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NOVEMBER 5, 2014 – BioPharm Insight -London,U.K. and New York, N.Y – CereSpir is in active discussions with multiple pharma companies to secure a partnership or financing to run two Phase III trials of its Alzheimer’s disease (AD) drug candidate CSP1103, said CEO Daniel Chain.

The New York-based company is also talking to investment banks for possible assistance in negotiations with a strategic partner or for IPO advisers, he added.

It has targeted either firms that have an imaging agent that may be used in the forthcoming trials, or ex-US companies, said Chain. Eli Lilly [NYSE:LLY] has a betaamyloid positron emission tomography (PET) imaging agent marketed as Amyvid (florbetapir F 18 Injection). Chain noted the company is likely to use PET amyloid imaging in Phase III trials.

Ideally the company is looking to retain US rights for the drug, noted Chain. Codevelopment
is a requirement for any deal, he added. CereSpir is in discussions with a mixture of large and midsized pharmaceutical companies in the US, Asia, Japan, the Middle East and Europe, he noted. A Phase II study for CSP1103 has already been completed and CereSpir believes it has
enough data to secure a partnership, he said. Chain declined to comment on how far along discussions were or when a deal could be announced.

In terms of deal structure the company would be looking for a combination of milestone and upfront payments as well as a substantial contribution to the trials’ cost, said Chain. The company is not interested in a company sale at this stage, although once Phase III data is available the preferred exit is a trade sale, he added.

The company is also raising money in tandem with partnership discussions and may consider conducting the trial alone if needed, said Chain. The company has largely been funded by one undisclosed private investor as well as the license source of CSP1103, Chiesi Farmaceutici, a privately owned, Parma, Italy based pharmaceutical company, he said. Chain declined to
comment on the amount CereSpir was looking to raise or the amount the company had raised to date.

CereSpir is also talking to various crossover funds with a view to a future IPO, he noted. If the company was to undertake a listing in the future it would list on the NASDAQ, he noted, declining to comment on any further details of a future IPO. The company is in discussions with a number of investment banks though has not formally engaged one yet, said Chain.

CereSpir has been in discussions with CROs and is close to making its final selection shortly, noted Chain. Cerespir has a list of less than five companies to choose from and will be narrowing down the selection and making a final decision once the company has agreed a final Phase III protocol with the FDA, he said.

The company is to run two Phase III studies with approximately 1,000 patients in each trial, said Chain. The program will be conducted in patients with mild cognitive impairment (MCI) with evidence to suggest they will develop AD in the future, he said. This will be done using PET amyloid scans and/or cerebrospinal fluid (CSF) amyloid measurements, he added. Chain declined to comment on the likely choice of primary endpoint though ruled out the use of the Alzheimer’s Disease Assessment Scale Cognitive subscale (ADASCog).

CSP1103 is a smallmolecule immunomodulator of the brain’s innate immune system. It is able to stimulate clearance of toxic protein aggregates in the brain by microglial phagocytosis and inhibit production of proinflammatory cytokines thought to be important in the pathogenesis of AD, said Chain.

by Hamish McDougall in London