Wilex AG announced the granting of US commercialisation rights for Rencarex (Girentuximab) to Prometheus Laboratories Inc. (Prometheus), San Diego, CA, USA. Prometheus is an established specialty pharmaceutical and diagnostics company with a proven track record in gastroenterology and oncology.
In return, Wilex will receive $39 million, $19 million upon signing and either $20 million after twelve months or alternatively the European commercial rights for an undisclosed product from Prometheus. In addition Wilex will receive milestone payments and royalties on US net sales of Rencarex. Furthermore Prometheus will co-fund a portion of the ongoing development of Rencarex. This potentially values the deal at over $145 million plus royalties on net sales in the United States.
Rencarex is a phase III product candidate for adjuvant use in non-metastatic clear cell Renal Cell Cancer (ccRCC). The deal includes the potential development in further indications. Prometheus markets Proleukin, an oncology product indicated for metastatic renal cell carcinoma and metastatic melanoma, in the US. If Rencarex receives approval in the USA Prometheus would be able to offer a treatment for both adjuvant and metastatic kidney cancer.
Professor Olaf G Wilhelm, CEO of Wilex AG, 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 commercialising 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 CEO 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 commercialise Rencarex in the United States.”
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 tumours 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.
Wilex AG is a biopharmaceutical company 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.
Prometheus Laboratories Inc. is committed to improving lives through the development and commercialisation of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualised patient care.