Navigation Links
Prometheus Obtains Exclusive US Commercialization Rights for RENCAREX®
Date:5/2/2011

SAN DIEGO, May 2, 2011 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced that it has signed an exclusive agreement with WILEX AG for commercialization rights in the United States for RENCAREX® (girentuximab).  RENCAREX® is a Phase III product candidate for adjuvant use in non-metastatic clear-cell renal cell cancer (ccRCC).

Under the terms of the agreement, WILEX will receive $19.0 million upfront payments and development fees plus milestone payments and royalties on U.S. net sales of RENCAREX®.  In addition, Prometheus will co-fund a portion of the ongoing development of RENCAREX®. The deal terms also include an agreement whereby WILEX may be granted commercialization rights outside of the United States, including but not limited to Europe, to one of Prometheus' marketed products or receive additional cash payments of up to $20 million.

Professor Olaf G. Wilhelm, Chief Executive Officer of WILEX, commented, "This is the deal we have been looking for, not only in financial, but also in commercial and strategic terms. We are very excited about WILEX'S new partnership with Prometheus since Prometheus has a proven track record in commercializing pharmaceutical and diagnostic products."

"We are very pleased to enter into this partnership with WILEX as we continue to build our oncology franchise," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "RENCAREX® is a great strategic fit with our current oncology portfolio in renal cell carcinoma. There is no product currently approved in the United States for patients who could have recurrence of ccRCC after a kidney resection.  We look forward to working with WILEX to complete the development process and commercialize RENCAREX® in the United States."

About RENCAREX®

RENCAREX® (girentuximab) is a highly specific chimeric monoclonal antibody that binds to a cell surface antigen, the CA IX-antigen, which is found on 95% of clear cell Renal Cell Carcinomas (ccRCC) and on various other solid tumors but not on healthy tissue. Approximately 208,500 new cases of kidney cancer are diagnosed each year worldwide and the most prevalent form is ccRCC. Roughly one third of the patients will die from RCC. Standard therapy for non-metastatic RCC is resection of the affected kidney (nephrectomy) followed by observation. Nevertheless, there is a high risk of disease recurrence. There is no adjuvant treatment approved by the FDA or EMA for patients after surgery. RENCAREX® is currently tested in a Phase III trial versus placebo in the adjuvant setting in 864 patients with non-metastatic clear cell renal cell cancer at high risk of recurrence after nephrectomy. WILEX expects the results from the interim analysis for efficacy of RENCAREX® in the second half of 2011. This analysis will provide critical information regarding the trial endpoint – disease-free survival – which could form the basis for the European application for marketing approval.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus' corporate offices are located in San Diego, California.

About WILEX AG

WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company's therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of oncological biomarker tests under the brand Oncogene Science. These biomarkers can be used as companion diagnostics in clinical trials and for therapy monitoring. Furthermore, the acquisition of Heidelberg Pharma AG is set to give WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX's customers and partners include leading international pharmaceutical companies.


'/>"/>
SOURCE Prometheus Laboratories Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Prometheus Presents Findings From Development of PROMETHEUS(R) IBS Diagnostic, First Blood Test for IBS, at ACG Annual Scientific Meeting
2. Prometheus and Rosetta Genomics Announce License and Collaboration Agreement
3. Prometheus Announces New Findings Regarding Patients at Risk for Celiac Disease at DDW
4. Prometheus Launches ProOnc Dx Cancer Diagnostics
5. Prometheus Acquires Exclusive Rights to PROLEUKIN(R) (aldesleukin) in the U.S.
6. Prometheus Announces New Method for Real-Time Monitoring of Patients Treated With Biologic Therapy
7. Prometheus and Bayer HealthCare Enter into Services Agreement to Conduct Mutational Analysis
8. Prometheus Highlights Record Performance in 2010
9. Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure
10. Terumo Heart Obtains IRB Approval from the University of Michigan to Initiate DuraHeart(TM) Left Ventricular Assist System U.S. Pivotal Trial
11. First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):