Ark Therapeutics looks for Cerepro partner as CEO steps down
This article was originally published in Scrip
Ark Therapeutics is no longer looking for a buyer, and instead will pursue a strategy of "selective partnering of programmes together with a plan to monetise certain assets", it said.
In addition, Ark's long-standing chief executive Nigel Parker is stepping down from his position to be replaced by former finance chief Martyn Williams.
Ark is now looking for a partner to take over the clinical development of its brain cancer gene therapy candidate Cerepro (sitimagene ceradenovec) and is also scaling down the development of Trinam, a VEGF-165 gene therapy that is in a Phase III trial for haemodialysis access, by modifying the existing trial to a Phase IIb and then seeking a partner for the Phase III trial. It expects data from the modified trial in mid 2011.
In March Ark withdrew the EU filing of Cerepro, dropping a previous appeal over a negative opinion from the CHMP. At the same time it initiated a full strategic review of its business and said it was in discussions with a number of parties regarding a potential sale of the company (scripnews.com, 9 March 2010).
In the latest move, Ark said that that the strategic review had shown that there was significant value in its assets that were not adequately reflected in the approaches received to date for the company as a whole.
The company is now in discussions with parties that are interested in discrete parts of the business and Ark believes that these may potentially result in "superior near-term value for shareholders". In addition, the cash runway for the company could be extended to beyond the second half of 2011, "providing the company with more time to realise the value of its pipeline".
approvable platform
Ark noted that the Cerepro marketing authorisation application review in Europe established that its adenoviral gene therapy platform was approvable. The EMA's Scientific Advisory Group on Oncology came to the conclusion that the pivotal trial supporting the approval of Cerepro was subject to bias and that an additional trial would be needed to secure approval. Ark estimates that this trial will take around four years, and while confident of Cerepro's clinical benefit, believes the cost will be too heavy to pursue on a standalone basis.
The US FDA is currently reviewing a BLA filing for Cerepro with a response expected in June.