SAN DIEGO, Jan 11, 2005 /PRNewswire-FirstCall via COMTEX/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today announced the formation of a partnership withSepracor Inc. (Nasdaq: SEPR) for development of new drug candidates targetedtoward treatment of central nervous system (CNS) disorders.
This research and development collaboration has been established toinvestigate potential clinical candidates resulting from ACADIA's extensivemedicinal chemistry and discovery platform against a broad array of selectivemuscarinic receptors (receptors that respond to acetylcholine, aneurotransmitter in the central nervous system). This includes ACADIA'sadvanced m1 agonist program, which would target neuropsychiatric/neurologicconditions and neuropathic pain.
This partnership also encompasses an option to select a preclinicalcompound from ACADIA's 5-HT2A program for use in combination with LUNESTA(TM)(eszopiclone), Sepracor's insomnia drug, for sleep-related indications.5-HT2A antagonists have been shown in clinical studies to affect sleeparchitecture in man, resulting in extended periods of slow wave sleep, whichmay have a positive effect on sleep quality.
"This important agreement with ACADIA gives us access to additionalportfolio candidates for treatment of CNS disorders, complementing our owninternal capabilities," said Timothy J. Barberich, Chairman and ChiefExecutive Officer of Sepracor Inc. "In particular, we are very excited aboutthe possibility of combining mechanistic approaches with LUNESTA, which may beused to address the pervasive unmet needs of patients with sleepdisturbances."
The U.S. Food and Drug Administration approved Sepracor's New DrugApplication for LUNESTA brand eszopiclone for the treatment of insomnia onDecember 15, 2004. Successful developments from this partnership couldenhance Sepracor's ability to address significant patient needs in the fieldof sleep disorders, including sleep apnea and insomnia.
"We are excited to be working with Sepracor, which is one of the onlyfully integrated, research-based pharmaceutical companies with a primary carecapability outside of the larger pharmaceutical companies," said Uli Hacksell,Ph.D., Chief Executive Officer of ACADIA. "Sepracor has a proven drugdevelopment infrastructure combined with a highly motivated sales force withprimary care reach as well as dedicated representatives focused on addressingpatients' needs with respect to CNS and respiratory disorders. We believethat this partnership will serve both companies well."
This collaboration includes an ongoing joint research and developmenteffort targeted toward the development of agonists and antagonists ofselective muscarinic receptors. Compounds that interact with certainselective muscarinic targets may have utility in the treatment of CNSdisorders, which is currently an area of therapeutic focus for Sepracor.
"Part of this collaboration will involve the investigation of ACADIA'sselective m1 agonist clinical candidates for the treatment of cognition inpatients with schizophrenia," said Mark H.N. Corrigan, M.D., Executive VicePresident, Research and Development at Sepracor. "Among the family ofcurrently marketed atypical antipsychotics, only clozapine improves cognitivefunction, yet its label contains a "black-box warning" relating to seriousside effects. We are hopeful that ACADIA's strategy will yield a new drugtherapy that can successfully and safely improve cognitive function forpatients with schizophrenia."
In connection with this collaboration, Sepracor is purchasing $10 millionof ACADIA common stock at a 40 percent premium to the 30-day average trailingclosing price per share as of the purchase date. Sepracor has also agreed topurchase up to an additional $10 million of ACADIA common stock at a25 percent premium on the one-year anniversary date of the collaboration,subject to customary closing conditions. These stock purchases, in theaggregate, shall not exceed 19.99 percent of ACADIA's then-outstanding commonstock. In addition to its equity investment, Sepracor will provide ACADIAwith research funding over a three-year term, and, if certain conditions aremet, will be required to pay ACADIA milestone payments as well as royalties onfuture product sales worldwide. Assuming the successful development of asingle product in the muscarinic program, Sepracor will be required to payACADIA up to approximately $40 million in aggregate payments, excludingroyalties. In addition, should the partnership successfully develop acombination product with LUNESTA for sleep-related indications, Sepracor willalso be obligated to pay ACADIA approximately $35 million in aggregatepayments plus applicable royalties. Additional details about this transactionwill be available in ACADIA's Current Report on Form 8-K, which ACADIA isexpected to file with the Securities and Exchange Commission.
ACADIA's Phase II programs encompassing ACP-103 for treatment-induceddysfunction in Parkinson's disease, ACP-103 as an adjunctive therapy forschizophrenia, and ACP-104 for treatment of schizophrenia, are not included aspart of this collaboration.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of novel treatmentsfor central nervous system disorders. ACADIA currently has five drug programsin clinical and preclinical development as well as a portfolio of drugdiscovery assets directed at large unmet medical needs, includingschizophrenia, Parkinson's disease, neuropathic pain, and glaucoma. Using itsproprietary drug discovery platform, ACADIA has discovered all of the drugcandidates in its product pipeline. ACADIA's corporate headquarters andbiology research facilities are located in San Diego, California and itschemistry research facilities are located near Copenhagen, Denmark.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated totreating and preventing human disease through the discovery, development andcommercialization of innovative pharmaceutical products that are directedtoward serving unmet medical needs. Sepracor's drug development program hasyielded an extensive portfolio of pharmaceutical compound candidates with afocus on respiratory and central nervous system disorders. The company'scommercialization efforts are carried out by its U.S.-based, 1,250-person,primary care and specialty-oriented sales force. Sepracor's corporateheadquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risksand uncertainties, including statements with respect to the purchase of sharesof ACADIA common stock, potential milestone and royalty payments under thecollaboration, the research and development of drug candidates under thecollaboration and the commercial launch of, and the safety, efficacy andpotential benefits of, LUNESTA brand eszopiclone and any compounds discoveredor developed under the collaboration. Actual events or results may differmaterially from those projected in any forward-looking statements due tovarious factors, including the risks and uncertainties inherent in drugdevelopment and commercialization. Among the factors that could cause actualresults to differ materially from those indicated by such forward-lookingstatements are: the ability of Sepracor and ACADIA to collaboratesuccessfully; the ability to fund, and the results of, research, developmentand clinical trials; the timing and success of submission, acceptance, andapproval of regulatory filings; the scope of Sepracor's and ACADIA's patentsand the patents of others; unexpected delays in commercial introduction of,and the commercial success of, LUNESTA; the ability of Sepracor and ACADIA toattract and retain qualified personnel; the ability of Sepracor and ACADIA tomeet the closing conditions required for the consummation of the stockpurchases; and certain other factors that are detailed in ACADIA's andSepracor's quarterly reports on Form 10-Q for the quarter ended September 30,2004 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent ACADIA'sexpectations and beliefs as of the date of this press release. ACADIAanticipates that subsequent events and developments may cause theseexpectations and beliefs to change. However, while ACADIA may elect to updatethese forward-looking statements at some point in the future, it specificallydisclaims any obligation to do so. These forward-looking statements shouldnot be relied upon as representing ACADIA's expectations or beliefs as of anydate subsequent to the date of this press release.
Lunesta is a trademark of Sepracor Inc.
Contact:
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive Officer
Thomas H. Aasen, Vice President and Chief Financial Officer
+1 858-558-2871