Acadia Pharmaceuticals Inc. capitalized on the recent jump in its shares, pricing an $89.1 million public offering.

The San Diego-based company sold 5.75 million shares at $15.50 per share, an offering expected to net $83.5 million. Underwriters have a 30-day overallotment option on 862,500 additional shares, which would add about $13.4 million to the gross proceeds if exercised.

The offering's $15.50 price is an increase of about 132 percent to the stock's $6.69 closing price on March 16. The shares gained 103 percent, to $13.61, on positive Phase II data the next trading day, and have continued to increase since then. Acadia's shares (NASDAQ:ACAD) gained 5 cents Thursday to close at $15.65.

The action around Acadia stemmed from Phase IIb data last month showing that adding ACP-103 to an atypical antipsychotic drug in schizophrenia patients demonstrated statistically significant antipsychotic effects, the primary endpoint. ACP-103, an oral, selective 5-HT2A inverse agonist, was added to risperidone (Risperdal, Johnson & Johnson) or haloperidol therapy.

Data showed Acadia's drug with low-dose risperidone improved antipsychotic efficacy compared to low-dose risperidone plus placebo (p=0.01), and comparable efficacy to high-dose risperidone plus placebo. Efficacy was measured by a reduction in the Positive and Negative Syndrome Scale. The co-therapy arm also showed an improved side-effect profile vs. high-dose risperidone. (See BioWorld Today, March 20, 2007.)

Acadia said in its registration statement that it will initiate the first of two planned pivotal Phase III trials this quarter, testing ACP-103 for Parkinson's disease psychosis. It described the disease as a debilitating psychiatric disorder that occurs in up to 40 percent of patients with PD, and the most common factor leading to nursing home placements of those patients. There are no therapies approved in the U.S. to treat Parkinson's disease psychosis, it said.

The company also plans to begin this quarter a Phase II trial of ACP-103 for treating sleep maintenance insomnia. An earlier proof-of-concept study demonstrated ACP-103 induced a statistically significant and dose-related increase in deep, or slow-wave, sleep in healthy older adults.

The second product in Acadia's pipeline is ACP-104, which has completed three initial Phase II trials in schizophrenia patients. It plans to initiate a Phase IIb trial this quarter in that indication. ACP-104, or N-desmethylclozapine, is the major metabolite of the antipsychotic drug clozapine. ACP-104 combines M1 muscarinic agonism, 5-HT2A inverse agonism and dopamine D2 and D3 partial agonism in a single compound.

Acadia said ACP-104 represents a new approach to schizophrenia therapy that combines an atypical antipsychotic efficacy profile with the potential benefit of enhanced cognition.

Acadia has full rights to both the ACP-103 and ACP-104 programs.

A neuropathic pain program partnered with Allergan Inc., of Irvine, Calif., is in Phase II clinical trials, while an Acadia-Allergan ophthalmic product is in the pre-investigational new drug application stage. Those companies have three collaborations, dating to the late-1990s and 2003.

Acadia also is in a collaboration with Sepracor Inc., of Marlborough, Mass., under which they are using Acadia's platform to discover compounds for central nervous system disorders. Sepracor made significant equity investments in Acadia as part of that January 2005 deal. (See BioWorld Today, Jan. 12, 2005.)

On its own, Acadia also has pre-IND programs in endocrine indications and neuropsychiatry and sleep indications, and preclinical programs in neuropsychiatry and schizophrenia, as well as a cannabinoid program in obesity.

Acadia in April 2006 raised nearly $60 million in a public offering of shares at $12 apiece. The company had about $83.3 million in cash on Dec. 31, with a net loss in 2006 of $45 million. Including the new shares, Acadia has 35 million shares outstanding, a number that excludes "in the money" options and warrants on about 4 million shares.

The book-running managers for the offering are Banc of America Securities LLC and Lehman Brothers Inc., with Deutsche Bank Securities Inc. co-lead manager. Co-managers are Piper Jaffray & Co., JMP Securities LLC and Rodman & Renshaw LLC.

No Comments