History
ENGLISH DEUTSCH
WILEX was founded in September 1997 by a team of clinical oncologists from the Technical University of Munich led by Professor Olaf G. Wilhelm. The founders had 15 years of experience in basis and clinical research on the uPA system and its role in tumour growth and tumour metastasis. This group was joined in 1999 by Professor Sven Warnaar of University of Leiden, Netherlands, who served until his retirement in 2003 as WILEX’s Chief Scientific Officer. In the early 1990s, Professor Warnaar and his team had discovered the G250 antibody (today: RENCAREX®; INN: Girentuximab) and the G250 (MN/CA IX) antigen as the therapeutic target of RENCAREX®.
The Company started operations in July 1998 after raising EUR 3 million in a financing round with a fund advised by Apax Partners as lead investor. To-date WILEX has raised EUR 68 million in four private financing rounds and EUR 55 million through its initial public offering in November 2006.
The funds were used to advance the clinical anti-cancer product portfolio of the Company and to build up pre-clinical research projects including academic collaborations. In particular, the clinical Phase I and Phase II study programme with the antibody RENCAREX® in renal cell cancer (RCC) were successfully completed and a Phase III study initiated. A new antibody based diagnostic imaging agent REDECTANE® has been developed. REDECTANE® is the radioactively labelled form of the antibody Girentuximab and was developed in cooperation with the Ludwig Institute for Cancer Research. In the uPA inhibitor programme, the two drug candidates WX-UK1 and MESUPRON® were brought from research into clinical development in cancer patients.
In January 2009 UCB and WILEX entered into strategic alliance to develop UCB’s preclinical oncology portfolio and UCB became strategic investor of WILEX.
The founding of WILEX Inc. in late 2010 and the acquisition of Heidelberg Pharma AG, recorded in the Commercial Register in March 2011, has changed the structure of the WILEX Group, resulting in an integrative approach by complementing our product development activities through diagnostic agents, an innovative platform technology and customer specific research.
Milestones in the Company’s history
| November 2011 | ARISER IDMC recommends conducting the final analysis of the pivotal Phase III trial with RENCAREX® |
| April 2011 | WILEX grants exclusive US commercialisation rights for RENCAREX® to Prometheus |
| January 2011 | WILEX announces start of interim analysis for its Phase III ARISER registration trial with RENCAREX® |
| November 2010 | WILEX acquires Oncogene Science assets from Siemens Healthcare Diagnostics |
| November 2010 | WILEX AG announces acquisition of Heidelberg Pharma AG |
| July 2010 | dievini Hopp BioTech holding, largest shareholder of WILEX AG, had to submit a tender offer for a mandatory takeover bid to all shareholders due to exceeding the threshold of 30% |
| May 2010 | REDECTANE® meets both endpoints specificity and sensitivity with superiority over CT in its pivotal Phase III trial |
| May 2010 | Final Phase II data of MESUPRON® confirm impressive increase in overall survival of patients with pancreatic cancer |
| November 2009 | WILEX receives second milestone of 5m Euro from UCB after the start of the clinical development of the MEK inhibitor WX-554 (first 5m Euro milestone payment in August 2009) |
| January 2009 | Strategic alliance with UCB Pharma to develop the preclinical oncological portfolio of UCB |
| June 2008 | Licensing agreement with IBA for the worldwide marketing, distribution and sales of the diagnostic agent REDECTANE® |
| February 2008 | FDA issues Special Protocol Assessment (SPA) for pivotal Phase III trial with REDECTANE® |
| December 2007 | Positive result of the interim analysis for futility of the Phase III ARISER trial with RENCAREX® |
| November 2006 | IPO of WILEX AG, Listing at the Regulated Market |
| June 2005 | Fierce Biotech selected WILEX AG as one of the Top 15 emerging Biotech Companies worldwide |
| May 2005 | Closing of a EUR 30 Mio. series C private equity round |
| October 2004 | WILEX acquires option for US marketing rights for RENCAREX® from Centocor |
| April 2004 | WILEX and Esteve sign co-development and marketing agreement for RENCAREX® in Southern Europe |
| September 2003 | WILEX awarded first Biotechnology Clinical Partnership Award from U.S. Department of Defense Breast Cancer Research Program for the uPA-programme |
| November 2002 | WILEX receives Drug Manufacturing Permission and international GLP certification from German authorities |
| April 2002 | WX-G250 receives Orphan Drug Designation in Europe |
| April 2001 | Transformation of Wilex Biotechnology GmbH in WILEX AG |
| November 2001 | License agreement with Bayer Corporation for the MN/CA IX antigen for RENCAREX®/WX-G250 antibody |
| June 2001 | WX-G250 receives Orphan Drug Designation in USA |
| November 2000 | Closing of a EUR 30 Mio. series B private equity round |
| August 1999 | Inlicensing of the G250 antibody (today RENCAREX®) from Centocor |
| April 1999 | Closing of a EUR 4.5 Mio. series A private equity round |
| July 1998 | Start of business operation of Wilex Biotechnology GmbH |
| March 1998 | Closing of a EUR 3 Mio. seedround |
| June 1997 | Winner of the 1. Munich Businessplan Competition 1996/97 and foundation of Wilex Biotechnology GmbH |
