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news.Acadia Pharmaceuticals and Sepracor have forged a partnership to develop new drug candidates against central nervous system disorders, including insomnia and schizophrenia. The news has boosted shares in both companies, with Acadia climbing over 9%.
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The R&D collaboration has been established to investigate potential clinical candidates resulting from Acadia’s medicinal chemistry and discovery platform against a broad array of selective muscarinic receptors (receptors that respond to acetylcholine, a neurotransmitter in the central nervous system).
This includes Acadia’s advanced m1 agonist program, which target neuropsychiatric/neurologic conditions and neuropathic pain.
This partnership also encompasses an option to select a pre-clinical compound from Acadia’s 5-HT2A program for use in combination with Lunesta (eszopiclone), Sepracor’s insomnia drug, for sleep-related indications. 5-HT2A antagonists have been shown in clinical studies to affect sleep architecture, resulting in extended periods of slow wave sleep, which may have a positive effect on sleep quality.
The FDA approved Sepracor’s new drug application (NDA) for Lunesta brand eszopiclone for the treatment of insomnia on December 15. Successful developments from this partnership could enhance Sepracor’s ability to address significant patient needs in the field of sleep disorders, including sleep apnea and insomnia.
The collaboration will also involve evaluating Acadia’s selective m1 agonist clinical candidates for the treatment of cognition in schizophrenia patients.
“Among the family of currently marketed atypical antipsychotics, only clozapine improves cognitive function, yet its label contains a “black-box warning” relating to serious side effects. We are hopeful that Acadia’s strategy will yield a new drug therapy that can successfully and safely improve cognitive function for patients with schizophrenia,” said Dr Mark Corrigan, executive vice president of R&D at Sepracor.
In connection with this collaboration, Sepracor is purchasing $10 million of Acadia common stock. Sepracor has also agreed to purchase up to an additional $10 million of Acadia common stock at a 25% premium on the one-year anniversary date of the collaboration, subject to customary closing conditions.
Sepracor will also provide Acadia with research funding over a three-year term, and, if certain conditions are met, will be required to pay Acadia milestone payments as well as royalties on future product sales worldwide.
If a product is successfully developed in the muscarinic program, Sepracor will be required to pay Acadia up to approximately $40 million in aggregate payments, excluding royalties. In addition, should the partnership successfully develop a combination product with Lunesta for sleep-related indications, Sepracor will also be obligated to pay Acadia approximately $35 million in aggregate payments plus applicable royalties.
Acadia’s phase II programs encompassing ACP-103 for treatment-induced dysfunction in Parkinson’s disease, ACP-103 as an adjunctive therapy for schizophrenia, and ACP-104 for treatment of schizophrenia, are not included as part of this collaboration.
In a separate announcement, Sepracor revealed less promising news for Lunesta. Sepracor has been forced to put back the drug’s commercial release date as the Federal government’s administrative process for formally classifying Lunesta as a Schedule IV controlled substance is not yet complete.
Sepracor’s plan to make Lunesta commercially available in early January 2005 is thus no longer feasible, but the company anticipates that the drug will be available to patients nationwide within the first quarter of 2005.