ninth most frequent cancer diagnosed in women. Bladder cancer is 4 times more likely to be found in men than women. Many of the survivors need frequent follow up and treatment, some as often as 2-4 times per year.
- The American Cancer Society estimates that 63,210 men and women (47,010 men and 16,200 women) will be diagnosed with and 13,180 men and women will die from cancer of the bladder in 2005.
- Common symptoms of bladder cancer include blood in the urine (making the urine slightly rusty to deep red), pain during urination, and frequent urination, or feeling the need to urinate without results.
American Cancer Society, Key Statistics for Bladder Cancer, www.cancer.org
National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov
National Cancer Institute, Cancer Topics, Bladder Cancer, http://www.cancer.gov
PhotoCure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the treatment and diagnosis of different types of cancer. The products are based on proprietary photodynamic technologies, targeting specific dermatology and oncology markets.
Through worldwide studies, PhotoCure is developing its technology for new indications, such as acne, colon cancer and cervical cancer. The aim is to create a broad pipeline of follow-on products and technologies. PhotoCure is also developing photochemical internalization (PCI), a technology for light-directed drug delivery through its subsidiary PCI Biotech AS. For more information about PhotoCure, visit our website at http://www.photocure.com/.
About GE Healthcare
GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE:GE ). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Source: GE Healthcare
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