ACADIA Pharmaceuticals Inc. (ACAD-NASDAQ)
Interview with:
Uli Hacksell, Ph.D., CEO
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drug discovery and clinical development of novel treatments for central nervous system disorders with five drug programs in clinical and preclinical development that include Parkinson's disease, schizophrenia, neuropathic pain and glaucoma.


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ACADIA Pharmaceutical has assembled a strong management team with extensive experience from big pharma operations and outstanding scientific expertise to ensure successful drug discovery and development efforts

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ACADIA Pharmaceuticals Inc.

3911 Sorrento Valley Blvd.
San Diego, CA 92121

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Uli Hacksell, Ph.D.
Chief Executive Officer

Interview conducted by:
Lynn Fosse, Senior Editor
January 13, 2005

Uli Hacksell, Ph.D.
Chief Executive Officer and Director

Dr. Hacksell has served as ACADIA’s Chief Executive Officer since September 2000 and as a member of the board of directors since October 2000. From February 1999 to September 2000, he served as ACADIA’s Executive Vice President of Drug Discovery. From August 1991 to February 1999, Dr. Hacksell held various senior executive positions at Astra, a pharmaceutical company, including Vice President of Drug Discovery and Technology as well as President of Astra Draco, one of Astra’s largest research and development subsidiaries, where he directed an organization of more than 1,100 employees. From August 1991 to May 1994, he served as Vice President of CNS Preclinical R&D at Astra Arcus, another subsidiary. Earlier in his career, Dr. Hacksell held the positions of Professor of Organic Chemistry and Department Chairman at Uppsala University in Sweden and also served as Chairman and Vice Chairman of the European Federation of Medicinal Chemistry. Dr. Hacksell received a Master of Pharmacy and a Ph.D. in Medicinal Chemistry from Uppsala University.

Company Profile:
ACADIA (Nasdaq: ACAD) is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five drug programs in clinical and preclinical development directed at large unmet medical needs and major commercial markets, including Parkinson's disease, schizophrenia, neuropathic pain and glaucoma. Using its proprietary drug discovery platform, ACADIA has discovered all of the drug candidates in its product pipeline. ACADIA's headquarters and biology research facilities are located in San Diego, California and its chemistry research facilities are located near Copenhagen, Denmark.

CEOCFOinterviews: Dr. Hacksell, what was your vision when you came to ACADIA and how has that developed?
Dr. Hacksell: “One of the reasons I joined ACADIA was that ACADIA’s discovery platform offered very exciting opportunities for coming up with new concepts for treating CNS (central nervous system) diseases, as well as for areas outside of CNS. ACADIA has a very productive and high quality discovery platform that has been validated, because it has created the starting points for each of our five development programs.”

CEOCFOinterviews: Will you give us a sense of what the development programs are and where you are with each one of them?
Dr. Hacksell: “We have five programs in clinical and pre-clinical development and three of them are owned entirely by ACADIA; the three internal programs deal with major unmet medical needs in schizophrenia and Parkinson’s disease. The two other programs are in collaboration with Allergan, Inc. One of these programs is targeting neuropathic pain and the other is targeting glaucoma.”

CEOCFOinterviews: What is the basis of the programs and what have you discovered?
Dr. Hacksell: “Let me start with our internal program ACP-103 for treatment-induced dysfunctions in Parkinson’s disease (PD). ACP-103 is a small molecule drug that acts potently and selectively as an inverse agonist on one of the serotonin receptors, the 5-HT2A receptor. This is a drug that has ideal drug properties. It fulfills all rules that scientists have set out for how a drug should behave in terms of physio-chemical characteristics. It is highly tolerated, safe, and it deals with an indication for which there is no approved treatment in the U.S. today. The PD treatments that are available today cause a number of the side effects. A large number of the patients on L-dopa or dopamine agonist therapy develop dyskinesias, or motoric disturbances, because of the current drug treatments. Many of the patients also develop hallucinosis and psychosis as a result of the current PD-therapies. We believe that we can treat these treatment-induced dysfunctions effectively with ACP-103 for two reasons: (1) because of ACP-103’s ability to block the 5-HT2A receptors and (2) the high tolerability of ACP-103 in patients, as we have demonstrated in a previous clinical trial.”

CEOCFOinterviews: Where are you in the process?
Dr. Hacksell: “Currently we have two ongoing clinical trials with ACP-103. One is a Phase II clinical trial where we study the ability of ACP-103 to reduce treatment-induced psychosis in PD patients. We expect to be able to report the results from that study in the first half of next year (2005). We also have another ongoing study with the NIH (National Institutes of Health). In this study we are investigating the ability of ACP-103 to reduce L-dopa induced dyskinesia in PD patients. In our earlier Phase Ib/IIa clinical trial in PD patients, we saw indications of the antidyskinetic activity of ACP-103 and the NIH study will provide us with additional data on this particular use of ACP-103.

We are also developing ACP-103 as an adjunctive therapy in schizophrenia. There are many antipsychotic drugs available to treat schizophrenia, but all of them have a number of problems. Current therapies are not effective in all patients and they have relatively severe side effects. With ACP-103 added on the top of a current antipsychotic agent, we believe that we can achieve a number of advantages including improved efficacy and a reduction of the side effects of the antipsychotic therapy. We hope to achieve these advantages by fine-tuning the therapy to provide a complete occupancy of the 5-HT2A receptors and only a partial occupancy of the dopamine D2 receptors. These are the receptors that you need to interact with in order to get an effective outcome in schizophrenia therapy.

This program is quite exciting for us and we have already reported on one study that demonstrated the ability of ACP-103 to reduce treatment-induced side effects.  In this study we gave healthy volunteers haloperidol, which is a traditional antipsychotic drug that blocks D2 receptors. The subjects developed two typical side effects; akathisia, which is a very uncomfortable syndrome of motoric restlessness, and high levels of prolactin. With ACP-103 we were able to reduce both of these side effects. We expect to be able to report the results of two Phase II clinical studies with ACP-103 in schizophrenia next year (2005). One trial is a side effect study in schizophrenic patients and the other clinical trial is a larger study where we will get data on the efficacy of ACP-103 as an adjunctive therapy on top of each of haloperidol and risperidol. With this study we expect to be able to show that we have an advantage of using adjunctive ACP-103 on top of all of the existing antipsychotic drugs.”

CEOCFOinterviews: You have another schizophrenia program in development as well!
Dr. Hacksell: “Yes, the other schizophrenia program that we have in development is ACP-104. This is a stand-alone treatment for schizophrenia with the potential for cognitive benefits. Today, cognition is a very important concept in schizophrenia therapy. We now realize that the current psychotic agents are not effective in dealing with the cognitive deficit that is the result of this disease. In fact most current therapies worsen the cognitive impairment. With ACP-104 we provide the possibility to improve cognition for the first time. ACP-104 is quite an interesting story. It is related to a discovery that was made at ACADIA that showed some patients that get clozapine therapy react very well to the clozapine therapy. These patients are fast metabolizers of clozapine and they produce large amounts of a metabolite of clozapine, which we have called ACP-104. This compound has the ability to stimulate muscarinic M1 receptors in addition to blocking the dopamine and serotonin receptors. The link between M1 receptors stimulation and cognition is well established in the scientific literature. When we made this discovery, we immediately realized that we had the opportunity to develop ACP-104 itself, as a new type of psychotic agent with cognitive benefits.”

CEOCFOinterviews: You have a couple of things going on with Allergan?
Dr. Hacksell: “Yes, and that’s very exciting as well. We have reported that we have moved into clinical studies with Allergan on a neuropathic pain program. This program has resulted from a discovery of a new mechanism to treat neuropathic pain highly effectively, which was made in collaboration with Allergan. This mechanism provides consistent and powerful relief of pain in various pre-clinical models. Our collaborative program is very exciting, particularly because existing therapies for neuropathic pain are not very effective. Allergan described this program at their R&D day in February of this year (2004). They also announced that they intend to take one of our compounds into Phase II clinical trials next year.

We also have a collaboration with Allergan in the area of glaucoma therapy. Allergan has in-licensed selective muscarinic agonists from ACADIA. These agonists produce a very pronounced and long-lasting reduction in intraocular pressure (increased fluid pressure within the eye). Allergan nominated a development candidate from this program late last year (2003) and is actively pursuing the development of this compound.”

CEOCFOinterviews: Why the collaborations on two of your discoveries; is it timing?
Dr. Hacksell: “These collaborations started at the an early stage of the drug discovery. So the clinical programs are the result of earlier R&D collaborations that we have with Allergan. We have a third ongoing drug discovery collaboration with Allergan in the area of ophthalmology. I see it as very positive that we have such a good track-record from our Allergan collaborations and that we have drugs in development where Allergan is in charge and is paying for the development.”

CEOCFOinterviews: I see that you have more than 100 targets for what you’ve discovered; how did you decide what to pursue first?
Dr. Hacksell: “To be honest, it’s a fantastic opportunity for us to have all of those new chemistries for more than 100 targets and to have the opportunity to pick the very best to move forward with into discovery research. We prefer to pick starting points in drug discovery that represent low risk, high benefit opportunities, because we know that if in order to succeed we need to minimize attrition. First of all, we select the right chemistries, chemistries that can make it to small molecule drugs, secondly, we select targets that have been validated through chemical experimentation.”

CEOCFOinterviews: You have research facilities in Denmark, is that related to your background?
Dr. Hacksell: “When ACADIA started as a drug discovery company it established headquarters in biology in San Diego, California and chemistry operations in Copenhagen. It was related to the fact that the founder of ACADIA, Mark Brann, had a strong scientific network in Denmark. He also realized that in Scandinavia, we could recruit high quality European chemists. In San Diego, the competition for chemists is much tougher and it would have been hard for ACADIA to recruit the same quality of chemists in San Diego as we have done in Denmark.”

CEOCFOinterviews: Can you tell us about your funding for all of the developments?
Dr. Hacksell: “We became a public company in early June of this year (2004). To date we have raised net proceeds of $114 million through the sale of our equity securities, including approximately $31 million from our initial public offering.  We have also received $31 million in payments from our various collaboration agreements and have the opportunity to receive up to approximately $80 million in additional payments under our three existing collaborations with Allergan (excluding any potential royalty payments). Furthermore, we have the Stanley Medical Research Institute providing up to $5 Million in development support for ACP-104.”

CEOCFOinterviews: Can you give us an idea of how long it would typically take to bring a product such as your developments to the market; a time line?
Dr. Hacksell: “I can not provide a specific estimate, but what I can say is that in 2005, we expect to have Phase II data in each of our three of our internal clinical programs. If you look at the standard time lines for Phase III studies and add to that the time for a standard regulatory process, then you can estimate when we may be approaching the market.”

CEOCFOinterviews: Will you address potential investors, why should they be interested now and what should they know about ACADIA that they may not realize when the first look at the company.
Dr. Hacksell: “The thing that should make investors excited is that we expect to reach many value-driving milestones in the relatively near future. Most of these milestones relate to Phase II clinical studies in our advanced programs. Another key aspect of ACADIA is that we have a broad pipeline. We have five programs in development and we are not just a ‘one trick pony’. Finally, ACADIA has a sustainable business. All of our 5 development programs have been generated from discoveries made at ACADIA with our proprietary technology.  This validates the quality and productivity of our discovery engine. We also have many new opportunities for development programs coming up from our discovery efforts. So breadth and depth in our clinical programs and sustainability because of the strength of our discovery capability are key aspects of ACADIA.”

CEOCFOinterviews: Can you close by telling us a little about the strength of your management team?
Dr. Hacksell: “In order to succeed in drug discovery and development you need to be aware of what you should and shouldn’t do. There are so many errors that you can make along the way to the market from a discovery program. We are drug hunters that have been there before. Collectively, we have taken more then twenty drugs into the clinic in our previous positions and several of them were taken all the way to the market. Our team has the skills and experience that you need to succeed in drug discovery and development.”


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