SAN DIEGO—ACADIA Pharmaceuticals Inc. and Meiji Seika Kaisha Ltd. announced in April their collaboration to develop and commercialize a novel class of pro-cognitive drugs called PCAPs to treat patients with schizophrenia and related disorders.
PCAPs—or pro-cognitive anti-psychotic molecules—are thought to be capable of dealing with both schizophrenia psychosis and the cognitive impairment left untreated or exacerbated by other drugs. Initially, the collaboration will focus on developing a product candidate, which was discovered by ACADIA and has been selected by the two companies for IND-track development.
Disturbances associated with schizophrenia include so-called "positive" symptoms, such as hallucinations and delusions, and a range of "negative" symptoms, including loss of interest and emotional withdrawal, as well as cognitive disturbances. These negative symptoms prevent patients with schizophrenia from readjusting to society. As a result, patients with the disease are normally required to be under medical care for their entire lives.
Dr. Uli Hacksell, CEO of ACADIA, notes that about 1 percent of the worldwide population suffers from schizophrenia during their lifetime and more than two million people in the United States are known to suffer from the disease. Ironically, he observes, the disease is not acknowledged at all in Japan, though he thinks this cultural practice may be changing. Hacksell estimates the total anti-psychotic market at about $20 billion annually, with about one-third of this going toward treatment of schizophrenia.
PCAPs, Hacksell believes, may also be used in the treatment of dementia. Meiji Seika was selected because of strong development and commercial capabilities and focus on CNS disorders, he says.
"We believe Meiji Seika is an excellent partner to help advance the development of this exciting program and to commercialize the resulting drugs in Asian markets," Hacksell says. He says he expects the drugs developed by the joint program, assuming it is successful, to reach the market in six to seven years.
In a formal statement, Dr. Osamu Makabe, senior vice president, research and development of Meiji Seika, said, "We are very pleased to be working with ACADIA having strong expertise within CNS drug discovery. We trust this collaboration will boost our portfolio of psychiatric products, a strategic therapeutic focus area for Meiji Seika. The exciting profile of this class of drugs may offer a promising new approach to treating schizophrenia and related disorders, including the potential to address cognitive disturbances frequently experienced by these patients, which represents an area of major unmet medical need."
The collaboration is based on a novel class of compounds that combine muscarinic m1 agonism with dopamine and serotonin receptor antagonism. These compounds have demonstrated a unique combination of pro-cognitive and antipsychotic activity in preclinical behavioral models.
Hacksell explains: "When rodents are introduced to an object, they look at it, smell it, etc. When you introduce a second object, the rat will spend more time with it. With PCAPs, this 'remembering' lasts over a longer time interval. With existing drugs, this is not observed."
The companies plan to initiate IND-enabling studies and co-develop a product candidate through completion of proof-of-concept clinical studies. ACADIA retains the right to develop and commercialize the product outside Asia. Based on the agreement, ACADIA is eligible to receive from Meiji Seika up to $25 million in aggregate payments, including upfront fees and development and regulatory milestone payments, as well as royalties on product sales in the Asian territory, if the product is commercialized successfully. Meiji Seika is responsible for the initial development expenses up to a specified level, and the companies will share the remaining expenses through clinical proof-of-concept. Meiji Seika is responsible for all costs associated with the development, manufacturing and commercialization of the product in the Asian territory after proof-of-concept, and is eligible to share a portion of any product-related revenues received by ACADIA in the rest of the world.
ACADIA's most advanced product candidates include pimavanserin in Phase III for Parkinson's disease psychosis and in Phase II for both schizophrenia and sleep maintenance insomnia. In addition, the company has a product candidate in Phase II for chronic pain and a product candidate in Phase I for glaucoma, both in collaboration with Allergan.
