BioWorld International Correspondent

With drug development programs in Parkinson's disease and neuropathic pain nearing the clinic, Brane Discovery Srl, a newly formed spinout from NiKem Research Srl, is about to embark on a road show seeking €7 million to €10 million in a Series A round.

The Milan, Italy-based firm has taken on ownership of all in-house drug discovery and development programs at NiKem, leaving the latter firm to focus on its third-party research services business. The initiative removes perceived conflicts of interest that could have hampered the NiKem business, while enabling the drug development projects to raise cash on their own merits.

"Some potential [NiKem] customers did not like the idea of having a company with internal R&D activity optimizing their own compounds," Brane CEO and co-founder, Carlo Farina, told BioWorld International. Moreover, the drug discovery programs are now at the stage where they need more cash than what NiKem, also of Milan, is able to provide.

Farina was previously CEO at NiKem. His position there has been taken on by Giuseppe Giardina. Joining Farina at Brane is Chief Scientific Officer Ruggero Farello, a co-founder and former CSO of Bresso, Italy-based Newron Pharmaceuticals SpA, which grossed CHF118.12 million (US$98.21 million) in an IPO on the Swiss Stock Exchange in Zurich late last year. Farello, who remains a non-executive director of Newron, has brought with him two former colleagues with expertise in preclinical development and clinical development.

Brane, with just eight employees, will operate according to a virtual model, while its parent has 83 staff on the payroll following the spinout.

Brane is setting out on a path that already has been taken by Newron and by a clutch of other Italian biopharmaceutical firms with origins in R&D centers run by international pharmaceutical firms. The NiKem organization was originally part of Smithkline Beecham (now London-based GlaxoSmithKline plc).

GSK still owns 7.5 percent of NiKem, and is therefore an indirect shareholder of Brane.

Like its forerunners, Brane will seek funding from international sources, because of the paucity of biotechnology investors in Italy. "We are looking to the main European countries - Switzerland, Germany, France and the UK," Farina said. The company is seeking funding to take its two lead programs to clinical proof of concept. An earlier stage oncology project, BND-002, is available for partnering immediately.

Brane's lead program, BND-003, involves a pyrrolidinone derivative. Another pyrrolidinone derivative, levetiracetam (Keppra), is marketed by Brussels, Belgium-based UCB SA in epilepsy. Other pyrrolidinones have demonstrated effects on improving learning and memory. In 2002, a group at based the University of Nagasaki, Japan, demonstrated that the pyrrolidinones nefiracetam and aniracetam had analgesic effects in animal models of pain. Brane aims to replicate this finding in a clinical setting.

"We have our own patent on a novel class of compounds," Farina said. BND-003 is slated to enter the clinic before the year-end.

Behind that is the Parkinson's program, BND-001, which is expected to begin a Phase I clinical trial around mid-2008. The company has not yet disclosed details, but the program, which involves a novel compound acting on a novel target, originated in GSK.

So, too, did BND-002, a series of vATPase (proton pump) inhibitors with potential application in cancer, particularly multidrug-resistant cancers. "All the multidrug-resistant cancers are associated with an overexpression of this vATPase enzyme," Farina said.

The company already has obtained preliminary pharmacological evidence in vivo that its inhibitors can resensitize previously resistant tumors to certain chemotherapeutic agents. Because of the complexity and cost of operating in the field, however, the company aims to find a partner for this program. It has several earlier-stage discovery projects under way as well.