Hopp’s bitter harvest as Wilex wanes and Sygnis sings swansong
This article was originally published in Scrip
While Dietmar Hopp clearly had a Midas touch when it came to investing in technology, the billionaire SAP founder has not had the same luck in the life sciences. Strategic changes will have to be on the cards at Wilex and Sygnis Pharma, two of dievini Hopp BioTech's leading portfolio companies.
Wilex, the Munich-based cancer therapeutic and diagnostic developer, revealed that its lead Rencarex programme had failed to hit its Phase III primary endpoint. Sygnis Pharma, the CNS-focused company essentially called it a day and reverted to a technology platform company by acquiring the Spanish DNA amplification technologies and product company X-Pol Biotech.
Regular readers of Stockwatch, Scrip’s investor-oriented commentary (www.scripintelligence.com, 19 June, 2012) will not have been surprised by the disappointing news released by Wilex. The Munich-based biotech announced that Rencarex, its highly specific IgG1 monoclonal that targets the antigen carbonic anhydrase IX, did not meet the primary endpoint of median disease-free survival in the Phase III ARISER study in clear cell renal cell carcinoma.
ARISER was an international multicenter, randomized 864 patient Phase III trial examining the efficacy of Rencarex versus placebo in the treatment of clear cell RCC patients who had had complete or partial nephrectomy no later than 12 weeks before study entry.
Originally licensed exclusively from Johnson & Johnson's Centocor unit in August 1999, Wilex signed a co-development and marketing deal in April 2004 giving Esteve exclusive marketing rights to Rencarex for Spain, Italy, Portugal, Greece and Andorra. In May 2011, Wilex licensed the exclusive US rights for Rencarex to Prometheus Laboratories, which was acquired by Nestle Health Science in July 2011.
Responses to the news were swift. Releasing the news after the Frankfurt market had closed on 15 October, the Wilex share price slumped from €3.969 to €1.580 on 16 October. In response to the news, Wilex CEO and chairman Professor Olaf Wilhelm revealed that the company would now focus its resources to drive the development of Redectane, the Phase III diagnostic antibody for clear cell RCC, and its other clinical programs.
Wilex's most advanced therapeutic program is anti metastatic and non-cytotoxic Mesupron upamostat, an orally available pro-drug of WX-UK1, which targets the urokinase plasminogen activator (uPA) system and other serine proteases, and is in Phase II trials against breast and pancreatic cancer. Wilex is looking for a partner for the compound.
Also in the clinic is WX-554 is an orally available, small-molecule mitogen-activated protein kinase (MEK) inhibitor that is one of five molecules that Wilex licensed from UCB Pharma in 2009. WX-554 is in a Phase I/II trial against solid tumors. The only other former UCB asset that has been identified by Wilex is WX-037, an oral small-molecule phosphatidylinositol-3-kinase/protein-kinase-(PI3K) signalling pathway inhibitor, which is currently in preclinical development.
dievini Hopp Biotech and affiliated companies – Curacyte and Verwaltungsgesellschaft Golf Club St Leon-Rot – own 47% of Wilex shares. Other significant shareholders include UCB (14%), TVM Capital (6%), Merlin/Excalibur Funds (3%), board members (2%) and a free float of 28%. Wilex had a cash balance of €28.7 million on 31 August, 2012 and employed 118 full time equivalents.
While Wilex's management is still talking about pushing ahead with its therapeutics ambitions, Sygnis Pharma has dumped its ambitions to become a CNS drug developer and has engineered a reverse acquisition into X-Pol Biotech and reinvented itself as a developer and marketer of DNA amplification technologies and products.
Under the terms of the deal, Sygnis, which was owned by dievini Hopp BioTech (55%), BASF (11%) and a free float of 34%, is acquiring 100% of X-Pol, a Genetrix company based in Tres Cantos near Madrid, through a capital increase. Former X-Pol shareholders will hold 77.5% of Sygnis shares. The new business focus is to develop and market X-Pol's platform. It is expected that first revenues will be realized in 2013. The company's first exclusive global license agreement was signed with Qiagen.
Interestingly, despite having experienced a torrid time with some of its leading portfolio assets, dievini Hopp Biotech, the largest shareholder in both Wilex and Sygnis, is not expected to waver in its belief in biotech (www.scripintelligence.com, 18 September, 2012).