Danish pharma group Lundbeck is prepared to spend “billions” to prep its candidate drug Lu AF35700 for the market.

The investigational compound, a novel antipsychotic, is entering clinical phase III program, which is currently planned to consist of two pivotal trials, the company says in a stock market release.

The first study is planned to enroll approximately 1,000 patients in approximately 15 countries including the US and Canada and is expected to last around three years.

"The initiation of the study demonstrates our global commitment to the development of Lu AF35700 and to the investigation of difficult-to-treat brain diseases such as treatment resistant schizophrenia," says R&D chief Anders Gersel Pedersen, adding:

"We are excited about advancing Lu AF35700 with its unique pharmacology into an area of highest unmet medical need. Today there is only one therapy approved for patients with treatment resistant schizophrenia, and its use is severely limited by its problematic safety profile."

Prior to the official release, Anders Gersel told Danish news site Berlingske Business that Lundbeck was investing “several billion kroners” in the studies with Lu AF35700.

Lu AF35700 has been granted Fast Track designation in treatment resistant schizophrenia by FDA, and the phase III program should pave the way for a regulatory submission in the US.

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